FDA aims to grant Pfizer shot full approval by Labor Day, insiders say

The FDA has set Labor Day, Sept. 6, as an unofficial deadline to grant full approval of Pfizer's COVID-19 vaccine, several people familiar with the matter told The New York Times

An FDA spokesperson told The Hill in a statement Aug. 3: "We cannot comment on specific timing" for full approval. "As we have said, 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 has been under increased pressure to fully approve the shot, as some experts believe full approval will boost the number of people getting vaccinated, as well as the number of vaccine mandates from businesses, government agencies and universities. 

Recent polls from the Kaiser Family Foundation indicate that some unvaccinated people would be more likely to take a fully approved vaccine. 

The U.S. Defense Department, the city of San Francisco and a number of universities and hospitals have said they will mandate COVID-19 vaccines once a vaccine is fully approved, the Times reported. 

"Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach, including 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 spokesperson told The Hill.


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