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

Details

• Alternative Title:
  N Engl J Med
• Personal Author:
  Shimabukuro, Tom T. ; Kim, Shin Y. ; Myers, Tanya R. ; Moro, Pedro L. ; Oduyebo, Titilope ; Panagiotakopoulos, Lakshmi ; Marquez, Paige L. ; Olson, Christine K. ; Liu, Ruiling ; Chang, Karen T. ; Ellington, Sascha R. ; Burkel, Veronica K. ; Smoots, Ashley N. ; Green, Caitlin J. ; Licata, Charles ; Zhang, Bicheng C. ; Alimchandani, Meghna ; Mba-Jonas, Adamma ; Martin, Stacey W. ; Gee, Julianne M. ; Meaney-Delman, Dana M.
  More +
• 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.
• Subjects:
  • Abortion, Spontaneous
  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems
  • COVID-19 Vaccines
  • Female
  • Humans
  • Infant, Newborn
  • Infant, Small for Gestational Age
  • Middle Aged
  More +
• Source:
  N Engl J Med. 2021;
• Pubmed ID:
  33882218
• Pubmed Central ID:
  PMC8117969
• Document Type:
  Text
• Genre:
  Journal Article
• Place as Subject:
  United States
• Download URL:
  https://stacks.cdc.gov/view/cdc/106333/cdc_106333_DS1.pdf
• File Type:
  [PDF - 487.59 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:157fa82cd64c894121d2196caa2d3c8b9acf4ea162f1768ed85e51e9536197864921d6949248a07c0e457cab6f0f6a5814f0b5aa145333b4af3ff3d0b63327e2