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. 2021 Jun 17;384(24):2273-2282.
doi: 10.1056/NEJMoa2104983. Epub 2021 Apr 21.

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

Tom T Shimabukuro  1 , Shin Y Kim  1 , Tanya R Myers  1 , Pedro L Moro  1 , Titilope Oduyebo  1 , Lakshmi Panagiotakopoulos  1 , Paige L Marquez  1 , Christine K Olson  1 , Ruiling Liu  1 , Karen T Chang  1 , Sascha R Ellington  1 , Veronica K Burkel  1 , Ashley N Smoots  1 , Caitlin J Green  1 , Charles Licata  1 , Bicheng C Zhang  1 , Meghna Alimchandani  1 , Adamma Mba-Jonas  1 , Stacey W Martin  1 , Julianne M Gee  1 , Dana M Meaney-Delman  1 ; CDC v-safe COVID-19 Pregnancy Registry Team
Collaborators, Affiliations

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

Tom T Shimabukuro et al. N Engl J Med. .

Erratum in

Abstract

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.

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Figures

Figure 1
Figure 1. Most Frequent Local and Systemic Reactions Reported in the V-safe Surveillance System on the Day after mRNA Covid-19 Vaccination.
Shown are solicited reactions in pregnant persons and nonpregnant women 16 to 54 years of age who received a messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccine — BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna) — from December 14, 2020, to February 28, 2021. The percentage of respondents was calculated among those who completed a day 1 survey, with the top events shown of injection-site pain (pain), fatigue or tiredness (fatigue), headache, muscle or body aches (myalgia), chills, and fever or felt feverish (fever).
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