Pfizer-BioNTech Ask to Expand COVID-19 Vaccine EUA to Those Aged 12 to 15 Years

Washington, DC—Pharmacists shouldn’t be surprised if they see another big influx of COVID-19-vaccine seekers in the near future—younger teenagers.

Pfizer and BioNTech SE have requested amendments to the United States’ emergency-use authorization (EUA) for the Pfizer-BioNTech vaccine (BNT162b2) to expand the use in adolescents aged 12 to 15 years. Those requests are based on data from the pivotal phase III trial in adolescents aged 12 to 15 years with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100% efficacy and robust antibody response after vaccination with the COVID-19 vaccine. The EUA now allows the vaccine for those aged 16 years and older.

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

“These submissions represent a critical step in Pfizer’s and BioNTech’s ongoing efforts to support governments in broadening global vaccination efforts,” according to the press release announcing the request for EUA expansion. “The companies look forward to working closely with the U.S. Food and Drug Administration (FDA) and other worldwide regulatory authorities as part of the companies’ efforts to expand emergency or conditional authorization of their COVID-19 vaccine in 12- to 15-year-olds as quickly as possible.”

Their trial, which enrolled 2,260 adolescents aged 12 to 15 years in the U.S., had 18 cases of COVID-19 observed in the1,129-member placebo group versus 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 1 month after the second dose. “This compares well (was non-inferior) to GMTs elicited by participants 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 earlier announcement.

Not only will pharmacies see more vaccine-seekers, but also more pharmacies are receiving the vaccine to administer, Jeff Zients, White House COVID-19 Response Coordinator, said at a recent press conference. “As we expand to more pharmacies, millions of Americans are able to get their shot at their local pharmacy, the same way they get their flu shot,” Zients noted. “Today, there are around 30,000 pharmacies participating in the program. That’s an increase of over 70% in less than two weeks. And we are on track to meet the President’s goal of nearly 40,000 local pharmacies by April 19th.”

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