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Pfizer-BioNTech Vaccine Shown Highly Effective in Young Adolescents

Before long, pharmacists shouldn’t be surprised if they see more youngsters in line for COVID-19 shots. Not only are states increasingly opening up vaccination to everyone, but Pfizer-BioNTech has released results of a new trial indicating very high efficacy and safety in the 12-15-year-old age group for the vaccine, which already has emergency use authorization for those aged 16 or older. Here is more information.

NEW YORK - More adolescents could soon be eligible for the Pfizer-BioNTech vaccine if the Food and Drug Administration signs off on expanding its emergency use authorization with data from a new trial.

The COVID-19 vaccine now has an EUA for those 16 and older.

Based on new trials, the companies announce that, in participants 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis. The press release also advises that the vaccine was well tolerated in the younger group.

The companies say they plan to submit the data to the FDA and the European Medicines Agency (EMA) as soon as possible to request expansion of the EUA.

The companies also provided an update on the Phase 1/2/3 study of BNT162b2 in children aged 6 months to 11-years-old.

https://www.businesswire.com/news/home/20210331005503/en/

“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, which enrolled 2,260 adolescents 12 to 15 years of age in the United States, had 18 cases of COVID-19 observed in the1,129-member placebo group vs. none in the vaccinated group of 1,131 participants. The study reports that vaccination with BNT162b2 elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. “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,” according to the press release.

In late March, 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. Included in the study are three age groups: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years.