Pfizer and BioNTech have submitted a request for European Union drug regulators to extend the approval of the companies’ coronavirus vaccine to include children aged 12 to 15.
The move could offer younger and less at-risk populations in Europe access to the shots for the first time.
In a statement on Friday, the two companies said their submission to the European Medicines Agency was based on an advanced study in more than 2,000 adolescents that showed the vaccine to be safe and effective. The children will continue to be monitored for longer-term protection and safety for another two years.
BioNTech and Pfizer previously had requested their emergency use authorization with the US Food and Drug Administration also be extended to children 12-15.
The Covid-19 vaccine made by Pfizer and BioNTech was the first one to be granted a greenlight by the EMA in December, when it was licensed for anyone age 16 and over across the 27-nation EU.
Meanwhile, Pfizer and Moderna have both begun vaccine trials on the youngest age group yet, with parental consent.
In the phase one trial for Pfizer, kids will receive their second dose 21 days after their first. For Moderna, it will be 28 days later. This is referred to as a “dosing” trial, allowing researchers to determine how much vaccine children can tolerate and how to protect them.
The second phase will involve splitting subjects into a placebo and a treatment group.
As for Pfizer, their study involves 5,000 children nationwide, and they expect to have results by the winter. “Together with our partner BioNTech, we have dosed the first healthy children in a global Phase study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in preventing Covid-19 in healthy children 6 months to 11 years old,” a spokesperson for Pfizer said in a statement.
“We are proud to start this much needed study for children and families eagerly awaiting a possible vaccine option,” they added. “We anticipate early safety results from this study could be available in the second half of 2021.”