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Pfizer-BioNTech Children's Vaccine Backed by FDA Advisory Panel

A panel advising the FDA recommended the Pfizer-BioNTech vaccine for kids. The decision now rests with the agency.

A U.S. Food and Drug Administration advisory committee recommended a lower dose of Pfizer  (PFE) - Get Pfizer Inc. Report and BioNTech's  (BNTX) - Get BioNTech SE Sponsored ADR Report Covid-19 vaccine for children ages 5 to 11.

The Vaccine and Related Biological Products Advisory Committee endorsed the vaccine and the FDA will now consider the recommendation. The agency could issue a final decision in the coming days. 

Next week the Centers for Disease Control and Prevention advisory group is expected to make its own recommendation on the vaccine. 

The biggest issue working against the children's vaccine is the risk of myocarditis, which appears highest in young men and male adolescents after their second dose of mRNA vaccines.

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

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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.

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

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.

Last week, the New York health-care group and its Mainz, Germany, partner told the U.S. Food and Drug Administration that their Covid-19 vaccine was 90.7% effective for children ages 5 to 11.