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The vaccine is now authorized for ages 12 and older in European Union member states and the UK.
The United Kingdom’s Medicines and Healthcare products Regulatory Authority (MHRA) announced on June 4, 2021, that it was giving temporary authorization of Pfizer and BioNTech’s COVID-19 vaccine for individuals aged 12 and older. Similarly, in a May 28, 2021 press release, Pfizer and BioNTech announced that the Conditional Marketing Authorization (CMA) for the COVID-19 Vaccine Comirnaty in the European Union (EU) has been expanded to include individuals 12 to 15 years of age, following the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The United States expanded authorization of the Pfizer/BioNTech COVID-19 vaccine to ages 12 to 15 on May 10, 2021.
“[The] extension of our COVID-19 vaccine authorization in the European Union is another critical milestone in our collective effort to broaden vaccination programs to as many people as possible,” said Ugur Sahin, MD, CEO and Co-founder of BioNTech, in the press release. “Making vaccines available to adolescents will help reopen schools and support the return to a normal day-to-day life.”
A Phase III clinical trial, which enrolled 2260 participants aged 12 to 15 years, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. A pediatric study evaluating the safety and efficacy of the COVID-19 vaccine in children 6 months to 11 years of age is ongoing. Data for children 2–5 years of age and 5–11 years of age are anticipated in September 2021, and the data readout and submission for the cohort of children six months to two years of age is expected in the fourth quarter of 2021.
BioNTech is the Marketing Authorization Holder of the vaccine in the European Union, and the holder of emergency use authorizations or equivalents in the US (jointly with Pfizer), the UK, Canada, and other countries.