Pfizer, BioNTech get US FDA nod for emergency use of COVID-19 vaccine in adolescents

Pfizer and BioNTech SE announced that the US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the US for use in this age group.

“Today’s expansion of our EUA represents a significant step forward in helping the US government broaden its vaccination program and help protect adolescents before the start of the next school year,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

The FDA based its decision on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed vaccine efficacy of 100 per cent in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine was also generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

As the next step following today’s FDA decision, the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommendations for use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 to 15 years of age based on the amended EUA.

“Since securing the EUA in December for individuals 16 years and older, we have been working tirelessly to get our COVID-19 vaccine authorized around the world so that governments can provide it to as many people as possible. Our work is not yet complete, as we continue our research into the use of our vaccine in pediatric populations. Our goal is to submit data for pre-school and school-age children in September,” said Ugur Sahin, CEO and Co-founder of BioNTech.

Pfizer and BioNTech have submitted the data in adolescents 12 to 15 years of age for scientific peer review for potential publication. The data also have been submitted to other regulators around the world, including the European Medicines Agency (EMA).

In addition, the pediatric study evaluating the safety and efficacy of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to 11 years of age is ongoing. Pfizer and BioNTech expect to have definitive readouts and, subject to the data generated, submit for an EUA or a variation to Conditional Marketing Authorizations for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children 6 months to 2 years of age are expected in the fourth quarter.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalents in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorisations in these countries.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorised for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older.