FDA Email Sparks Vaccine Safety Debate for Alaska’s Children

A recently shared internal FDA email has sparked controversy, revealing that agency staff identified at least 10 child deaths potentially linked to COVID-19 vaccines. The findings, based on VAERS data analysis, highlight concerns over delayed safety signals and mandate policies during the pandemic. The email, obtained and shared by the Washington Post on November 29, 2025, calls for major reforms at the FDA.

In the email, FDA Director of the Center for Biologics Evaluation and Research (CBER) Vinay Prasad wrote, “It is horrifying to consider that the US vaccine regulation, including our actions, may have harmed more children than we saved. This requires humility and introspection.” The deaths, involving children aged 7 to 16, were rated as “likely, probable, or possible” attributions to vaccination, with Prasad noting the analysis was long overdue despite reports dating back to 2021.

Myocarditis was one of the main adverse reactions for young boys attributed to the COVID-19 vaccine. It is highly likely that the FDA knew of the risks of heart damage among teenagers when they issued an EUA to Pfizer in May 2021.

“Worse, the FDA delayed acknowledgement of the safety signal until after it could extend marketing authorization to younger boys 12-15, had the acknowledgement come early, these younger boys, who likely did not require COVID-19 vaccination, may have chosen to avoid the products.”

In Alaska, according to data from the Association of Immunization Managers, as late as April of 2023, a total of 165,187 children under the age of 18 had received one dose of a COVID-19 vaccine. The physical effects on these children are likely to get overlooked due to the evolution of reporting COVID related events. Prasad described this as, “any small differences in opinion about specific cases are due only to the fact that subjective attribution of death is inherently a topic where reasonable people may have subtle disagreements.”

Dr. Prasad acknowledges that VAERS is passively reported and it is incumbent on the provider to input the information for safety surveillance. Due to the cumbersome nature of the process, Prasad stated that “many more deaths may be unreported.”

Prasad concludes the memo asserting openness to vigorous debate on matters of public health. He states that all debates should remain internal until ready to be made public, stopping any selective reporting of information. “Some staff may not agree … submit your resignation letters” stated Prasad not mincing words.

The HHS under the leadership of Secretary Robert F. Kennedy Jr. is moving forward to restoring gold standard evidence based medicine. This email from the FDA indicates that serious introspection is occurring to understand the direct health effects related to the COVID-19 vaccines, especially on children.