FDA Chief Medical Officer and Center for Biologics Evaluation and Research Director Vinay Prasad has called for the agency to reflect following reports that children’s deaths are linked to the COVID-19 vaccine.
In an email to staff obtained by The Daily Caller News Foundation, Prasad said Office of Biostatistics and Pharmacovigilance (OBPV) career staff have “found that at least 10 children have died after and because of receiving COVID-19 vaccination. These deaths are related to vaccination (likely/probable/possible attribution made by staff). That number is certainly an underestimate due to underreporting, and inherent bias in attribution.”
“The team has performed an initial analysis of 96 deaths between 2021 and 2024, and concludes that no fewer than 10 are related. If anything, this represents conservative coding, where vaccines are exculpated rather than indicted in cases of ambiguity. The real number is higher,” Prasad added, calling the matter a “profound revelation.”
“For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” Prasad said. “Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death. In many cases, such mandates were harmful. It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.”
“Did COVID-19 vaccine programs kill more healthy kids than it saved?” he asked, going on to explain the lack of reliable data on the subject.
“Comparing the number of kids who died from COVID against these deaths would be a flawed comparison,” he wrote. “We do not know how many fewer kids would have died had they been vaccinated, and we do not know how many more kids died from taking vaccines than has been voluntarily reported. Instead, the truth is we do not know if we saved lives on balance.”
“There is no doubt that without this FDA commissioner, we would not have performed this investigation and identified this safety concern,” Prasad further wrote. “This fact also demands serious introspection and reform. Why were these deaths not actively reviewed in real time? Why did it take until 2025 to perform this analysis, and take necessary further actions? Deaths were reported between 2021 and 2024, and ignored for years.”
The American Academy of Pediatrics (AAP) issued guidance in August that recommends that children under the age of two receive the COVID-19 vaccine, despite the Trump administration’s shift away from such recommendations.
According to the AAP’s updated vaccine schedule, children between 6 and 23 months should receive a COVID-19 vaccine, while children between the ages of 2 and 18 “should be offered a single dose of age-appropriate COVID-19 vaccine.” Similarly, the AAP asserted in its policy statement for the COVID-19 vaccine that children 6 months through 18 years of age who are “moderately or severely immunocompromised require 2 or more doses of age-appropriate 2025-2026 COVID-19 vaccine depending on previous vaccination status.”
Meanwhile, the CDC updated its policy to allow individuals to choose whether or not to receive a COVID-19 vaccine. “Informed consent is back,” explained Deputy CDC Secretary O’Neill. “CDC’s 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent.”
