Former Food and Drug Administration Commissioner Dr. Scott Gottlieb said he believes that Pfizer’s vaccine for children 5 to 11 years old will be authorized for use by the end of October.
Gottlieb, who sits on Pfizer’s board of directors, said on CBS’ “Face the Nation” Sunday that “In a best-case scenario, given that timeline they’ve just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween.
“If everything goes well, the Pfizer data package is in order, and FDA ultimately makes a positive determination, I have confidence in Pfizer in terms of the data that they’ve collected. But this is really up to the Food and Drug Administration to make an objective determination.”
Pfizer is expected to have enough data from clinical trials to seek emergency use authorization (EAU) from the FDA.
According to Reuters, the agency would make the decision to grant EUA within three weeks.
Moderna’s vaccine for children 5 to 11 is expected to be available by November. Moderna officials have said it expects the company’s trial results on the vaccine for children to be presented to the FDA by the end of October.
The FDA requires two months of data before considering EUA. For full licensure of a new drug, the agency requires six months of safety data on trial participants.
Approval of use of a vaccine for 5-11 year olds would come at a time when children represent more than 28% of new COVID-19 infections, according to the American Academy of Pediatrics.
Pfizer’s vaccine was authorized for use in children ages 12-15 in May. Moderna’s vaccine is authorized for use in those 18 and older. The Johnson & Johnson vaccine was OK’d for use in those over 18, as well.
On Friday, the FDA said it would work to approve the COVID-19 vaccines for children quickly, once the companies submitted their data.
A vaccine for those ages 6 months to 2 years old is likely to come early next year.
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