Despite having no definitive data, Sen. Ron Johnson (R-WI) in a letter to health secretary Robert F. Kennedy, Jr. suggested there was a conscious effort by the Biden administration’s FDA to cover up the safety risks of COVID-19 vaccines.
No child deaths were directly linked to COVID-19 vaccines, according to the FDA’s long-awaited analysis of adverse events.
Late last year, former CBER director Vinay Prasad claimed in a leaked internal memo that “at least 10 children have died after and because of receiving COVID-19 vaccination.” The FDA, after much blowback from the industry and independent experts, promised to disclose its analysis by the end of 2025, but the agency largely kept its specific findings under wraps.
Those findings were made publicly available last week as part of a letter from Sen. Ron Johnson (R-WI) to health secretary Robert F. Kennedy, Jr., seeking for greater transparency around the safety of COVID-19 vaccines.
These shots, made by some of the biggest companies such as Pfizer, BioNTech and Moderna, were approved for emergency use under the first administration of President Donald Trump.
The FDA’s report, dated Dec. 5, flagged 96 “unique” pediatric deaths in the U.S. as of Aug. 14, 2025, as reported to the agency’s Vaccine Adverse Event Reporting System (VAERS). Of these, “no cases were classified as certain in relation to COVID-19 vaccination,” the report read—a stark contradiction to Prasad’s initial claim of causality.
Meanwhile, seven deaths were “possibly” related to the shots. “It is important to note that possible cases could also be explained by alternative etiology,” the report reads. Two deaths were classified as “probably” linked to the vaccines, which according to the FDA’s own review means they are “unlikely to be attributed to alternative etiology though an alternative etiology cannot be ruled out.”
The regulator zeroed in on these probable or possible cases and noted that most of them involved myocarditis, a known risk factor of COVID-19 vaccines. Still, while myocarditis is flagged on the labels for these shots, the potential deaths arising from this adverse event “represent greater severity of the known risk of myocarditis, and the reporting of fatal outcomes is not currently described” in these products’ labels.
Anyone can log reports onto the VAERS, including healthcare providers, manufacturers and patients who receive the vaccines. Reports on the system “generally cannot be used to determine if a vaccine caused or contributed to an adverse event or illness,” the FDA itself notes on the VAERS website.
Still, Johnson, in his letter to Kennedy, relied on the sheer volume of reports to VAERS to suggest that the FDA under former President Joe Biden should have known that there were some safety concerns surrounding COVID-19 vaccines. “The raw number of reports to VAERS should have been cause enough to raise the alarm,” Johnson wrote, claiming that officials at the time decided to stick with an old algorithm “that they knew hid safety signals.”
The senator is now asking to meet with Kennedy to figure out how to expedite the discovery of how former FDA officials under Biden allegedly overlooked or obscured the harms of COVID-19 shots. “The public deserves complete transparency about the safety of the COVID-19 vaccines,” Johnson wrote. “HHS must ensure that there is no delay in achieving that objective.”
Vaccine manufacturers have seen dwindling sales from their immunization portfolios, driven in large part by the rhetoric of and policies from Kennedy. The trend started in October last year, when Sanofi reported a 17% hit to their vaccine sales. Pfizer, which markets the COVID-19 vaccine Comirnaty alongside BioNTech, sustained a 6% year-on-year decline in its overall revenue for 2025, bogged down by its pandemic products. Comirnaty crashed 20% year-on-year to under $4.4 billion worldwide.
