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FDA Panel Recommends Approval Of Pfizer COVID-19 Vaccine For Kids Aged 5-11

(Photo by Michael M. Santiago/Getty Images)

Dylan Housman Healthcare Reporter
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The Food and Drug Administration’s (FDA) panel of vaccine experts voted Tuesday to recommend approval of Pfizer’s COVID-19 vaccine for children aged 5-11.

The agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0 with one abstention that, based on the totality of scientific evidence available the benefits of the Pfizer vaccine outweigh the risks for children 5-11 years of age. It will now be up to top FDA leadership to grant approval for the shot, at which point the Centers for Disease Control and Prevention (CDC) and its vaccine experts will make an official recommendation on its use.

The scientists, doctors and public health experts who make up VRBPAC debated the risk of kids developing myocarditis from vaccination versus COVID-19 itself, and whether or not tens of millions of children need to be vaccinated even if healthy and at low risk of complications from the virus. (RELATED: Some Of The CDC’s Own Advisers Doubt The Need For Universal COVID Boosters)

The panel reviewed data which showed that the risk of developing myocarditis from vaccination is lower in kids than the risk of developing it from COVID-19 at current infection rates. However, if infection rates drop to the lowest levels of the pandemic, the risk-reward becomes far more balanced. Still, members of the panel pointed out that myocarditis from vaccination appears to be more common in adolescents than kids aged 5-11, and hospitalizations from COVID-induced myocarditis have been more serious than those caused by vaccination.

Pfizer’s dose for kids aged 5-11 is just one-third the amount of the dose for ages 12 and older, and side effects reported in clinical trials were similar for young children to those reported in other age groups. Dr. Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, pointed out to the panel that their decision today would not necessitate any kind of mandate or other public policy, which would be determined by other agencies.

Since the COVID-19 pandemic began, nearly two million kids aged 5-11 have been infected, Marks said. Only 166 children aged 5-11 have died of COVID-19 since the start of the pandemic, according to CDC data.