Vinay Prasad, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, reportedly authored a memo stating the agency has identified 10 pediatric deaths from 2021-24 directly linked to COVID-19 vaccines.
The memo, obtained by The Washington Post, has not been independently confirmed by Scripps News. It is unclear how the FDA determined the vaccines caused the deaths.
During an interview with Fox News on Saturday, FDA Commissioner Martin A. Makary suggested the memo could lead to changes in the approval process for COVID-19, flu and other vaccines.
“We’re not just going to rubber-stamp new products that don’t work, that fail in a clinical trial,” Makary told Fox News. “It makes a mockery of science if we’re just going to rubber-stamp things with no data.”
The memo also suggested changes to the annual flu vaccine framework, criticizing “low-quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods.”
Makary and Prasad accused the Biden administration of concealing data showing the risks outweighed the benefits of approving COVID-19 vaccines for children and young adults.
“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 said. “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 has scaled back its COVID-19 guidelines, recommending the vaccine for children ages 6 months and older only after consulting a doctor.
The American Academy of Family Physicians supports making COVID-19 vaccines available to any family that wants them but stops short of recommending them for all children.
The American Academy of Pediatrics recommends boosters for children at high risk and says vaccines should be available for parents who choose them.
