FDA authorizes Pfizer vaccine for emergency use in children as young as 12

WASHINGTON (NewsNation Now) — The FDA announced the Pfizer-BioNTech coronavirus vaccine has been authorized for emergency use in adolescents 12 to 15 years old.

Previously, only those 16+ were eligible for the vaccine. The company had announced recently they would seek authorization to expand the age range.

“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,” said Acting FDA Commissioner Janet Woodcock, M.D.

Shots could begin as soon as Thursday, after a federal vaccine advisory committee issues recommendations for using the two-dose vaccine in 12- to 15-year-olds. An announcement is expected Wednesday.

“This is a watershed moment in our ability to fight back the COVID-19 pandemic,” Dr. Bill Gruber, a Pfizer senior vice president who’s also a pediatrician, told The Associated Press.

Studies conducted by Pfizer showed the vaccine not only was safe for teenagers, but also nearly eliminated all risk of catching COVID-19.

The company did note that some children have similar reactions to adults from the second shot including fever, chills, and aches.

The Biden administration issued a statement Monday calling it a “positive development.”

“In the coming days, we will hear more from the Centers for Disease Control and Prevention (CDC) on its recommendations. 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,” said President Joe Biden.

Next up is testing whether the vaccine works for even younger children. Both Pfizer and Moderna have begun U.S. studies in children ages 6 months to 11 years. Those studies explore whether babies, preschoolers and elementary-age kids will need different doses than teens and adults. Gruber said Pfizer expects its first results sometime in the fall.

Outside of the U.S., AstraZeneca is studying its vaccine among 6- to 17-year-olds in Britain. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.

Children are far less likely than adults to get seriously ill from COVID-19, yet they represent nearly 14% of the nation’s coronavirus cases. At least 296 have died from COVID-19 in the U.S. alone, and more than 15,000 have been hospitalized, according to a tally by the American Academy of Pediatrics.

That’s not counting the toll of family members becoming ill or dying — or the disruption to school, sports and other activities so crucial to children’s overall well-being.

Experts say children must get the shots if the country is to vaccinate the 70% to 85% of the population necessary to reach what’s called herd immunity.

Read the full EUA:

This is a developing story, check back soon for updates.

The Associated Press contributed to this report.