Pfizer-BioNTech submit COVID-19 vaccine data to FDA for kids 5-11
Companies expect to request emergency approval for the shot in kids ages 5 to 11 in coming weeks
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Pfizer-BioNTech submitted clinical trial data from a COVID-19 vaccine study among kids ages 5-11 to the Food and Drug Administration (FDA), the companies announced Tuesday. A request for emergency approval is anticipated to follow in the coming weeks.
Trial data included findings released last week among 2,268 participants ages 5-11, which suggested the smaller dose shot was safe, well tolerated and resulted in neutralizing antibody responses.
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"It's official: We have submitted initial data from the pivotal trial of our COVID-19 vaccine in children 5 to under 12 years of age to the @US_FDA," Pfizer CEO Albert Bourla wrote in a Tweet on Tuesday.
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"These data have been shared with the FDA for the Agency’s initial review," reads a company release posted Tuesday. Pfizer-BioNTech also intend to submit the data to other regulatory authorities, including the European Medicines Agency (EMA).
Meanwhile, trial results on younger age groups, like children ages 6 months to under 5 years, are expected by the fourth quarter. The companies also plan to submit data from the late-stage trial to a peer-reviewed publication.