The recommendation was for the use of BNT162b2 for immunization to prevent COVID-19 in individuals 16 years of age and older. CHMP advisors based their recommendation on scientific evidence provided by Pfizer and BioNTech including data from a phase III clinical trial which was published in the New England Journal of Medicine on December 10.

Based on the CHMP opinion, the European Commission (EC) is expected to make a final decision on the CMA soon. If the EC grants the EMA, the decision will be immediate applicable to all 27 European Union member states.

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Various announcements and updates regarding the Pfizer-BioNTech COVID-19 vaccine were made during the weekend and on Monday, December 14. These included...

FDA issues EUA for Pfizer, BioNTech COVID-19 vaccine
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. The move comes after...

FDA in final stages before issuing Pfizer, BioNTech EUA
The U.S. Food and Drug Administration (FDA) has informed Pfizer and BioNTech that it will work rapidly toward the finalization and issuance of an emergency...

Pfizer, BioNTech's COVID-19 vaccine shows 95% efficacy
In a trial of more than 40,000 participants, Pfizer-BioNTech's COVID-19 vaccine showed a 95% efficacy against the SARS-CoV-2 virus, according to results...

FDA committee gives nod to move Pfizer, BioNTech COVID-19 vaccine toward EUA
A COVID-19 vaccine candidate from Pfizer-BioNTech, BNT162b2, passed a major milestone today when a U.S. Food and Drug Administration (FDA) advisory committee...