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Pfizer, BioNTech Children's Vaccine to be  Reviewed by FDA Advisory Group

The Vaccines and Related Biological Products Advisory Committee will review data and recommend whether the FDA should authorize use.

Advisors to the U.S. Food and Drug Administration are meeting Tuesday to discuss whether to endorse Pfizer  (PFE) - Get Pfizer Inc. Report and BioNTech's  (BNTX) - Get BioNTech SE Sponsored ADR Report vaccine for use in young children. 

The panel, known as the Vaccines and Related Biological Products Advisory Committee, is expected to review data and vote to recommend whether the FDA should authorize use, the Wall Street Journal reported Tuesday. 

The FDA must clear the vaccine before it can be used outside of testing. The agency does not have to accept decisions by the panel, but a positive recommendation could go a long way towards the FDA approving the treatment for children five to 11 years old.

The panel is reportedly likely to debate the risk of a heart inflammation condition known as myocarditis that has been found in a some young men who have received messenger RNA vaccines. 

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U.S. health authorities have said that the risk of myocarditis appears highest in young men and male adolescents after their second dose of mRNA vaccines. 

Earlier this month, Pfizer and BioNTech officially requested emergency use authorization for the children's shot. 

Nearly 5.9 million children have been infected with COVID-19 since the pandemic started, according to the American Academy of Pediatrics.

Pfizer is the only fully approved FDA vaccine for individuals 16 and over, and is also authorized for emergency use in children aged 12 to 15.

Last week, the FDA said that results from the late-stage study of the companies' vaccine met the criteria for immune responses in children. The FDA also confirmed data from the company showing that the shot was found to be safe and nearly 91% effective at preventing symptomatic Covid-19.