FDA officials are expected to claim a connection between the COVID vaccine and pediatric deaths when they brief a CDC vaccine recommendation panel next week.
According to reporting from multiple outlets citing anonymous sources, officials with the Food And Drug Administration will present data that they allege connects COVID vaccination with the deaths of at least 25 children.
Scripps News has not yet independently verified the reporting.
Officials will show the data to the CDC's Advisory Committee on Immunization Practices, which is preparing to develop new recommendations for COVID vaccine protocols at a meeting next week.
The CDC's vaccine recommendations will come as states, health providers and insurers all seek guidance ahead of the U.S. flu season. Some states do not allow pharmacists to administer the vaccine without the panel’s approval.
The information concerning child deaths is said to be drawn from the Vaccine Adverse Event Reporting System, a federal reporting tool for tracking side effects associated with vaccines. Doctors, patients, pharmacists and even bystanders who see reports of side effects may submit reports.
But experts warn that reports sent through the tool cannot be immediately verified for their accuracy, since such a verification requires further investigation by health experts.
FDA Commissioner Marty Makary told CNN last week that the agency would investigate reports that children had died after receiving a COVID vaccine. Makary characterized it as an "intense investigation" but did not make clear at the time when the reports were received or when the investigations began.
Robert F. Kennedy, Jr., who oversees the FDA and the CDC as the Secretary of Health and Human Services, has told Scripps News the FDA, CDC and other health agencies had made unanimous decisions to change vaccine recommendations. Other health experts dispute this claim.
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In an interview with Scripps News, Kennedy questioned the effectiveness of mRNA vaccines despite overwhelming scientific research. He also warned against virus mutations and dosage control issues.
"You can't control the amount of antigen that everybody is getting," he said. "When you give a vaccine, you want to know exactly how much antigen is because some people react very, very badly and can get very, very badly injured."
