This week, the CEO of Pfizer said that the pharmaceutical giant’s COVID-19 vaccine trials on children aged 5-11 could soon be wrapping up and their data submitted to the Food and Drug Administration (FDA) for emergency use authorization.
On Monday, the FDA fully approved the Pfizer-BioNTech vaccine for patients 16 and older as The Blaze reports, becoming the first vaccine to clear the hurdle from emergency use authorization (EUA).
NBC News reported that Pfizer expects to be able to submit data on toddlers and children younger than 4 not long afterward. Following the FDA’s announcement on Monday, the American Academy of Pediatrics called on the agency to “work aggressively to authorize a vaccine for ages 11 and younger.”
Speaking with NBC’s Lester Holt that evening, CEO Albert Bourla said he expected that Pfizer will soon be wrapping up its “very large studies” on children younger than 12 as soon as September to submit to the FDA to acquire EUA.
He also said he hopes the FDA approval will abate so-called “vaccine hesitancy.”
“Based on the longer-term follow-up date that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Bourla told Holt.
“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” he said.
The timeline for a children’s vaccine is not something that top federal health officials have been quite so optimistic about, as The New York Times recently reported.
The FDA has said they will be waiting for Pfizer to submit their data on children so they will be able to maintain a “good safety dataset.”
“[W]e certainly want to make sure that we get it right in the children ages 5 through 11 and then even younger children after that,” said Dr. Peter Marks of the FDA, who heads the agency’s Center for Biologics Evaluation and Research.
“I’ve got to be honest, I don’t see the approval for kids 5 to 11 coming much before the end of 2021,” Dr. Francis S. Collins, director of the National Institutes of Health, recently told NPR.
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