Pfizer and BioNTech have submitted data supporting the vaccination of children 5 to <12 years of age with COMIRNATY® (COVID-19 mRNA vaccine) to the European Medicines Agency (EMA) for a variation of the Conditional Marketing Authorization (CMA) in the European Union (EU).
The variation request includes data from a Phase 2/3 study, which is enrolling children 6 months to <12 years of age. The 2,268 participants who were 5 to <12 years of age received a 10-µg 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 antibody responses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30-µg doses. 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 5 to <12 years of age.
The same data have been submitted to the U.S. Food and Drug Administration and will be filed with other regulatory authorities in the coming weeks. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.