COVID-19 Vaccine Is Safe For Pregnant Women, Preliminary Results Indicate

Early data does not indicate any apparent safety concerns for pregnant women who are vaccinated with mRNA COVID-19 vaccine during the third trimester of pregnancy.

These results stem from a review of data from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy registry, and the Vaccines Adverse Events Reporting System (VAERS). It included 35,691 participants aged 16 to 54 years who identified themselves as pregnant.

Overall, injection-site pain was more frequently reported among pregnant individuals than among non-pregnant ones, while headache, myalgia, chills, and fever were reported less frequently.

Of the 35,691 women, 3958 were enrolled in the v-safe pregnancy registry, 827 of whom completed pregnancy during the study period. Among the 827, 115 (13.9%) pregnancy losses occurred, and 712 (86.1%) live births occurred. Adverse outcomes among offspring included preterm birth in 9.4% of the cases and small size for gestational age in 3.2%.  The most commonly reported adverse event reported to the VAERS was spontaneous abortion (n = 46).

“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. Continued monitoring is needed to further assess maternal, pregnancy, neonatal, and childhood outcomes associated with maternal COVID-19 vaccination, including in earlier stages of pregnancy and during the preconception period. Meanwhile, the present data can help inform decision making about vaccination by pregnant persons and their health care providers,” the researchers concluded.

—Michael Potts

Reference:

Shimabukuro TT, Kim SY, Myers TR, et al. Preliminary findings of mRNA COVID-19 vaccine safety in pregnant persons. Published online April 21, 2021. NEJM. DOI: 10.1056/NEJMoa2104983