USFDA Likely To Give COVID-19 Vaccine Emergency Use Authorization In Few Weeks

The US Food and Drug Administration (FDA) is likely to approve emergency use authorization (EUA) of COVID-19 vaccine within a few weeks from now, experts believe.

According to the director of the FDA Center for Biologics Evaluation and Research, Dr. Peter Marks, FDA is likely to issue the authorization for coronavirus vaccine once any of the candidates being tested meet the efficacy criteria in large human trials.

The reports of the possibility of emergency use authorization of the COVID-19 vaccine in the U.S. has come amid speculations that Russia may plan to launch its version of coronavirus vaccine in the second week of August.

Dr. Marks shared his opinion on the possibility of emergency use authorization during an online event called the Disease Control and Prevention Summit. He said that the FDA is completely ready to issue authorization provided the vaccine is being used in an appropriate setting.

That means that the FDA will provide approval for emergency or expedited use of the vaccine once it meets the efficacy requirements. Dr. Marks further said that the FDA is giving priority to COVID-19 vaccine trials to accelerate the approval process for authorization. However, it should meet the efficacy requirement and the safety profile should not be compromised.

“We’d like to hope that when that happens, it will be a matter of weeks before we could actually potentially have something like an emergency use authorization,” Dr. Marks said during the event. “Emergency use authorization will be for the population for which we have appropriate data.”

“We’re going to need a vaccine that’s probably in the order of 70% effective and 70%, at least, of the population is going to need to take it,” he said in one of his earlier teleconferences.

In the U.S, two COVID-19 vaccine candidates entered late-stage clinical trials in humans on Monday, July 27. One of the coronavirus vaccines being tested is by Moderna, while the other one has been collaboratively developed by Pzifer and BioNTech.