BioNTech in ‘final stages’ before seeking EU approval to give teenagers vaccine

Trial results for use of Pfizer-BioNTech vaccine in babies expected in September

The results of trials testing the use of the Pfizer-BioNTech in children aged between five and 12 are expected in July. Photograph: Laetitia Vancon/New York Times

The chief executive of BioNTech, Ugur Sahin, has said the company is in the "final stages" before seeking approval from European regulators to administer its Covid-19 vaccine, jointly made with Pfizer, to children aged 12 and over.

BioNTech and Pfizer asked regulators in the United States this month to approve emergency use of their vaccine for adolescents aged 12 to 15.

A trial published at the end of March found the companies’ Covid-19 vaccine was safe, effective and produces robust antibody responses in adolescents.

The Pfizer/BioNTech two-shot vaccine is already authorised for use in those aged 16 and above.


Meanwhile, BioNTech expects results by September from trials testing the Covid-19 vaccine in babies as young as six months old, Mr Sahin told German magazine Spiegel.

“In July, the first results could be available for the five to 12 year olds, in September for the younger children,” he said, adding that it takes about four to six weeks to evaluate the data.

“If all goes well, as soon as the data is evaluated, we will be able to submit the application for approval of the vaccine for all children in the respective age group in different countries,” he said.

Young people are less likely to suffer severe cases of Covid-19 and more likely to have asymptomatic infection, allowing them to unwittingly transmit the virus to others. – Reuters