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.
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| http://dx.doi.org/10.1016/j.arcped.2017.01.018 | DOI Listing |
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