Emergency use authorization was awaited. An analysis that included 1,005 vaccine participants in this age group found the vaccine to be 100% effective in preventing COVID-19.
At a press conference Monday night, Acting FDA Commissioner Janet Woodcock said the vaccine would be distributed to adolescents on the same schedule and dose as adults.
“This vaccine is exactly the same dose and the same regimen that has already been distributed, so all these places, these pharmacies, these vaccination centers, all these sites can just spread to the younger age group,” Woodcock said.
“The extension by the FDA of the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12 to 15 is an important step in the fight against the COVID-19 pandemic,” said said Janet Woodcock, MD, acting commissioner of the FDA. “Today’s action allows a younger population to be protected from COVID-19, which brings us one step closer to a return to a sense of normalcy and the end of the pandemic. Parents and guardians can rest assured that the agency has undertaken a rigorous and thorough review of all that is available. data, as we have with all of our emergency use permits for the COVID-19 vaccine. “
The emergency use authorization could particularly benefit students and families when it comes to schools, making it easier for students to return to normal school in person in the fall if they are not now.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, called the expansion of the vaccine to this age group as “a critical step to continue reducing the immense public health burden caused by the COVID pandemic.” 19. “
Marks said Monday night that there would be additional issues for the younger age groups they wanted to discuss.
“As we approach young children, ages 11 and under, different doses of vaccine will need to be used,” Marks said. “And there are also different considerations on the benefits and the risks because we know that young children have been susceptible to this interesting multi-inflammatory syndrome with COVID-19, and we have to make sure that we don’t go and see anything. harm in younger children. “
Pfizer, which means that it would no longer be distributed under emergency use authorization.
Alex Tin contributed reporting.