Pfizer, BioNTech submit expanded CMA to EMA for COVID-19 vaccine

By The Science Advisory Board staff writers

April 30, 2021 -- Pfizer and BioNTech announced on Friday they have submitted regulatory documents in the European Union (EU) for use of their COVID-19 vaccine Comirnaty in adolescents 12 to 15 years of age.

The companies submitted a variation to the conditional marketing authorization (CMA) for the vaccine to the European Medicines Agency (EMA). If approved, the amended CMA will be valid in all 27 member states of the EU.

The companies have already submitted a similar request to the U.S. Food and Drug Administration (FDA) for emergency use authorization for the vaccine and plan to request additional amendments with other regulatory authorities worldwide.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech's messenger RNA (mRNA) technology, was developed by both BioNTech and Pfizer. BioNTech is the marketing authorization holder in the EU, and the holder of emergency use authorizations in the U.S. (jointly with Pfizer), U.K., Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.

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