PMID- 32741674
OWN - NLM
STAT- MEDLINE
DCOM- 20210427
LR  - 20210427
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 38
IP  - 40
DP  - 2020 Sep 11
TI  - Safety evaluation of adverse events following vaccination with Havrix, Engerix-B 
      or Twinrix during pregnancy.
PG  - 6215-6223
LID - S0264-410X(20)30970-1 [pii]
LID - 10.1016/j.vaccine.2020.07.041 [doi]
AB  - BACKGROUND: Vaccination of pregnant women against hepatitis A virus (HAV) or 
      hepatitis B virus (HBV) may benefit the mother and the fetus but is not routinely 
      recommended. However, the risk associated with vaccination should be weighed 
      against the risk of HAV or HBV infection. Data on safety profiles after hepatitis 
      A, B or combined AB immunization during pregnancy are limited. METHODS: We 
      searched the GSK Worldwide Safety Database for adverse events (AEs) following 
      immunization of pregnant women with HAV (Havrix, GSK), HBV (Engerix-B, GSK) or 
      the combined hepatitis AB (Twinrix, GSK) vaccine since market authorization 
      through 31 January 2018, covering at least 25 years. AE reports (spontaneous, 
      post-marketing surveillance and clinical trial cases) in the GSK Worldwide Safety 
      Database were identified using a systematic search and were reviewed by 
      clinicians to ascertain pregnancy status at time of vaccination and characterize 
      adverse pregnancy outcomes, including pregnancy-related AEs and AEs in infants 
      regardless of the causality assessment. RESULTS: Overall, 613, 700 and 363 
      pregnancies with exposure to Havrix, Engerix-B and Twinrix, respectively, were 
      reported. Of these, 378, 339 and 194 were analyzed. The most frequently 
      identified pregnancy outcomes were live infants (288, 223 and 151), spontaneous 
      abortions (43, 57 and 26) and elective terminations (25, 24 and 9). A total of 
      19, 29 and 10 cases of congenital anomalies were reported. Of these, 17, 20 and 7 
      were major birth defects. The most commonly reported pregnancy-related AE and AE 
      in infants were premature delivery (28) and jaundice (11), respectively. No 
      maternal deaths were reported. Congenital anomalies were reported in all recorded 
      infant deaths. CONCLUSIONS: This review did not indicate any concerning pattern 
      of adverse pregnancy outcomes following exposure to any of the 3 vaccines during 
      pregnancy.
CI  - Copyright (c) 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.
FAU - Celzo, Froilan
AU  - Celzo F
AD  - GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: 
      Froilan.x.Celzo@gsk.com.
FAU - Buyse, Hubert
AU  - Buyse H
AD  - GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: 
      Hubert.m.buyse@gmail.com.
FAU - Welby, Sarah
AU  - Welby S
AD  - GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: 
      Sarah.x.Welby@gsk.com.
FAU - Ibrahimi, Abdelilah
AU  - Ibrahimi A
AD  - GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: 
      Abdelilah.x.Ibrahimi@gsk.com.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20200730
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Engerix-B)
RN  - 0 (Hepatitis A Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Vaccines, Combined)
RN  - 0 (twinrix)
SB  - IM
MH  - Female
MH  - *Hepatitis A Vaccines/adverse effects
MH  - *Hepatitis B/prevention & control
MH  - Hepatitis B Vaccines/adverse effects
MH  - Humans
MH  - Infant
MH  - Pregnancy
MH  - Vaccination/adverse effects
MH  - Vaccines, Combined
OTO - NOTNLM
OT  - Combined hepatitis AB vaccine
OT  - Hepatitis A vaccine
OT  - Hepatitis B vaccine
OT  - Pregnancy
OT  - Pregnancy outcomes
OT  - Vaccine safety
COIS- Declaration of Competing Interest The authors declare the following financial 
      interests/personal relationships which may be considered as potential competing 
      interests: [FC, HB, SW and AI are employees of the GSK group of companies. FC, HB 
      and SW own restricted shares of the GSK group of companies.].
EDAT- 2020/08/04 06:00
MHDA- 2021/04/28 06:00
CRDT- 2020/08/04 06:00
PHST- 2020/03/27 00:00 [received]
PHST- 2020/07/14 00:00 [revised]
PHST- 2020/07/20 00:00 [accepted]
PHST- 2020/08/04 06:00 [pubmed]
PHST- 2021/04/28 06:00 [medline]
PHST- 2020/08/04 06:00 [entrez]
AID - S0264-410X(20)30970-1 [pii]
AID - 10.1016/j.vaccine.2020.07.041 [doi]
PST - ppublish
SO  - Vaccine. 2020 Sep 11;38(40):6215-6223. doi: 10.1016/j.vaccine.2020.07.041. Epub 
      2020 Jul 30.