US Health Authorities Review Safety of COVID Vaccines in Pregnant Women and Children

Federal health officials in the United States are currently evaluating safety data concerning COVID-19 vaccines administered to pregnant women and children. This review comes amid ongoing discussions about the vaccine's safety profile in these vulnerable populations. The U.S. Food and Drug Administration (FDA) is specifically analyzing reports of potential birth defects observed after vaccination during pregnancy and is preparing a presentation on pediatric deaths potentially linked to COVID vaccination.

The upcoming meeting with the CDC's vaccine advisory committee is scheduled for September 18 and 19, marking a critical step in assessing the current evidence. While investigating, experts emphasize that the main tool used—the Vaccine Adverse Event Reporting System (VAERS)—is primarily designed to identify potential safety signals rather than establish causality. Dr. Demetre Daskalakis, former director of the CDC's National Center for Immunization and Respiratory Diseases, clarified that VAERS generates hypotheses that require further study.

Large-scale studies, including monitoring over 23,000 pregnant women in one registry and more than 45,000 in another database, have so far indicated no increased risk of major birth defects, miscarriages, or other adverse pregnancy outcomes linked to COVID vaccines. Pfizer also reported that in clinical trials involving pregnant women, the rate of birth defects in vaccinated individuals was comparable to the general population.

FDA Commissioner Dr. Marty Makary has stated that the agency intends to release all safety data transparently to the medical community to address public concerns. Additionally, there is discussion about potentially updating vaccination guidelines for older adults, possibly recommending booster shots predominantly for those aged 75 and above, or for younger individuals with underlying health conditions. Currently, COVID vaccines are approved for adults 65 and older and for high-risk younger adults.

For further insights, the New England Journal of Medicine offers detailed information on COVID vaccine recommendations. Overall, health authorities continue to monitor and analyze the safety evidence to guide vaccination policies and reassure the public.

Source: https://medicalxpress.com/news/2025-09-covid-vaccine-safety-pregnancy-kids.html