July 31, 2020 -- The FDA could issue an emergency use authorization for a coronavirus vaccine in a “matter of weeks” after clinical trial data meet the requirements for efficacy, a top FDA official said Wednesday.
The authorization would speed up the process for producing a vaccine and making it available to the public.
“We’d like to hope that when [efficacy] happens, it will be a matter of weeks before we could actually potentially have something like an emergency use authorization,” said Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research, which approves vaccines.
Marks made the comments Wednesday during an online event called the Disease Control and Prevention Summit.
Even still, that authorization is likely months down the road, he said on an FDA podcast called FDA Insight, which was released Monday. Two vaccine candidates began advanced clinical trials this week with tests on a large group of people. First, it takes time to enroll people in the trial, he said, and then it takes several months to see indications that the vaccine is effective.
“And so because we’re talking about these things that take on the order of several months, I think the earliest we could be seeing a vaccine is a number of months from now,” he said
He called the accelerated timeline “wonderful” for moving a vaccine forward quickly. Typically, vaccines follow a step-by-step process to reduce the risk of financial investment, he said, but right now, multiple steps are being funded at the same time to create a COVID-19 vaccine quickly. However, safety is the top priority, he said.
“At the end of the day, we have to make sure that all of the boxes are checked and that we have a safe, effective, high-quality vaccine that people are able to receive,” he said on the podcast.
He considers the leading vaccines that entered advanced clinical trials this week to be “trailblazers” that will provide more information for the next vaccine candidates. If multiple options become available, patients should speak with their doctors to determine the best option, Marks said on the podcast. One may work better in older adults, and another may have fewer side effects in certain groups.
“Now, how much of it will be deployed and how long that will take I can’t answer today,” he said on the podcast. “But I know there are teams working on that and they’re trying to make that as quick as possible and to make it make as much sense as possible so that the first vaccine that’s ready to go goes out to the people who need it most and that ultimately everyone who wants to get vaccinated can get vaccinated.”