Pfizer/BioNTech’s Covid-19 vaccine’s clinical trial results showed 100% efficacy and that it’s well-tolerated in youths ages 12 to 15, the companies announced on Wednesday.
The companies plan to submit the data to the FDA as soon as possible for expanded emergency use authorization of their vaccines to adolescents.
In a Phase 3 trial of 2,260 participants ages 12 to 15 in the US, the vaccines elicited robust antibody responses one month after the second dose, exceeding those demonstrated in adults, Pfizer reported.
The participants will be monitored for two years after receiving the second dose to ensure safety and protection.
“We share the urgency to expand the authorization 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 Pfizer CEO Albert Bourla.
“We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
A return to the classroom isn’t the only factor at play, as health experts emphasize the importance of protecting as many people as possible through vaccination.
“We all long for a normal life. This is especially true for our children,” said BioNTech CEO Ugur Sahin.
“The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant.”
Pfizer recently announced that the safety demonstrated in this adolescent trial helped the company decide to begin testing its vaccine in younger children.