A U.S. Food and Drug Administration advisory committee is set to meet Tuesday to decide whether it is safe for young children to receive a COVID-19 vaccine.
The FDA’s Vaccines and Related Biological Products Advisory Committee will decide whether to recommend the Pfizer-BioNTech vaccine for children ages 5 to 11 years old.
On Friday, the FDA posted its analysis of Pfizer’s clinical trials ahead of Tuesday’s meeting. Researchers said they found that the vaccine was effective in preventing hospitalization and death in the age group, weighed against potential serious side effects. of taking the vaccine.
FDA scientists said they were able to confirm the results from Pfizer testing that showed the vaccine was nearly 91% effective at preventing symptomatic infection in young children. No new or unexpected side effects were found, according to the FDA.
The study did address cases of myocarditis that were seen after the second dose of the vaccine in older, mostly male teens and young men. The agency noted that the study wasn’t large enough to have detected cases of the heart inflammation or other such rare side effects.
The Centers for Disease Control and Prevention says COVID-19 has killed more than 637 Americans aged 18 and under.
Nearly 6.2 million children have been infected with the coronavirus with more than 1.1 million cases in the last six weeks, according to the American Academy of Pediatrics.
If the FDA advisory board approves the vaccine for use in the age group, a CDC advisory group would have to approve it and the CDC director would have to sign off on the guidance. Children could be able to begin getting the vaccinations anytime after that.
Should the vaccine be approved by the FDA and CDC for use in children ages 5-11, the Biden administration says it has purchased enough doses for everyone in that age group in America.
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