Trump administration’s FDA plans presentation linking COVID-19 shots to child deaths, citing VAERS reports
Planned briefing reportedly will highlight about 25 child deaths and reports of birth defects drawn from the federal VAERS database; public health experts warn VAERS contains unverified reports
The Food and Drug Administration under President Donald Trump is preparing a presentation that will link COVID-19 vaccinations to children’s deaths and to birth defects in pregnancies, according to multiple news organizations citing current and former officials.
The Washington Post reported Friday that next week’s presentation will focus on roughly 25 reports of child deaths gathered from the federal Vaccine Adverse Event Reporting System, or VAERS. The New York Times and NBC News also reported on the planned briefing. The accounts appear to be drawn from VAERS, a publicly accessible, passive reporting system that includes unverified reports submitted by health care providers, manufacturers, patients and members of the public.
The Centers for Disease Control and Prevention explicitly cautions that a report to VAERS "does not mean that a vaccine caused an adverse event" and notes that "anyone" can file a report. The system is intended to help public health authorities detect unusual or unexpected patterns that warrant further investigation, not to establish causation on its own.
Health and Human Services communications director Andrew Nixon told HuffPost that the reports “should be considered pure speculation” until details are shared publicly, while confirming that the FDA and CDC review VAERS reports as part of routine safety surveillance. FDA Commissioner Marty Makary told CNN last week that the agency was "looking into" VAERS reports about children dying after COVID-19 vaccination and that a report would be released following what he described as an "intense investigation."
The projected briefing comes after Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the FDA, directed the CDC to stop recommending that healthy children and pregnant women receive regular COVID-19 boosters. Kennedy also dismissed all 17 members of the CDC’s vaccine advisory panel in June and appointed new members, a move that has been criticized by public health experts and professional medical groups.
Critics of the planned presentation warned against drawing conclusions from VAERS data without further analysis. Dr. Angela Rasmussen, a virologist at Canada’s Vaccine and Infectious Disease Organization, wrote on social media that "manipulating VAERS is one of the oldest tricks in the anti-vax book" and said the use of raw VAERS reports to justify policy decisions was not scientific and could endanger lives.
Public health agencies regularly assess signals that emerge from VAERS alongside other data sources and formal studies to determine whether a vaccine is associated with a particular adverse event. Historically, signals identified in VAERS have sometimes prompted more rigorous investigation that either confirmed a rare association or found the signal to be coincidental.
According to the news reports, the FDA’s presentation will also highlight reports alleging birth defects following COVID-19 vaccination during pregnancy. The CDC and other public health organizations have repeatedly said that large studies and surveillance data have shown COVID-19 vaccination during pregnancy is safe and that pregnant people are at increased risk for severe illness from COVID-19.
The agencies named in the reporting did not immediately provide a full public outline of the planned presentation. HHS officials have not released the specific VAERS reports cited in the accounts published by news organizations, and some HHS spokespeople advised caution until any briefing is publicly posted.
The planned use of VAERS data for a high-profile briefing underscores broader tensions between the administration’s vaccine policy decisions and the positions of major public health bodies, which continue to recommend COVID-19 vaccination and boosters for many populations based on available evidence. Public health experts said that any claims linking vaccines to deaths or birth defects should be evaluated through established epidemiologic methods before being used to drive policy.
The FDA and CDC said they routinely monitor vaccine safety and investigate potential signals. It remained unclear when the agencies would publicly release the full analysis referenced in news reports or how the findings, if any, would affect current recommendations.
Officials and outside public health experts said transparent presentation of methods and data will be critical for evaluating any claims drawn from VAERS. Until such an analysis is made public, federal officials and scientists urged caution in interpreting unverified reports as evidence of causation.