
Federal health officials are preparing to present information next week that suggests a link between COVID-19 vaccines and more than two dozen pediatric deaths, according to media reports.
Reporting by the Washington Post and the New York Times indicates that officials with the Food and Drug Administration (FDA) will make the presentation at next week's meeting of the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP). The meeting is scheduled to include discussions and votes on recommendations for updated COVID-19 vaccines, which received FDA approval in late August but for a more limited population than previous COVID vaccines.
According to the Post, the FDA presentation will reportedly be based on information submitted to the Vaccine Adverse Event Reporting System (VAERS), which contains unverified reports of injuries or side effects believed to be associated with vaccination. VAERS reports can be submitted by anyone, even if it's unclear whether a vaccine caused the injury. CDC and FDA monitor the system for safety signals and investigate reports further when they believe it is warranted.
"A VAERS report alone does not indicate whether a vaccine caused or contributed to an adverse event," the CDC website states. "Only scientists and public health professionals can make this determination after thorough investigation."
FDA investigating VAERS reports
But Department of Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine critic who once suggested COVID vaccines were "the deadliest vaccine ever made," has argued VAERS and other federal vaccine-monitoring systems are insufficient and in April said he wanted to upgrade them to better capture adverse events.
FDA Commissioner Marty Makary, MD, said in a recent interview with CNN that the FDA was doing an "intense investigation" of reports from VAERS, including speaking with families of children who had died and reviewing autopsy reports. "We think the public deserves to have that information," he said.
Although it's unclear what recommendations ACIP will make for COVID-19 vaccines, several members of the newly reconstituted group have been vocal critics of the mRNA COVID vaccines.