PMID- 38462432
OWN - NLM
STAT- MEDLINE
DCOM- 20240408
LR  - 20240408
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 42
IP  - 9
DP  - 2024 Apr 2
TI  - Safety monitoring of bivalent mRNA COVID-19 vaccine among pregnant persons in the 
      vaccine adverse event reporting System - United States, September 1, 2022 - March 
      31, 2023.
PG  - 2380-2384
LID - S0264-410X(24)00262-7 [pii]
LID - 10.1016/j.vaccine.2024.02.084 [doi]
AB  - BACKGROUND: Pregnant persons are at increased risk of severe COVID-19 illness. 
      Bivalent mRNA COVID-19 vaccination is recommended for everyone, including 
      pregnant persons. However, data are limited on the safety of bivalent mRNA 
      COVID-19 vaccination during pregnancy. OBJECTIVE: To evaluate and summarize 
      reports to the Vaccine Adverse Event Reporting System (VAERS), a national 
      spontaneous reporting system, among pregnant persons who received bivalent mRNA 
      COVID-19 vaccine. METHODS: VAERS U.S. reports of adverse events (AEs) in pregnant 
      persons who received the bivalent mRNA COVID-19 vaccine from 9/1/2022-03/31/2023 
      were identified. Clinicians reviewed all reports and available medical records. 
      AEs of these reports were compared with AEs reported to VAERS following 
      monovalent mRNA COVID-19 booster vaccination in pregnancy. RESULTS: VAERS 
      received 136 reports for pregnant persons who received bivalent mRNA COVID-19 
      vaccine; 87 (64 %) after BNT162b2 (Pfizer-BioNTech), and 48 (35 %) after 
      mRNA-1273 (Moderna); 28 (20.6 %) reports were classified as serious. The most 
      common pregnancy-specific outcomes reported included 12 (8.8 %) spontaneous 
      abortions (<20 weeks gestation), 6 (4.4 %) episodes of preterm delivery, and 5 
      (3.7 %) reports of preeclampsia. One stillbirth (>/=20 weeks gestation) was 
      reported. No maternal or infant deaths were reported. There were 6 reports of AEs 
      in infants, which included 3 reports of admissions to the neonatal intensive care 
      unit: two infants with low birth weight, and one infant with a patent ductus 
      arteriosus and patent foramen ovale. Non-pregnancy-specific adverse events were 
      mostly COVID-19 infection and systemic reactions (e.g., headache, fatigue). 
      Pregnancy-specific conditions were reported less frequently after bivalent mRNA 
      COVID-19 vaccination compared to monovalent mRNA COVID-19 booster vaccination 
      (3rd and 4th dose). CONCLUSIONS: Based on this review of reports to VAERS, the 
      safety profile of bivalent mRNA COVID-19 vaccination in pregnant persons was 
      comparable to that observed for monovalent mRNA COVID-19 booster vaccination (3rd 
      and 4th dose) in pregnant persons.
CI  - Published by Elsevier Ltd.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, USA. Electronic address: 
      psm9@cdc.gov.
FAU - Carlock, Grace
AU  - Carlock G
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, USA.
FAU - Fifadara, Nimita
AU  - Fifadara N
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, USA.
FAU - Habenicht, Tei
AU  - Habenicht T
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, USA.
FAU - Zhang, Bicheng
AU  - Zhang B
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, USA.
FAU - Strid, Penelope
AU  - Strid P
AD  - Preparedness and Response Branch, Division of Healthcare Quality Promotion, 
      National Center for Zoonotic and Emerging Infectious Diseases, USA.
FAU - Marquez, Paige
AU  - Marquez P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Zoonotic and Emerging Infectious Diseases, USA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20240311
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (BNT162 Vaccine)
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Vaccines)
SB  - IM
MH  - Female
MH  - Humans
MH  - Infant, Newborn
MH  - Pregnancy
MH  - Adverse Drug Reaction Reporting Systems
MH  - BNT162 Vaccine
MH  - *COVID-19/prevention & control
MH  - COVID-19 Vaccines/adverse effects
MH  - United States/epidemiology
MH  - *Vaccines
OTO - NOTNLM
OT  - Adverse events
OT  - BA.4/BA.5 strains
OT  - Bivalent mRNA COVID-19 vaccine
OT  - COVID-19
OT  - Coronavirus
OT  - Epidemiology
OT  - Pregnancy
OT  - SARS-CoV-2
OT  - Surveillance
OT  - Vaccine safety
OT  - mRNA COVID-19 vaccines
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- 2024/03/11 00:42
MHDA- 2024/04/08 06:42
CRDT- 2024/03/10 22:54
PHST- 2023/09/25 00:00 [received]
PHST- 2024/02/04 00:00 [revised]
PHST- 2024/02/27 00:00 [accepted]
PHST- 2024/04/08 06:42 [medline]
PHST- 2024/03/11 00:42 [pubmed]
PHST- 2024/03/10 22:54 [entrez]
AID - S0264-410X(24)00262-7 [pii]
AID - 10.1016/j.vaccine.2024.02.084 [doi]
PST - ppublish
SO  - Vaccine. 2024 Apr 2;42(9):2380-2384. doi: 10.1016/j.vaccine.2024.02.084. Epub 
      2024 Mar 11.