Meanwhile, the first children were dosed last week in a global Phase 1/2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine in children aged 6 months to 11 years old.
In the US (and many other jurisdictions), the vaccine is currently authorized for people aged 16+, although vaccination campaigns have prioritised older populations. But Albert Bourla, chairman and CEO of Pfizer, and Ugur Sahin, CEO and Co-founder of BioNTech, say that vaccinating children will help global efforts to curb the virus.
“Across the globe, we are longing for a normal life,” said Sahin. “This is especially true for our children. 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.
“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.”
The Phase 3 trial
The Phase 3 trial covered 2,260 adolescents in the US. In the trial, 18 cases of COVID-19 were observed in the placebo group, compared to none in the vaccinated group.
“Vaccination with BNT162b2 elicited SARS-CoV-2–neutralizing antibody geometric mean titers of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose,” report the companies.
“This compares 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 companies plan to submit these data to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for a requested amendment to the Emergency Use Authorization of BNT162b2 and the EU Conditional Marketing Authorization for COMIRNATY to expand use in adolescents 12-15 years of age as quickly as possible.