I VACCINI CONTRO IL VIRUS EBOLA Francesco Donato · Diagnosi precoce (ai primi sintomi della...
58
I VACCINI CONTRO IL VIRUS EBOLA Francesco Donato Unità di Igiene, Epidemiologia e Sanità Pubblica Dipartimento di Specialità Medico Chirurgiche Scienze Radiologiche e Sanità Pubblica Università degli Studi di Brescia
Transcript of I VACCINI CONTRO IL VIRUS EBOLA Francesco Donato · Diagnosi precoce (ai primi sintomi della...
I VACCINI CONTRO IL VIRUS EBOLA
Francesco Donato
Unitagrave di Igiene Epidemiologia e Sanitagrave Pubblica
Dipartimento di Specialitagrave Medico Chirurgiche Scienze
Radiologiche e Sanitagrave Pubblica
Universitagrave degli Studi di Brescia
Percheacute abbiamo bisogno di un
vaccino contro il virus Ebola
13567 casi
riportati al
311014
Il controllo (profilassi) dellrsquoinfezione in
assenza di un vaccino come interrompere la
catena di trasmissione
1 Diagnosi precoce (ai primi sintomi della malattia)
2 Isolamento dei casi
3 Isolamento e sorveglianza dei contatti
4 Protezione del personale che ha contatti con malati o
materiale infetto
5 Disinfezione ed eliminazione del materiale infetto (oggetti e
ambienti)
Scenario di contenimento
70 pazienti in struttura sanitaria o in ambiente
a ridotto rischio di trasmissione entro 31122014
Scenario di non contenimento
Nessun incremento della di pazienti in struttura
a ridotto rischio di trasmissione entro 31122014
I vaccini contro il virus Ebola
in sperimentazione
Lo sviluppo di un vaccino contro Ebola
1 La guarigione si accompagna ad immunitagrave protettiva umorale (IgG)
2 Studi su animali (primati non umani) hanno mostrato efficacia
protettiva di sieri iperimmuni
3 Fino agli anni 2000 non vi egrave stato interesse per un vaccino a causa
della autolimitazione dei focolai epidemici
4 Nel 2001 la minaccia del bioterrorismo (antrace) ha fatto rinascere
lrsquointeresse per un vaccino
5 I vaccini da virus inattivato o subunitagrave finora si sono dimostrati
inefficaci in studi su animali
6 A partire dagli anni 2000 si egrave dimostrata lrsquoefficacia di vaccini a
DNA con adenovirus o altri virus come vettori (plasmidi) in
sperimentazione animale
VACCINI RICOMBINANTI (A DNA)
I vaccini contro il virus Ebola
in sperimentazione
efficacia e sicurezza
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Percheacute abbiamo bisogno di un
vaccino contro il virus Ebola
13567 casi
riportati al
311014
Il controllo (profilassi) dellrsquoinfezione in
assenza di un vaccino come interrompere la
catena di trasmissione
1 Diagnosi precoce (ai primi sintomi della malattia)
2 Isolamento dei casi
3 Isolamento e sorveglianza dei contatti
4 Protezione del personale che ha contatti con malati o
materiale infetto
5 Disinfezione ed eliminazione del materiale infetto (oggetti e
ambienti)
Scenario di contenimento
70 pazienti in struttura sanitaria o in ambiente
a ridotto rischio di trasmissione entro 31122014
Scenario di non contenimento
Nessun incremento della di pazienti in struttura
a ridotto rischio di trasmissione entro 31122014
I vaccini contro il virus Ebola
in sperimentazione
Lo sviluppo di un vaccino contro Ebola
1 La guarigione si accompagna ad immunitagrave protettiva umorale (IgG)
2 Studi su animali (primati non umani) hanno mostrato efficacia
protettiva di sieri iperimmuni
3 Fino agli anni 2000 non vi egrave stato interesse per un vaccino a causa
della autolimitazione dei focolai epidemici
4 Nel 2001 la minaccia del bioterrorismo (antrace) ha fatto rinascere
lrsquointeresse per un vaccino
5 I vaccini da virus inattivato o subunitagrave finora si sono dimostrati
inefficaci in studi su animali
6 A partire dagli anni 2000 si egrave dimostrata lrsquoefficacia di vaccini a
DNA con adenovirus o altri virus come vettori (plasmidi) in
sperimentazione animale
VACCINI RICOMBINANTI (A DNA)
I vaccini contro il virus Ebola
in sperimentazione
efficacia e sicurezza
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
13567 casi
riportati al
311014
Il controllo (profilassi) dellrsquoinfezione in
assenza di un vaccino come interrompere la
catena di trasmissione
1 Diagnosi precoce (ai primi sintomi della malattia)
2 Isolamento dei casi
3 Isolamento e sorveglianza dei contatti
4 Protezione del personale che ha contatti con malati o
materiale infetto
5 Disinfezione ed eliminazione del materiale infetto (oggetti e
ambienti)
Scenario di contenimento
70 pazienti in struttura sanitaria o in ambiente
a ridotto rischio di trasmissione entro 31122014
Scenario di non contenimento
Nessun incremento della di pazienti in struttura
a ridotto rischio di trasmissione entro 31122014
I vaccini contro il virus Ebola
in sperimentazione
Lo sviluppo di un vaccino contro Ebola
1 La guarigione si accompagna ad immunitagrave protettiva umorale (IgG)
2 Studi su animali (primati non umani) hanno mostrato efficacia
protettiva di sieri iperimmuni
3 Fino agli anni 2000 non vi egrave stato interesse per un vaccino a causa
della autolimitazione dei focolai epidemici
4 Nel 2001 la minaccia del bioterrorismo (antrace) ha fatto rinascere
lrsquointeresse per un vaccino
5 I vaccini da virus inattivato o subunitagrave finora si sono dimostrati
inefficaci in studi su animali
6 A partire dagli anni 2000 si egrave dimostrata lrsquoefficacia di vaccini a
DNA con adenovirus o altri virus come vettori (plasmidi) in
sperimentazione animale
VACCINI RICOMBINANTI (A DNA)
I vaccini contro il virus Ebola
in sperimentazione
efficacia e sicurezza
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Il controllo (profilassi) dellrsquoinfezione in
assenza di un vaccino come interrompere la
catena di trasmissione
1 Diagnosi precoce (ai primi sintomi della malattia)
2 Isolamento dei casi
3 Isolamento e sorveglianza dei contatti
4 Protezione del personale che ha contatti con malati o
materiale infetto
5 Disinfezione ed eliminazione del materiale infetto (oggetti e
ambienti)
Scenario di contenimento
70 pazienti in struttura sanitaria o in ambiente
a ridotto rischio di trasmissione entro 31122014
Scenario di non contenimento
Nessun incremento della di pazienti in struttura
a ridotto rischio di trasmissione entro 31122014
I vaccini contro il virus Ebola
in sperimentazione
Lo sviluppo di un vaccino contro Ebola
1 La guarigione si accompagna ad immunitagrave protettiva umorale (IgG)
2 Studi su animali (primati non umani) hanno mostrato efficacia
protettiva di sieri iperimmuni
3 Fino agli anni 2000 non vi egrave stato interesse per un vaccino a causa
della autolimitazione dei focolai epidemici
4 Nel 2001 la minaccia del bioterrorismo (antrace) ha fatto rinascere
lrsquointeresse per un vaccino
5 I vaccini da virus inattivato o subunitagrave finora si sono dimostrati
inefficaci in studi su animali
6 A partire dagli anni 2000 si egrave dimostrata lrsquoefficacia di vaccini a
DNA con adenovirus o altri virus come vettori (plasmidi) in
sperimentazione animale
VACCINI RICOMBINANTI (A DNA)
I vaccini contro il virus Ebola
in sperimentazione
efficacia e sicurezza
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Scenario di contenimento
70 pazienti in struttura sanitaria o in ambiente
a ridotto rischio di trasmissione entro 31122014
Scenario di non contenimento
Nessun incremento della di pazienti in struttura
a ridotto rischio di trasmissione entro 31122014
I vaccini contro il virus Ebola
in sperimentazione
Lo sviluppo di un vaccino contro Ebola
1 La guarigione si accompagna ad immunitagrave protettiva umorale (IgG)
2 Studi su animali (primati non umani) hanno mostrato efficacia
protettiva di sieri iperimmuni
3 Fino agli anni 2000 non vi egrave stato interesse per un vaccino a causa
della autolimitazione dei focolai epidemici
4 Nel 2001 la minaccia del bioterrorismo (antrace) ha fatto rinascere
lrsquointeresse per un vaccino
5 I vaccini da virus inattivato o subunitagrave finora si sono dimostrati
inefficaci in studi su animali
6 A partire dagli anni 2000 si egrave dimostrata lrsquoefficacia di vaccini a
DNA con adenovirus o altri virus come vettori (plasmidi) in
sperimentazione animale
VACCINI RICOMBINANTI (A DNA)
I vaccini contro il virus Ebola
in sperimentazione
efficacia e sicurezza
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Scenario di non contenimento
Nessun incremento della di pazienti in struttura
a ridotto rischio di trasmissione entro 31122014
I vaccini contro il virus Ebola
in sperimentazione
Lo sviluppo di un vaccino contro Ebola
1 La guarigione si accompagna ad immunitagrave protettiva umorale (IgG)
2 Studi su animali (primati non umani) hanno mostrato efficacia
protettiva di sieri iperimmuni
3 Fino agli anni 2000 non vi egrave stato interesse per un vaccino a causa
della autolimitazione dei focolai epidemici
4 Nel 2001 la minaccia del bioterrorismo (antrace) ha fatto rinascere
lrsquointeresse per un vaccino
5 I vaccini da virus inattivato o subunitagrave finora si sono dimostrati
inefficaci in studi su animali
6 A partire dagli anni 2000 si egrave dimostrata lrsquoefficacia di vaccini a
DNA con adenovirus o altri virus come vettori (plasmidi) in
sperimentazione animale
VACCINI RICOMBINANTI (A DNA)
I vaccini contro il virus Ebola
in sperimentazione
efficacia e sicurezza
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
I vaccini contro il virus Ebola
in sperimentazione
Lo sviluppo di un vaccino contro Ebola
1 La guarigione si accompagna ad immunitagrave protettiva umorale (IgG)
2 Studi su animali (primati non umani) hanno mostrato efficacia
protettiva di sieri iperimmuni
3 Fino agli anni 2000 non vi egrave stato interesse per un vaccino a causa
della autolimitazione dei focolai epidemici
4 Nel 2001 la minaccia del bioterrorismo (antrace) ha fatto rinascere
lrsquointeresse per un vaccino
5 I vaccini da virus inattivato o subunitagrave finora si sono dimostrati
inefficaci in studi su animali
6 A partire dagli anni 2000 si egrave dimostrata lrsquoefficacia di vaccini a
DNA con adenovirus o altri virus come vettori (plasmidi) in
sperimentazione animale
VACCINI RICOMBINANTI (A DNA)
I vaccini contro il virus Ebola
in sperimentazione
efficacia e sicurezza
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Lo sviluppo di un vaccino contro Ebola
1 La guarigione si accompagna ad immunitagrave protettiva umorale (IgG)
2 Studi su animali (primati non umani) hanno mostrato efficacia
protettiva di sieri iperimmuni
3 Fino agli anni 2000 non vi egrave stato interesse per un vaccino a causa
della autolimitazione dei focolai epidemici
4 Nel 2001 la minaccia del bioterrorismo (antrace) ha fatto rinascere
lrsquointeresse per un vaccino
5 I vaccini da virus inattivato o subunitagrave finora si sono dimostrati
inefficaci in studi su animali
6 A partire dagli anni 2000 si egrave dimostrata lrsquoefficacia di vaccini a
DNA con adenovirus o altri virus come vettori (plasmidi) in
sperimentazione animale
VACCINI RICOMBINANTI (A DNA)
I vaccini contro il virus Ebola
in sperimentazione
efficacia e sicurezza
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
VACCINI RICOMBINANTI (A DNA)
I vaccini contro il virus Ebola
in sperimentazione
efficacia e sicurezza
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
I vaccini contro il virus Ebola
in sperimentazione
efficacia e sicurezza
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Diffusione dellrsquoinfezione in una popolazione di suscettibili ed immuni
individuo infetto
individuo suscettibile
individuo immune
R0=2
(nel caso del morbillo R0=15-17)
R0=casi secondari al caso indice
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Adenovirus
Virus della
stomatite
vescicolare
bovina
Virus para-
influenzale
Vaccino a
subunitagrave
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
I vaccini contro Ebola abbiamo
tempo per le sperimentazioni
laquotradizionaliraquo
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
TRIAL DI FASE III
popolazione in studio
selezione con
criteri definiti potenziali
partecipanti non partecipanti
partecipanti
invito
randomizzazione
non partecipanti
Trattamento
(vaccino)
Controllo
(placebo o altro)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Unrsquoalternativa ai trial di fase III i trial di comunitagrave (laquostepped wedge designraquo)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
I vaccini contro il virus Ebola
chi vaccinare
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Obiettivi della vaccinazione
bull Protezione dellrsquoindividuo dipende dallrsquoefficacia del vaccino
bull Protezione della comunitagrave immunitagrave ldquodi greggerdquo (herd
immunity) dipende dallrsquoefficacia del vaccino e dal grado di
copertura vaccinale dei suscettibili (tasso critico di copertura)
per interrompere la catena di contagio
CHI VACCINARE CONTRO EBOLA
Chi vaccinare
bull Personale sanitario e non sanitario ad alto rischio di infezione
(profilassi pre-esposizione)
bull Contatti di soggetti malati (profilassi post-esposizione)
bull Popolazione generale (adulti e bambini) (profilassi pre-
esposizione)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Siamo pronti a utilizzare un
vaccino contro il virus Ebola
su scala mondiale
Il caso della polio
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Poliomielite lrsquoOms dichiara lrsquoemergenza sanitaria internazionale
Donato Greco - membro del Comitato indipendente della Regione europea dellrsquoOms per la
certificazione dellrsquoeradicazione della poliomielite
8 maggio 2014 - A seguito della diffusione straordinaria del virus polio registrata nel 2014
del rischio di salute pubblica che questa pone a livello internazionale e della necessitagrave di
intervenire con azioni coordinate il 5 maggio scorso il Direttore Generale
dellrsquoOrganizzazione mondiale della sanitagrave (Oms) ha dichiarato unrsquoemergenza di sanitagrave
pubblica di rilevanza internazionale
La conclusione del Comitato di dichiarare lrsquoemergenza sanitaria mondiale egrave stata unanime e
rappresenta il massimo livello di allarme sanitario possibile Egrave solo la seconda volta nella
storia dellrsquoOms (la prima egrave stata con la pandemia influenzale 2009-10) che viene dichiarato
questo tipo di emergenza
La diffusione dei casi e le misure per contenerla
Le motivazioni dellrsquoallarme sono nella continua esportazione di casi di polio da Paesi
ancora endemici a Paesi vicini nel 2013 il 60 dei casi erano da importazione e ci sono
evidenze che abbiano contribuito a questa diffusione anche viaggiatori adulti Questo trend egrave
continuato nei primi mesi del 2014 Una diffusione internazionale del virus egrave avvenuta da 3
dei 10 Paesi endemico-epidemici in Asia centrale (dal Pakistan allrsquoAfghanistan) in Medio
oriente (dalla Siria allrsquoIraq) e in Africa centrale (dal Camerun alla Guinea equatoriale)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Corsera 9 luglio 2014
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
I vaccini lrsquoinformazione e la
disinformazione
i vaccini e lrsquoautismo
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
I conflitti di interesse nella ricerca scientifica
Il caso Wakefield - 1
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Il caso Wakefield i retroscena
bull Wakefield venne contattato da uno studio legale che aveva intenzione di intentare causa allrsquoazienda produttrice del vaccino trivalente per i possibili danni a bambini affetti da autismo e altri disturbi
bull Wakefield ricevette i 12 casi descritti nellrsquoarticolo dalle famiglie interessate alla causa (di essi 11 citarono poi in giudizio le aziende) ricevendo allrsquoinizio circa 56000 euro per occuparsi del caso
bull Alla fine Wakefield ricevette un compenso di circa 486000 euro piugrave le spese per il suo ruolo nella causa contro il vaccino trivalente
bull Wakefield era coinvolto in un brevetto riguardante un nuovo vaccino monovalente contro il morbillo In una celebre conferenza successiva alla pubblicazione dellrsquoarticolo su Lancet sostenne che lrsquoassociazione tra vaccino e autismo era dovuta allrsquoimpiego del trivalente anzicheacute del monovalente
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
bull Andrew Wakefield the gastroenterologist whose suggestion of a link between autism bowel disease and the measles virus sparked a UK wide scare over the safety of the measles mumps and rubella (MMR) vaccine has been found guilty of dishonesty and irresponsibility by the General Medical Council
bull The UK regulator held that Dr Wakefield abused his position subjected children to intrusive procedures such as lumbar puncture and colonoscopy that were not clinically indicated carried out research which flouted the conditions of ethics committee approval and brought the medical profession into disrepute
bull Although the paper conceded that it had not found a definite link Dr Wakefield caused a furore when he suggested during a press conference that single vaccines for measles mumps and rubella might be preferable to a triple vaccine
bull Dr Wakefield 52 failed to disclose to the Lancet that the study had received funding from the legal aid board through a solicitor who hoped to mount a legal action against the manufacturer and that he had also filed a patent application for a new vaccine
bull His failure to mention these conflicts of interest was contrary to his duties as senior author of the Lancet paper the GMC panel found and he had dishonestly represented that the children in the paper had come through GPs or paediatricians by the standard route
bull Ten of the paperrsquos 13 authors later retracted the interpretation of the data (BMJ 2004328602) Subsequent research has found no evidence of a link between the vaccine and autism
Wakefield was dishonest and irresponsible over MMR research says
the General Medical Council (BMJ 2010340c593 Published 29 January 2010)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Cochrane Database Syst Rev 2012 Feb 152CD004407 doi 10100214651858CD004407pub3
Vaccines for measles mumps and rubella in children
Demicheli V1 Rivetti A Debalini MG Di Pietrantonj C
BACKGROUND
Mumps measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness disability and death However public debate over
the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists despite its almost universal use
and accepted effectiveness
OBJECTIVES
To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age
SEARCH METHODS
For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011 Issue 2) which includes
the Cochrane Acute Respiratory Infections Groups Specialised Register PubMed (July 2004 to May week 2 2011) and Embasecom (July 2004 to
May 2011)
SELECTION CRITERIA
We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo do nothing or a
combination of measles mumps and rubella antigens on healthy individuals up to 15 years of age
MAIN RESULTS
We included five randomised controlled trials (RCTs) one controlled clinical trial (CCT) 27 cohort studies 17 case-control studies five time-series
trials one case cross-over trial two ecological studies six self controlled case series studies involving in all about 14700000 children and
assessing effectiveness and safety of MMR vaccine Based on the available evidence one MMR vaccine dose is at least 95 effective in preventing
clinical measles and 92 effective in preventing secondary cases among household contacts Effectiveness of at least one dose of MMR in
preventing clinical mumps in children is estimated to be between 69 and 81 for the vaccine prepared with Jeryl Lynn mumps strain and between
70 and 75 for the vaccine containing the Urabe strain Vaccination with MMR containing the Urabe strain has demonstrated to be 73 effective
in preventing secondary mumps cases Effectiveness of Jeryl Lynn containing MMR in preventing laboratory-confirmed mumps cases in children
and adolescents was estimated to be between 64 to 66 for one dose and 83 to 88 for two vaccine doses
A significant risk of association with febrile seizures and MMR exposure during the two previous weeks (RR 110 95 CI 105 to 115) was
assessed in one large person-time cohort study involving 537171 children aged between three months and five year of age Increased risk of febrile
seizure has also been observed in children aged between 12 to 23 months (relative incidence (RI) 409 95 CI 31 to 533) and children aged 12 to
35 months (RI 568 95 CI 231 to 1397) within six to 11 days after exposure to MMR vaccine (hellip)
Exposure to the MMR vaccine was unlikely to be associated with autism asthma leukaemia hay fever
type 1 diabetes gait disturbance Crohns disease demyelinating diseases bacterial or viral infections
AUTHORS CONCLUSIONS
The design and reporting of safety outcomes in MMR vaccine studies both pre- and post-marketing are largely inadequate The evidence of
adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
Grazie per lrsquoattenzione
Lrsquoautore della presente relazione egrave un docente universitario
dellrsquoUniversitagrave degli Studi di Brescia
Conflitti di interesse nessuno
ldquoIl sonno della ragione
genera mostrirdquo (F Goya)
