Atlanta, GA—After months of uncertainty and a lot of questions from expectant mothers, the national CDC now is officially recommending that pregnant women be vaccinated against COVID-19.

At a virtual White House briefing, CDC Director Rochelle P. Walensky, MD, MPH, said the recommendation was based on a recent study published in The New England Journal of Medicine. “We know that this is a deeply personal decision, and I encourage people to talk to their doctors or primary care providers to determine what is best for them and for their baby,” Dr. Walensky added. 

Noting that clinical trials of COVID-19 vaccines did not include pregnant women, she pointed out that data on vaccination safety in pregnant women and babies were limited.

Discussing preliminary findings of post-COVID-19 vaccine surveillance for the mRNA vaccines, Dr. Walensky said, “Importantly, no safety concerns were observed for people vaccinated in the third trimester or safety concerns for their babies.”

CDC researchers said their study, conducted from December 14, 2020, to February 28, 2021, 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 women.

The focus was on 35,691 v-safe participants, aged 16 to 54 years, who identified as pregnant. Pregnant women reported injection-site pain more frequently than nonpregnant women, but headache, myalgia, chills, and fever were reported less frequently.

Among 3,958 participants enrolled in the v-safe pregnancy registry, the authors report that 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%), although no neonatal deaths were reported.

While the groups are not directly comparable, researchers advise that calculated proportions of adverse pregnancy and neonatal outcomes in women vaccinated against COVID-19 who had a completed pregnancy were similar to pregnant women in studies conducted before the pandemic.

Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion, at 46 cases, the study noted.

“Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines,” the authors concluded. “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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