BioNTech Up; Seeks to Expand EU CMA of Covid-19 Vaccine to Adolescents

By Michael Dabaie

BioNTech SE ADRs rose 7% to $191.84 in Friday morning trading.

Pfizer Inc. and BioNTech earlier said they submitted a request to expand conditional marketing authorization of Covid-19 vaccine Comirnaty in the EU to adolescents.

The companies said they submitted to the European Medicines Agency to request an extension of the indication for use in adolescents 12 to 15 years of age.

The companies already submitted a similar request to the U.S. Food and Drug Administration for the Emergency Use Authorization and plan to request additional amendments with other regulatory authorities worldwide.

The 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 the 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, the companies said.

The Pfizer-BioNTech Covid-19 vaccine has been granted conditional marketing authorisation by the European Commission to prevent Covid-19 in people from 16 years of age.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

04-30-21 1050ET