A dose of Pfizer’s COVID-19 vaccine.Photo: Daniel Pockett/Getty
Pfizer/BioNTech says its COVID-19 vaccine is good to go for children ages 5 to 11 after its own study, with plans to seek approval from the Food and Drug Administration and other agencies soon.
On Monday, the companyissuedits first test results from this age group, reporting that there was a “favorable safety profile and robust neutralizing antibody responses” in the kids, using a smaller dose in the two shots than older people would receive (10 µg instead of 30 µg). They said the results showed the “vaccine was safe, well-tolerated” among children.
Pfizerearned FDA approval for its vaccineamong people ages 16 and up last month. The vaccine is stillunder emergency use approval for kids aged 12 to 15as the FDA continues to fully vet the shot.
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Results from the other two age groups from the trial (children 2 to 5 years and children 6 months to 2 years) are expected later this year.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech, in a statement. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
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source: people.com
