The application includes data results from the companies’ clinical trial of 2,228 participants aged between 12 and 15 years, the release said.
“Pfizer Inc. and BioNTech SE today announced they have submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration [FDA] to expand the approval of COMIRNATY (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years,” the press release said on Thursday.
In the coming weeks, Pfizer and BioNTech are planning to use the same clinical data to apply for an approval with the European Medicines Agency as well as other regulatory authorities around in the world, the release added.
On May 10, FDA issued an emergency authorization for the Pfizer-BioNTech COVID-19 vaccine for use in adolescents 12-15 years of age. Should FDA clear the new application, the Pfizer-BioNTech will become the first vaccine manufacturer with the full license for inoculating this age group.