The FDA has authorized Pfizer's COVID-19 vaccine to be used in children as young as 12.
The agency said May 10 it has expended the emergency use authorization for the vaccine to include children between the ages of 12 and 15. The shot was already authorized for people ages 16 and older.
Research released by Pfizer in March showed the vaccine was 100 percent effective in preventing COVID-19 in children ages 12 to 15 in a phase 3 clinical trial.
"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," acting FDA Commissioner Janet Woodcock, MD, said in a news release.
Former FDA Commissioner Scott Gottlieb, MD, has predicted that 10 million kids ages 12 to 15 could be vaccinated against COVID-19 before the next school year. There are about 17 million children between the ages of 12 and 15 in the U.S.
"Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in the news release.
Pfizer said it plans to apply in September for emergency authorization for its vaccine to be given to children ages 2 to 11.