WHAT YOU NEED TO KNOW:
- Pfizer and its partner BioNTech announced that they will soon seek approval for their COVID-19 vaccine for children 5 and up.
- The Pfizer vaccine received full authorization from the US FDA for people 16 and older in August but it’s still under emergency use authorization for children 12-15 years old.
- Pfizer remains the only vaccine approved for use in kids as young as 12 in the country.
Pfizer and partner BioNTech announced this week that it will soon ask for approval from the FDA for use of its Covid-19 vaccine in children ages 5 and over.
In an interview published Friday, the vaccine manufacturers said that they are looking to make 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.
In May, the Food and Drug Administration (FDA) approved the Pfizer Covid-19 vaccine for emergency use in adolescents 12 to 15 years old and granted full approval of the vaccine for recipients 16 and older in August.
As of this writing, the FDA has not given approval for vaccines for children 12 and younger.
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.
On Friday, Ugur Sahin, BioNTech’s chief executive, urged 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.
Source: The Hill