The Food and Drug Administration is expected to clear Pfizer-BioNTech’s COVID-19 vaccine for administration to adolescents early next week, according to a federal health official with knowledge of the agency’s plans.
The move would allow many U.S. middle and high school students to be vaccinated against COVID-19 well before the start of the next school year, using a shot that Pfizer has demonstrated “100% effectiveness” in children from 12 years old with side effects similar to those that have occurred in young adults.
An FDA spokesperson declined to comment on its early approval of an amendment to Pfizer’s emergency use authorization, saying only that the regulator “is working to review this request as quickly and transparently as possible. “.
The New York Times first reported FDA plans to extend the authorization of Pfizer’s vaccines to adolescents. Pfizer would be the firstlicensed for adolescents in the United States
The FDA has previously said it does not plan to convene a meeting of its advisory committee to consider the amendment, as it did before authorizing vaccines by Pfizer, Moderna and Johnson & Johnson.
However, the Centers for Disease Control and Prevention will also need to revise their recommendations for using the Pfizer vaccine before most providers can begin giving the first doses to adolescents. CDC officials said they plan to quickly convene a meeting of their advisory committee on vaccination practices, following the FDA amendment.
A CDC official told a webinar hosted by the Infectious Diseases Society of America over the weekend that the agency was actively preparing to present data from Pfizer’s trials to the panel of vaccine advisers.
Opening up Pfizer’s vaccines to adolescents could lead to increased demand for a nationwide vaccination campaign that has started to slow in recent weeks.
More than 21% of doses delivered to jurisdictions have yet to be declared administered, according to CDC figures released on Monday, and many states say they are no longer ordering their entire allocated supply of doses.
But rolling out the plans over the summer could pose some challenges for vendors as well.
The CDC currently recommends that vaccines be given on their own in most cases, more than 14 days before and after any other vaccine. Federal health officials have repeatedly warned that adolescent vaccinations dropped during last year’s pandemic and posed a risk as students planned to return to school in the fall.
“We are coming into the summer when a lot of teens come to the office to get their routine immunizations. And so, if we missed them by then, we may not be able to catch up with them in the near future, ”says Dr. Sean O’Leary, a pediatric infectious disease specialist at the University of Colorado.
O’Leary acknowledged that rolling out the doses to younger recipients could also pose logistical challenges, although he said a number of pediatricians have already successfully administered some doses of the COVID-19 vaccine. Pfizer photography is currently permitted for recipients as young as 16 years of age.
“I don’t know how many thousands of doses we’ve given at this point, but we, you know, we’re good to go. For places that gave birth to 16 and 17 year olds, I don’t. I think it will be a real pivot to start delivering to kids ages 12 to 15, ”O’Leary predicted.