The drug company Pfizer formally asked the feds Friday to approve its coronavirus vaccine for emergency use — a request that opens the door to a US release before Christmas, according to the firm.
The Manhattan-based drug company — which hinted earlier in the day they would seek approval — is now the first to seek the green light for an experimental jab from the Food and Drug Administration, which must decide whether to allow high-risk Americans to receive it by mid-December.
“It is with great pride and joy — and even a little relief — that I can say that our request for emergency use authorization for our COVID-19 vaccine is now in the FDA’s hands,” Pfizer’s chief executive, Dr. Albert Bourla, said in a video Friday. “This is a historic day.”
If the request is granted, a limited number of people — most likely first responders and health care workers — will be allowed to get the shots before the FDA completes a months-long approval process, according to the New York Times.
The agency has said its standard for emergency approval is high, and officials plan to take roughly three weeks to review Pfizer’s vaccine, the paper reported. An outside panel of experts will then meet review the application on Dec. 10 and could make it available just days later.
On Wednesday, amid a surge in COVID-19 cases nationally, Pfizer announced its experimental vaccine was 95 percent effective and posed no serious safety concerns in a major clinical trial.
The biotech firm Moderna, which also says it has a 95 percent success rate, expects to seek emergency federal approval in coming weeks, the company has said.
If the vaccines are both approved for emergency use, there could be enough doses to immunize about 20 million Americans, according to federal and company officials.
Pfizer plans to increase its manufacturing early next year and possibly have hundreds of millions doses available by the spring.
Both firms say they are working with governments worldwide on a plan for distribution while they await approval from regulatory agencies.