Image of Dana M. Meaney-Delman, M.D.

Pregnancy concerns are cited as one of the top reasons for vaccine hesitancy among long-term care workers, but there were no obvious signs of third trimester adverse events among pregnant women who received Pfizer and Moderna’s mRNA COVID-19 vaccines, according to preliminary research findings.

Investigators from the Centers for Disease Control and Prevention analyzed data entered into the agency’s voluntary tracking systems during the first three months of the vaccines’ rollout. These included the v-safe after-vaccination health checker surveillance app, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System.

Fully 35,691 v-safe participants aged 16 to 54 years old identified as pregnant, with vaccinations occurring in all trimesters of pregnancy. Many participants in the v-safe pregnancy registry were healthcare workers and were in the highest priority group for COVID-19 vaccination.

Pregnant women reported more injection site pain than nonpregnant women, but less instances of headache, myalgia, chills and fever, investigators found. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Others included preterm birth, small size for gestational age, congenital anomalies and neonatal death. 

The proportions of adverse pregnancy and neonatal outcomes in vaccinated pregnant women were similar to incidences reported in pre-pandemic studies of pregnant women, reported Dana M. Meaney-Delman, M.D., and colleagues. These studies are not directly comparable, the researchers acknowledged, but “such comparisons are helpful to provide a crude sense of whether there are any unexpected safety signals in these early data,” they wrote.

Continued monitoring is needed to further assess post-vaccination outcomes, including in the earlier stages of pregnancy and during the preconception period, the researchers concluded.

Pregnant women were not included in the initial clinical trials of the COVID-19 vaccines, but such trials are now taking place, according to CBS News. “Growing evidence suggests the vaccine is as safe for pregnant patients as it is for non-pregnant individuals,” the news outlet reported. What’s more, the American College of Obstetrics and Gynecologists recommends that the vaccines not be withheld from pregnant or breastfeeding patients, and the CDC has issued similar guidance, it stated. 

Full findings were published in the New England Journal of Medicine.