Scott Gottlieb, who sits on Pfizer’s board, on Wednesday said it is still possible the FDA will approve Pfizer and BioNTech’s COVID-19 vaccine for young children by Halloween, CNBC reported.
Pfizer submitted initial trial data for kids ages 5 to 11 to the FDA on Tuesday, and the company should file a formal application needed for emergency use authorization "shortly," Gottlieb said.
"They’ve seen a lot of clinical data," Gottlieb said. "I’ve long said October is a possibility but it is an optimistic possibility. If it slips, it could slip to mid-November."
The comments come after The Wall Street Journal reported that clearance of the Pfizer vaccine for children 5 to 11 years old may not come until November.
Pfizer released data last week that showed a two-dose regimen of 10 micrograms is safe and generates a "robust" immune response in a clinical trial of children ages 5 to 11.
Pfizer was expected to request emergency authorization for use of the vaccine in young children by the end of this month, but it now says it will file an application "in the coming weeks."
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