FDA Memo Links 10 Child Deaths to COVID-19 Vaccines

A memo from the Food and Drug Administration (FDA) reportedly identifies a troubling connection between COVID-19 vaccines and the deaths of ten children. The document, authored by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, covers pediatric deaths occurring between 2021 and 2024. This information was revealed in a report by The Washington Post, though it has not been independently verified.

The memo raises questions about the criteria used by the FDA to determine causation between the vaccines and these deaths. During a recent interview with Fox News, FDA Commissioner Martin A. Makary indicated that the findings could prompt a reassessment of the approval process for various vaccines, including those for COVID-19 and influenza. “We’re not just going to rubber-stamp new products that don’t work, that fail in a clinical trial,” Makary stated emphatically. “It makes a mockery of science if we’re just going to rubber-stamp things with no data.”

Concerns Over Vaccine Approval Processes

The memo also highlights the need for reform in the annual flu vaccine framework, criticizing what it describes as “low-quality evidence, poor surrogate assays, and uncertain vaccine effectiveness” in existing studies. Makary and Prasad have raised concerns about the transparency of data regarding the risks and benefits of approving COVID-19 vaccines for children and young adults, accusing the Biden administration of withholding critical information.

“The COVID shot was amazing for people at risk and for older people, especially when it was a good match for the circulating virus at the time, back in 2020,” Makary explained. “We saw a reduction in the severity of illness and lives saved. But now recommending that a 6-year-old girl get another 70 mRNA COVID shots, one each year for the rest of her life, is not based on science.”

The Centers for Disease Control and Prevention (CDC) has recently adjusted its guidelines regarding COVID-19 vaccinations. The agency recommends that children aged six months and older receive the vaccine only after consulting with a healthcare provider.

Recommendations from Health Organizations

While the American Academy of Family Physicians supports making COVID-19 vaccines available to families who wish to have them, it does not endorse universal vaccination for all children. Meanwhile, the American Academy of Pediatrics advocates for booster shots specifically for children identified as high-risk and emphasizes that vaccines should remain accessible to parents who choose to immunize their children.

As the dialogue surrounding the safety and efficacy of COVID-19 vaccines continues, the implications of the FDA memo may influence future health policies and vaccination strategies for pediatric populations. Public health officials and healthcare providers will likely monitor the situation closely as further developments unfold.