Speaker 1: It's Wednesday, October seven. I'm Oscar Ramirez from the Daily
Speaker 1: Dive podcast in Los Angeles, and this is reopening America.
Speaker 1: The FDA has put out guidelines on the protocols to
Speaker 1: follow before a vaccine can get emergency use authorization. They
Speaker 1: want an expert panel to review any vaccine and also
Speaker 1: want two months of safety data. This will definitely put
Speaker 1: any vaccine out of reach before the election. The White
Speaker 1: House has also agreed to these guidelines. Angelica Levito, health
Speaker 1: reporter at Bloomberg News, joins us for how a vaccine
Speaker 1: will be properly vetted. Thanks for joining us, Angelica, Thank
Speaker 1: you for having me. I wanted to talk about vaccines
Speaker 1: and the f d A. We're all waiting for, uh,
Speaker 1: the vaccine candidates to put out information saying, you know,
Speaker 1: whether they're safe and effective and all that. But then
Speaker 1: after that comes the approval process. The FDA has to
Speaker 1: approve those and get that ready. We've heard about the
Speaker 1: timetables for all of this. The president wants something done
Speaker 1: before election day. Uh, it really seems like it might
Speaker 1: be a little bit after that. UM, but we're getting
Speaker 1: some guidance from the FDI on what they want to do,
Speaker 1: what kind of UH protocol they want to go through,
Speaker 1: and they want at least two months of safety data
Speaker 1: before they approve anything. So Angelica tell us a little
Speaker 1: bit about what kind of goals the FDA is setting, right,
Speaker 1: So it's a really good question. And to be clear,
Speaker 1: at first, the FDA has signaled that it will use
Speaker 1: its emergency use authorization powers, which basically means that, well,
Speaker 1: it won't approve a vaccine, it will allow it to
Speaker 1: be used in this emergency use. Obviously, we're in a
Speaker 1: pandemic um so the regulations are a little bit different there.
Speaker 1: But in order to do that, what they're saying is
Speaker 1: they want to see two months following the end of
Speaker 1: the trial to see how everybody is doing before they
Speaker 1: make a decision. And that's important because we're hearing that
Speaker 1: even if we get um some of the initial results
Speaker 1: in October, obviously, then you have to wait another few months,
Speaker 1: which could really push back the timeline faster than what
Speaker 1: some of the federal officials have been promising. We have
Speaker 1: four vaccine candidates right now in late stage trials. We
Speaker 1: have Fiser, Maderna, Astra, Zeneca, Johnson, and Johnson obviously all
Speaker 1: in that kind of different stages. I think astro Zenica's
Speaker 1: trial is still on hold right now. Um so really
Speaker 1: you who are we looking at to have something done? Uh,
Speaker 1: you know at the earliest possible correct, So, astro Zenica's
Speaker 1: trial is still on hold. We're expecting results from FISER
Speaker 1: and majournal sometime this fall and that's the first reporting though.
Speaker 1: Right after that we would still need two months of
Speaker 1: data after that. I'm just trying to get the timetable
Speaker 1: down right, Yeah, And that's what the FDA is signaling
Speaker 1: they want is two months of data that will give
Speaker 1: them time to make sure that none of the trial
Speaker 1: participants are having any adverse effects. And that way they
Speaker 1: can review all of the data, include how people did
Speaker 1: during the trial and then after the trial. How does
Speaker 1: the White House figure into all of this, because, uh,
Speaker 1: we're hearing that you know, the White House is objecting
Speaker 1: to some of the FDA's vaccine standards. Do they have
Speaker 1: the power to do that? So it has been reported
Speaker 1: that the White House was opposed to some of these
Speaker 1: guidelines because ultimately they will slow down the time frame. However,
Speaker 1: the FDA went ahead today and publish them, signaling that
Speaker 1: the FDA is going forward with them and that it's
Speaker 1: ready to move forward. Angelica, talk to me a little
Speaker 1: bit about public trust in vaccines, because that's so important
Speaker 1: right now. We're already getting a lot of polls that
Speaker 1: are saying people don't want to even take the first
Speaker 1: generation vaccine. So even as fast as uh these companies
Speaker 1: can push out these vaccines, a lot of people are saying, well,
Speaker 1: I kind of want to wait till the second round
Speaker 1: or a bunch of people have taken it and and
Speaker 1: I see that it's safe. Um, So rushing all of
Speaker 1: the stuff, it doesn't really seem like it's going to
Speaker 1: do anything one way or the other. And that's the
Speaker 1: purpose of FDA saying we want two months of data
Speaker 1: once the trial is complete. And then also they're convening
Speaker 1: this advisory committee, and it's pretty typical whatever there is
Speaker 1: a vaccine candidate or FDA has this advisory meeting um
Speaker 1: for all kinds of different approvals that it goes through.
Speaker 1: But there is concerned that maybe they wouldn't enlist their
Speaker 1: committee here and sort of move quickly. But now what
Speaker 1: happens is that in order for the committee to meet
Speaker 1: all of the materials that they're reviewing the data. Everything
Speaker 1: must be made public, so that will ideally give the
Speaker 1: public a window into what the safety data looks like.
Speaker 1: And then, of course the recommendation from these outside experts
Speaker 1: who have no connection to the FDA. They were really
Speaker 1: independent and their job is to give their unbiased advice
Speaker 1: to the FDA. So that should hopefully help people as
Speaker 1: they make their determinations. But of course it's really up
Speaker 1: to the FDA to say, here's what we know and
Speaker 1: here's what we don't know. And we're hearing a lot
Speaker 1: of from the White House. Obviously we're hearing from the FDA.
Speaker 1: Now what are we hearing from the drug companies themselves
Speaker 1: that are making these vaccine candidates. As you mentioned, Fiser
Speaker 1: and Maderna might be kind of first on the block
Speaker 1: to to have their data ready and available. How are
Speaker 1: they figuring into this whole discussion. They're all saying that
Speaker 1: they'll bide by the regulations that the FDA sets out
Speaker 1: and that they are committed to following all the rules.
Speaker 1: And of course, earlier this fall they had published that
Speaker 1: letter saying that they're committed to the science and promise
Speaker 1: they will not rush of vaccines. So they say that
Speaker 1: they're ready to commit to all of those guidelines. Well,
Speaker 1: we're still some time away before we really get some
Speaker 1: more concrete information on this. I know the President wants
Speaker 1: to get it as soon as possible. He even said
Speaker 1: it after being discharged from Walter Read. He said that
Speaker 1: vaccines coming in moments. I think he mentioned So we'll
Speaker 1: see how how true that actually is. But you know,
Speaker 1: there's a lot of competing interest here, and I think
Speaker 1: the chief interest among all of them is is safety
Speaker 1: for the American people and making sure that these vaccines
Speaker 1: really do work and help stop the spread of the coronavirus.
Speaker 1: So we'll see on all of that. Angelica Levito, health
Speaker 1: reporter at Bloomberg News, thank you very much for joining us. Great,
Speaker 1: thank you so much for having me. I'm Oscar Ramirez,
Speaker 1: and this has been reopening America. Don't forget difference today's
Speaker 1: big news stories. You can check me out on the
Speaker 1: Daily Dive podcast every Monday to Friday. So follow us
Speaker 1: on I Heart Radio or wherever you get your podcast.