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No Obvious Safety Signals ID'd for mRNA COVID-19 Vaccine in Pregnancy

THURSDAY, April 22, 2021 -- Preliminary findings indicate no obvious safety signals for pregnant women who receive mRNA COVID-19 vaccines, according to a study published online April 21 in the New England Journal of Medicine.

Tom T. Shimabukuro, M.D., from the U.S. Centers for Disease Control and Prevention in Atlanta, and colleagues used data from the "v-safe after vaccination health checker" surveillance system, the v-safe pregnancy register, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the safety of mRNA COVID-19 vaccines in pregnant persons.

The researchers identified 35,691 pregnant v-safe participants aged 16 to 54 years. Compared with nonpregnant women, pregnant persons more often reported injection-site pain but less frequently reported headache, myalgia, chills, and fever. Overall, 827 of the 3,958 participants enrolled in the v-safe pregnancy registry had a completed pregnancy, of which 13.9 and 86.1 percent resulted in a pregnancy loss and a live birth, respectively. Adverse neonatal outcomes included preterm birth and small for gestational age (9.4 and 3.2 percent, respectively); there were no reports of neonatal deaths. Calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against COVID-19 with a completed pregnancy were similar to incidences in studies involving pregnant women conducted before the pandemic, although these proportions were not directly comparable. Spontaneous abortion was the most frequently reported event among the 221 pregnancy-related adverse events reported to the VAERS (46 cases).

"The present data can help inform decision making about vaccination by pregnant persons and their health care providers," the authors write.

One author disclosed financial ties to the pharmaceutical industry, including companies that have developed COVID-19 vaccines.

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