FDA panel approves Pfizer’s COVID
vaccine for kids ages 5-11
By Jackie Salo
New York Post
An FDA advisory panel Tuesday approved Pfizer’s COVID-19 vaccine for children ages 5 to 11, setting the stage for the kiddie group to start getting jabs as early as next week.
The approval was the first regulatory hurdle for the immunization for the age group.
The federal Food and Drug Administration must now consider formal approval of the shot, and if the agency OKs it as expected, an advisory panel with the CDC will consider it Nov. 2.
That panel is expected to approve it, too, and send its recommendation to agency chief Dr. Rochelle Walensky for a final anticipated OK.
Dr. Anthony Fauci on Sunday said that if approved, the vaccine could be available for the young age group sometime in the first two weeks of November.
“If all goes well, and we get the regulatory approval and the recommendation from the CDC, it’s entirely possible, if not very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November,” Fauci said on ABC’s “This Week.”
Walensky also has said the Biden administration is prepared to roll out the vaccine to the age group immediately, pending approval.
“The administration is working on the operations and logistics. So, as soon as we have both the FDA authorization and the CDC recommendations, there will be vaccine out there so children can start rolling up their sleeves,” Walensky said Sunday on NBC’s “Meet the Press.”
Children between ages 5 and 11 currently represent about 9 percent of all reported coronavirus cases in the country, according to data presented to the FDA advisory panel Tuesday.
While young kids have proven to be less likely to get seriously ill from the deadly virus as opposed to older people, many children remain in high-transmission situations such as schools and can pick up and transmit COVID-19 to others, experts have said.
The coronavirus is “not going away,’’ said FDA adviser Jeannette Lee of the University of Arkansas. “We have to find a way to live with it, and I think the vaccines give us a way to do that.’’
Another agency adviser, Dr. Eric Rubin of Harvard University, said, “We’re never going to learn about how safe this vaccine is unless we start giving it.”
FDA researchers said in a recent study that the vaccine had proven to be highly effective at protecting kids from COVID-19.
The immunization for 5- to 11-year-olds involves two doses, each about a third of the adult-sized vaccine’s pair of shots.
Pfizer’s vaccine has already been approved for children age 12 and older.
Moderna and Johnson & Johnson’s vaccines are only authorized for those 18 and older.
With AP
___
https://nypost.com/2021/10/26/fda-panel-approves-pfizers-covid-vaccine-for-kids-ages-5-11/