Pfizer/BioNTech submit initial data on Covid-19 vaccine for people ages 5 to 11 to FDA, but aren't seeking EUA yet
CNN
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, but are not yet seeking emergency use authorization.
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.
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