In a statement on Friday, the two companies said they had applied for their conditional market authorization to be expanded in the EU, allowing adolescents to receive the jab. The pair had already submitted a similar request to the US Food and Drug Administration earlier in April.
The firms said that their vaccine had been tested on 2,260 participants aged 12 to 15 years and was “generally well tolerated”. “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,” the statement read.
The Pfizer/BioNTech jab was the first approved by the EU’s drug regulator, and has been widely used across the 27-nation bloc with additional orders made. Currently the European Medicines Agency has authorized the use of the jab in people over the age of 16.BioNTech CEO Ugur Sahin told Der Spiegel earlier this week that he expects the analysis of trial data to take between four and six weeks, meaning adolescents may be able to receive the jab as early as June.
Speaking on Thursday, German Health Minister Jens Spahn said that vaccinations for children over the age of 12 would take place during the summer holidays, but suggested the current immunization schedule may not allow that in June, with only 25% of Germans having received at least one shot so far.