FDA Approves Pfizer Vaccine For 12- To 15-Year-Old Children

The Food and Drug Administration approved the Pfizer-BioNTech COVID-19 vaccine for 12- to 15-year-olds in the U.S. — the first to be authorized for children under age 16. 

On Monday, the FDA amended its previous emergency use authorization for the Pfizer vaccine — which only allowed inoculation of those 16 and up — to include the younger age group. 

This significant change will allow younger students to return to in-person school more safely in the fall. 

About 1.5 million children age 11 to 17 have had reported cases of COVID-19, per the FDA. Children generally have “milder” cases than adults. 

In a late March news release, Pfizer said that its study of the vaccine’s use in participants 12 to 15 years old found that it was safe and extremely effective in preventing COVID-19 cases.  

The company has begun trials to test the vaccine, which is administered in two doses three weeks apart, with children under age 11.  

“It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” Ugur Sahin, CEO of BioNTech, said in the release.

The other two vaccines currently authorized for use in the U.S. — Moderna and Johnson & Johnson — have so far been approved for people aged 18 and up.

More than 582,000 people in the U.S. have died from the coronavirus so far. As the country races to vaccinate as many people as possible, over 115 million people have been fully vaccinated.

Acting FDA commissioner Janet Woodcock called the new vaccine authorization for younger people “a significant step in the fight against the COVID-19 pandemic,” adding in the agency’s news release: “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.”