FDA willing to fast track coronavirus vaccine before phase three trials end

Commissioner of U.S. Food and Drug Administration Dr. Stephen M. Hahn                                Erin Scott | Reuters

Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Dr. Stephen Hahn told the newspaper that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.

Phase three trials test a large number of participants to compare an experimental drug to standard therapies and evaluate the overall risks and benefits of the medication.

Hahn’s 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 was too weak to support widespread application of the treatment. That announcement came a day after President Donald Trump accused the FDA, without any evidence, of trying to hurt him politically by dragging its feet in approving new coronavirus vaccines and treatments.

He said it’s likely that data from phase three trials would come out in November. However, he said as the trials progress, if the results show the vaccine is very effective, that could be October.

The Financial Times reported last week that the Trump administration was considering an emergency use authorization before the Nov. 3 election for an experimental coronavirus vaccine developed in the U.K. by Oxford University and AstraZeneca.

At the time, a spokesperson for the Department of Health and Human Services, which includes the FDA, said any reports about an emergency authorization for a vaccine prior to the election were “absolutely false.” AstraZeneca said it had not discussed such a move with the U.S. government.

Already, China and Russia have each approved vaccines without waiting for the completion of phase three trials, which come with the most rigorous testing for a potential new drug. Public health officials in the U.S. and elsewhere have warned that the move could be unsafe.

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Article URL : https://www.cnbc.com/2020/08/30/fda-willing-to-fast-track-coronavirus-vaccine-before-phase-three-trials.html