feam nov 2006 p bégué vaccinations against infectious human diseases in france conference of feam...

FEAM nov 2006 P Bégué

Vaccinations against infectious human diseases in France

Conference of FEAM Brussels

Pierre Bégué

Paris


Methods for immunisations in France

• Two regimens:mandatory:D,T,Polio,BCG others are recommended

• Some occupational immunisations are mandatory: Hepatitis B, D T BCG Polio

• Vaccinations for children: 90% private doctors (50% pediatricians),10% public


Immunisation schedule in France: elaboration,spreading

• Annually reviewed by French Hygiene National Council and Technical committee for vaccinations(CTV): Advices

• Health Ministry : decision• Published:first in weekly epidemiological

bulletin(BEH), medical papers(free), internet, councils (medical, pharmacy),

• Immunisations guide:every 3 years• Internet:all advices (ministry site)

Immunisation programme France 2006:infants

BCG: naissance si risque, sinon entre 6 et 12 mois Sans risque ,avant 6 ans et pour les collectivités

24 m

MMR2HBV3Hib 4 boost

PaPolioDT16-18 m

MMR1Pn4

boost

12 m

---3HBV2--------4 m

---2--------3 m

Pn 1HBV1HibPaPolioDT2 m

MMRpneumo7c

Hepatitis B

HibPertussisacell

PolioDTâge

Immunisation programme France 2006: children adolescents

dT ev 10y

allid>65y

idRub:si

sero -id>26y

idC.upidSome pers.

18-26y

A rC. upiddT16-18 y

A rCatch-up

Catch-up

id11-13 y

At riskAt risk

6 y

InfluenzaMMRHBVPn 23PaPolioDTage


Immunisation schedule in France: details 1-Pertussis

• Early primo-immunisation 2,3,4 m

• 2nd booster : 11-13 y

• Vaccines for young adults if parents in next future: dTPolioPac vaccines (Boostrix, Repevax)

• To limit resurgence of pertussis in progress since 90’s


Effects of immunisation 1959-1986 upon age of pertussis cases in France

0

2

4

6

8

10

12TrousseauItalie

0

1

2

3

4

5

7

8

1-2 3-4 5-6 7-12 2 3 4 5 6 7 8-12 15-20 20-25 25-35 > 35mois mois mois mois ans ans ans ans ans ans ans ans ans ans ans

AGE

%

6

Immunisation programme France 2006: children adolescents

dT ev 10y

allid>65y

idRub:si

sero -id>26y

idC.upidSome pers.

18-26y

A rC. upiddT16-18 y

A rCatch-up

Catch-up

id11-13 y

At riskAt risk

6 y

InfluenzaMMRHBVPn 23PaPolioDTage


Immunisation schedule in France: details 2 Hepatitis B

• All children before 13 y, especially infants by 3 doses 0-1-6 scheme

• Newborns from AgHbs positive mothers:1st dose before 12 h of life(+ Ig) and at 2 and 6 months.4 doses for lower than 2000g .

• Poor coverage in infants:<25%, in spite of consensus conference after multisclerosis and HBV vaccine crisis.


Immunisation schedule in France: details 3 Pneumococcal vaccine

• Heptavalent conjugate vaccine for all infants 2-24 months,

• Heptavalent conjugate vaccine with addition of 23-polysaccharide vaccine for certain high risk 24-59 m children

• Pneumo 23 vaccine for certain high risk persons > 6 years


Immunisation schedule in France: details 4 varicella vaccine

• Selective vaccine in France for• Susceptible adults :1. in contact with immunosuppressed

patients, or 2. 3 days after exposure3. Occupational:health workers in care for

young children or for patients candidates to severe varicella


Efficacy evaluation of immunisation programme in France:coverage

• Certificate of 24th month:mandatory, filled by doctors, sent to District: results 1,5-2 Y later+++

• School:triennal survey of 3 samples of 5-6, 10-11 and 13-15 years old children

• Limited surveys in day-care centers)• Adults: army (no military duty since 1996),

influenza: yearly, Hepatitis B punctual, workers, travellers


Efficacy evaluation of immunisation programme in France:diseases

• National Institute of sanitary veille:InVS

• Declaration mandatory

• Networks:pertussis (Renacoq*), rubella, meningitis (Epibac*)

• Reference labs: Influenza, Enterovirus (polio), Hepatitis, Neisseria,etc…


Efficacy evaluation of immunisation programme in France:coverage (2000)

-24 months: DTPolio:3 doses 98%, 3d+Boost: 88%, Pertussis: 3 d 97%, 3d+ Boost: 87%,

– 6 Y:Booster DTIPV:91%,– 11 Y:Booster :97%

Adults :growing lack of coverage with age: less 5 y- tetanus booster : 70% at 20 y, 20% at 60-69 y,15% at 70-79 y.


Efficacy evaluation of immunisation programme in France: MMR coverage

• 24 months: 86,4% (2002), heterogenous

• 4 years: 92% (2003)

• 10 y: 1st dose: 95%, 2nd dose: 51%


Rougeole La couverture vaccinale en France en 1995(à 24 mois)

< à 75 %

75 - 79 %

80 - 82 %

83 - 87 %

88 - 98 %

Non renseigné

BEH 16 2004

Measles :more than 10 years cases in France

0

10

20

30

40

50

60

70

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

% cas

BEH 2004 N°16

Measles in Provence Alpes Côte Measles in Provence Alpes Côte d’Azur Region 2003d’Azur Region 2003

• 25 hospitalisations

• 5 severe cases

• Pneumonias:2

• Neurological cases:2

• Digestive cases: 9

• All not immunised


Measles in Provence Alpes Côte Measles in Provence Alpes Côte d’Azur Region 2003d’Azur Region 2003

11 y39,41Alpes de Hte Provence

Mean age Incidence for 100000

departments

20 y2,45Bouches du Rhône

15 y6,4Vaucluse


Measles PACA:age of cases

0

5

10

15

20

25

30

35

40

0-3 ans 4-6 ans 7-13 ans 14-19ans

20-29 30 etplus

AHP1384


Incidence of rubella infections during pregnancy and CRS in France:1976-1998

0

10

20

30

40

50

1976 78 80 82 84 86 88 90 92 94 96 98

years


MMR immunisation in France 2005

• New strategy : programme of elimination for measles and rubella 2005-2010, mandatory declaration, biological diagnosis of measles, 2 doses MMR before 25 th month, catch-up for older until 26 y


Adverse events of immunisations

• Reporting is an obligation for all the health workers and for manufacturers since 1995 (as for other drugs)

• For post-immunisations events:– If severe– If unexpected


Compensation for vaccine injury in France

• Compensation for mandatory vaccines ,by a national agency for indemnity of medical adverse events (ONIAM):General Director of Health,member of State Council,etc..

• Indemnity for recommended vaccines by a Regional arbitration Committee( 5 CRIC)


Prices of vaccines in France (1)

• Vaccines are written on a list of refundable drugs after Health High Authority advice: usefulness of drug(service rendu)

• Prices are set by interministry Committee: indications sometimes more restrictive than licensure’s

• Hexavalent vaccine(infanrix hexa*) no reimbursed in France


Prices of vaccines in France (2)

• All mandatory vaccines are free or entirely reimbursed

• Recommended vaccines are reimbursed partly by Social Security and by mutual societies

• Vaccines are free in public centers ,vaccines bought by Department’s Council

• Occupational vaccines are paid by employers


Obstacles to vaccination in France:two recent crisis

• Hepatitis B vaccineHepatitis B vaccine and multisclerosis: two consensus meetings(2003-2004): imputability eliminated,recommendations for <13y children reinforced, but failure for HBVcoverage raise!

• Macrophagic myofasciitisMacrophagic myofasciitis: imputation of muscular diseases and fatigue syndroms to aluminium-based adjuvants.Studies negative.

• No problems for autism and measles nor mercury of thimerosal in France


Opponents to vaccines in France(1)

• Leagues present since a long time: « Ligue nationale pour la liberté des vaccinations » invited to participate (speech) in a national debate for BCG obligation by ministry 14 november 2006

• Newspapers : l’Impatient , most famous • Arguments: freedom (libertaires), harmfulness of

vaccines for immunological reasons: cancer, auto-immunes diseases, lack of impact on diseases(sic)


Obstacles and difficulties for vaccination in France

• Mandatory vaccines : agreed by some parents opponents , not by some others

• Legal obligation to send to school is stronger than legal obligation to immunise before schooling


Opponents and breaks to vaccines in France(2)

• Homeopathy in great progress, helps to vaccines suspicion

• Parents and doctors are often in agree for refuse of vaccines , false certificates or homeopathic dosage (1/1000 vaccine!)

• Precaution principle: false friend, different from prevention principle!(E.Aron)


Survey of mothers’opinion for MMR vaccine:

French health education committee 1993 • Four types of mothers:• Type 1: ecologists, want alternative

medicine(homeopathy), against vaccines:2-4%• Type 2: consumerists, want free choice for time

and kind of vaccine:15% ,information possible• Type 3: empirists: look to risk-benefit ratio , ask

for information: 25%• Type 4: dependants: want to be reassured.

Confiance in vaccines : 50-60%, to inform


Improvements for vaccination in France: 1°) Insufficiencies

• Public information by medias

• Bad-feeling for campains:weakness of MMR campains(1989-2002), hepatitis B campain criticized(1995), influenza vaccine campain limited to aged people

• No teaching of children for vaccines at school


Improvements for vaccination in France: 2°) Insufficiencies

• Poor teaching of vaccinology to medicine students, quite absent during studies

• Weakness of the Health authorities commitment: National day for vaccination 7th October 2006 : unknown to any doctors

• Too many Agencies

• Bad feeling for manufacturers


Improvements for vaccination in France

• Consensus meetings• Scientific experts reports : HBV,Vaccines, BCG

and TB• Infovac France permanent network for doctors

since 2003( private)• Motivation of young doctors for understanding

objectives of vaccination• Vaccines themas choosen in congresses

feam nov 2006 p bégué vaccinations against infectious human diseases in france conference of feam...

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