FDA COVID-19 Vaccine Process Is 'Thoughtful And Deliberate,' Says Ex-FDA Head : Coronavirus Updates Rachel Martin speaks with former Food and Drug Administration commissioner Dr. Mark McClellan about this week's FDA advisory panel on COVID-19 vaccine research.
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FDA COVID-19 Vaccine Process Is 'Thoughtful And Deliberate,' Says Former FDA Head

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FDA COVID-19 Vaccine Process Is 'Thoughtful And Deliberate,' Says Former FDA Head

FDA COVID-19 Vaccine Process Is 'Thoughtful And Deliberate,' Says Former FDA Head

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Early in last night's debate, President Trump made a promise that his own Food and Drug Administration thinks he probably can't keep.


PRESIDENT DONALD TRUMP: We have a vaccine that's coming. It's ready. It's going to be announced within weeks.

MARTIN: While that timeline is ambitious, the FDA says it is making progress. A panel of experts held an all-day session yesterday to hear where we stand on a new coronavirus vaccine. Dr. Mark McClellan was the FDA commissioner under George W. Bush. He's currently at the Duke Margolis Center for Health Policy at Duke University. Dr. McClellan, thanks for being here this morning.

MARK MCCLELLAN: Good morning, Rachel.

MARTIN: So from what you saw at that meeting yesterday, should the American public feel confident in the FDA's progress toward a vaccine?

MCCLELLAN: Rachel, I think the American public should feel more confident. That was a meeting that involved a range of independent expert perspectives, public input and a lot of discussion of many of the issues that are still in process as we get towards a vaccine. We've made incredible progress at an unprecedented pace but still some issues to resolve. And those all came up during a full-day meeting yesterday.

MARTIN: What were the issues when you were sitting there? What struck your ear as being the biggest obstacle to getting a vaccine?

MCCLELLAN: Well, one was just making sure everyone knew in detail what the FDA process currently is and getting a chance to discuss key aspects of that process - the tens of thousands of people that are in trials now, that FDA is looking for the vaccines to show that they really have an impact on outcomes that matter, like the occurrence of infections and serious consequences for those infections. And then some big discussions around things like getting lots of data on the safety of a vaccine and taking time to do that versus the fact that we're in the midst of a public health emergency. And making a vaccine available sooner could help with that.

MARTIN: Right. I mean, this seems to be such a tension, wanting to make sure that there's a vaccine available as soon as possible but making sure that in doing so, corners aren't cut. I mean, this is also - it's causing consternation among Americans who just don't trust the process or at least are skeptical about it. I mean, how do you begin to bridge that trust gap?

MCCLELLAN: Well, the tension between trying to make decisions that get products available quickly, especially when there's such a big unmet medical need, versus taking the time to get all the evidence - that's a tension that FDA lives with every day in the areas of new medical product development. I think what's different here is that there's so much at stake. This is a vaccine that would be potentially used by tens, hundreds of millions of Americans to help us get out of the pandemic. And it's also occurring at a time when there's been a lot of politics involved. And I think the net effect of the politics, coupled with the fact that we are really taking steps faster, not necessarily cutting corners but taking steps faster to make a vaccine available - that's increased this level of tension in the public.

And I think people, for the most part - the experts, the others listening, found this very reassuring to know that even though FDA is going fast, it's not cutting corners. And it's trying to be very thoughtful and deliberate about getting the evidence needed before the vaccine becomes available, even to people in the highest-risk groups like health care workers and people living in nursing homes or who are at high risk of complications.

MARTIN: Is there a possibility - I mean, there are so many trials happening. Is there a chance that Americans would have more than vaccine available to them?

MCCLELLAN: There is a chance they'll have more than one vaccine. There are six vaccines that the federal government is really backing. And the reason things are going so much faster is that these very large clinical trials to test whether the vaccines work or not are happening at the same time as the government working with the manufacturers are going ahead with very large-scale manufacturing. So it's not really cutting corners so much as making what's normally a very long, linear process a parallel one. So there'll be lots of vaccine available, not for everybody but for lots of doses, when these trials are done. And that's part of this effort to make the vaccines available faster without cutting corners.

That said, people are worried that there is enough safety data available. And, Rachel, it's important to know that this is not the last step in the process. There will be another meeting like this before any particular vaccine gets considered for approval. So more chances to to make sure we're doing this right.

MARTIN: And just briefly, you think still spring, midsummer - when will we see a vaccine (unintelligible)?

MCCLELLAN: I think early availability could come later this year but probably not large-scale availability until spring or summer. And that means we'll have a chance to learn a lot more as the vaccines gradually become available.

MARTIN: Mark McClellan, head of the FDA under President George W. Bush.

Thanks so much for taking the time.

MCCLELLAN: Good to be with you.

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