PMID- 33358703
OWN - NLM
STAT- MEDLINE
DCOM- 20210427
LR  - 20210427
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 39
IP  - 4
DP  - 2021 Jan 22
TI  - Reports of cell-based influenza vaccine administered during pregnancy in the 
      Vaccine Adverse Event Reporting System (VAERS), 2013-2020.
PG  - 678-681
LID - S0264-410X(20)31613-3 [pii]
LID - 10.1016/j.vaccine.2020.12.045 [doi]
AB  - BACKGROUND: In November 2012, the first cell cultured influenza vaccine, a 
      trivalent subunit inactivated influenza vaccine (Flucelvax((R)), ccIIV3), was 
      approved in the United States for adults aged >/=18 years. A quadrivalent version 
      (ccIIV4) was later approved in 2016 and replaced ccIIV3. The safety of ccIIV3 or 
      ccIIV4 (ccIIV) was not assessed for pregnant women or their infants during 
      pre-licensure studies. OBJECTIVE: To assess the safety of ccIIV administered 
      during pregnancy in pregnant women and their infants whose reports were submitted 
      to VAERS during 2013-2020. MATERIAL AND METHODS: We searched VAERS for United 
      States reports of adverse events (AEs) in pregnant women who received ccIIV from 
      1 July 2013 through 31 May 2020. Clinicians reviewed reports and available 
      medical records and assigned a primary clinical category for each report. Reports 
      were coded as serious based on the Code of Federal Regulations definition. 
      RESULTS: VAERS received 391 reports following ccIIV administered to pregnant 
      women. Twenty-four (6.1%) were serious. Two neonatal deaths were reported. No 
      maternal deaths occurred. Among reports with trimester information (n = 340), 
      ccIIV was administered during the second trimester in 170 (50%). The most 
      frequent pregnancy-specific AE was premature delivery in 85 (21.7%) reports, 
      followed by dysmature placenta in 13 (3.3%) and pre-eclampsia/eclampsia in ten 
      (2.3%). The most common non-pregnancy specific conditions were infectious 
      conditions in 32 (8.2%). Among infant conditions, low birth weight was reported 
      in 62 (15.9%) reports. Fifteen birth defects were reported; in 12 with 
      gestational age information, administration of the vaccine occurred late in the 
      second trimester or later. CONCLUSIONS: Review of maternal ccIIV reports in VAERS 
      was not unexpectedly different from other maternal influenza vaccine safety VAERS 
      reviews.
CI  - Copyright (c) 2020 Elsevier Ltd. All rights reserved.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, United 
      States. Electronic address: pmoro@cdc.gov.
FAU - Marquez, Paige
AU  - Marquez P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, United 
      States.
LA  - eng
PT  - Journal Article
DEP - 20201225
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Female
MH  - Gestational Age
MH  - Humans
MH  - Infant
MH  - *Influenza Vaccines/adverse effects
MH  - *Influenza, Human/prevention & control
MH  - Pregnancy
MH  - *Premature Birth
MH  - United States/epidemiology
OTO - NOTNLM
OT  - Adverse event
OT  - Cell cultured influenza vaccine
OT  - Pharmacovigilance
OT  - Surveillance
OT  - Vaccine safety
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2020/12/29 06:00
MHDA- 2021/04/28 06:00
CRDT- 2020/12/28 10:39
PHST- 2020/10/31 00:00 [received]
PHST- 2020/12/09 00:00 [revised]
PHST- 2020/12/12 00:00 [accepted]
PHST- 2020/12/29 06:00 [pubmed]
PHST- 2021/04/28 06:00 [medline]
PHST- 2020/12/28 10:39 [entrez]
AID - S0264-410X(20)31613-3 [pii]
AID - 10.1016/j.vaccine.2020.12.045 [doi]
PST - ppublish
SO  - Vaccine. 2021 Jan 22;39(4):678-681. doi: 10.1016/j.vaccine.2020.12.045. Epub 2020 
      Dec 25.