Positive topline data from a phase 3 trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescent participants demonstrated 100% efficacy and strong antibody responses.
The pivotal phase 3 trial enrolled 2260 participants 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection in the United States. Participants were randomly assigned 1:1 to receive 2 intramuscular injections of either BNT162b2 (n=1131) or placebo (n=1129) spaced 21 days apart.
Findings showed that BNT162b2 demonstrated a vaccine efficacy of 100% with no cases of COVID-19 compared with 18 cases in the placebo group. Vaccination with BNT162b2 also showed strong immunogenicity 1 month after the second dose, eliciting SARS-CoV-2 neutralizing antibody geometric mean titers (GMTs) of 1239.5. This was noninferior to the GMTs (705.1) elicited by participants 16 to 25 years of age reported in a previous analysis. The vaccine was well tolerated with a consistent side effect profile with that seen in participants 16 to 25 years of age.
Pfizer and BioNTech will request Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) to expand use in adolescents 12 to 15 years of age, as soon as possible. The Companies plan to submit study data for scientific peer review for potential publication.
“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 CEO, 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.”
Additionally, the Companies have dosed the first healthy children in a global phase 1/2/3 seamless study to evaluate BNT162b2 in children 6 months to 11 years of age.
In December 2020, BNT162b2 was granted EUA by the FDA for active immunization to prevent COVID-19 in individuals 16 years of age and older. The vaccine is administered intramuscularly as a 2-dose series (0.3mL each) spaced 21 days apart.
Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents. [press release]. New York, NY and Mainz, Germany: Pfizer Inc. and BioNTech SE; March 31, 2021.