Covid-19 roundup: Pfizer/BioNTech submit vaccine data to FDA for younger children; Doctors kept prescribing hydroxychloroquine
Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.
A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.
The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.
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