Pfizer and BioNTech have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine Comirnaty? in children five to under 12 years of age. 

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 authorised in the EU for individuals five 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 randomised, controlled trial that included about 4,500 children five 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-μg 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 favourable safety profile, robust immune responses and a vaccine efficacy rate of 90.7 percent in participants without prior SARS-CoV-2 infection, measured from seven days after the second dose, during a period when Delta was the prevalent strain. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine.

In addition, Pfizer and BioNTech have submitted requests for authorisation of their COVID-19 vaccine in this age group to other regulators around the world. The companies expect initial pivotal data from their ongoing clinical trial in two to under five years of age this quarter, and in six months to under two years of age in the first quarter 2022, with full data readouts to follow.