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EU regulator approves Pfizer-BioNTech vaccine booster for ages 12 to 17

Pfizer Inc. and BioNTech 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® as a booster dose (30ug) at least six months after the second dose in adolescents 12 through 17 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, the decision will be immediately applicable to all 27 EU member states, making booster vaccines available to everyone 12 years and older.

The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel. The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available.

The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) earlier this year as an expansion to the existing EUA for the primary series. The companies are also planning to file the data with other regulatory authorities in the coming weeks. The Pfizer-BioNTech COVID-19 Vaccine is currently the only COVID-19 vaccine authorized for this age group both in a primary series as well as a booster in the U.S. and Europe.

Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the EC. The companies do not expect the introduction of booster doses for adolescents 12 through 17 years of age in the EU, if authorized, to impact the existing supply agreements in place with governments and international health organizations around the world.

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.


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