Pfizer COVID-19 vaccine full approval projected for September
Agency also intends to expand authorization for kids age 8 and up by September, sources said
The Food and Drug Administration (FDA) will weigh full approval of Pfizer’s COVID-19 vaccine by a projected goal of September, sources within the agency confirmed to Fox News.
While it’s not immediately clear when in September the goal was set for, the New York Times reported Wednesday the FDA "accelerated its timetable" toward licensure with an "unofficial deadline" of "Labor Day or sooner," citing multiple people familiar with the matter.
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The FDA is also seeking to expand emergency approval of Pfizer’s COVID-19 vaccine to younger children ages 8 and up by September, sources told Fox News. The vaccine is currently eligible for children as young as 12, and trials are underway in younger age groups.
"Our ongoing review of the biologics license application for the Pfizer-BioNTech COVID-19 vaccine is moving forward as rapidly as possible in keeping with the high-quality complete assessment that the public expects from the FDA," the agency wrote to Fox News in an email.
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"We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated," the statement continues.
The FDA said it has taken an "all-hands-on-deck approach" given the urgency of the pandemic, and efforts were said to include "identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge."
The FDA announced July 16 it formally accepted Pfizer-BioNTech’s request for full approval, or licensure of the vaccine for those 16 and older, and granted the application "priority review." The agency had noted a deadline of January 2022 but said it "intends to complete the review far in advance of [that] date."
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The FDA has not yet approved any COVID-19 vaccine but has given emergency use authorization (EUA) to vaccines developed by Pfizer-BioNTech, Moderna and Johnson & Johnson.
Full FDA approval will allow vaccines to be used and marketed directly to consumers in the post-pandemic. The FDA's approval will likely promote more unvaccinated Americans to get their shots. Around a third of unvaccinated adults said they would be more likely to get vaccinated if one of the COVID-19 vaccines earned full FDA approval, according to a June survey from the Kaiser Family Foundation (KFF).
Fox Digital's RN White, Connie McDonough and Jeanette Settembre contributed to this report.