The US Food and Drug Administration might not complete its review of Pfizer’s Covid-19 vaccine until Christmas, according to the head of the federal network coordinating Covid-19 vaccine clinical trials.
Pfizer announced Monday that early data shows its vaccine is more than 90% effective.
The drug giant says it could apply to the FDA for emergency use authorization soon after safety data on the vaccine is gathered next week.
Dr. Larry Corey, who runs the Covid-19 Prevention Network, which is funded by the National Institutes of Health, said he thought it would then take several weeks for the FDA to finish reviewing the vaccine’s safety and efficacy data, as well as information about its manufacturing.
“I want to set the expectation that this is a big decision,” said Corey.
Alex Azar, the secretary of Health and Human Services, has said the process of getting FDA authorization will take several weeks, while Dr. Anthony Fauci says vaccinations will likely start a bit before Christmas.
Corey pointed out that it took more than four weeks for the FDA to consider an application by Eli Lilly and Co for its antibody therapy. Lilly applied to the FDA for emergency use authorization on October 7 and received it on November 9.
“You can look at that timing as a marker,” Corey said. “There’s a lot of data to review.”
Corey believes it will take about 10 days for the FDA to review Pfizer’s clinical trial data. The agency also needs to review Pfizer’s manufacturing data.
“I’m not sure how long that review will take, but it could be two weeks. I think that’s reasonable,” Corey said.
If approved, Pfizer’s vaccine would first be given to priority groups such as health care workers, the elderly, and those with underlying health conditions that make them more vulnerable to Covid-19 complications.
Fauci told CNN on Tuesday that the US “likely will be able to start dispensing vaccines in December.”
He also told Australia’s ABC network that “vaccinations will start in December, very likely some time a bit before the Christmas holidays.”
Fauci is director of the National Institute of Allergy and Infectious Diseases, which created the Covid-19 Prevention Network last summer.
Azar said Monday that the process of getting authorization for Pfizer’s vaccine would be “in the several week time period.”