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Speaker 1: Welcome to Prognosis. I'm Laura Carlson. It's day one eighty

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Speaker 1: two since coronavirus was declared a global pandemic. Today's main story.

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Speaker 1: Health agencies and drug companies are taking steps to reassure

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Speaker 1: the public that they're developing a vaccine safely and not

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Speaker 1: being guided by political pressure. They might have to do

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Speaker 1: a lot for the public to trust an eventual vaccine,

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Speaker 1: but first, here's what happened in virus news today. India's

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Speaker 1: coronavirus fatalities are creeping up. The country recently surpassed Brazil

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Speaker 1: to have the world's second highest number of cases. India

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Speaker 1: has reported more than one thousand deaths from COVID nineteen

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Speaker 1: for eight consecutive days. That's higher than the daily death

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Speaker 1: toll in other hard hit nations like the US, Brazil, Russia,

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Speaker 1: and Mexico, with almost seventy four thousand virus related deaths.

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Speaker 1: India has the world's third most people killed by the virus.

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Speaker 1: In at least one US city, Halloween festivities are canceled.

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Speaker 1: Los Angeles is not allowing door to door trigger treating

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Speaker 1: as well as other traditional Halloween gatherings this year to

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Speaker 1: curb the spread of the virus. That's according to the

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Speaker 1: city's Department of Public Health. So called trunk or treating

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Speaker 1: events where children go from car to car to receive

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Speaker 1: treats have also been banned, as have gatherings with non

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Speaker 1: household members, even those out doors. Finally, one of the

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Speaker 1: most promising coronavirus vaccines has stumbled, delivering a reality check

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Speaker 1: about the odds of developing a drug quickly. Astra Zeneca

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Speaker 1: paused tests of its experimental shot after one patient became ill.

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Speaker 1: Doing so is routine in the farming industry. The patient's

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Speaker 1: illness could be a harbinger of something worrisome or something

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Speaker 1: entirely unrelated to the vaccine, But in a world crippled

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Speaker 1: by the pandemic, the setback comes as a reminder that

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Speaker 1: vaccines can fail, or worse, that they can sometimes deliver

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Speaker 1: more harm than good, a disclaimer for politicians and governments

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Speaker 1: promising that a COVID nineteen fix is around the corner,

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Speaker 1: and that brings us to today's main story. Rate. An

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Speaker 1: unsubstantiated claim two weeks ago by President Donald Trump that

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Speaker 1: the Deep State was slowing approval of a COVID nineteen

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Speaker 1: vaccine has set off an effort by government officials and

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Speaker 1: private industry to ensure the White House doesn't interfere with

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Speaker 1: a methodical, careful scientific process. Leaders of the U s.

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Speaker 1: Food and Drug Administration are trying to insulate the agency's

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Speaker 1: vaccine reviewers from outside political pressure. They're also making clear

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Speaker 1: to f d A staff that the political noise shouldn't

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Speaker 1: influence the agency's decisions. F d A Commissioner Stephen Hahn

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Speaker 1: last week sent an email to all seventeen thousand staff

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Speaker 1: members promising that the agency would adhere to strictly the

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Speaker 1: science in a vaccine review. I talked to Bloomberg senior

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Speaker 1: editor for Healthcare Drew Armstrong about why measures like these

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Speaker 1: are necessary and what agencies and companies are trying to

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Speaker 1: do to make sure the public can trust an eventual vaccine.

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Speaker 1: What are pharmaceutical companies like Astra Zenica doing to try

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Speaker 1: and quell fears that a vaccine might be rushed or unsafe.

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Speaker 1: We're in such an interesting time right now for the

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Speaker 1: development of these vaccines because you have these two forces

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Speaker 1: pushing on exact opposite sides, and it's created a really

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Speaker 1: interesting tension for both the companies developing these vaccines. The

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Speaker 1: government's overseeing them and pretty much all of science. Because

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Speaker 1: on one hand, you have this desire for there to

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Speaker 1: be incredibly robust safety and efficacy data, the type of

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Speaker 1: thing that you want on any vaccine, because you're giving

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Speaker 1: a healthy people and you want to know that it

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Speaker 1: works and that it's not going to create any harm.

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Speaker 1: And then on the other hand, you have in the

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Speaker 1: United States close to a thousand people dying a day

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Speaker 1: of this disease, which is a real counterweight. And so

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Speaker 1: you have these dual desires pushing against each other, and

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Speaker 1: the development of these vaccines is stuck right in the middle. Um.

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Speaker 1: So one of the things that we have seen uh

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Speaker 1: to try and reassure the public that these will be

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Speaker 1: safe and that they will be effective, is a pledge

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Speaker 1: from vaccine makers that are engaged with the US government

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Speaker 1: that they will not submit anything to the US until

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Speaker 1: they have robust safety and efficacy data. Now that is

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Speaker 1: would in normal times be a very very bland statement,

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Speaker 1: but put up against some of the public statements from

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Speaker 1: the President um where he has accused parts of the

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Speaker 1: FDA of being the deep state to slow him down

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Speaker 1: or giving optic, mystic timelines about a vaccine being ready

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Speaker 1: before election day, which obviously has pretty serious political implications.

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Speaker 1: It has seemed to be a necessary step by by

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Speaker 1: the industry to kind of protect health regulators inside the

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Speaker 1: US government from some of those pressures. And I definitely

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Speaker 1: want to talk about the political pressures and certainly the

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Speaker 1: role of the f d A, but let's stay on this,

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Speaker 1: this development that's happened with astra zenica in the course

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Speaker 1: of you know, a usual vaccine study, UM a participant

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Speaker 1: falling ill. Is this an unusual step in the process

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Speaker 1: at all. It's not. And I think to understand this

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Speaker 1: a little bit better, you have to know how these

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Speaker 1: things get handled. Anytime you have a large trial of

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Speaker 1: a drug, you have a group of scientists who are

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Speaker 1: helping oversee what's happening there, called the Data Safety Monitoring Board.

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Speaker 1: Their job is to look at anything that happens into

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Speaker 1: the trial that might be a worrying side effect or

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Speaker 1: adverse events what the industry calls it, and make sure

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Speaker 1: it's not related to the vaccine. So any time anyone

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Speaker 1: gets sick, whether or not it seems like it's related

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Speaker 1: or not, they look at this. If someone is in

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Speaker 1: a car accident, um, you know, or it gets god forbid,

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Speaker 1: hit by a bus crossing the street, they have a

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Speaker 1: heart attack. You have to look at it because, as

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Speaker 1: odd as it seems, you want to make sure you

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Speaker 1: don't have you know, let's just say hypothetically that that

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Speaker 1: the drug or the vaccine didn't cause one of those things.

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Speaker 1: A lot of those can be looked at and ruled

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Speaker 1: out relatively quickly, but then you get a category of

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Speaker 1: things that you might say, you know, hey, we need

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Speaker 1: to actually pause and examine this a little bit further.

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Speaker 1: Sometimes they will be found not to have any relation

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Speaker 1: to the vaccine. It's just bad luck that happens. Anytime

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Speaker 1: you have a large trial tens of thousands of people.

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Speaker 1: People get sick, and you know that that can happen

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Speaker 1: in the course of the trial. Things can happen to people,

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Speaker 1: but you have to investigate that and you have to

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Speaker 1: make sure that it's not something that is potentially caused

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Speaker 1: by the vaccine. That's an important step, and I think

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Speaker 1: in general people should probably take confidence that this is

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Speaker 1: happening right now. It's certainly might you know, set back

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Speaker 1: the timeline or the best possible timeline to see these

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Speaker 1: types of things, but it should give people confidence in

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Speaker 1: the science, that science is going to be allowed to

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Speaker 1: play out. Any adverse events caused by these vaccines are

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Speaker 1: going to be looked at, and that they're going to

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Speaker 1: do the hard work and the sometimes you know, unfairseeming

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Speaker 1: work of trying to find a vaccine that's um that's

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Speaker 1: safe and effective. And so let's also take a look

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Speaker 1: at the role of the f d A. You know,

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Speaker 1: once the pharmaceutical companies have a vaccine that they think

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Speaker 1: is safe and effective, what pledges or what stance have

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Speaker 1: they taken in terms of guaranteeing that a vaccine that

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Speaker 1: they approve is going to be safe and effective. You know,

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Speaker 1: the f d A has always had very high standards.

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Speaker 1: It's been thought of as the kind of gold standard

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Speaker 1: for the world in terms of drawing and healthcare regulation.

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Speaker 1: And one of the things that we've seen, UM is

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Speaker 1: that the FDA has really had to emphasize to people

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Speaker 1: because of some of this noise coming from the President

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Speaker 1: UM about vaccine timelines and other things, that you know,

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Speaker 1: it's not willing to let things be politicized, that it

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Speaker 1: is going to stick to the science, that it will

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Speaker 1: do a full and deep review of these vaccine products.

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Speaker 1: And that will do so transparently and let the public

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Speaker 1: see the data. You've also seen some reports out there

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Speaker 1: of top government scientists saying they wouldn't participate in a

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Speaker 1: process that they thought the scientifically compromised. You know, the

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Speaker 1: FDA is attempting to guard its reputation here quite carefully,

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Speaker 1: and that's become harder and harder when you know the

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Speaker 1: vaccine has gotten wrapped up in a political environment where

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Speaker 1: the president's re election depends quite heavily on the administration's

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Speaker 1: response to this virus. So they're doing their best to

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Speaker 1: emphasize that independence, try to kind of shield the agency

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Speaker 1: from real or perceived pressures. Because the public confidence in

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Speaker 1: the agency is um it has its own significant importance,

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Speaker 1: along as well as the scientific integrity of the agency. Now,

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Speaker 1: looking at this highly politicized landscape of the development and

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Speaker 1: approval process of COVID nineteen treatments and therapies, what have

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Speaker 1: been some of the say, political tools that have been

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Speaker 1: deployed to perhaps either fast track or expedite the availability

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Speaker 1: of these UM treatments for for COVID nineteen. Right, So,

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Speaker 1: when we think about the tools that have been deployed,

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Speaker 1: I would I would emphasize that, you know, they're less

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Speaker 1: political tools and more policy tools. Um, the Operation Warp

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Speaker 1: Speed program that the Trump administration has set up is

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Speaker 1: essentially a way of artificially stimulating demand for a vaccine

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Speaker 1: by striking billions of dollars worth of deals with pharmaceutical

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Speaker 1: companies to say, we are going to pay for the

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Speaker 1: manufacturing these, We're gonna help fund the development they use,

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Speaker 1: and to allow them to kind of produce or attempt

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Speaker 1: to chase multiple, multiple different vaccine targets all at once.

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Speaker 1: That's kind of the strongest policy tool that I think

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Speaker 1: we've seen applied here, which is, you know, part of

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Speaker 1: the role of government. I mean, you want the government

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Speaker 1: to kind of come in and provide incentives and do

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Speaker 1: things that private industry might not necessarily do on its own.

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Speaker 1: And in this case, it's saying, let's have everybody chase

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Speaker 1: after the exact same thing all at once, even if

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Speaker 1: we know there's going to be a great deal of failure,

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Speaker 1: maybe only one of you is going to win. You

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Speaker 1: want to reduce the risk for the pharmaceutical industry, so

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Speaker 1: you get lots and lots of chances to do that.

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Speaker 1: That's almost certainly the strongest policy option that the government has.

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Speaker 1: At the same time, we will also soon need to

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Speaker 1: see the government take steps to encourage people to get

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Speaker 1: these vaccines. Um. I think that because of the political

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Speaker 1: environment we're in where we have a presidential election coming

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Speaker 1: up in less than two months, the vaccine itself, the

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Speaker 1: development of the vaccine, access to the vaccine, people's willingness

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Speaker 1: to take a vaccine, has really been wrapped up in

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Speaker 1: the political process, and that presents some not insignificant challenges,

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Speaker 1: not just to developing this, not just getting it approved,

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Speaker 1: as we've talked about with some of the pushback from

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Speaker 1: the pharma companies and trying to protect the FDA, but

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Speaker 1: then also in terms of getting people to then take it,

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Speaker 1: which is the most important thing once you have a vaccine.

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Speaker 1: Vaccines are important not just because they protect individuals, but

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Speaker 1: because they protect society. And if you don't have lots

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Speaker 1: and lots of uptake to protect broad parts of society,

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Speaker 1: you won't be able to solve this problem. So looking ahead,

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Speaker 1: is there a broader risk or danger here, and that

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Speaker 1: we might be in a situation in which we have

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Speaker 1: and of available and approved vaccine, but one that the

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Speaker 1: public doesn't trust I think that's a real concern if

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Speaker 1: you look at some of the polling data out there.

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Speaker 1: One poll from early August by the Gallup Organization UM

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Speaker 1: suggested that about a third of Americans wouldn't take a

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Speaker 1: vaccine when one becomes available. Another more recent poll showed

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Speaker 1: that a large majority of Republicans and Democrats but that

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Speaker 1: a vaccine approval process was going to be politicized. And

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Speaker 1: I think that as we get closer to an election,

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Speaker 1: with so much hinging on a vaccine um and it

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Speaker 1: being such a priority for this president and UH and

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Speaker 1: the Democrats making it an issue as well, we are

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Speaker 1: going to see some of those concerns increase more and more.

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Speaker 1: The noise around this is going to get louder and louder,

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Speaker 1: and I think if we're not careful, we could see

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Speaker 1: permanent damage done to trust of vaccines and drug in

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Speaker 1: this country. That was Drew Armstrong and that's it for

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Speaker 1: our show today. For coverage of the outbreak from one

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Speaker 1: and twenty bureaus around the world, visit Bloomberg dot com

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Speaker 1: slash coronavirus and if you like the show, please leave

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Speaker 1: Spotify it's the best way to help more listeners find

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Speaker 1: our global reporting. The Prognosis Daily edition is produced by

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Speaker 1: top foreheads Jordan gas Pure, Magnus Henrickson, and me Laura Carlson.

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Speaker 1: Today's main story was reported by Drew Armstrong. Original music

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Speaker 1: by Leo cedri Our. Editors are Rick Shine and Francesca Levi.

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Speaker 1: Francesca Levi is Bloomberg's head of podcasts. Thanks for listening,

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