Pfizer/BioNTech submit initial data on Covid-19 vaccine for people ages 5 to 11 to FDA, but aren't seeking EUA yet

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. This is the first submission of data to the FDA for a Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.