FDA Releases Stricter Vaccine Requirements

House has also agreed to these guidelines. Angelica Levito, health reporter at Bloomberg News, joins us for how a vaccine will be properly vetted. Thanks for joining us, Angelica, Thank you for having me. I wanted to talk about vaccines and the f d A. We're all waiting for, uh, the vaccine candidates to put out information saying, you know, whether they're safe and effective and all that. But then after that comes the approval process. The FDA has to

approve those and get that ready. We've heard about the timetables for all of this. The president wants something done before election day. Uh, it really seems like it might be a little bit after that. UM, but we're getting some guidance from the FDI on what they want to do, what kind of UH protocol they want to go through, and they want at least two months of safety data before they approve anything. So Angelica tell us a little bit about what kind of goals the FDA is setting, right,

So it's a really good question. And to be clear, at first, the FDA has signaled that it will use its emergency use authorization powers, which basically means that, well, it won't approve a vaccine, it will allow it to be used in this emergency use. Obviously, we're in a pandemic um so the regulations are a little bit different there. But in order to do that, what they're saying is they want to see two months following the end of the trial to see how everybody is doing before they

make a decision. And that's important because we're hearing that even if we get um some of the initial results in October, obviously, then you have to wait another few months, which could really push back the timeline faster than what some of the federal officials have been promising. We have four vaccine candidates right now in late stage trials. We have Fiser, Maderna, Astra, Zeneca, Johnson, and Johnson obviously all in that kind of different stages. I think astro Zenica's

trial is still on hold right now. Um so really you who are we looking at to have something done? Uh, you know at the earliest possible correct, So, astro Zenica's trial is still on hold. We're expecting results from FISER and majournal sometime this fall and that's the first reporting though. Right after that we would still need two months of

data after that. I'm just trying to get the timetable down right, Yeah, And that's what the FDA is signaling they want is two months of data that will give them time to make sure that none of the trial participants are having any adverse effects. And that way they can review all of the data, include how people did during the trial and then after the trial. How does the White House figure into all of this, because, uh, we're hearing that you know, the White House is objecting

to some of the FDA's vaccine standards. Do they have the power to do that? So it has been reported that the White House was opposed to some of these guidelines because ultimately they will slow down the time frame. However, the FDA went ahead today and publish them, signaling that the FDA is going forward with them and that it's ready to move forward. Angelica, talk to me a little bit about public trust in vaccines, because that's so important

right now. We're already getting a lot of polls that are saying people don't want to even take the first generation vaccine. So even as fast as uh these companies can push out these vaccines, a lot of people are saying, well, I kind of want to wait till the second round or a bunch of people have taken it and and I see that it's safe. Um, So rushing all of the stuff, it doesn't really seem like it's going to

do anything one way or the other. And that's the purpose of FDA saying we want two months of data once the trial is complete. And then also they're convening this advisory committee, and it's pretty typical whatever there is a vaccine candidate or FDA has this advisory meeting um for all kinds of different approvals that it goes through. But there is concerned that maybe they wouldn't enlist their

committee here and sort of move quickly. But now what happens is that in order for the committee to meet all of the materials that they're reviewing the data. Everything must be made public, so that will ideally give the public a window into what the safety data looks like. And then, of course the recommendation from these outside experts who have no connection to the FDA. They were really independent and their job is to give their unbiased advice

to the FDA. So that should hopefully help people as they make their determinations. But of course it's really up to the FDA to say, here's what we know and here's what we don't know. And we're hearing a lot of from the White House. Obviously we're hearing from the FDA. Now what are we hearing from the drug companies themselves that are making these vaccine candidates. As you mentioned, Fiser and Maderna might be kind of first on the block to to have their data ready and available. How are

they figuring into this whole discussion. They're all saying that they'll bide by the regulations that the FDA sets out and that they are committed to following all the rules. And of course, earlier this fall they had published that letter saying that they're committed to the science and promise they will not rush of vaccines. So they say that they're ready to commit to all of those guidelines. Well, we're still some time away before we really get some

more concrete information on this. I know the President wants to get it as soon as possible. He even said it after being discharged from Walter Read. He said that vaccines coming in moments. I think he mentioned So we'll see how how true that actually is. But you know, there's a lot of competing interest here, and I think the chief interest among all of them is is safety for the American people and making sure that these vaccines really do work and help stop the spread of the coronavirus.

So we'll see on all of that. Angelica Levito, health reporter at Bloomberg News, thank you very much for joining us. Great, thank you so much for having me. I'm Oscar Ramirez, and this has been reopening America. Don't forget difference today's big news stories. You can check me out on the Daily Dive podcast every Monday to Friday. So follow us on I Heart Radio or wherever you get your podcast.