WEBVTT - FDA Releases Stricter Vaccine Requirements

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<v Speaker 1>It's Wednesday, October seven. I'm Oscar Ramirez from the Daily

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<v Speaker 1>Dive podcast in Los Angeles, and this is reopening America.

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<v Speaker 1>The FDA has put out guidelines on the protocols to

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<v Speaker 1>follow before a vaccine can get emergency use authorization. They

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<v Speaker 1>want an expert panel to review any vaccine and also

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<v Speaker 1>want two months of safety data. This will definitely put

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<v Speaker 1>any vaccine out of reach before the election. The White

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<v Speaker 1>House has also agreed to these guidelines. Angelica Levito, health

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<v Speaker 1>reporter at Bloomberg News, joins us for how a vaccine

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<v Speaker 1>will be properly vetted. Thanks for joining us, Angelica, Thank

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<v Speaker 1>you for having me. I wanted to talk about vaccines

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<v Speaker 1>and the f d A. We're all waiting for, uh,

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<v Speaker 1>the vaccine candidates to put out information saying, you know,

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<v Speaker 1>whether they're safe and effective and all that. But then

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<v Speaker 1>after that comes the approval process. The FDA has to

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<v Speaker 1>approve those and get that ready. We've heard about the

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<v Speaker 1>timetables for all of this. The president wants something done

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<v Speaker 1>before election day. Uh, it really seems like it might

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<v Speaker 1>be a little bit after that. UM, but we're getting

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<v Speaker 1>some guidance from the FDI on what they want to do,

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<v Speaker 1>what kind of UH protocol they want to go through,

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<v Speaker 1>and they want at least two months of safety data

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<v Speaker 1>before they approve anything. So Angelica tell us a little

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<v Speaker 1>bit about what kind of goals the FDA is setting, right,

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<v Speaker 1>So it's a really good question. And to be clear,

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<v Speaker 1>at first, the FDA has signaled that it will use

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<v Speaker 1>its emergency use authorization powers, which basically means that, well,

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<v Speaker 1>it won't approve a vaccine, it will allow it to

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<v Speaker 1>be used in this emergency use. Obviously, we're in a

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<v Speaker 1>pandemic um so the regulations are a little bit different there.

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<v Speaker 1>But in order to do that, what they're saying is

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<v Speaker 1>they want to see two months following the end of

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<v Speaker 1>the trial to see how everybody is doing before they

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<v Speaker 1>make a decision. And that's important because we're hearing that

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<v Speaker 1>even if we get um some of the initial results

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<v Speaker 1>in October, obviously, then you have to wait another few months,

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<v Speaker 1>which could really push back the timeline faster than what

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<v Speaker 1>some of the federal officials have been promising. We have

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<v Speaker 1>four vaccine candidates right now in late stage trials. We

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<v Speaker 1>have Fiser, Maderna, Astra, Zeneca, Johnson, and Johnson obviously all

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<v Speaker 1>in that kind of different stages. I think astro Zenica's

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<v Speaker 1>trial is still on hold right now. Um so really

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<v Speaker 1>you who are we looking at to have something done? Uh,

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<v Speaker 1>you know at the earliest possible correct, So, astro Zenica's

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<v Speaker 1>trial is still on hold. We're expecting results from FISER

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<v Speaker 1>and majournal sometime this fall and that's the first reporting though.

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<v Speaker 1>Right after that we would still need two months of

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<v Speaker 1>data after that. I'm just trying to get the timetable

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<v Speaker 1>down right, Yeah, And that's what the FDA is signaling

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<v Speaker 1>they want is two months of data that will give

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<v Speaker 1>them time to make sure that none of the trial

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<v Speaker 1>participants are having any adverse effects. And that way they

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<v Speaker 1>can review all of the data, include how people did

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<v Speaker 1>during the trial and then after the trial. How does

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<v Speaker 1>the White House figure into all of this, because, uh,

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<v Speaker 1>we're hearing that you know, the White House is objecting

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<v Speaker 1>to some of the FDA's vaccine standards. Do they have

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<v Speaker 1>the power to do that? So it has been reported

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<v Speaker 1>that the White House was opposed to some of these

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<v Speaker 1>guidelines because ultimately they will slow down the time frame. However,

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<v Speaker 1>the FDA went ahead today and publish them, signaling that

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<v Speaker 1>the FDA is going forward with them and that it's

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<v Speaker 1>ready to move forward. Angelica, talk to me a little

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<v Speaker 1>bit about public trust in vaccines, because that's so important

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<v Speaker 1>right now. We're already getting a lot of polls that

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<v Speaker 1>are saying people don't want to even take the first

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<v Speaker 1>generation vaccine. So even as fast as uh these companies

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<v Speaker 1>can push out these vaccines, a lot of people are saying, well,

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<v Speaker 1>I kind of want to wait till the second round

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<v Speaker 1>or a bunch of people have taken it and and

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<v Speaker 1>I see that it's safe. Um, So rushing all of

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<v Speaker 1>the stuff, it doesn't really seem like it's going to

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<v Speaker 1>do anything one way or the other. And that's the

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<v Speaker 1>purpose of FDA saying we want two months of data

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<v Speaker 1>once the trial is complete. And then also they're convening

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<v Speaker 1>this advisory committee, and it's pretty typical whatever there is

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<v Speaker 1>a vaccine candidate or FDA has this advisory meeting um

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<v Speaker 1>for all kinds of different approvals that it goes through.

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<v Speaker 1>But there is concerned that maybe they wouldn't enlist their

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<v Speaker 1>committee here and sort of move quickly. But now what

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<v Speaker 1>happens is that in order for the committee to meet

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<v Speaker 1>all of the materials that they're reviewing the data. Everything

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<v Speaker 1>must be made public, so that will ideally give the

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<v Speaker 1>public a window into what the safety data looks like.

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<v Speaker 1>And then, of course the recommendation from these outside experts

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<v Speaker 1>who have no connection to the FDA. They were really

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<v Speaker 1>independent and their job is to give their unbiased advice

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<v Speaker 1>to the FDA. So that should hopefully help people as

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<v Speaker 1>they make their determinations. But of course it's really up

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<v Speaker 1>to the FDA to say, here's what we know and

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<v Speaker 1>here's what we don't know. And we're hearing a lot

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<v Speaker 1>of from the White House. Obviously we're hearing from the FDA.

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<v Speaker 1>Now what are we hearing from the drug companies themselves

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<v Speaker 1>that are making these vaccine candidates. As you mentioned, Fiser

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<v Speaker 1>and Maderna might be kind of first on the block

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<v Speaker 1>to to have their data ready and available. How are

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<v Speaker 1>they figuring into this whole discussion. They're all saying that

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<v Speaker 1>they'll bide by the regulations that the FDA sets out

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<v Speaker 1>and that they are committed to following all the rules.

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<v Speaker 1>And of course, earlier this fall they had published that

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<v Speaker 1>letter saying that they're committed to the science and promise

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<v Speaker 1>they will not rush of vaccines. So they say that

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<v Speaker 1>they're ready to commit to all of those guidelines. Well,

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<v Speaker 1>we're still some time away before we really get some

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<v Speaker 1>more concrete information on this. I know the President wants

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<v Speaker 1>to get it as soon as possible. He even said

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<v Speaker 1>it after being discharged from Walter Read. He said that

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<v Speaker 1>vaccines coming in moments. I think he mentioned So we'll

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<v Speaker 1>see how how true that actually is. But you know,

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<v Speaker 1>there's a lot of competing interest here, and I think

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<v Speaker 1>the chief interest among all of them is is safety

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<v Speaker 1>for the American people and making sure that these vaccines

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<v Speaker 1>really do work and help stop the spread of the coronavirus.

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<v Speaker 1>So we'll see on all of that. Angelica Levito, health

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<v Speaker 1>reporter at Bloomberg News, thank you very much for joining us. Great,

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<v Speaker 1>thank you so much for having me. I'm Oscar Ramirez,

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<v Speaker 1>and this has been reopening America. Don't forget difference today's

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<v Speaker 1>big news stories. You can check me out on the

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<v Speaker 1>Daily Dive podcast every Monday to Friday. So follow us

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<v Speaker 1>on I Heart Radio or wherever you get your podcast.