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FDA Launches New Probe Into Covid Vaccine Safety Claims

Agency scrutinizes reports involving child deaths, pregnant women after shots
Posted Sep 12, 2025 2:47 PM CDT
FDA Launches New Probe Into Covid Vaccine Safety Claims
A pharmacist administers a vaccine to a patient at a CVS on Tuesday in Miami.   (AP Photo/Rebecca Blackwell)

The Food and Drug Administration is taking a closer look at reports of deaths among young people and pregnant women following COVID-19 vaccinations—an inquiry that comes despite years of global research affirming the vaccines' strong safety record, reports the New York Times. The new review appears to reflect mounting pressure from Health Secretary Robert F. Kennedy Jr. and his supporters, who've long called for deeper probes into vaccine-related adverse events.

The timing is notable: The FDA's reviews are ramping up just before a key CDC panel is set to recommend policies on COVID vaccines for this fall—potentially affecting both insurance coverage and access in several states. One focus is a set of about two dozen deaths in children reported after vaccination, including at least one case tied to myocarditis, an inflammation of the heart muscle. The Washington Post notes that career scientists fear that Trump health officials are prepping a presentation to the CDC's Advisory Committee on Immunization Practices that would link the vaccine to those deaths.

CDC data shows that about 1,800 children under 18 have died from COVID itself. Experts caution that many adverse-event reports—including those in the government's Vaccine Adverse Event Reporting System, or VAERS—are unverified or unrelated to vaccination. Another FDA review is examining birth defect reports among babies born to vaccinated mothers. So far, large studies have found no increase in birth defects after vaccination. In fact, vaccinated pregnant women had lower rates of stillbirth in an analysis that looked at nearly 180 separate studies.

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