So far, large federal studies have shown no higher risk for major birth defects, miscarriage or other complications
TUESDAY, Sept. 16, 2025 (HealthDay News) — Federal health officials are reviewing safety data on COVID vaccines in pregnant women and children, and may also reconsider recommendations for older adults.
The U.S. Food and Drug Administration (FDA) is analyzing reports of possible birth defects after vaccination during pregnancy, while also preparing a presentation on deaths in children following COVID vaccination.
The meeting is scheduled for Sept. 18 and 19 with the U.S. Centers for Disease Control and Prevention’s (CDC) vaccine advisory group, CNN reported.
Experts stress that the system being used for part of the review — the Vaccine Adverse Event Reporting System (VAERS) — is designed to only flag potential safety signals, not to prove that vaccines caused health problems.
“VAERS is a system that generates hypotheses,” Dr. Demetre Daskalakis, who recently stepped down as director of the CDC’s National Center for Immunization and Respiratory Diseases, told CNN.
So far, large studies have shown that COVID vaccines are safe in pregnancy. CDC monitoring included more than 23,000 pregnant women in one registry and more than 45,000 in another database.
Those studies showed no higher risk of major birth defects, miscarriage or other complications. Pfizer also reported that in a clinical trial of pregnant women, the rate of birth defects in vaccinated participants was similar to that in the overall population.
FDA Commissioner Dr. Marty Makary said the agency plans to share all available safety data.
“We’re going to make that available to the medical community in full transparency, because this is the question that Americans are asking,” Makary told CNN.
The CDC advisory group may also debate whether to adjust vaccine guidance for older adults, possibly recommending shots mainly for those 75 and older or younger people with underlying conditions.
COVID vaccines remain approved for adults 65 and older and for younger adults at high risk for severe illness.
More information
The New England Journal of Medicine has more on COVID vaccine recommendations.
SOURCE: CNN, Sept. 12, 2025
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