The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States. In the trial, 18 cases of Covid-19 were observed in the placebo group versus none in the vaccinated group.
The vaccine, BNT162b2, elicited SARS-CoV-2-neutralising antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose, according to a report of the two companies.
The results exceeded those recorded earlier in vaccinated participants aged 16 to 25 years old, said the report.
The two companies plan to submit these data to the US Food and Drug Administration and the European Medicines Agency as soon as possible to request expansion of the Emergency Use Authorisation and EU Conditional Marketing Authorisation for BNT162b2. — Bernama