Submissions to the European Medicines Agency and other regulatory authorities are also planned, they said.
This is the first data submission to the FDA for a Covid-19 vaccine for young children. The Pfizer / BioNTech vaccine is approved for people 16 years of age and older and has an EUA for people 12 to 15 years of age.
Pfizer CEO Albert Bourla said he was unsure how long this process will take.
‘I think it is not appropriate for me to comment on how long the FDA will take to review the data
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