Getting the Public to Trust a Vaccine

coronavirus fatalities are creeping up. The country recently surpassed Brazil to have the world's second highest number of cases. India has reported more than one thousand deaths from COVID nineteen for eight consecutive days. That's higher than the daily death toll in other hard hit nations like the US, Brazil, Russia, and Mexico, with almost seventy four thousand virus related deaths. India has the world's third most people killed by the virus.

In at least one US city, Halloween festivities are canceled. Los Angeles is not allowing door to door trigger treating as well as other traditional Halloween gatherings this year to curb the spread of the virus. That's according to the city's Department of Public Health. So called trunk or treating events where children go from car to car to receive treats have also been banned, as have gatherings with non

household members, even those out doors. Finally, one of the most promising coronavirus vaccines has stumbled, delivering a reality check about the odds of developing a drug quickly. Astra Zeneca paused tests of its experimental shot after one patient became ill.

Doing so is routine in the farming industry. The patient's illness could be a harbinger of something worrisome or something entirely unrelated to the vaccine, But in a world crippled by the pandemic, the setback comes as a reminder that vaccines can fail, or worse, that they can sometimes deliver more harm than good, a disclaimer for politicians and governments promising that a COVID nineteen fix is around the corner,

and that brings us to today's main story. Rate. An unsubstantiated claim two weeks ago by President Donald Trump that the Deep State was slowing approval of a COVID nineteen vaccine has set off an effort by government officials and private industry to ensure the White House doesn't interfere with a methodical, careful scientific process. Leaders of the U s. Food and Drug Administration are trying to insulate the agency's

vaccine reviewers from outside political pressure. They're also making clear to f d A staff that the political noise shouldn't influence the agency's decisions. F d A Commissioner Stephen Hahn last week sent an email to all seventeen thousand staff members promising that the agency would adhere to strictly the

science in a vaccine review. I talked to Bloomberg senior editor for Healthcare Drew Armstrong about why measures like these are necessary and what agencies and companies are trying to do to make sure the public can trust an eventual vaccine. What are pharmaceutical companies like Astra Zenica doing to try and quell fears that a vaccine might be rushed or unsafe.

We're in such an interesting time right now for the development of these vaccines because you have these two forces pushing on exact opposite sides, and it's created a really interesting tension for both the companies developing these vaccines. The

government's overseeing them and pretty much all of science. Because on one hand, you have this desire for there to be incredibly robust safety and efficacy data, the type of thing that you want on any vaccine, because you're giving a healthy people and you want to know that it works and that it's not going to create any harm. And then on the other hand, you have in the United States close to a thousand people dying a day

of this disease, which is a real counterweight. And so you have these dual desires pushing against each other, and the development of these vaccines is stuck right in the middle. Um. So one of the things that we have seen uh to try and reassure the public that these will be safe and that they will be effective, is a pledge from vaccine makers that are engaged with the US government that they will not submit anything to the US until

they have robust safety and efficacy data. Now that is would in normal times be a very very bland statement, but put up against some of the public statements from the President um where he has accused parts of the FDA of being the deep state to slow him down or giving optic, mystic timelines about a vaccine being ready before election day, which obviously has pretty serious political implications.

It has seemed to be a necessary step by by the industry to kind of protect health regulators inside the US government from some of those pressures. And I definitely want to talk about the political pressures and certainly the role of the f d A, but let's stay on this, this development that's happened with astra zenica in the course of you know, a usual vaccine study, UM a participant falling ill. Is this an unusual step in the process

at all. It's not. And I think to understand this a little bit better, you have to know how these things get handled. Anytime you have a large trial of a drug, you have a group of scientists who are helping oversee what's happening there, called the Data Safety Monitoring Board. Their job is to look at anything that happens into the trial that might be a worrying side effect or adverse events what the industry calls it, and make sure

it's not related to the vaccine. So any time anyone gets sick, whether or not it seems like it's related or not, they look at this. If someone is in a car accident, um, you know, or it gets god forbid, hit by a bus crossing the street, they have a heart attack. You have to look at it because, as odd as it seems, you want to make sure you don't have you know, let's just say hypothetically that that the drug or the vaccine didn't cause one of those things.

A lot of those can be looked at and ruled out relatively quickly, but then you get a category of things that you might say, you know, hey, we need to actually pause and examine this a little bit further. Sometimes they will be found not to have any relation to the vaccine. It's just bad luck that happens. Anytime you have a large trial tens of thousands of people. People get sick, and you know that that can happen

in the course of the trial. Things can happen to people, but you have to investigate that and you have to make sure that it's not something that is potentially caused by the vaccine. That's an important step, and I think in general people should probably take confidence that this is

happening right now. It's certainly might you know, set back the timeline or the best possible timeline to see these types of things, but it should give people confidence in the science, that science is going to be allowed to play out. Any adverse events caused by these vaccines are going to be looked at, and that they're going to do the hard work and the sometimes you know, unfairseeming work of trying to find a vaccine that's um that's

safe and effective. And so let's also take a look at the role of the f d A. You know, once the pharmaceutical companies have a vaccine that they think is safe and effective, what pledges or what stance have they taken in terms of guaranteeing that a vaccine that they approve is going to be safe and effective. You know, the f d A has always had very high standards. It's been thought of as the kind of gold standard for the world in terms of drawing and healthcare regulation.

And one of the things that we've seen, UM is that the FDA has really had to emphasize to people because of some of this noise coming from the President UM about vaccine timelines and other things, that you know, it's not willing to let things be politicized, that it is going to stick to the science, that it will do a full and deep review of these vaccine products. And that will do so transparently and let the public

see the data. You've also seen some reports out there of top government scientists saying they wouldn't participate in a process that they thought the scientifically compromised. You know, the FDA is attempting to guard its reputation here quite carefully, and that's become harder and harder when you know the vaccine has gotten wrapped up in a political environment where the president's re election depends quite heavily on the administration's

response to this virus. So they're doing their best to emphasize that independence, try to kind of shield the agency from real or perceived pressures. Because the public confidence in the agency is um it has its own significant importance,

along as well as the scientific integrity of the agency. Now, looking at this highly politicized landscape of the development and approval process of COVID nineteen treatments and therapies, what have been some of the say, political tools that have been deployed to perhaps either fast track or expedite the availability of these UM treatments for for COVID nineteen. Right, So, when we think about the tools that have been deployed, I would I would emphasize that, you know, they're less

political tools and more policy tools. Um, the Operation Warp Speed program that the Trump administration has set up is essentially a way of artificially stimulating demand for a vaccine by striking billions of dollars worth of deals with pharmaceutical companies to say, we are going to pay for the manufacturing these, We're gonna help fund the development they use, and to allow them to kind of produce or attempt to chase multiple, multiple different vaccine targets all at once.

That's kind of the strongest policy tool that I think we've seen applied here, which is, you know, part of the role of government. I mean, you want the government to kind of come in and provide incentives and do things that private industry might not necessarily do on its own. And in this case, it's saying, let's have everybody chase after the exact same thing all at once, even if we know there's going to be a great deal of failure,

maybe only one of you is going to win. You want to reduce the risk for the pharmaceutical industry, so you get lots and lots of chances to do that. That's almost certainly the strongest policy option that the government has. At the same time, we will also soon need to see the government take steps to encourage people to get

these vaccines. Um. I think that because of the political environment we're in where we have a presidential election coming up in less than two months, the vaccine itself, the development of the vaccine, access to the vaccine, people's willingness to take a vaccine, has really been wrapped up in the political process, and that presents some not insignificant challenges, not just to developing this, not just getting it approved, as we've talked about with some of the pushback from

the pharma companies and trying to protect the FDA, but then also in terms of getting people to then take it, which is the most important thing once you have a vaccine. Vaccines are important not just because they protect individuals, but because they protect society. And if you don't have lots and lots of uptake to protect broad parts of society,

you won't be able to solve this problem. So looking ahead, is there a broader risk or danger here, and that we might be in a situation in which we have and of available and approved vaccine, but one that the public doesn't trust I think that's a real concern if you look at some of the polling data out there. One poll from early August by the Gallup Organization UM suggested that about a third of Americans wouldn't take a

vaccine when one becomes available. Another more recent poll showed that a large majority of Republicans and Democrats but that a vaccine approval process was going to be politicized. And I think that as we get closer to an election, with so much hinging on a vaccine um and it being such a priority for this president and UH and the Democrats making it an issue as well, we are going to see some of those concerns increase more and more.

The noise around this is going to get louder and louder, and I think if we're not careful, we could see permanent damage done to trust of vaccines and drug in this country. That was Drew Armstrong and that's it for our show today. For coverage of the outbreak from one and twenty bureaus around the world, visit Bloomberg dot com slash coronavirus and if you like the show, please leave us a review and a rating. On Apple Podcasts or Spotify it's the best way to help more listeners find

our global reporting. The Prognosis Daily edition is produced by top foreheads Jordan gas Pure, Magnus Henrickson, and me Laura Carlson. Today's main story was reported by Drew Armstrong. Original music by Leo cedri Our. Editors are Rick Shine and Francesca Levi. Francesca Levi is Bloomberg's head of podcasts. Thanks for listening, l