BRIEF—Comirnaty data filed with EMA for 5-12 year olds

Pfizer and German partner BioNTech today said they had submitted data supporting the vaccination of children aged five to <12 years with Comirnaty (COVID-19 mRNA vaccine) to the European Medicines Agency for a variation of the Conditional Marketing Authorization (CMA) in the European Union (EU).

The variation request includes data from a Phase II/III study, which is enrolling children six months to <12 years of age. The 2,268 participants who were five to <12 years of age received a 10µg dose level in a two-dose regimen administered 21 days apart.

In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose.

The COVID-19 vaccine was well tolerated in the younger age group.

The 10-µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children five to <12 years of age.

The same data have been submitted to the US Food and Drug Administration and will be filed with other regulatory authorities in the coming weeks.