INFLUVAC - INFLUVAC - CT 12580 - Version anglaise

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Description

Présentation INFLUVAC, suspension injectable en seringue préremplie, vaccin grippal inactivé à antigènes de surface B/1 seringue préremplie en verre de 0,5 ml avec aiguille - Code CIP : 3365216 Mis en ligne le 21 mai 2013 Substance active (DCI) antigènes de surface du virus de la grippe, souche B/Wisconsin/1/2010 - souche analogue utilisée (NYMC BX-39) dérivée de B/Hubei-Wujiagang/158/2009 ((OISEAU/POULE/OEUF)) antigènes de surface du virus de la grippe, inactivé, souche A/Victoria/361/2011 (H3N2) - souche analogue utilisée A/Victoria/361/2011, IVR-165 ((OISEAU/POULE/OEUF)) antigènes de surface du virus de la grippe, souche A/California/7/2009 (H1N1) - souche dérivée utilisée (NYMC X-181) ((OISEAU/POULE/OEUF)) Code ATC J07BB02 Laboratoire / fabricant ABBOTT PRODUCTS SAS INFLUVAC, suspension injectable en seringue préremplie, vaccin grippal inactivé à antigènes de surface B/1 seringue préremplie en verre de 0,5 ml avec aiguille - Code CIP : 3365216 Mis en ligne le 21 mai 2013

Sujets

• Maladie infectieuse
• Médecine

Informations

• Publié par: haute-autorite-sante-maladies-infectieuses
• Publié le: 07 novembre 2012
• Nombre de lectures: 72
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

The legally binding text is the original French version

TRANSPARENCYCOMMITTEE
Opinion
7 November 2012


INFLUVAC, suspension for injection in prefilled syringe, surface
antigen inactivated influenza vaccine
B/1 0.5 ml prefilled glass syringe with needle (CIP code: 34009 336 521 6 6)

Applicant: ABBOTT PRODUCTS SAS

INN

ATC Code (2012):

Reason for review

List concerned

Indication concerned

surface antigen inactivated influenza virus

J07BB02 (seasonal influenza vaccines)
Request by the Directorate-General for Health and the Social Security
Directorate
National Health Insurance (CSS L.162-17)

“Prophylaxis of influenza

HAS Medical, Economic and Public Health Assessment Division

1/6

01BACKGROUND

 Following the update in February 20121to the High Council for Public Health (HCSP) guidelines
for seasonal influenza vaccination in certain populations, the Director-General for Health and the
Director for Social Security referred the matter to the Committee, in order for the possibility of
changing the terms of inclusion for influenza vaccines currently appearing in the decree of 10 June
2011 to be examined.2

 view of new available data, in particular following the 2009 pandemic and the 2010-2011In
influenza season, its opinion dated 16 February 2012 the HCSP recommends that the in
population eligible for seasonal influenza vaccination be extended, on a long-term basis, to
the following groups:
-Pregnant women in any trimester of pregnancy;
-Obese individuals with a body mass index (BMI)≥40 kg/m².
This HCSP opinion is accompanied by a report detailing the arguments on which the guidelines are
based.3

As a reminder, in its opinion429 December 2010, the HCSP had already recommended that of
pregnant women with no associated risk factors and obese individuals5 be vaccinated should
against influenza for the 2010-2011 influenza season, speculating that the circulating
A(H1N1)pdm09 virus had retained its pandemic characteristics as far as population type affected
and aggressiveness were concerned. In accordance with that 2010 opinion, the HCSP had again
recommended that these two populations should be vaccinated for the 2011-2012 influenza
season,6 the exception, however, of women in the first trimester of pregnancy due to limited with
efficacy and safety data.

 It should also be noted that pregnant women with risk factors for complications of influenza are
already among the populations in which influenza vaccination is recommended and reimbursed
(see decree of 10 June 2011).

02THERAPEUTIC INDICATIONS

Prophylaxis of influenza, especially in those who run an increased risk of associated
“
complications.
Use should be based on official recommendations.

This vaccine is indicated in adults and children from 6 months of age.

03POPULATIONS AFFECTED BY THE EXTENSION OF INFLUENZA
VACCINE REIMBURSEMENT

According to the HCSP guidelines, in view of the new data available and whatever the types and
subtypes of influenza virus circulating, the following groups of people are now included in the
population eligible for influenza vaccination:

1 Highcontre la grippe saisonnière dans certaines populations Council for Public Health. Avis relatif à l’actualisation de la vaccination
(2femmes enceintes et personnes obèses). 16 February 2012.
ursed National Health Insurance.
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enceintes et les personnes obèses. Collection Avis et Rapports. 16 February 2012.
4High Council for Public Health. Avis relatif à l’actualisation de la stratégie vaccinale contre la grippe 2010-2011. 29 December 2010.
dividuals whose bod is≥30 kg/m².
65uP rcilbaeH .htlvi Ay rmeass st iilnadàe fx High CoeusnOcbiiln ef olaniccavertnoc eipgra l1-01 2peutla’lcaoi nsitaa stde lgie raté July 202012. 1311 .

HAS Medical, Economic and Public Health Assessment Division

2/6

03.1PREGNANT WOMEN IN ANY TRIMESTER OF PREGNANCY

 a predisposition to severe complications for the mother and fetus inPregnancy is recognised as
cases of influenza virus infection.
In cases of influenza infection, several studies have shown an increased risk of hospitalisation due
to pulmonary and cardiovascular complications in pregnant women in any trimester of pregnancy,
and particularly from the second trimester of pregnancy onwards7,8,9. These data were confirmed
during the 2009 pandemic10,11,12,13,14. An increased mortality rate in pregnant women with influenza,
in comparison with pregnant women in the general population, was reported during the influenza
A(H1N1)pdm2009 pandemic, particularly in the USA15,16. However, French monitoring data
collected during this pandemic did not demonstrate any increased risk of death in pregnant women
hospitalised for influenza in France, in comparison with pregnant women in the general
population17.
The impact of seasonal influenza on pregnancy is difficult to evaluate due to a lack of relevant data
available. However, for the 2009 pandemic, the results of a British cohort study18 suggest an
increased risk of perinatal infant mortality and premature delivery (before 32 weeks’ gestation) in
women hospitalised for influenza A (H1N1), in comparison with pregnant women in the general
population.

 Furthermore, clinical studies have shown that the immune response to influenza vaccination in
pregnant women is comparable to that obtained in non-pregnant women19 and that influenza
vaccination reduces the risks of respiratory illness with fever observed in pregnant women20.
Other studies have demonstrated that maternal influenza vaccination confers protection on
neonates, who cannot be vaccinated before the age of 6 months, in particular reducing the risk of
respiratory infections20,21,22,23
.

 In terms of safety, in April 2012 ANSM published a pharmacovigilance report on the use of
influenza vaccines in pregnant women24 to the vaccines used during international exposed
vaccination campaigns in the 2009/2010 influenza A (H1N1) pandemic. These data supplement
the existing safety data in pregnant women vaccinated against seasonal influenza.25,26,20 Analysis


7 Neuzil KM, et al. Impact of influenza on acute cardiopulmonary hospitalisation in pregnant women, Am J Epidemiol. 1998; 148 (11):
1094-102.
8Hospitalizations with respiratory illness among pregnant women during influenza season. Obstet Gynecol. 2006; 107 (6):Cox S, et al.

1315-22.
9Hartert T, et al. Maternal morbidity and perinatal outcomes among pregnant women with respiratory hospitalizations during influenza
stetric necology. 2003; 189: 1705-12.
1s0yGrnou JanObf oalsanoereci .mA. 1)1Nnf itiec. ondipEoimenI ltcefdnme 9ap2 00iwht A(Henzanfluic ivisnetni tludA .s ntieat precae-mnraniI naC ,oBD, et al, Bitar Frmuh
121y in0n1a1n;c 1p3r9eg (i8n)g: 1d 0r2u-i2t.n9of nceasJuiim 74 39;00 2tecnaL .ASU eht
eson DJ, Honein MA, Rasmussen SA, et al. H1N1 2009 influenza vir
(9688): 451-58.
12Creanga AA, et al. Severity of 2009 pandemic influenza A (H1N1) virus infection in pregnant women. Obstet Gynecol. 2010; 115: 717-
26.
13Risk of severe outcomes among patients admitted to hospital with pandemic (H1N1) influenza. CMAJ. 2010; 182:Campbell A, et al.
349-55.
14al. Risk factors for severe outcomes following 2009 influenza A (H1N1) infection: a global pooled analysis. Kerkhove MD, et Van
11P56LoS Med. 2011 ;(8)7 :1e0001350E3p .3 1 (2)u5b 1: 01l Jues .. 5JoALM A. e2i0u1 0,;K Jet al. Severe 2090H N1 1nilfeuzn1( 22 :)010263 ;357-. lP naedMA ,tea influenmic 2009
a in pregnant and postpartum women in California. N Engl J Med.
Siston . za A(H1N1) virus illness among pregnant women in the United Stat
1517-25.
17Dubar G, et al. 10).French experience of 2009 A/H1N1v influenza in pregnant women. PLoS One. 2010; 5
18 ontina: oroh cal ts afcome outatalreni.MP hg tK inontiecnf iN1H19/002 lanretam ret, KurincPierce M( rshuP,t ro BleckrapS,P k kuz ,JJ
. 11; 342: d3214.
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Review.
20SE, et al. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008; 359Zaman K, Roy E, Arifeen
(21tenpro neciiv gnemoder angew tnpitalizauces host onilfitnod eu ina nzuegnE J l.deM002 E7.atrr ium Nn:E up b0280S pe1 15): 1555-64.F .] rtbeRo, animre Bot detcerroc[ E bert, Roiman Bre46.8)6 :06( ;93
Benowitz I, Esposito DB, Gracey KD, et al. Influenza vac
t2h2. Arch iirefnI nilC .stnafn0; 5 201Dis.ect 6-.13155)2 : 11( ciE AA kyU ,i ek, TMimKl Aov ,tea .lM tareanl influenza vacc noitanieffe dnainn octa nzuefl sniivuroi neftcoungin yants inf
Pediatr Adolesc Med. 2011 1 1.
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