Pfizer and BioNTech seeking approval for COVID-19 vaccine in children 5 and over
Pfizer and BioNTech announced it will soon seek approval for use of its COVID-19 vaccine in children ages 5 and over.
“We will be presenting the results from our study on five- to 11-year-olds to authorities around the world in the coming weeks,” said Ozlem Tureci, the co-founder of BioNTech and its chief medical officer.
The Pfizer-BioNTech vaccine received approval from the Food and Drug Administration for emergency use in 12 to 15-year-olds. According to the New York Times, vaccines for children 12 and younger have yet to be approved by the FDA.
“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,” said Scott Gottlieb, the former commissioner of the FDA and a member of the Pfizer board.