The German laboratory BioNTech is about to present to the European Union (EU) an application for its vaccine against COVID-19, developed together with the American Pfizer, to be authorized among young people between 12 and 15 years of age from June.
“In Europe, we are in the last stages before submitting” data from clinical trials to the European Medicines Agency (EMA) and validation “will take between four and six weeks,” said Ugur Sahin, co-founder and director of BioNTech at German weekly Spiegel. So far, this vaccine is licensed only for people over 16 years of age.
In the United States, BioNTech and its partner Pfizer already presented a petition in early April to expand the vaccination authorization and reach the population between 12 and 15 years old.
This request is based on data from phase 3 clinical trials in this age group published at the end of March that “demonstrated 100% efficacy” in preventing the disease, according to these laboratories. The vaccine was also “well tolerated and the side effects seen were in line with those recorded” among people between the ages of 16 and 25, the labs said.
For children between 5 and 12 years old, Sahin estimates that there will be more clinical data in July and that everything indicates that there could be an authorization in September, when the children return to class in the northern hemisphere.
Sahin estimated that in Europe it will be possible to reach a “herd immunity in July or at the latest in August”, and showed his confidence in the vaccine against new variants of the virus such as the one registered in India.