Bilan français des effets indésirables du vaccin Prévenar 13(®)

OBJECTIVE: To describe the profile and the incidence of adverse events (AEs) reported with Prevenar 13(®) since its commercialization. METHOD: Analysis of all adverse events reported with Prevenar 13(®) in France between 1st July 2010 and 31 October 2014. RESULTS: In 4 years and 4 months, 376 AEs, including 252 severe (67%), were recorded, 83 of which occurred following an injection of Prevenar 13(®) alone: 39 cutaneous AEs, 16 neurological AEs, four cases of collapse or shock, nine cases of fever, and one of thrombocytopenia. For the serious AEs, the outcome was favorable in 88% of cases and none of the 12 reported deaths were attributed to a side effect of vaccination. Fifty-nine cases of pneumococcal disease that suggest an ineffective vaccine were reported, but only 16 can be considered as a real failure of the vaccination. DISCUSSION: In many cases, Prevenar 13(®) was administered on the same day as a hexavalent vaccine with which the AEs reported were expected. The profile of AEs reported following Prevenar 13(®) alone is similar to that seen with Prevenar 7(®). CONCLUSION: Since its release in 2010, the Prevenar 13(®) pharmacovigilance survey, which includes more than 11,800,000 distributed doses, did not show any new information in terms of tolerance safety.