Pfizer-BioNTech Covid vaccine shows 100% efficacy in adolescents
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New York: Covid-19 vaccine -BNT162b2 -demonstrated 100 per cent efficacy and robust antibody responses in a Phase 3 trial in adolescents between 12 to 15 years old, announced Pharmaceutical companies Pfizer and BioNTech on Wednesday
The Phase 3 clinical trial enrolled 2,260 adolescents aged between 12 to 15 years old in the US.
In the trial, 18 cases of Covid-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131).
Vaccination with BNT162b2 elicited SARS-CoV-2-neutralising antibody geometric mean titres (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose.
This compared well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. Further, BNT162b2 administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age.
The BNT162b2 has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorised for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Covid-19 for use in individuals 16 years of age and older.
(From IANS with edits)