The Pfizer-BioNTech COVID-19 vaccine has demonstrated 100 percent efficacy and robust antibody responses in a Phase 3 trial in adolescents 12 to 15 years of age, the two companies announced on Wednesday.
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 initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant,” said Ugur Sahin, CEO and co-founder of BioNTech.
“It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” Sahin said.
The two companies plan to submit these data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency as soon as possible to request expansion of the Emergency Use Authorisation and EU Conditional Marketing Authorization for BNT162b2.
“We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorisation 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 the next school year,” said Albert Bourla, Chairman and Chief Executive Officer of Pfizer.
The FDA authorised Pfizer-BioNTech COVID-19 vaccine for emergency use in the United States in December last year.
The vaccine, the first that got FDA approval in the country, was authorised for use in individuals 16 years of age and older.