NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) and BioNTech SE's (BNTX) COVID-19 vaccine has received the conditional marketing authorization in the European Union for use in adolescents 12 to 15 years of age.
The authorization of the vaccine Comirnaty (BNT162b2) is valid in all 27 EU member states.
The EU decision was based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Participants received two 30 ?g doses of the COVID-19 vaccine. Results from the trial, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses.
Comirnaty has already received the conditional marketing authorization from the European Commission to prevent COVID-19 in people from 12 years of age.
In addition, Pfizer Inc. (PFE) and BioNTech said that 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 submit for an Emergency Use Authorization or a variation to Conditional Marketing Authorizations 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.
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