German drugmaker BioNTech and its US partner Pfizer announced that they have filed an application for approval of their Covid vaccine for 12- to 15-year-olds on Friday, paving the way for a license in June.
Based on a clinical study showing 100% efficacy for this age group, the drugmakers applied for an extension of the authorisation granted so far for people over 16, according to a statement. Such a process usually takes between four and six weeks.
The two companies had already filed a similar request in the US for an extension of the FDA's emergency approval in early April.
The applications are based on data from a phase 3 clinical study published at the end of March. The study showed the vaccine was also “generally well tolerated.”
Side effects were “generally consistent with those observed” in people aged 16 to 25, Pfizer and BioNTech said at the end of March.
No vaccine currently exists for children, who are less likely to suffer severe cases of the disease and whose vaccination has not been a priority until now.
The Brussels Times
