FDA Memo Links 10 Child Deaths to COVID-19 Vaccines

A memo from the Food and Drug Administration (FDA) reportedly associates ten pediatric deaths from 2021 to 2024 with COVID-19 vaccines. Authored by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, the document was obtained by The Washington Post but has not been independently verified by other outlets, including Scripps News. The specifics regarding how the FDA linked these deaths to the vaccines remain unclear.

During a recent interview with Fox News, FDA Commissioner Martin A. Makary indicated that the findings in this memo could potentially lead to significant adjustments in the vaccine approval process for COVID-19, influenza, and other vaccines. He stated, “We’re not just going to rubber-stamp new products that don’t work, that fail in a clinical trial.” Makary emphasized the importance of data integrity in maintaining scientific credibility.

The memo further critiques the existing framework for the annual flu vaccine, pointing out issues such as “low-quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods.” Both Makary and Prasad have accused the Biden administration of withholding data that suggests the risks of approving COVID-19 vaccines for children and young adults may outweigh the benefits.

Makary remarked on the effectiveness of the COVID-19 vaccine for at-risk populations, particularly older individuals, during 2020 when it was well-matched to circulating variants. “We saw a reduction in the severity of illness and lives saved,” he noted. However, he raised concerns about the ongoing recommendation for children, saying, “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.”

In response to the evolving landscape of COVID-19 recommendations, the Centers for Disease Control and Prevention (CDC) has adjusted its guidelines, now advising that the vaccine for children aged six months and older should only be administered after consulting a physician. While the American Academy of Family Physicians supports the availability of COVID-19 vaccines for families that desire them, it stops short of an outright recommendation for all children.

The American Academy of Pediatrics advocates for booster shots for children at high risk, while also stating that vaccines should be accessible to parents who choose to vaccinate their children. This ongoing debate underscores the complexities of vaccine recommendations amid shifting data and public sentiment regarding COVID-19 vaccinations for younger populations.

As discussions continue to unfold, the implications of the FDA’s findings and the subsequent responses from health organizations could significantly shape public health policies and vaccine strategies moving forward.