JOURNAL ARTICLE

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

Tom T Shimabukuro, Shin Y Kim, Tanya R Myers, Pedro L Moro, Titilope Oduyebo, Lakshmi Panagiotakopoulos, Paige L Marquez, Christine K Olson, Ruiling Liu, Karen T Chang, Sascha R Ellington, Veronica K Burkel, Ashley N Smoots, Caitlin J Green, Charles Licata, Bicheng C Zhang, Meghna Alimchandani, Adamma Mba-Jonas, Stacey W Martin, Julianne M Gee, Dana M Meaney-Delman
New England Journal of Medicine 2021 April 21
33882218

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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magdalena pina

Pregnant persons? Are you serious? Why not pregnant women? When medicine gets involved with ideology, loses one of its primary goals: be true and be real.
Reality does not hurt! Ideology does!!

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gene 2018

13.9 % of pregnancy loss is so high to considered as a meaningful result. Isn't so?

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