Adverse events following pandemic influenza vaccine Pandemrix® reported in the French military forces—2009–2010

doi:10.1016/j.vaccine.2011.01.056

Vaccine

Volume 29, Issue 14, 21 March 2011, Pages 2576-2581

https://doi.org/10.1016/j.vaccine.2011.01.056 Get rights and content

Abstract

Background

In the face of the A(H1N1) 2009 influenza pandemic, in October 2009 the French military health service (SSA) initiated a large vaccination campaign with Pandemrix^® vaccine in the military forces. The aim of this study was to describe vaccine adverse events (VAE) reported during this campaign.

Methods

VAE and the number of people vaccinated were surveyed by the SSA Epidemiological network across all military forces during the campaign, from October 2009 to April 2010. For each case, a notification form was completed, providing patient and clinical information. Three types of VAE were considered: non-serious, serious and unexpected.

Results

There were 315.4 reported VAE per 100,000 vaccinations. Vaccination and VAE incidence rate peaks coincided with influenza epidemic peak in early December. The number of injected doses was 49,138, corresponding to a 14.5% vaccination coverage among military personnel, and 155 VAE were reported, including 5 serious VAE (1 Guillain-Barre syndrome, 2 malaises and 1 convulsive episode). Most VAE were non-serious (97.1%). Among these, 6 cases of local, rapidly regressive paresthesia were observed.

Discussion

The military VAE surveillance system constitutes the only observatory on benign VAE in France. The reporting rate was much higher after the pandemic vaccine than after the seasonal vaccine, which may be a reflection of stimulated reporting. This report provides a useful description of VAE among military personnel during a mass emergency vaccination program, showing that the tolerance of the pandemic vaccine appeared acceptable.

Introduction

Influenza can rapidly disseminate within populations living in confined settings, causing considerable morbidity and disrupting daily activity. This could have harmful consequences among military forces, since they may be subject to operational imperatives [1], [2]. Therefore the French Military Health Service initiated a prevention strategy based on immunization. From 1999, a triennial anti-influenza vaccination scheme was applied to the entire French armed forces. It concerned all subjects at enrolment. Anti-influenza immunity was then maintained by vaccination every three years. The aim of this strategy was not to protect individuals, but to obtain a collective immunity by way of the protection of part of the workforce [3], [4]. Hence, the triennial strategy is designed to protect a young and healthy population, rather than elderly subjects or those with immunological deficiency as recommended by French civil health authorities. According to two studies conducted in 1990 and 1995 among military units that applied this strategy, vaccine effectiveness ranged from 65% to 89% [5], [6], [7].

In April 2009, a new strain of influenza A(H1N1) virus emerged from Mexico, quickly spreading to all continents, and fulfilling the World Health Organization (WHO) criteria for the definition of pandemic influenza [8], [9]. In October 2009, in view of this threat, an extended immunization campaign against pandemic influenza was conducted by the French military health service, vaccination being recommended for all military, including those who served outside continental France (on navy ships and international operation zones). The French military forces were mainly vaccinated with the Pandemrix^® vaccine (Glaxo Smith Kline), the most widely used during the French civil vaccination campaign [10]. It is a monovalent split influenza virus, which is inactivated and contains antigen A/California/7/2009 (H1N1)v-like strain (X-179A). This vaccine, propagated in eggs, contains 3.75 μg haemagglutinin and adjuvant with AS03, a squalene based emulsion [11]. A much smaller amount of non-adjuvanted vaccines was used (Panenza^®), only addressing pregnant women, which concerned few subjects among the military forces [12].

From November 2009, a large increase in reported vaccine adverse events (VAE), compared to reports for previous years, was detected by the French military epidemiological surveillance network. A large number of these adverse events were attributed to pandemic influenza vaccination by the physicians who performed the vaccinations. This work presents the results of pandemic influenza VAE surveillance among French military forces.

Section snippets

The usual surveillance system for VAE in the French forces

VAE in the armed forces have been under surveillance since 2002 by the Epidemiological and Public Health departments of the French military health service [13]. The military epidemiological surveillance concerns all active military personnel in all branches of the armed forces. For each suspected case, military physicians who see the patient complete a notification form providing information concerning the patient, the clinical symptoms and the vaccines administered. The forms are transmitted

Reporting rate for pandemic influenza VAE

During the military vaccination program, 49,138 doses were injected:

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4450 (9.1%) concerned hospital health care workers who were vaccinated as a priority between 15th October and 15th November 2009;
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44,688 (90.9%) concerned the other military personnel, who were vaccinated between 16th November 2009 and 18th April 2010.

Most of the injections (77.9%) were performed between October and December (Fig. 1). The French military health service supervised vaccination of POI (43,740 doses) while the other

Reporting rate for VAE

The 2009–2010 pandemic vaccination campaign was accompanied by significantly increased VAE reports in the military forces: 155 cases were attributed to the pandemic vaccine between October 15, 2009 and April 18, 2010, while VAE incidence for all other vaccines was 45 cases only for the same period and 79 cases during the whole of 2009 (Mayet et al., unpublished data). The observed increase of VAE report could be explained by readier recourse to physicians by the VAE cases, on account of the

Conclusion

The French military surveillance system efficiently described non-serious VAE after pandemic influenza vaccine, in complement to the data from the French drug vigilance centre. This report of VAE among military personnel during a mass emergency vaccination program could be extrapolated to healthy subjects in French general population in the 20–60 age group. The reporting rate was much higher after A(H1N1) 2009 vaccine than after other vaccines, including seasonal influenza, and this may, in

Acknowledgements

Authors would like to thank all the military physicians, the staff of the Epidemiological and public Health departments, and the staff of Regional Directorates of the French military health service, who participated actively in the military epidemiological surveillance network by way of the quality of their notifications and reports.

Conflict of interest statement: Authors have no conflicts of interest to declare.

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After allergic-like symptoms (752 reports) [21] and local reactions (402 reports), the third-most-often reported AEFI was paresthesia. This unexpected adverse event was also frequently reported in Sweden and France but with no description of its associated clinical features [22–26]. This paper describes the clinical and epidemiological characteristics of this unexpected AEFI as reported to the Quebec VAERS system and further assessed in ensuing case–control study and clinical investigations.
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The available data suggest that even severe central nervous system demyelination i.e. acute encephalitis/disseminated encephalomyelitis and transverse myelitis may very rarely be associated with vaccination against novel influenza A/H₁N₁ or with A/H₁N₁ infection itself.
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Adverse events following pandemic influenza vaccine Pandemrix® reported in the French military forces—2009–2010

Abstract

Background

Methods

Results

Discussion

Introduction

Section snippets

The usual surveillance system for VAE in the French forces

Reporting rate for pandemic influenza VAE

Reporting rate for VAE

Conclusion

Acknowledgements

Vaccine

Rev Epidemiol Sante Publique

J Clin Virol

Med Mal Infect

Arch Med Res

Rev Epidemiol Sante Publique

Vaccine

J Clin Virol

Virus Res

Lancet

Lancet Infect

Surveillance de la grippe saisonnière dans les armées françaises de 2004 à 2008: Système militaire d’observation de la grippe[[n1]]Surveillance of seasonal influenza in French military forces from 2004 to 2008

Bull Epidemiol Hebd

The Japanese experience with vaccinating schoolchildren against influenza

N Engl J Med

Adverse events following pandemic influenza vaccine Pandemrix^® reported in the French military forces—2009–2010