Federal officials gave the green light Monday for use of Pfizer’s COVID-19 vaccine for adolescents 12 to 15 years old.
The Food and Drug Administration added the new age group to the two-shot vaccine’s emergency use authorization; in December, the FDA said it was safe for those 16 and older.
“This is a promising development in our fight against the virus,” President Biden said in a statement after the approval was announced. “If you are a parent who wants to protect your child, or a teenager who is interested in getting vaccinated, today’s decision is a step closer to that goal.”
The amended authorization comes after approximately 1.5 million COVID-19 cases in kids 11 to 17 were reported to the U.S. Centers for Disease Control and Prevention between March 1, 2020, and April 30, 2021.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock said in a statement.
“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. 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,” she said.
Children and adolescents generally have milder cases of COVID-19 than adults, but at least 297 children had died of COVID-19 in the U.S. as of last month, according to the American Academy of Pediatrics.
Biden said at the White House last week that his administration was making the vaccination of adolescents a priority.
“I want American parents to know that if that announcement comes, we are ready to move immediately … to make about 20,000 pharmacy sites across the country ready to vaccinate those adolescents as soon as the FDA grants its OK,” Biden said.
The president said his administration also plans to ship vaccines directly to pediatricians’ offices, “so parents and their children can talk to their family doctor about it and get the shot from a provider they trust the most — easy, fast, and free.”
Pfizer’s Phase 3 clinical trial for kids aged 12 to 15 years old enrolled 2,260 adolescents in the U.S.
In the trial, 18 cases of COVID-19 were observed in the placebo group versus none in the vaccinated group and “administration was well tolerated,” with side effects such as fatigue and headache generally consistent with those observed in participants 16 to 25, Pfizer said on March 31.
After Monday’s announcement Biden said more information would be forthcoming and called it a promising step in the road back to normalcy.
“In the coming days, we will hear more from the Centers for Disease Control and Prevention (CDC) on its recommendations,” Biden said in his statement. “I look forward to speaking more about what today’s news means for our vaccination program, but the bottom line is: The light at the end of the tunnel is growing, and today it got a little brighter.”