Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced Friday that they have submitted a request to expand conditional marketing authorization or CMA of their Covid vaccine Comirnaty (BNT162b2) in the European Union to adolescents.
The companies submitted a variation to the CMA in the EU to the European Medicines Agency or EMA to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, 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 for the Emergency Use Authorization or EUA. They also plan to request additional amendments with other regulatory authorities worldwide.
Comirnaty has already been granted CMA by the European Commission to prevent COVID-19 in people from 16 years of age.
The latest submission is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial 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 also was generally well tolerated. Participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
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