Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY ® in Children 5 to under 12 Years of Age in the European Union
Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today 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 5 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 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 2/3 randomized, controlled trial that included ~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-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 2/3 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.
Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for pediatric doses, under their existing supply agreement with the EC. The companies do not expect the introduction of pediatric doses in the United States and the European Union, if authorized, to impact the existing supply agreements in place with governments and international health organizations around the world.
Pfizer and BioNTech have submitted requests for authorization 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 2 to under 5 years of age this quarter, and in 6 month to under 2 years of age in the first quarter 2022, with full data readouts to follow.
COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are ongoing.