Research & Development
Pfizer and BioNTech announces first US FDA's EUA of COVID-19 Vaccine in aged 12 to 15 years
11 May 2021 -

Healthcare company Pfizer Inc (NYSE:PFE) and immunotherapy company BioNTech SE (Nasdaq: BNTX) on Monday jointly reported the receipt of US Food and Drug Administration (FDA) 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, based on BioNTech proprietary mRNA technology, authorized in the US for use in this age group.

Under a pivotal Phase 3 clinical trial, the partnership enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. The vaccine was well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will now meet to discuss recommendations for use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 to 15 years of age.

In addition, the partners have submitted the data in adolescents 12 to 15 years of age for scientific peer review for potential publication as well as submitted to other regulators around the world, including the European Medicines Agency (EMA). The paediatric study is evaluating the safety and efficacy of the Pfizer-BioNTech COVID-19 Vaccine in children six months to 11 years of age and is ongoing.

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