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

Details

• Alternative Title:
  Vaccine
• Personal Author:
  Moro, Pedro L. ; Carlock, Grace ; Fifadara, Nimita ; Habenicht, Tei ; Zhang, Bicheng ; Strid, Penelope ; Marquez, Paige
• Description:
  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.
  
  
• Subjects:
  Adverse Drug Reaction Reporting Systems BNT162 Vaccine COVID-19 COVID-19 Vaccines Female Humans Infant, Newborn Pregnancy United States Vaccines
• Keywords:
  Adverse Events BA.4/BA.5 Strains Bivalent MRNA COVID-19 Vaccine Coronavirus Epidemiology MRNA COVID-19 Vaccines SARS-CoV-2 Surveillance Vaccine Safety
• Source:
  Vaccine. 42(9):2380-2384
• Pubmed ID:
  38462432
• Pubmed Central ID:
  PMC11649039
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  42
• Issue:
  9
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:667bf1085b97e83e8e55caccaffd74ac7affb3b668d0a4ed2b397d13958ca604cd411094c2a96bf5ff99a0a2fe1d7ef63a13ad25fcdcc2175d966466f76f10d3
• Download URL:
  https://stacks.cdc.gov/view/cdc/175226/cdc_175226_DS1.pdf
• File Type:
  [PDF - 95.21 KB ]