With Delta variant surging, FDA hustles to grant Pfizer's COVID-19 vaccine a full approval: reports

FDA
Pfizer applied for full approval for its COVID-19 vaccine on May 7, six months after the FDA granted it a nod for emergency use. (Andrew Harnik, Associated Press)

The FDA has stepped up its efforts to grant full approval for Pfizer and BioNTech’s COVID-19 vaccine, setting an unofficial deadline of Labor Day, The New York Times reports.

With the Delta variant of the coronavirus surging across the United States, there's more urgency to combat it with a full vaccine approval. Quoting a senior official at the agency, STAT reported that the FDA is in “sprint” mode to sanction the shot.   

What would a full endorsement from the FDA do to combat the disease? A June poll by the Kaiser Family Foundation found that 3 in 10 unvaccinated adults say they would be more likely to get vaccinated if one of the shots currently authorized for emergency use were to receive full approval.

Additionally, a full approval would give businesses, the government and organizations such as colleges and the military the legal muscle to mandate vaccinations. 

While saying that the agency "can't comment on specific timing," an FDA spokesperson released the following statement. 

"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."

During an earnings call last week, Pfizer CEO Albert Bourla said a full approval would help convince holdouts to get vaccinated.

“Some people will change their reluctance to willingness,” Bourla said. “And in terms of timelines, I leave it to the FDA.”

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The Pfizer-BioNTech vaccine scored its emergency nod on December 11. On May 7, the companies applied for full approval and nabbed a priority review, which typically reduces the process from 10 to six months. 

Moderna, maker of the second-most used COVID-19 vaccine in the U.S., secured its emergency blessing a week after Pfizer and filed for full approval on June 1. Johnson & Johnson, maker of a single-shot COVID-19 vaccine, earned its emergency OK in February but has yet to file for a full approval.

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As of July 29, about 57% of the U.S. population had received at least one shot and 49% were fully vaccinated, CDC data show. 

At the same time, new cases are surging. The 7-day moving average of daily new cases in late July hit 66,606 cases, up significantly from the June 19 low of 11,483 cases. 

Last month President Joe Biden urged for full approval of the vaccine, saying it could come “at the end of August, beginning of September, October."