The chief of the U.S. Food and Drug Administration is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible, according to an interview in The Financial Times.
Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Stephen Hahn told the publication that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.
“It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told The Financial Times. “If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination.”
The comments come a week after the FDA granted emergency authorization of convalescent plasma to treat hospitalized Covid-19 patients, despite concerns among some health officials that data from clinical trials is too weak to support widespread application of the treatment yet. That announcement was on the heels of President Trump accusing the FDA, without any evidence, of trying to hurt him politically by dragging its feet in approving new coronavirus vaccines and treatments.
The best of the Muslim Times’ collection for war against Covid 19:
In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.
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