The Food and Drug Administration is likely to authorize the Pfizer-BioNTech COVID-19 vaccine for adolescents within the next week, according to The New York Times and CNN.
The vaccines have been authorized for use only in adults and older teens. The FDA authorization would allow the Pfizer-BioNTech shots to be given to 12- to 15-year-olds for the first time, once the Centers for Disease Control and Prevention also signs off.
Many parents have been eagerly awaiting vaccines for their children, hoping for protection and to return school and social lives to something more normal.
"What I'm hearing right now is support for the measure," said Dr. Shelly McDonald-Pinkett, chief medical officer of Howard University Hospital in Washington, D.C. "Parents want their children to be in school and they want them to be protected."
Her clinic, which has vaccinated 33,000 adults and older teens, would be ready to offer Pfizer-BioNTech shots to younger adolescents as soon as they are allowed, she said.
Initial trials of the COVID-19 vaccines were conducted only in adults, and by Pfizer-BioNTech in teens ages 16 to 17, so younger teens and children have not been eligible to receive them.
But in a more recent trial, Pfizer-BioNTech showed in 2,260 adolescents, ages 12 to 15, that the two-dose vaccine was extremely safe and entirely effective. Out of the 16 adolescents infected by COVID-19 in the trial, all had received the placebo; none had gotten the active vaccine.
The side effect profile in adolescents was similar to that of older teens and young adults, said Dr. Bill Gruber, a pediatrician and Pfizer senior vice president in charge of the children's trials.
Although teenagers generally have mild disease if they notice it all, they can get quite ill and pass on the virus to more vulnerable people, even without knowing they're contagious, said Gruber, McDonald-Pinkett and others. Also, their lives have been extremely limited by the pandemic for the last year – missing out on in-person school, sports, arts and the ability to just hang out with friends without worrying about infecting their parents and grandparents.
The FDA is expected to modify its emergency use authorization for the Pfizer-BioNTech vaccine within the next week to allow younger adolescents to receive the shot.
The other two authorized vaccines, from Moderna and Johnson & Johnson, are so far allowed to be used only in adults. Moderna is testing its vaccine in adolescents and younger children, and J&J plans to but has not yet begun similar studies. Novavax, whose vaccine is not yet authorized for use in the United States, also has begun late-stage trials in adolescents.
The vaccines are authorized only for emergency use, though Pfizer says it is working with regulators toward full approval. To do that requires jumping through more regulatory hoops, including having longer-term data on vaccine recipients, which wasn't possible earlier in the pandemic.
Now that the FDA has signed off on the shots in younger adolescents, the CDC will need to give its blessing.
First, an advisory committee will meet to make its recommendations about whether the vaccine is safe and effective enough to use in younger adolescents. No date has been set, though they already have a meeting scheduled for Wednesday to discuss rabies and dengue vaccines. Then the CDC director would need to issue a formal recommendation for use.
This article originally appeared on USA TODAY: COVID-19 vaccine for younger teens: FDA to OK Pfizer shot soon