Pharmaceuticalcompanies Pfizer and BioNTech on Wednesday announced that their Covid-19vaccine -BNT162b2 demonstrated 100 per cent efficacy and robust antibodyresponses in a Phase 3 trial in adolescents between 12 to 15 years old.
ThePhase 3 clinical trial enrolled 2,260 adolescents aged between 12 to 15 yearsold in the US.
"Weshare the urgency to expand the authorisation of our vaccine to use in youngerpopulations and are encouraged by the clinical trial data from adolescentsbetween the ages of 12 and 15," Albert Bourla, Chairman and Chief ExecutiveOfficer, Pfizer, said in a statement.
Inthe trial, 18 cases of Covid-19 were observed in the placebo group (n=1,129)versus none in the vaccinated group (n=1,131).
Vaccinationwith BNT162b2 elicited SARS-CoV-2-neutralising antibody geometric mean titres(GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset ofadolescents one month after the second dose.
Thiscompared well (was non-inferior) to GMTs elicited by participants aged 16 to 25years old (705.1 GMTs) in an earlier analysis. Further, BNT162b2 administrationwas well tolerated, with side effects generally consistent with those observedin participants 16 to 25 years of age.
TheBNT162b2 has not been approved or licensed by the US Food and DrugAdministration (FDA), but has been authorised for emergency use by FDA under anEmergency Use Authorization (EUA) to prevent Covid-19 for use in individuals 16years of age and older.
"Weplan to submit these data to FDA as a proposed amendment to our Emergency UseAuthorisation 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 thenext school year," Bourla added.