The Food and Drug Administration is likely to authorize emergency use Pfizer Inc.’s coronavirus vaccine in adolescents 12- to 15-years old “within several days,” White House chief medical adviser Anthony Fauci said Wednesday.
“I think it is going to be very soon,” Fauci said in an interview with NBC News. “I mean, I don’t want to get ahead of the FDA, but I believe it is going to be within several days. I cannot imagine it is going to be much longer than that.”
Pfizer Inc. Chairman and CEO Albert Bourla said in a conference call Tuesday that he expected the announcement “shortly.” The drugmaker developed the shot in partnership with Germany’s BioNTech SE.
Advisers to the Centers for Disease Control and Prevention are scheduled to meet May 12 to review use of Pfizer’s shot in adolescents, a CDC spokeswoman confirmed to Bloomberg News in an email Wednesday. That panel -- which ordinarily initiates a review after FDA clearance -- will analyze scientific data before voting on whether to recommend use of the shot in teens, and their scheduled meeting is another indication that regulators are readying authorization.
Expanding shot eligibility to minors would pave the way for a significant expansion of a US vaccine effort that is seeing reduced demand as many of the country’s most vulnerable and eager residents have already received at least their first shot. Pfizer has also said it plans to submit additional requests for children from 2-to-5 years old and those between the ages of 5 and 11 by September, after completing studies on the safety and efficacy of the vaccine for children.
{{/usCountry}}Expanding shot eligibility to minors would pave the way for a significant expansion of a US vaccine effort that is seeing reduced demand as many of the country’s most vulnerable and eager residents have already received at least their first shot. Pfizer has also said it plans to submit additional requests for children from 2-to-5 years old and those between the ages of 5 and 11 by September, after completing studies on the safety and efficacy of the vaccine for children.
{{/usCountry}}President Joe Biden said Tuesday that once the authorization comes, the U.S. was ready to “immediately move to make about 20,000 pharmacy sites across the country ready to vaccinate those adolescents.”
He said the federal government would ship vaccines directly to pediatricians and that teens could get their first and second shots of the vaccine in different locations if they were “on the move this summer.”