On May 28, 2021, Pfizer and BioNTech announced that the Conditional Marketing Authorization for COMIRNATY in the European Union (EU) had been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The extended indication for the CMA for COMIRNATY^® is valid in all 27 EU member states.

COMIRNATY^® was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents. Distribution and administration of COMIRNATY^® by the EU member states will continue to be determined according to the populations identified in the EU and per national guidance.

The EU decision is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Participants received two 30 μg doses of the COVID-19 vaccine. Results from this trial, which were published in The New England Journal of Medicine on May 27, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine was also generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

In addition, the pediatric study evaluating the safety and efficacy of the COVID-19 vaccine in children 6 months to 11 years of age is ongoing. Pfizer and BioNTech expect to have definitive readouts and, subject to the data generated, submit for an Emergency Use Authorization (e.g., in the U.S.) or a variation to Conditional Marketing Authorizations (e.g., in the EU) for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children 6 months to 2 years of age are expected in the fourth quarter.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.