CHMP recommends approval of Comirnaty for children 5 to under 12 years with COVID-19.

The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. If the EC grants the variation regarding a vaccination in this age group, the decision will be immediately applicable to all 27 EU member states. If approved, Comirnaty will be the first COVID-19 vaccine authorized in the European Union for individuals 5 to under 12 years of age.

The positive opinion adopted by the CHMP is based on scientific evidence shared by the companies, including results from a Phase II/III randomized, controlled trial that included about 4,500 children 5 to under 12 years of age (2,268 from the original group and 2,379 from the supplemental safety group). Participants in this age group received a two-dose regimen of 10-µg doses administered 21 days apart, as compared to the 30-microg doses used in individuals 12 years and older. This dose level was carefully selected for use in the trial based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study.

The Phase II/III trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose, during a period when Delta was the prevalant strain. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine.