The U.S. Food and Drug Administration is expected to authorize the use of the Pfizer-BioNTech COVID-19 vaccine in people age 12-15 within the next week, sources told the New York Times and The Associated Press.
The two-dose Pfizer vaccine is already approved for use in people 16 and older. Last month, Pfizer said the vaccine is effective in younger adolescents, noting the vaccine demonstrated 100% efficacy and "robust antibody responses," exceeding those reported in a trial of 16- to 25-year-olds.
After the promising results, Pfizer on April 9 requested amendments to its U.S. Emergency Use Authorization of the vaccine to expand its use to kids ages 12-15.
An unnamed federal official told The AP and the New York Times the FDA is expected to expand the emergency use authorization by early next week, perhaps sooner.
After the FDA expands the emergency use authorization, the federal vaccine advisory committee will likely meet to discuss whether to recommend the shot for adolescents. The Centers for Disease Control and Prevention would then adopt the committee's recommendation before shots can begin. This process could be completed in just a few days.
The source told The AP they expect the Pfizer vaccine will get FDA approval to be used in even younger children sometime this fall.
Pfizer plans to file for full FDA approval by the end of the month, Forbes says. If it gets approved, Pfizer would be able to market the vaccine directly to consumers and would help make booster shots available to the public without another emergency use authorization.
Meanwhile, Moderna, the other two-dose COVID vaccine approved for use in the U.S., is expected to later this year release results of its study on the efficacy of the shot in kids 12 to 17 years old.
Expanding the use of vaccines to younger people is good news in the fight against COVID-19 in Minnesota and elsewhere. Vaccinating teens and kids in the months to come could mean fewer disruptions to in-person learning, activities and sports.
While younger people are at lower risk of serious side effects from the disease some still do get very sick. And kids and teens have started to make up a larger share of the new virus cases as a growing number of adults become vaccinated and restrictions are loosened.
This has prompted state health officials to encourage teenagers to get the COVID-19 vaccine, prioritizing 16- and 17-year-olds at the state's vaccination clinics last week, and recommending students of all ages get tested for COVID frequently.