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Speaker 1: Welcome to Prognosis. I'm Francesco Leavie. Laura Carlson is out.

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Speaker 1: It's stayed two ten since coronavirus was declared a global

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Speaker 1: pandemic Today's main story. This week, regulators took steps that

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Speaker 1: made it all but impossible for a vaccine to be

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Speaker 1: released to the public before it's been thoroughly tested. That

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Speaker 1: dashed President Trump's hopes of a pre election inoculation and

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Speaker 1: put on display the tense relationship between the White House

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Speaker 1: and federal health agencies. But first, here's what happened in

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Speaker 1: virus News today. President Donald Trump's sudden decision to walk

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Speaker 1: away from stimulus talks with Democrats probably killed the chances

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Speaker 1: of a relief package before the November election, even though

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Speaker 1: hours later Trump sent weets that appeared to reverse course.

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Speaker 1: Any aid to struggling Americans and businesses might now be

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Speaker 1: delayed until That has put the economic rebound at risk

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Speaker 1: of stalling in the fourth quarter, economists say, and it

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Speaker 1: could leave the Federal Reserve under pressure to provide more support.

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Speaker 1: Economists say growth will likely slow and the economy will

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Speaker 1: be even more vulnerable to another shock. Today, US House

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Speaker 1: Speaker Nancy Pelosi signaled in a call with Treasury Secretary

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Speaker 1: Stephen Manuken that she was open to a standalone airline

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Speaker 1: relief bill without a comprehensive package. Indianapolis based pharmaceutical giant

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Speaker 1: Eli Lily is seeking emergency authorization of the treatment it's

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Speaker 1: developing with Canadian biotech absile Era Biologics. The authorization from

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Speaker 1: the Food and Drug Administration would allow high risk patients

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Speaker 1: recently diagnosed with mild to moderate COVID nineteen to see

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Speaker 1: the therapy. Finally, a mobile phone app that travelers can

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Speaker 1: use to show their COVID free will begin trials this month.

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Speaker 1: It could be a step towards resuming more long haul flights.

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Speaker 1: The Common Pass application will be tested on certain routes

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Speaker 1: with carriers United Airlines and Cafe Pacific Airways. Volunteers must

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Speaker 1: take a coronavirus at a certified health lab and upload

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Speaker 1: results onto their phones, with the app generating a bar

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Speaker 1: code to show that their disease free. Authorities, including US

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Speaker 1: Customs and Border Protection and the Centers for Disease Control

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Speaker 1: and Prevention, will observe the process. Now for today's main story.

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Speaker 1: In the flood of news that's come out this week,

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Speaker 1: you may have missed some small but significant steps that

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Speaker 1: regulators took. Yesterday, the Food and Drug Administration, which has

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Speaker 1: been at odds with the White House promising an approved

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Speaker 1: vaccine by the election, released guidelines that all but killed

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Speaker 1: the chances that would happen. The FDA has been working

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Speaker 1: for months to hammer out clear standards for vaccines seeking

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Speaker 1: fast track approval. Yesterday, the agency made a series of

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Speaker 1: moves that all but assured that a shot won't be

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Speaker 1: widely available by election day. I talked to senior editor

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Speaker 1: for Healthcare Drew Armstrong about what the implications are for

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Speaker 1: a fast vaccine and for Trump's reelection. So, Drew, tell

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Speaker 1: me about the f d A guidelines that were released yesterday. Yeah,

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Speaker 1: So I hate to understand this. You have to rewind

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Speaker 1: a little bit back to the All of the political

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Speaker 1: dynamics and noise um and regulatory efforts are on trying

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Speaker 1: to get a vaccine as soon as possible. Basically, the

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Speaker 1: US has this fast track vaccine effort called Operation and

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Speaker 1: Warp Speed that has been trying to shave the usually

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Speaker 1: years long timeline that takes to make a vaccine down

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Speaker 1: into months. Now. The reality, though, is that any of

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Speaker 1: these vaccines that are going to be used are going

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Speaker 1: to have to go through the f d A, and

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Speaker 1: typically FDA review for any vaccine or medical device or

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Speaker 1: drug it can take months and months and months. But

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Speaker 1: because we're in the middle of a pandemic, there is

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Speaker 1: this policy called an Emergency Use Authorization and everybody calls

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Speaker 1: it an eu A in f DA world, and so

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Speaker 1: that's how well we can talk about it here. But

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Speaker 1: what it basically says is that in an emergency situation,

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Speaker 1: you can use a little bit less data and a

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Speaker 1: little bit less information on the safety and effectiveness of

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Speaker 1: these vaccines in order to get them out to at

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Speaker 1: least some part of the American public than you would otherwise. Now,

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Speaker 1: the big fight in d C and one of the

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Speaker 1: questions that everybody's been asking is what data is going

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Speaker 1: to be required, How safe do we need to know

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Speaker 1: they are, how effective we need to know they are.

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Speaker 1: And there's been a long wait for the FDA to

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Speaker 1: come out with a what's called a guidance document that

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Speaker 1: basically says, here's where we're setting the threshold on all

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Speaker 1: of those things. Here's exactly where we want these drug

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Speaker 1: makers who are working on these vaccines. Here's what they want.

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Speaker 1: We need them to tell us about how this works.

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Speaker 1: And so that's kind of been the setup. So fast

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Speaker 1: forward to yesterday. The f d A had come up

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Speaker 1: with this guidance and had been close to putting it

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Speaker 1: out for some time now, and they had to send

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Speaker 1: it over to the White House for approval. The White House, though,

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Speaker 1: um where keep in mind President Trump wants to move

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Speaker 1: as fast as possible and it's accused the FDA of

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Speaker 1: being part of the deep state and sabotaging his selection.

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Speaker 1: Chances has been sitting on this guidance basically where saying,

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Speaker 1: you know, it's perpetually kind of under review. What happened

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Speaker 1: yesterday was basically the FDA didn't kind of an end

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Speaker 1: run around the White House, and the FDA, which is

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Speaker 1: trying to hold a relatively high standard here, snuck this

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Speaker 1: guidance in a different document essentially ahead of a meeting

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Speaker 1: that they were going to have. So FDA basically said

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Speaker 1: we're just gonna go ahead and put these out in

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Speaker 1: this other method, and boom, it kind of kicked off

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Speaker 1: this whole thing of FDA making this end run around

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Speaker 1: the White House. Basically, so even the release of these

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Speaker 1: guidelines was somewhat controversial. What did we learn when they

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Speaker 1: finally came out, What did they actually say? So what

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Speaker 1: we learned is actually not that new um FDA had

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Speaker 1: been saying publicly what was going to be in these

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Speaker 1: but it basically said that drug maker is gonna be

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Speaker 1: required to have two months a median of two months

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Speaker 1: of safety data on any vaccine that they apply um

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Speaker 1: for one of these emergency use authorizations for, and that

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Speaker 1: any vaccine is going to have to go through a

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Speaker 1: panel of experts at the FDA, that the FDA will

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Speaker 1: set up this event and the experts will all talk

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Speaker 1: about it. This all seems, you know, relatively benign, and

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Speaker 1: you know, the FDA has been selling drugmakers some of

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Speaker 1: this stuff already. They've been saying, hey, here's what these

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Speaker 1: standards are going to be. The reality is, though, that

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Speaker 1: with President Trump calling for a vaccine by election day,

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Speaker 1: a lot of people raising concerns about political interference this

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Speaker 1: delay of these guidelines under review by the White House,

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Speaker 1: FDA went out and basically said, hey, we're putting this

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Speaker 1: marker down. It's on paper. If anybody tries to roll

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Speaker 1: us or push this through in the way that they

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Speaker 1: shouldn't be. We have laid out our standards for how

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Speaker 1: this is gonna work in print that probably serves as

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Speaker 1: a degree of pushback against any kind of political interference,

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Speaker 1: which has been a big concern at the FDA through

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Speaker 1: this process. So what is the significance of this announcement

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Speaker 1: for that election day timeline? What are the chances that

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Speaker 1: a vaccine will be released by then? I think certainly

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Speaker 1: in terms of election day timeline that is down to

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Speaker 1: slim to none. Um. You know, I think it's worth

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Speaker 1: keeping in mind that the only person who was really

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Speaker 1: pushing this election day um timeline was President Trump. His

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Speaker 1: re election potentially on November three, entirely hinges on his

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Speaker 1: response to the coronavirus uh pandemic, and you know, he's

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Speaker 1: been very much out there saying, you know, we might

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Speaker 1: have a vaccine by election day, you know, and at

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Speaker 1: times accusing the FDA of slowing down work to hurt

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Speaker 1: him politically. But every other scientist in his administration, people

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Speaker 1: in the drug industry, basically every piece of kind of

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Speaker 1: knowledgeable expertise working on this has called that very very unlikely. Fiser,

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Speaker 1: the New York based drug maker that has a vaccine

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Speaker 1: is probably furthest along was the company that was most likely,

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Speaker 1: um to potentially have some results by then. But even so,

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Speaker 1: it was gonna take always take a while for FDA

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Speaker 1: to review these things, um, and for them to then

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Speaker 1: get out to the public. So I think, you know,

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Speaker 1: this guidance document from f D A plus a few

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Speaker 1: other things that happened yesterday have really pretty firmly put

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Speaker 1: the nail on the coffin on any possibility of a

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Speaker 1: vaccine being ready by election day. Briefly talk about what

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Speaker 1: else happened yesterday to put the nail in the coffin.

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Speaker 1: As you say, Um, the FDA win't even further than

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Speaker 1: this guidance. You know. I think one of the other

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Speaker 1: things that happened yesterday was that, um, you know, we

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Speaker 1: saw the head of President Trump's Operation Warp Speed program

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Speaker 1: UM make some remarks where he said, you know, no

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Speaker 1: vaccine maker should apply for an emergency use authorization unless

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Speaker 1: they're ready to deliver millions of doses right away. So

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Speaker 1: that's another piece of delay. UM. We saw the Fiser

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Speaker 1: CEO come out on Twitter and say that they would

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Speaker 1: definitely be very conscious of the science and we're interested

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Speaker 1: in you know, didn't want to do anything to undercut

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Speaker 1: the f d A after the FDA put out that guidance. UM,

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Speaker 1: so you know, a lot of things stacking up all

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Speaker 1: at once, basically to make it more and more difficult

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Speaker 1: for this already unlikely ambitious timeline actually to to happen.

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Speaker 1: And finally, how did the Trump administration react to this news? Yeah,

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Speaker 1: that's a great action. And UM, you might not be

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Speaker 1: surprised to know that the reaction from Trump came on Twitter,

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Speaker 1: um late uh late last night. He put out a

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Speaker 1: tweet um, which he has done before, in which he

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Speaker 1: said new FDA rules make it more difficult for them

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Speaker 1: to speed up vaccines for approval before election day. Just

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Speaker 1: another political hit job. And then he tagged FDA Commissioner

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Speaker 1: Stephen Hahn in his tweet. UM. This is not the

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Speaker 1: first time that he has accused people in the public

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Speaker 1: health agencies, UM, in government of being part of the

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Speaker 1: deep state or being politically motivated to slow him down.

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Speaker 1: Just for the record, UM, We've talked to lots of

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Speaker 1: folks in those agencies. There is no evidence whatsoever that

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Speaker 1: there's any kind of conspiracy against the president. Um. Everybody

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Speaker 1: that I've spoken to in the scientific community inside and

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Speaker 1: outside government wants to get a vaccine as quickly as possible.

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Speaker 1: But you know, along with that priority, they are very

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Speaker 1: very worried about undermining trust in science, undermining trust in regulators,

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Speaker 1: and make sure that when a vac scene does come

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Speaker 1: to market, that people believe that it's on the market

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Speaker 1: because it is safe and because it is effective, not

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Speaker 1: because it was pushed along in order to help the

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Speaker 1: president's reelection. Drew, thank you so much for your time,

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Speaker 1: Happy to do it. That was Drew Armstrong and that's

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Speaker 1: it for our show. Recoverage of the outbreak from one

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Speaker 1: bureaus around the world. Visit bloomberg dot com, slash coronavirus

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Speaker 1: and if you like the show, please leave us a

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Speaker 1: review and a rating on Apple Podcasts or Spotify. It's

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Speaker 1: the best way to help more listeners find our global reporting.

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Speaker 1: The Prognosis Daily edition is produced by top foreheads Broden Gospel,

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Speaker 1: A Magnus Hendrickson, and Laura Carlson. Today's main story was

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Speaker 1: reported by Drew Armstrong. Original music by Leo Sitterard. Our

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Speaker 1: editors are Rick Shine and me Francesca Leaving. I'm also

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Speaker 1: Bloomberg's head of podcasts, l