Pfizer-BioNTech COVID-19 Vaccine Shows Positive Topline Results in Adolescents

The results from a phase 3 trial in a population of 2260 American adolescents aged 12 to 15 years found that the Pfizer-BioNTech COVID-19 vaccine BNT162b2 showed 100% efficacy and robust antibody responses. Additionally, the level of efficacy exceeded those recorded in earlier study participants aged 16 to 25 years, according to a Pfizer press 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, in the press release. “We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization [EUA] 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.”

During the trial, the investigators observed 18 cases of COVID-19 among the placebo group (n=1129), while no cases were recorded among the vaccinated group (n=1131). In the latter group, the investigators found that BNT162b2 induced SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1239.5, which demonstrates there was a strong level of immunogenicity in a subset of adolescents 1 month following the second vaccine dose.

In the earlier analysis assessing BNT162b2 in participants aged 16 to 25 years, GMTs of 705.1 were recorded. This shows that the adolescent population GMTs were non-inferior in comparison with this older population. Further, in the adolescent population, adverse effects to BNT162b2 administration were also generally consistent with those observed in participants aged 16 to 25 years.

As quickly as possible, Pfizer and BioNTech plan to submit a request for an amendment to the EUA for BNT162b2 to the FDA and EMA based on these data that expands the use of the vaccine to include adolescents aged 12 to 15 years. In addition, participants who were enrolled in the phase 3 trial will continue to be monitored for an additional 2 years to further assess long-term protection and safety following the second dose.

“Across the globe, we are longing for a normal life. This is especially true for our children,” said Ugur Sahin, CEO and co-founder of BioNTech, in the press release. “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.”

REFERENCE

Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents. New York, NY: Pfizer and BioNTech; March 31, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal. Accessed March 31, 2021.