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FDA chief: ‘No pressure from anyone’ to expedite approval process for COVID-19 vaccine

Published: Aug. 20, 2020 at 10:23 AM EDT
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WASHINGTON (Gray DC) - It is unclear when Americans can return to life as normal without a coronavirus vaccine or cure. The search is costing taxpayers billions of dollars and the head of the Food and Drug Administration tells Gray Television Washington News Bureau’s Peter Zampa he cannot promise results any time soon.

Watch the full one-on-one interview with FDA Commissioner Dr. Stephen Hahn:

The fastest researchers have ever developed a vaccine took roughly four years. FDA Commissioner Dr. Stephen Hahn says we could be on the brink of history with a COVID-19 vaccine.

“I don’t have a crystal ball here, but we have made historic progress in this country,” said Hahn.

Hahn says it would be inappropriate to say when the FDA might approve a vaccine for distribution, but he says things are moving faster than ever before.

“That’s not because anyone has been cutting corners. It’s because it’s taken a concerted effort and we haven’t done things in sequence, we’ve done things in parallel,” said Hahn.

Taxpayer dollars are funding seven private trials. The farthest along are projects from Moderna and Pfizer whose vaccines and placebos have already been injected into thousands of human test subjects.

But the president has said he would like to see a vaccine around the beginning of November, and noted it might help his reelection chances if a vaccine is approved by then.

“The only facts FDA will look at with respect to a vaccine when the data come to us is those data and science and the medicine,” said Hahn. “I’ve had absolutely no pressure from anyone.”

Recent polls say one-third of Americans would not get a free vaccine if it is available. But Hahn says they want to ease concerns by clueing the public in on their expedited process.

“That can occasionally lead to concerns. Are corners going to be cut? Are we doing the right studies to determine safety and effectiveness? By being transparent, as we have, about what our criteria for determination of safety and efficacy, and also making sure that there’s a public advisory committee of scientific experts from around the country to actually look at our decision making – that should provide additional confidence to the American people,” said Hahn.

Until a vaccine is available, the FDA is trying to fast track treatments. In June the agency revoked its emergency approval of the drug hydroxychloroquine when studies found it to be ineffective and potentially dangerous.

Now there are calls to deploy an unproven toxic plant extract, oleandrin. The president says his administration is taking a look at its potential use.

“We’ll look at it. We’re looking at a lot of different things,” said President Donald Trump. “I will say the FDA has been great.”

Hahn would not say whether the president has spoken to him about it.

“I’m not going to comment on my conversations with anyone regarding this subject. But I can tell you is that the only considerations we’re going to use are science and data,” said Hahn.

Remdesivir is one approved drug that is still in use to fight COVID-19 and the FDA continues testing other potential remedies.

In addition to therapeutics, Hahn says his agency is keen on ramping up rapid testing. The FDA recently approved the emergency use authorization of the diagnostic test SalivaDirect developed by the Yale School of Public Health.

“It’s a really important advance and should help us move the ball forward with testing,” said Hahn.

Hahn says in addition to the fast results, the ease of collection is key in SalivaDirect and the test does not require as many scarce resources as others.

The latest numbers show more than 173 thousand Americans have died from the coronavirus.

Copyright 2020 Gray DC. All rights reserved.

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