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