The US Food and Drug Administration (FDA) should authorize coronavirus vaccine candidates from Pfizer and Moderna within a week of meetings held to discuss them, a top official said Thursday.
Pfizer’s vaccine will be discussed by the FDA’s vaccine advisers December 10 and Moderna’s December 17, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told an American Medical Association webinar.
“One question that will come up is how fast will we see a vaccine authorized after that. It will depend on the discussion at the advisory committee but we are hoping that within about a week afterwards we will see an authorization if everything goes well for each of those,” Marks said.
It’s a piece of good luck that the Pfizer and Moderna coronavirus vaccines appear to have a 95% efficacy, Marks said.
“It is a high bar. They had 95% effectiveness across a wide range of individuals. We are lucky that these first vaccines out the gate, if everything checks out in our review, seem to be very good vaccines,” he said.
“By August to October of this year it became clearer to us that the first vaccines that came through would indeed likely be granted emergency use authorization because of the incredibly pressing nature of this crisis,” Marks added.
Doctors cannot yet tell patients how long the vaccines will protect them from infection, Marks said.
“We know that we’re going to get at least months of protection out of this. And it’s months of protection that will help us all climb out of this Covid-19 crisis,” he said.
Volunteers in the clinical trials will be followed for at least two years and regularly checked to see how long the vaccines’ protections last, Marks said.