Pfizer and BioNTech announced that the US Food and Drug Administration (FDA) has authorised their COVID-19 vaccine for adolescents ages 12 to 15. This is the first COVID-19 vaccine to receive Emergency Use Authorization (EUA) for this age group in the United States.
Albert Bourla, Chairman and Chief Executive Officer, Pfizer said:
“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. 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.”
Trial data shows 100% vaccine effectiveness for 12 to 15-year-olds
The FDA made its decision based on evidence from a pivotal Phase 3 clinical trial that recruited 2,260 participants ages12- to 15-years. The trial’s analytic data released on March 31, 2021, revealed 100% vaccine effectiveness in participants with or without previous SARS-CoV-2 infection, as well as strong antibody responses.
After the second dose, participants will be tracked for another two years to ensure long-term protection and safety despite that the study outcomes demonstrating that the vaccine was well tolerated. Following today’s FDA resolution, the Advisory Committee on Immunization Practices (ACIP) of the United States Centers for Disease Control and Prevention (CDC) will meet to review guidelines for use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents aged 12 to 15 years old based on the revised EUA.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech commented:
“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.”
Acting FDA Commissioner Dr Janet Woodcock said in her statement:
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
Safety and effectiveness study for children aged 6 months to 11 years also underway
Pfizer and BioNTech have filed the data-based evidence from 12 to 15-year-old participants for scientific peer-review and publication to international regulators including the European Medicines Agency (EMA). Furthermore, a pediatric study investigating the safety and effectiveness of the Pfizer-BioNTech COVID-19 Vaccine in children aged 6 months to 11 years is also underway.
Pfizer and BioNTech also anticipate having conclusive readouts in September and, based on the results, apply for a EUA or a variation to Conditional Marketing Authorizations for two cohorts: children 2-5 years old and 5-11 years old. The readout and submission for the cohort of children 6 months to 2 years of age are expected in the Q4.
The Pfizer-BioNTech COVID-19 Vaccine
BioNTech and Pfizer developed the COVID-19 vaccine jointly. The Pfizer-BioNTech COVID-19 Vaccine is engineered using BioNTech’s patented mRNA platform. BioNTech is the European Union’s Marketing Authorization Holder and the holder of Emergency Use Authorizations or alternatives in the United States (with Pfizer), the United Kingdom, Canada, and other countries ahead of a planned application for absolute marketing authorizations in these countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the United States Food and Drug Administration (FDA), although it has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19), caused by acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 12 and up.
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.