BRIEF—Pfizer and BioNTech request EUA for COVID-19 vaccine in adolescents

Pfizer and BioNTech yesterday requested amendments to the US Emergency Use Authorization (EUA) of their vaccine (BNT162b2/Comirnaty) to expand the use in adolescents 12 to 15 years of age from the US Food and Drug Administration.

The companies plan to request similar rulings by other regulatory authorities worldwide in coming days.

These requests are based on data from the pivotal Phase III trial in adolescents 12 to 15 years of age 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.

Top-line results from an efficacy analysis on 12 to 15 year old participants through cases accrued by March 31, 2021 from the Phase III trial were recently announced.

In this analysis, BNT162b2 was well tolerated with side effects generally consistent with those observed in participants 16 to 25 years of age.

All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.