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. 2014 Sep 29;9(9):e108489.
doi: 10.1371/journal.pone.0108489. eCollection 2014.

Risk of narcolepsy associated with inactivated adjuvanted (AS03) A/H1N1 (2009) pandemic influenza vaccine in Quebec

Jacques Montplaisir  1 , Dominique Petit  2 , Marie-Josée Quinn  2 , Manale Ouakki  3 , Geneviève Deceuninck  4 , Alex Desautels  5 , Emmanuel Mignot  6 , Philippe De Wals  7
Affiliations

Risk of narcolepsy associated with inactivated adjuvanted (AS03) A/H1N1 (2009) pandemic influenza vaccine in Quebec

Jacques Montplaisir et al. PLoS One. .

Abstract

Context: An association between an adjuvanted (AS03) A/H1N1 pandemic vaccine and narcolepsy has been reported in Europe.

Objective: To assess narcolepsy risk following administration of a similar vaccine in Quebec.

Design: Retrospective population-based study.

Setting: Neurologists and lung specialists in the province were invited to report narcolepsy cases to a single reference centre.

Population: Patients were interviewed by two sleep experts and standard diagnostic tests were performed. Immunization status was verified in the provincial pandemic influenza vaccination registry.

Main outcome measures: Confirmed narcolepsy with or without cataplexy with onset of excessive daytime sleepiness between January 1st, 2009, and December 31st, 2010. Relative risks (RRs) were calculated using a Poisson model in a cohort analysis, by a self-controlled case series (SCCS) and a case-control method.

Results: A total of 24 cases were included and overall incidence rate was 1.5 per million person-years. A cluster of 7 cases was observed among vaccinated persons in the winter 2009-2010. In the primary cohort analysis, 16-week post-vaccination RR was 4.32 (95% CI: 1.50-11.12). RR was 2.07 (0.70-6.17) in the SCCS, and 1.48 (0.37-7.03) using the case-control method. Estimates were lower when observation was restricted to the period of pandemic influenza circulation, and tended to be higher in persons <20 years old and for cataplexy cases.

Conclusions: Results are compatible with an excess risk of approximately one case per million vaccine doses, mainly in persons less than 20 years of age. However, a confounding effect of the influenza infection cannot be ruled out.

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Conflict of interest statement

Competing Interests: Jacques Montplaisir received grants/support from Merck and GlaxoSmithKline, served as an advisor for Sanofi-Aventis, Servier, Merck, Jazz Pharmaceutical, Valeant Pharmaceutical, and Impax Laboratories, and received honoraria for speaking engagements from Valeant Pharmaceutical and Otsuka Pharmaceutical. Dominique Petit, Marie-Josée Quinn, Geneviève Deceuninck, and Manale Ouakki have no conflict of interest to report. Alex Desautels received grants from GlaxoSmithKline and Novartis, and received honoraria from GlaxoSmithKline. Emmanuel Mignot received grants from GlaxoSmithKline, Jazz Pharmaceutical, and Novo-Nordisk. Philippe De Wals received research grants, honoraria, and reimbursements of travel expenses from vaccine manufacturers including GlaxoSmithKline, Novartis, and Sanofi Pasteur. This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Distribution of dates of onset of 23 narcolepsy cases according to CDC week, in province of the Quebec, 2009–2010.
See this image and copyright information in PMC

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