Pfizer to seek approval for vaccine in children 5 and over

Pfizer and BioNTech announced this week that it will soon seek approval from global regulators for use of its coronavirus vaccine in children ages 5 and over.

The vaccine makers said in an interview published on Friday that they are looking to produce smaller doses of the vaccine for younger children.

“We will be presenting the results from our study on five- to 11-year-olds to authorities around the world in the coming weeks,” Ozlem Tureci, the co-founder of BioNTech and its chief medical officer, told German news outlet Der Spiegel.

The Food and Drug Administration (FDA) approved the Pfizer-BioNTech coronavirus vaccine for emergency use in adolescents 12 to 15 years old in May and granted full approval of the vaccine for recipients 16 and older last month.

Vaccines for children 12 and younger have yet to be approved by the FDA, according to The New York Times.

Scott Gottlieb, the former commissioner of the FDA and a Pfizer board member, said in August that the vaccine maker “could be in a position” to file an application for vaccine approval in children as early as October.

“This fall, Pfizer is going to be in a position … to file data with the FDA at some point in September and then file the application potentially as early as October, so that’ll put us on a time frame where the vaccine could be available at some point late fall, more likely early winter, depending on how long FDA takes to review the application,” Gottlieb said on CBS’s “Face the Nation” at the time.

Ugur Sahin, BioNTech’s chief executive, on Friday, called for people who are currently eligible to get the vaccine to do so ahead of an expected wave of COVID-19 infections this fall.

“There are still about 60 days left for us as a society to avoid a tough winter,” he said, according to the Times.