Pfizer and BioNTech on Wednesday, 31 March, announced that the phase 3 trial of their COVID-19 vaccine on adolescents of ages 12-15 had shown 100 percent efficacy and “robust antibody responses”.
A press release from the company said that the response evoked by the vaccine exceeded what was recorded in participants in vaccine trials aged 16-25 years, and it was well tolerated by the 2,260 adolescents who were part of the trial.
The companies said that they planned to submit the data to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to expand emergency-use authorisation of the vaccine among adolescents aged 12-15 years as quickly as possible.
At the moment, the vaccine is authorised in the US for emergency use in people over the age of 16.
“We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“We plan to submit the data to FDA as a proposed amendment to our emergency-use authorisation in the coming weeks and to other regulators around the world, with the hope of starting vaccination of this age group before the beginning of the next academic year,” he added.
Speaking about the need to vaccinate children under the age of 18, Ugur Sahin, CEO and Co-founder of BioNTech, said, “It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.”
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