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The agency plans to present accounts of deaths involving children and birth defects to an influential C.D.C. panel meeting next week.
Sept. 12, 2025, 12:00 p.m. ET
The Food and Drug Administration is examining rare cases involving the deaths of young people after they received Covid vaccines and is also seeking undisclosed details about the safety of the shots for pregnant women.
The agency’s review follows years of exhaustive work by government officials and academic researchers worldwide who have validated the safety of the vaccines.
Many public health experts view the new focus as a political exercise in service of the health secretary, Robert F. Kennedy Jr., who has repeatedly suggested that the inoculations are deadly. And some of Mr. Kennedy’s anti-vaccine allies have been pressuring the government to delve deeper into the databases that include reports of harmful effects from the Covid shots.
The F.D.A.’s efforts could ratchet up tensions over the vaccine and tarnish the legacy of President Trump’s championing of vaccines during the pandemic. He has received widespread, bipartisan credit for Operation Warp Speed, the government-financed program that rapidly delivered millions of lifesaving Covid vaccines using mRNA technology.
The agency’s reviews are gearing up in the week before an influential Centers for Disease Control and Prevention committee is scheduled to discuss the Covid shots and issue recommendations for the fall that could limit insurance coverage and availability in some states.
At the meeting, Dr. Tracy Beth Hoeg, an F.D.A. official who previously advised Dr. Joseph Ladapo, the Florida surgeon general and vaccine critic, is expected to present details about a small number of deaths in children that were attributed to the shots.
