The Pfizer/BioNTech group announced on Friday 30 April that it had submitted an application to the European Medicines Agency (EMA) to extend the authorisation of its Covid-19 vaccine so that it could be administered to young people aged 12 to 15 years.
The two companies explained in a statement that the request is based on data from a pivotal phase 3 clinical trial that involved 2,260 participants aged 12–15 years.
“Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses”, they detailed in a statement, adding that the vaccine was “generally well tolerated” during the trial.
A similar application to the one submitted to the EMA has also been made to the U.S. Food and Drug Administration (FDA) who are responsible for authorising the marketing of medicines in the United States. Pfizer and BioNTech say they will also approach other regulatory authorities around the world regarding this issue.
The European Union is counting on the delivery of 250 million doses of the vaccine developed by the two companies (see EUROPE 12698/1) in the second quarter. (Original version in French by Agathe Cherki)