FDA Could Issue Emergency Use Authorization for COVID-19 Vaccine Within Weeks After Clinical Trial Data Meet Efficacy Requirements

Speaking at a recent online event called the Disease Control and Prevention Summit, Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research, which approves vaccines, said “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.” However, on an FDA podcast called FDA Insight, Marks cautioned that such an authorization was still months away. Referring to two vaccine candidates that had entered into advanced clinical trials and were being tested on a large group of people, Marks said that enrolling people in a trial takes time and the vaccine’s effectiveness would be visible only after months, suggesting that a vaccine would become available several months from now.

Instead of the step-by-step process that was usually followed for developing vaccines in order to reduce the risk of financial investment, multiple steps were currently being funded at the same time to move a COVID-19 vaccine quickly, according to Marks, although safety remained the top priority. Calling the leading vaccines that had just entered advanced clinical trials as “trailblazers”, Marks said that they would provide more information for the next vaccine candidates. Given that more than one vaccine was in advanced clinical trials, Marks said that there was a possibility of multiple options becoming available to the people, with one working better in older adults and another causing fewer side effects among certain groups. In that case, Marks suggested that patients should speak with their doctors to choose the best vaccine option.

“Now, how much of it will be deployed and how long that will take I can’t answer today,” said Marks. “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.”

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US Food and Drug Administration (FDA)