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COVID-19 and Women’s Health

mRNA COVID-19 Vaccine Safety in Pregnant Women

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BACKGROUND AND PURPOSE:

  • The clinical trials for mRNA-based COVID-19 vaccines did not include any pregnant women, so safety data in this group was initially limited
    • However, many pregnant women in the general population have since received these vaccines, providing a cohort in which to assess safety data
  • Shimabukuro et al. (NEJM, 2021) reported preliminary findings regarding mRNA COVID-19 vaccine safety in pregnant persons from three U.S. vaccine safety monitoring systems

METHODS:

  • Setting
    • United States
    • Data from December 14, 2020, to February 28, 2021
  • Data sources
    • The “V-safe after vaccination health checker” surveillance system
    • The V-safe pregnancy registry | Telephone-based survey collects detailed information
    • The Vaccine Adverse Event Reporting System (VAERS)
  • Primary outcomes
    • Non–pregnancy-specific adverse events
    • Pregnancy- and neonatal-specific adverse events

Note: Pregnancy and neonatal outcomes were derived from patients who enrolled in the registry

RESULTS:

  • 35,691 v-safe participants self-identified as pregnant
    • Majority of the participants were
      • Between 25 to 34 years of age | Non-Hispanic White (approximately 75%)
  • 3958 participants were enrolled in the registry

Vaccine-related side effects (V-safe)

  • Injection-site pain was reported more frequently among pregnant women than among nonpregnant women
  • The following were reported less frequently among pregnant women
    • Headache
    • Myalgia
    • Chills
    • Fever

Pregnancy Outcomes

  • 827 participants completed pregnancy
    • Live birth: 86.1%
    • Spontaneous abortion: 12.6%
    • Stillbirth (0.1%)
    • Other outcomes (induced abortion and ectopic pregnancy): 1.2% 

Neonatal Outcomes

  • Preterm birth: 9.4%
  • Small for gestational age: 3.2%
  • There were no neonatal deaths

Adverse Events (VAERS)

  • 221 reports
    • Nonpregnant related: 70.1%
    • Pregnancy related: 29.9%
  • Most frequently reported pregnancy-related adverse events
    • Spontaneous abortion (37 first trimester, 2 second trimester, 7 unknown or not reported)
    • No congenital anomalies (EUA reporting requirement)

CONCLUSION:

  • While not directly comparable, the proportions of adverse outcomes in vaccinated women were similar to those reported in studies involving pregnant women before the pandemic
  • Further longitudinal study is important, especially in women vaccinated in the first trimester
  • The authors conclude that

Early data from the v-safe surveillance system, the v-safe pregnancy registry, and the VAERS do not indicate any obvious safety signals with respect to pregnancy or neonatal outcomes associated with Covid-19 vaccination in the third trimester of pregnancy

Learn More – Primary Sources:

Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

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Related ObG Topics:

Safety and Efficacy Data of BNT162b2 COVID-19 Vaccine
The Moderna Vaccine: Study Results Presented to ACIP CDC Committee
Vaccines in Pregnant and Lactating Women: Is Immune Response Similar to that of Non-Pregnant Patients?
COVID-19 mRNA Vaccine Effectiveness in the Real World Including in Those Partially Immunized

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