Pfizer submits data on Covid-19 vaccine for kids ages 5 to 11 to FDA
Pfizer and BioNTech said Tuesday they have submitted Covid-19 vaccine data on children ages 5 to 11 to the US Food and Drug Administration for initial review.
A formal submission to request EUA for the vaccine is expected to follow in the coming weeks, the companies said in a statement.
Submissions to the European Medicines Agency and other regulatory authorities are also planned, they said.
The Companies announced positive topline results from the pivotal trial on September 20, 2021. In the trial, which included 2,268 participants 5 to <12 years of age, the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses. These results – the first from a pivotal trial of any COVID-19 vaccine in this age group – were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 μg doses. The 10 μg dose was carefully selected as the preferred dose ...
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