The US Food and Drug Administration insists it is working as quickly as possible to review applications for full approval of the Covid-19 vaccines as the number of cases continues to rise and vaccination rates decline across the country.
Though the FDA has yet to disclose a time line for when its work will be done, medical experts and sources familiar with the process tell CNN that full approval could come within the next couple of months. While that would amount to a record fast pace, the urgency is rising for a fully approved vaccine given the troubling surge in Covid cases sweeping the country.
An FDA official told CNN on Wednesday that the agency continues to work as fast as possible to review the applications. The official noted that as part of the emergency use authorization granted last year, the vaccines have already undergone a "thorough scientific evaluation" in order to "meet FDA's rigorous standards for safety, effectiveness, and manufacturing quality."
Still, federal medical officials and business leaders agree that full FDA approval would be helpful in the fight against vaccine hesitancy and would support companies eager to issue vaccine mandates to employees returning to the office.
Where the process stands: The FDA should have all the paperwork and data from the vaccine trials from Pfizer and be in the reviewing process, medical experts said.
In July, Pfizer announced that the FDA had granted its vaccine a priority review, accelerating the process from 10 months to six, meaning that technically approval should be granted by January.
But the acting commissioner of the FDA, Dr. Janet Woodcock, has said the FDA intends to complete the review far in advance of its January deadline. Multiple officials told CNN the FDA is working nonstop to get through the review process and grant approval.
Former FDA Commissioner Dr. Scott Gottlieb said on Wednesday that he believed the approval could come as early as next month.
"I long felt that the FDA would approve the vaccine probably within a three- to four-month time frame from when the application was submitted. Those applications were submitted about two and a half, three months ago. ... So I think that puts you on (an) end of August, September time frame in terms of when these are going to be approved."
Medical experts stressed that the vaccination approval process takes time, even for something as vital as Covid-19 vaccines.
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