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.