The Food and Drug Administration authorized the Pfizer-BioNTech coronavirus vaccine to be used in teenagers ages 12 to 15, making it the first to be deemed safe for people under 16.
“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,” acting FDA Commissioner Janet Woodcock said Monday. “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.”
The Pfizer shots were previously only authorized for use in people 16 and older. Pfizer petitioned the FDA for use authorization in young people after trial results in March found the shots were 100% efficacious and produced a “robust antibody response.” The U.S.-based trial enrolled 2,260 adolescents in the age range. All eighteen of the COVID-19 cases occurred in the placebo group, and none occurred within the vaccinated group.
“With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Monday.
The expanded EUA for the Pfizer shots will open up vaccinations to a wide swath of the population that has been shown less likely than older adults to experience severe disease due to coronavirus infection. Pfizer also announced last week that it expects to file an EUA application for its vaccine to be used in children age 2 to 11 in September.
“[Sixteen] million more Americans… just became eligible to be vaccinated,” Dr. Ashish Jha, dean of Brown University’s School of Public Health said Monday. “Vaccinating them will add a lot to population immunity.”
To date, roughly 46% of all Americans 16 and older have received at least one dose, according to federal data. Vaccinations are higher among adults 18 and older, with roughly 58% having received at least one dose, because the other two vaccines from Moderna and Johnson & Johnson have been authorized for adults 18 and older.