PMID- 28242152
OWN - NLM
STAT- MEDLINE
DCOM- 20180305
LR  - 20180305
IS  - 1769-664X (Electronic)
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
EDAT- 2017/03/01 06:00
MHDA- 2018/03/06 06:00
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]
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.