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

Rhea-AI Summary

BioNTech (BNTX) and Pfizer have received FDA's Emergency Use Authorization for their COVID-19 vaccine for individuals aged 12 to 15, marking it as the first vaccine approved for this group in the U.S.

The decision was based on a Phase 3 trial involving 2,260 participants, demonstrating 100% efficacy and robust antibody responses. The companies have also submitted data to the European Medicines Agency (EMA) and expect further global authorizations soon. Research continues into the vaccine's effectiveness in younger children, with data submissions anticipated in September.

Positive

• FDA expanded Emergency Use Authorization for the vaccine to include ages 12-15.
• 100% efficacy reported in Phase 3 trial for ages 12-15.
• Ongoing research into vaccine use in younger children, with potential submissions expected in September.

Negative

• None.

• In a Phase 3 trial, the vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years
• Data also submitted to European Medicines Agency (EMA) and other global regulators, with additional authorizations expected in coming weeks 

NEW YORK and MAINZ, GERMANY, May 11, 2021 — 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 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.”

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 authorizations in these countries.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized 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. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.

AUTHORIZED USE IN THE U.S.:

The Pfizer-BioNTech COVID19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:

• Do not administer Pfizer-BioNTech COVID-19 vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 vaccine
• Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 vaccine
• Monitor Pfizer-BioNTech COVID-19 vaccine recipients for the occurrence of immediate adverse reactions according to the Cente

FAQ

What is the latest news about BioNTech (BNTX) vaccine authorization for adolescents?

The FDA has granted Emergency Use Authorization for BioNTech's COVID-19 vaccine for individuals aged 12 to 15.

How effective is the BioNTech COVID-19 vaccine for ages 12-15?

The Phase 3 trial showed a 100% efficacy rate for the vaccine in ages 12 to 15.

When can we expect more data on the BioNTech vaccine for younger children?

BioNTech plans to submit data for children aged 6 months to 11 years in September.

What are the next steps after the FDA's EUA for BioNTech's vaccine?

The CDC's Advisory Committee on Immunization Practices will discuss recommendations for the vaccine's use in adolescents.