FDA Memo Links 10 Child Deaths to COVID-19 Vaccines, Sparks Debate

The Food and Drug Administration (FDA) has reportedly identified a concerning link between COVID-19 vaccines and the deaths of ten children between 2021 and 2024. A memo authored by Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research, outlines this connection. The memo was obtained by The Washington Post but has not yet been independently verified by other news organizations, including Scripps News.

The memo raises questions about how the FDA concluded that the vaccines caused these fatalities. During an interview with Fox News on Saturday, FDA Commissioner Martin A. Makary indicated that the findings could influence the vaccine approval process for COVID-19, influenza, and other vaccines. “We’re not just going to rubber-stamp new products that don’t work, that fail in a clinical trial,” Makary stated, emphasizing the importance of data in the approval process.

In addition to addressing the COVID-19 vaccine, the memo criticized the current framework for annual flu vaccines. It cited issues such as “low-quality evidence, poor surrogate assays, and uncertain vaccine effectiveness” derived from poorly conducted case-control studies. Makary and Prasad accused the Biden administration of withholding crucial data that indicates the risks associated with COVID-19 vaccines for children and young adults may outweigh their benefits.

Makary elaborated on the vaccine’s effectiveness, stating, “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. We saw a reduction in the severity of illness and lives saved.” He expressed concerns about the ongoing recommendation for children to receive multiple mRNA COVID-19 vaccines throughout their lives, stating, “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.”

As the debate continues, the Centers for Disease Control and Prevention (CDC) has updated its guidelines regarding COVID-19 vaccinations. The agency now recommends that children aged six months and older receive the vaccine only after consultation with a healthcare provider.

The American Academy of Family Physicians supports making COVID-19 vaccines available to families that wish to vaccinate their children but does not advocate for universal vaccination of all children. Meanwhile, the American Academy of Pediatrics continues to recommend booster shots for children considered at high risk and supports parents who choose to vaccinate their children.

The implications of the FDA memo are significant, potentially reshaping perceptions and policies surrounding COVID-19 vaccinations for children. As health authorities and policymakers navigate these complex issues, the conversation about the safety and efficacy of vaccines remains a critical public health concern.