PMID- 28242152 OWN - NLM STAT- MEDLINE DCOM- 20180305 LR - 20200409 IS - 1769-664X (Electronic) IS - 0929-693X (Print) IS - 0929-693X (Linking) VI - 24 IP - 5 DP - 2017 May TI - [Post-licensure safety surveillance for Prevenar 13((R)) in France]. PG - 439-444 LID - S0929-693X(17)30044-1 [pii] LID - 10.1016/j.arcped.2017.01.018 [doi] AB - OBJECTIVE: To describe the profile and the incidence of adverse events (AEs) reported with Prevenar 13((R)) since its commercialization. METHOD: Analysis of all adverse events reported with Prevenar 13((R)) 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((R)) 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((R)) 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((R)) alone is similar to that seen with Prevenar 7((R)). CONCLUSION: Since its release in 2010, the Prevenar 13((R)) pharmacovigilance survey, which includes more than 11,800,000 distributed doses, did not show any new information in terms of tolerance safety. CI - Copyright (c) 2017 Elsevier Masson SAS. All rights reserved. FAU - Agier, M-S AU - Agier MS AD - Service de pharmacologie, centre regional de pharmacovigilance et d'information sur le medicament, CHRU de Tours, 2, boulevard Tonnelle, 37044 Tours cedex 09, France. FAU - Marchand, S AU - Marchand S AD - Service de medecine pediatrique, hopital Clocheville, CHRU de Tours, 49, boulevard Beranger, 37044 Tours cedex 09, France. FAU - Paret, N AU - Paret N AD - Centre de pharmacovigilance, centre antipoison, hospices civils de Lyon, 162, avenue Lacassagne, 69003 Lyon, France. FAU - Gautier, S AU - Gautier S AD - Centre regional de pharmacovigilance, CHRU de Lille, 1, place de Verdun, 59045 Lille cedex, France. FAU - Jonville-Bera, A-P AU - Jonville-Bera AP AD - Service de pharmacologie, centre regional de pharmacovigilance et d'information sur le medicament, CHRU de Tours, 2, boulevard Tonnelle, 37044 Tours cedex 09, France. Electronic address: jonville-bera@chu-tours.fr. LA - fre PT - Journal Article TT - Bilan francais des effets indesirables du vaccin Prevenar 13((R)). DEP - 20170224 PL - France TA - Arch Pediatr JT - Archives de pediatrie : organe officiel de la Societe francaise de pediatrie JID - 9421356 RN - 0 (13-valent pneumococcal vaccine) RN - 0 (Pneumococcal Vaccines) SB - IM MH - Adverse Drug Reaction Reporting Systems/legislation & jurisprudence MH - Child MH - Child, Preschool MH - Drug Approval/*legislation & jurisprudence MH - Female MH - Follow-Up Studies MH - France MH - Humans MH - Immunogenicity, Vaccine/*immunology MH - Infant MH - Infant, Newborn MH - Male MH - Meningitis, Pneumococcal/*immunology/*prevention & control MH - Pneumococcal Vaccines/administration & dosage/*adverse effects MH - Pneumonia, Pneumococcal/*immunology/*prevention & control MH - *Product Surveillance, Postmarketing PMC - PMC7133411 EDAT- 2017/03/01 06:00 MHDA- 2018/03/06 06:00 PMCR- 2017/02/24 CRDT- 2017/03/01 06:00 PHST- 2016/07/29 00:00 [received] PHST- 2016/12/28 00:00 [revised] PHST- 2017/01/18 00:00 [accepted] PHST- 2017/03/01 06:00 [pubmed] PHST- 2018/03/06 06:00 [medline] PHST- 2017/03/01 06:00 [entrez] PHST- 2017/02/24 00:00 [pmc-release] AID - S0929-693X(17)30044-1 [pii] AID - 10.1016/j.arcped.2017.01.018 [doi] PST - ppublish SO - Arch Pediatr. 2017 May;24(5):439-444. doi: 10.1016/j.arcped.2017.01.018. Epub 2017 Feb 24.