Pfizer Will Ask U.S. FDA for Approval of Its Vaccines in 5-11 Year-Olds "In Days"

Pfizer Will Ask U.S. FDA for Approval of Its Vaccines in 5-11 Year-Olds “In Days”

We’ve not yet finished debating the vaccination of 12-15 year-olds. But Pfizer’s CEO, who hinted at “annual re-vaccinations” against Covid over the weekend, is already looking to go one step further by asking the U.S. Food and Drug Administration (FDA) “in days” to authorise the use of its vaccine in even younger children. MailOnline has the story.

On Sunday, in an appearance on ABC’s This Week, Albert Bourla was asked when the country should expect the shots to be approved in kids between ages five and 11.
The New York-based firm, along with its German partner BioNTech, recently released data that it said showed the vaccine was safe and effective in a [sic] smaller doses in elementary schoolers.
“I think we are going to submit this data pretty soon,” Bourla told host George Stephanopoulos.
“It’s a question of days, not weeks, and then it is up to FDA to be able to review the data and come to their conclusions and approve it or not.”
According to clinicaltrials.gov, Pfizer’s study in younger children worked similarly to the way it did in older children and adults.
A total of 4,500 younger kids from ages six months to 11 years were enrolled at nearly 100 clinical trial sites in 26 U.S. states, Finland, Poland and Spain
About half of the ages five-to-11 group were given two doses 21 days apart and the other half were given placebo shots.
The team then tested the safety, tolerability and immune response generated by the vaccine by measuring antibody levels in the young subjects.
Pfizer said it had selected lower doses for Covid vaccine trials in children than are given to teenagers and adults. …
Bourla assured that Pfizer would be ready to ship these smaller doses across the country if the FDA authorises the shot in younger children. …
Unlike the larger clinical trial conducted in adults, the pediatric trial did not measure efficacy by comparing the number of Covid cases among the vaccine group to the number in the placebo group.
Instead, scientists looked at levels of neutralizing antibodies in young vaccine recipients and compared the levels to those seen in adults.
The companies expect data on how well the vaccine works in children between ages two and five and between six months and two years of age by the end of the year.

Worth reading in full.