Concerns Raised Over COVID-19 Vaccine Safety for Children
A medical officer at the Food and Drug Administration (FDA) is raising serious concerns about the safety of COVID-19 vaccines for children. Dr. Vinay Prasad, the FDA’s Chief Medical Officer, has revealed data suggesting a possible link between the vaccines and the deaths of at least ten children.
In an email to staff, Dr. Prasad stated that the FDA will, for the first time, acknowledge the potential for COVID-19 vaccines to have caused fatalities in American children. He emphasized that these were young, healthy children who were at very low risk of death from the virus itself.
He pointed out that, driven by the Biden administration, schools and workplaces required the vaccine, compelling individuals to get vaccinated, but this coercion resulted in deaths, and mandates can be harmful.
Dr. Prasad, who was chosen for his position by an FDA Commissioner appointed by President Donald Trump, also expressed concern that the reported number of deaths is likely an underestimate due to underreporting and other biases. He argued that studies on COVID-19 vaccines and boosters often do not adequately assess the risks and benefits for younger people.
The medical officer also highlighted reports of vaccine-induced myocarditis, a heart condition primarily affecting young, healthy males, a group that typically experiences milder effects from COVID-19. He questioned why it took so long for this analysis to be conducted, as deaths were reported between 2021 and 2024, but seemingly ignored for years.
Dr. Prasad believes that the reasons for downplaying these deaths may be due to “cultural and systemic” issues within the agency. He contrasted the current administration’s approach to health and safety protocols with that of previous administrations.
He asserted that the U.S. government’s COVID-19 vaccine mandates for young people might have been harmful, especially when considering the low risk the virus posed to this age group. He added that the elderly, who were more vulnerable to the virus, benefited most from early vaccinations.
Dr. Prasad also compared differing opinions within the FDA. He noted the resignations of two top vaccine reviewers, Dr. Marion Gruber and Dr. Philip Krause, who disagreed with the former Center for Biologics Evaluation and Research (CBER) Director Peter Marks. The disagreement stemmed from Marks’ push for annual boosters for everyone, regardless of age or risk, while Gruber and Krause preferred a risk-based approach.
Another point of contention was Marks’ submission of a Biologics License Application (BLA) to the FDA, which Dr. Prasad argued allowed the Biden administration to implement unethical COVID-19 mandates. Marks resigned in March, citing the spread of vaccine misinformation by President Trump’s Health and Human Services (HHS) Secretary, Robert F. Kennedy Jr.
Dr. Prasad stressed that he favors approving products with benefits that outweigh the risks, rather than promoting products driven by financial incentives.
Despite the serious nature of the data and accusations in his message, Dr. Prasad intended it as a call for change. He urged the agency to embrace humility and introspection moving forward. He also issued a clear warning to staff who compromise the integrity of vaccine reviews. He wrote that there shouldn’t be a need for the commissioner to find deaths in children to identify it.
