Positive top-line results for Comirnaty COVID-19 vaccine in children 5 to 11 years

20 September 2021

Results from a Phase II/III trial of Comirnaty showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10µg administered 21 days apart, a smaller dose than the 30µg dose used for people 12 and older, were announced today by Pfizer (NYSE: PFE) and German partner BioNTech (Nasdaq: BNTX).

The antibody responses in the participants given 10µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30µg doses. The 10µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group.

Comirnaty has been one of the most successful vaccines in the fight against the COVID-19 pandemic, generating sales of $7.8 billion in the second quarter of this year and the company expects full-year sales to hit $33.5 billion.

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