US FDA likely to issue emergency use authorization for coronavirus vaccine

While the COVID-19 cases in the US surpassed 4 million as of July 28, US Food and Drug Administration revealed that it was set to give an emergency use authorization (EUA) to the coronavirus vaccine in just a few weeks, director of the FDA Center for Biologics Evaluation and Research, Dr. Peter Marks said at a live-streamed Disease Control and Prevention Summit. Further, he added that once the vaccine met the efficacy requirement, it would be available for immediate use by the public.  

At an online FDA podcast titled FDA Insights, Dr. Marks said that the focus of the agency is to make the medical device treatment against the COVID-19 disease available fast and to as many people as it can reach. He was heard saying that while the agency was aware that there could be some mild symptoms for selected people such as a rash on the arm, the FDA has sought to eliminate those challenges for 100 percent efficacy of the vaccines. He added, that the vaccines will have met the standards and the use will be expedited.  

The vaccines would be administered to a relatively broad population, the population for which we have appropriate data, Dr. Marks said.

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He added that it could be a matter of weeks before people could actually potentially have something like an emergency use authorization. However, he warned that there “wouldn’t be a vaccine which might be 100 percent effective, but some protection is better than nothing and people may have to be revaccinated.” Earlier this month, CBER’s Director was heard saying at an FDA teleconference that the FDA was now willing to license COVID vaccines with a dismal 50 percent efficacy which will be administered to almost seven billion people for them to get back to “normal”.  

FDA approved batch testing

On July 19, the FDA issued an emergency use authorization for Quest Diagnostics for the pool or batch testing in the US—a testing technique with increased capacity, allowing over four test samples to be tested at once. As per the technique deployed in the pool testing, any test that turns back negative implies all four tests as negative and vice-versa. Earlier, Dr Anthony Fauci, the US' top infectious disease expert, mentioned that the White House coronavirus task force was "seriously considering" pool testing for COVID-19.

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