Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents

Rhea-AI Summary

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) announced that the FDA has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals aged 12 to 15, making it the first vaccine authorized for this age group in the U.S. This decision follows a Phase 3 trial with 2,260 participants showing 100% efficacy and good tolerance of the vaccine. Monitoring for long-term safety will continue for two years post-vaccination. The CDC's Advisory Committee will shortly discuss recommendations for this age group.

Positive

• FDA expanded EUA for COVID-19 vaccine to include ages 12-15.
• Vaccine showed 100% efficacy in Phase 3 trial with 2,260 participants.

Negative

• None.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. 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 U.S. for use in this age group.

“Today’s expansion of our EUA represents a significant step forward in helping the U.S. 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. “We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world.”

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 a vaccine efficacy of 100% 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 a next step following today’s FDA decision, the U.S. 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,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Our work is not yet co

FAQ

What age group is included in the expanded EUA for Pfizer-BioNTech's COVID-19 vaccine?

The expanded EUA includes individuals aged 12 to 15.

What was the efficacy rate of the COVID-19 vaccine in the Phase 3 trial for ages 12 to 15?

The vaccine demonstrated 100% efficacy in the Phase 3 trial.

Who is responsible for discussing the recommendations for the vaccine use in adolescents?

The CDC's Advisory Committee on Immunization Practices (ACIP) will discuss the recommendations.

When was the original EUA for Pfizer-BioNTech's COVID-19 vaccine granted?

The original EUA was granted in December for individuals 16 years and older.