Transcript Présentation PowerPoint - Viral Hepatitis Prevention Board

Hepatitis B vaccination
Safety issues
Impact of safety issues and
international point of view
France
Nicole Guérin
Impact of safety issues
• On recommendations and immunization schedule
• On surveillance of hepatitis B
– Compulsory report
• On surveillance of AEFI
• On immunization coverage
– Children and adolescents
– At risk population
• On producers
– Sales
– Judiciary affairs
• Conclusion
Hepatitis B Policy in France
• Until 1994: targetted policy
– Beneficial for at risk immunized persons
– Ineffective on carriers and viral propagation
• From 1994 à 1998, in addition to targetted policy
– vaccination of infants and 11-13 years old children
during 10 to 12 years
– boosters at 11-13 years for children immunized during
infancy
Policy since 1998
• Vaccination of infants with a 3 doses schedule
• Vaccination of 11-13 years old children with a 3
doses schedule
• Clear definition of at risk groups (3 doses
schedule)
• Suppression of boosters except for special
indications
Source: (BEH 4 Août 1998)
Definition of at risk groups for hepatitis
B
• Personnel of health care and prevention centers
• Personnel possibly in contact with blood (direct or not)
• Other expositions:
– Newborns from infected mothers, IV drug users,
children living in collectivity
– patients susceptible of receiving massives ou iteratives
transfusions
– Persons in contact with an infected persosn (including
sexual contacts)
– Travellers to, and residents in, countries of medium or
high endemy,
Source: (BEH 4 Août 1998)
Policy of booster doses for hepatitis B vaccination
• No more recommandation of booster dose after the 3
injections of the initial schedule
• Except for health workers and other professionnel
submitted to the article L 3111 of the « Code de la Santé
Publique »
– if age at first 3 doses < 25 years: no booster
– si age at first 3 doses > 25 ans and serology showing
– anti HBs > 10mUI/ml: no booster.
– anti HBs < 10 mUI/ml: booster dose followed by another
serology:
• if antibody anti HBs  10 mUI/ml no more booster
• if antibody anti HBs < 10 mUI/ml, discuss need for
additional doses (no more than a total of 6)
Source: BEH 4 Août 1998
Impact on recommendations:
• Rapport « Dartigues » published in 2002
• Advice of the Academy of Medecine
• Immunization schedule 2003
–
–
–
–
Immunization of infants
Catch up of children up to 11 years
at risk population: definition (+ piercing..)
2003 schedule includes recommendations for
use of Hexavalent vaccines, in order to increase
Hep B coverage in infants
Surveillance of hepatitis B
• Compulsory report by decree 1999
• Implementation since february 2003
• Case definition :
– Tout tableau clinique ou biologique évocateur d'une
hépatite virale aiguë peut être imputé au VHB si des
IgM anti-HBc sont détectées dans le sérum du patient.
– Tout tableau clinique ou biologique évocateur d'une
hépatite virale chronique peut être imputé au VHB si
l'AgHBs est mis en évidence dans le sérum du patient.
Surveillance of adverse events
• Studies
• Benefit risk
• But the conclusion of Afssaps is for exemple:
« 2 epidemiological studies have been recently
published in the NEJM. These studies still do not
allow to formally eliminate anassociation between
the vaccine and the occurrence of a poussée de
SEP (06-02-01) »
Coverage at 24 months:
(through health certificates)
100
90
80
70
60
50
40
30
20
10
0
1998
1999
2000
2001
HepB
MMR
BCG
DTPolio
DRESS 2/08/02, provisional figures
Hib
Impact on immunization
coverage
• Survey on 6779 children 0 to 24 months
(2001)
–
–
–
–
At 4 months: 24,2%
A 6 months: 33,2%
A 12 months: 39,1%
A 24 months: 41,4%
Coverage between 6 months and
24 months
(through a survey 2001on 6779 children)
100
90
80
70
60
50
40
30
20
10
0
6 months
12 months
18 months
24 months
HepB
MMR
BCG
DPTPolio
Hib
Gaudelus and al. Submitted to Arch fr Pédiatr 2003
Reasons for delays and no Hep B
vaccinations
• Delays
–
–
–
–
–
Infections 40%
Too many shots 9%
Polemic 6%
Forgotten 3%
Others 27%
• No vaccination
–
–
–
–
–
Fear of MS 2%
Too many shots 19%
Wait until 2 years 23%
Not proposed 16%
Others 27%
Gaudelus and al. Submitted to Arch fr Pédiatr 2003
Coverage rate
Hépatite B - année 2000
Couverture vaccinale* par tranche
d'âge
85%
100%
80%
58%
60% 40% 40%
37%
34%
32%
40%
4%
20%
3%
3%
2%
1%
0%
0-2
3 - 9 10 - 19 20 - 29 30 - 39 40 - 50
ans
ans
ans
ans
ans
ans
Couverture vaccinale annuelle
* Estimation
Couverture vaccinale cumulée
Couverture vaccinale
Hepatite B - année 2001
Couverture Vaccinale* par tranche
d'âge
100%
85%
90%
80%
70%
60%
60%
50%
35%35% 35%
35%
32%
40%
30%
20%
3%
2%
2%
1%
10%
1%
0%
0-2
3 - 9 10 - 19 20 - 29 30 - 39 40 - 50
ans
ans
ans
ans
ans
ans
Couverture vaccinale annuelle
Couverture vaccinale cumulée
Immunization coverage Hepatitis B April
2002 GSK-Sofres survey
Percentage of persons having received at least one dose of
vaccine
80
70
60
50
40
30
20
10
0
Total
0-13
14-18
19-24
25-34
35-44
45-54
>55
Children immunization coverage
Hepatitis B GSK Sofres survey April 2002
Percentage of persons having received at least one dose of
vaccine
45
40
35
30
25
20
15
10
5
0
0-13 <1
1
2
3
4
5
6
7
8
9
10
11
12
13
Hepatitis B immunization coverage in a reference
center for drug users
(BEH 07/2003)
Caracteristics of new patients, without history of Hep B (clinical
or serological), knowing their immunization status
Men/Total
1999
49/64
2000
58/77
2001
98/120
>=3 doses
29 (45%)
12 (16%)
26 (22%)
1-2 doses
10 (16%)
13 (17%)
21 (18%)
0 dose
25 (39%)
52 (68%)
73 (61%)
Impact on producers
• Sales
• Judiciary affairs
– 138 suits currently treated (GSK)
– ….
HEPATITE B 1996 et 2001
Nombre d'enfants vaccinés en France*
Nombre d'enfants vaccinés
1200000
1000000
800000
600000
400000
200000
0
0-29 mois
* estimation
8-14 ans
1996
2001
Controls measures against Hep B
• National plan for 2002-2005
– Assess different strategies of Hep B vaccination
•
•
•
•
•
At risk groups
Recall compulsory immunization for health workers
Information for private health workers
Information for occupational hasard
Organisation of a large consultation on conditions of
implementation of the recommended strategy
Conclusions
•
•
•
•
•
•
Technical recommendations are here
But no political commitment
Resulting in poor coverage
Hundreds of suits being treated
….
The only hope is the use of hexavalent
vaccines for infants, recommended, but not
yet on the market