In a Phase 3 trial in adolescents 12-15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants 6-25 years of age, according to a news release.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We plan to submit these data to FDA as a proposed amendment to our emergency use authorization 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.”
The trial enrolled 2,260 adolescents 12-15 years of age in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group, compared with none in the vaccinated group.
Pfizer and BioNTech plan to submit the data for scientific peer review for potential publication.
Last week, Pfizer and BioNTech dosed the first healthy children in a global Phase 1/2/3 seamless study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 11 years of age.
