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

Details

• Personal Author:
  Alimchandani M ; Burkel VK ; Chang KT ; Ellington SR ; Gee JM ; Green CJ ; Kim SY ; Licata C ; Liu R ; Marquez PL ; Martin SW ; Mba-Jonas A ; Meaney-Delman DM ; Moro PL ; Myers TR ; Oduyebo T ; Olson CK ; Panagiotakopoulos L ; Shimabukuro TT ; Smoots AN ; Zhang BC
• Corporate Authors:
  CDC v-safe COVID-19 Pregnancy Registry Team
• Description:
  Background: Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Methods: From December 14, 2020, to February 28, 2021, we used data from the "v-safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Results: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes. [Description provided by NIOSH]
• Subjects:
  Communicable Diseases Health Care Facilities Workforce And Services Infant, Newborn Occupational Health Pregnancy Safety Safety Management Urogenital System Women
• Keywords:
  Coronavirus COVID-19 Health Effects Humans Immunizations Medical Monitoring Neonates Prenatal Exposure Recording Systems Reproductive Effects Reproductive Health Ribonucleic Acids RNA Safety Monitoring Surveillance Surveillance Programs Vaccines

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• ISSN:
  0028-4793
• Document Type:
  Text
• Genre:
  Journal Article
• Place as Subject:
  Georgia ; Maryland ; Ohio ; OSHA Region 3 ; OSHA Region 4 ; OSHA Region 5
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  WTCHP - World Trade Center Health Program
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Volume:
  384
• Issue:
  24
• NIOSHTIC Number:
  nn:20062634
• Citation:
  N Engl J Med 2021 Jun; 384(24):2273-2282
• Contact Point Address:
  Dr. Shimabukuro, Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30329
• Email:
  tshimabukuro@cdc.gov
• Federal Fiscal Year:
  2021
• Peer Reviewed:
  True
• Source Full Name:
  New England Journal of Medicine
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:fa0f08de983c4772943eabe3f601063161a2f912f41a8bd6f7b521ce94cdc0ac0d2fec6e914ece6bdcb1175aeefea91d9e47d9f380ae34520416cd094790a409
• Download URL:
  https://stacks.cdc.gov/view/cdc/225839/cdc_225839_DS1.pdf
• File Type:
  [PDF - 464.85 KB ]