Welcome the prognosis. I'm Laura Carlson. It's day one and sixty six since coronavirus was declared a global pandemic. Today's main story using the blood plasma of recovered COVID patients to treat very sick ones. It's a promising experimental tool in the fight against the disease. But what should we make of today's decision by the White House to expand access to the treatment even before researchers fully understand it.
But first, here's what happened in virus news today. After suffering one of Europe's earliest and fiercest outbreaks, Italy emerged as an unlikely role model for its handling of the pandemic. The country managed to reduce infections and fatalities dramatically in June and July after two months of strict lockdown, but as cases flare in Europe, Italy's success may now be in jeopardy. On Saturday, Italy recorded the most new cases
since mid May. The intensity and duration of Italy's lockdown is widely seen as one of the reasons why cases continue to fall. After curbs started to be gradually lifted in early May, restrictions were maintained for a full six weeks after new infections peaked, and schools never reopened. Unlike in France or Germany, Hong Kong has confirmed the first known case of a coronavirus reinfection. A man was infected with the virus this month after recovering from an initial
bout in April. Scientists say they found the second infection in the thirty three or old who had no symptoms when he was screened at an airport after returning from Europe. Researchers at the University of Hong Kong say they know it is a reinfection because they used genomic sequence analysis to prove that he had been reinfected by two different strains. The findings suggests there may not be long lasting immunity
from the virus in those who recover. The South Korean government is deciding whether to raise social distancing restrictions to the highest level, as officials warn the country is at the risk of a quote massive nationwide outbreak. An additional three d and ninety seven new virus cases were reported on Sunday, the highest number since March seven. Jung Un Kyung, head of Korea's Centers for Disease Control and Preventions set at a briefing on Sunday that case is are rising
in seventeen cities and provinces across the nation. And now for today's main story, President Donald Trump expanded access to a coronavirus treatment that involves blood plasma donated by people who have recovered from COVID nineteen. But while convalescent plasma as it's known, is a promising therapy, researchers don't yet
fully understand how well it works. I spoke with Bloomberg's Michelle fake Cortez about what the announcement means and the concerns that agencies like the f d A are letting pressures from the White House rather than science guide their decisions. What is the promise of plasma as a treatment for COVID nineteen. Convalescent plasma is basically bringing in reinforcements to help someone who's newly infected with coronavirus fight it off.
When you think about an infection, there is a pathogen that your body encounters and your immune system fights it off using antibodies. These antibodies remain in your blood and in your system for some extended period perhaps life long after you successfully fight off that infection. So think of these antibodies as your soldiers in your fight against the virus.
What convalescent plasma does is it takes your blood, your antibodies, your fighters, and gives them to another person who's been newly infected, and it takes up the battle for them. So obviously there's all kinds of questions around it. What antibodies specifically do you need, Because the body makes a wide variety, at what point should you get the antibodies. If you've had the infection for a while, you've made your own antibodies, so maybe someone else's don't help, but
perhaps early on in the infection they do. Has convalescent plasma been used before with other diseases. Convalescent plasma has been used for over a hundred years, and in fact, it won the first Nobel Prize for treatment of diphtheria. So it is a known quantity. That being said, because of the way viruses infections move, we don't yet have
definitive proof that it works. There haven't been any clinical trials that have been completed that show that convalescent plasma actually does help you recover more quickly or lower mortality from any type of infection. Again, there's great hope that this does work, and we know that millions of people get blood transfusions all the time. So it's considered very very safe. Because it's safe, it doesn't have to be all that beneficial in order to make a difference in
patients lives. Usually, when we're thinking about drugs, we have safety versus efficacy. In this case, we know there's not a safety risk. So even if it helps a little bit, if you're not hurting anybody, why not go forward. The bottom line is, though, we really want evidence, We really want proof that this product is going to benefit people.
And what evidence is there that the use of convalescent plasma works with regard to COVID nineteen, The Mayo Clinic had a program that showed that people who received a high dose of convalescent plasma were thirty five percent less likely to die than those who received a lower dose of that plasma, but everyone in the trial received plasma.
The way that it was talked about by the Trump administration and f d A Commissioner Han was that convalescent plasma itself reduced mortality by but because everybody did get the convalescent plasma. It wasn't the plasma itself that was making the difference. Likely it was the high dose antibodies
versus the low dose antibodies. But again, there wasn't a clinical trial, so there are other things that could have been playing a role, other variables like how sick the patients were, how old the patients were, whether they got it early in their infection or late in their infection. So without those kind of controls, we really don't know how effective it was at all. And when you look at a thirty five percent reduction in mortality, that's a
relative risk reduction. When you look at the actual numbers from the program that was done by the Mayo Clinic, we saw that people who had a high dose of antibodies were eight point nine percent likely to die. People who had a lower dose or thirteen point seven percent more likely to die. Now, while that is a thirty five percent decrease in depths, it doesn't mean that half
of all the people didn't die. And it's those kind of nuances around statistical analysis and math that most people don't follow anyway, and so some of the details might get lost in translation. We've recently seen an emergency Use authorization issued with regard to convalescent plasma. Now, how does this exactly speed up the process of medical facilities and physicians acquiring and issuing this as a treatment for COVID nineteen?
An expanded use authorization is essentially like an approval in that it allows hospitals and doctors to prescribe the therapy and to use it unilaterally. They don't have to enroll their patients in a clinical trial, they don't have to track their outcomes. They don't have to report any kind of an improvement or deceleration in their response to the therapy. They will have to tell the f d A if there's been any terrible side effects with it, but that's
a generally pretty high bar. That's when you've had a serious adverse event. But these patients who are going to be getting plasma under the emergency Use authorization will get it just like people get any approved medicine. So how they ultimately do isn't going to be tracked by anyone, So we won't really know if they are better off than if they had just gotten standard of care. And will the emergency use authorization affected all the acquisition or say,
the distribution of this convalescent plasma. It can be really tricky to get convalescent plasma. This isn't a product that's being made in a laboratory. You literally have to take it out of people's bodies, and there are a number of companies out there who do that. You've probably seen them on the side of the road in small little buildings, Biolife other places like that. Also, the American Red Cross and hospitals have set up their own plasma donation centers.
So getting access to the plasma requires people to be willing to donate after they've already gone through an infection, So you have to know you've been infected, you have to be willing to donate, and you have to have a place to go to do the donation. But there's already a lot of demand for blood products in general, and donations have gone down, so the entire industry is actually already under pressure. Exactly how this emergency Use authorization
is going to impact the industry isn't entirely clear. The hope is that it will make it easier for these organizations to gather the plasma and to distribute it widely across the country where it's needed. Is it likely that we are going to see more uses of the emergency use authorization in the future, for potentially, say the development of a COVID nineteen vaccine. Emergency use authorizations get products to patients markedly faster than any other kind of approach
used by regulators. It's a critical tool during the pandemic because we don't really have time in a lot of cases to make sure we're dotting every eye and crossing every t so the standard is lower. It's just they want to make sure that it's safe and that it has some suggestion that there might be a benefit. But there is a broader issue here that is concerning a lot of people in the industry and in science and medicine in general. So the concern is that politics is
entering into play here. Certainly, everyone is anxious, beyond measure to get new treatments and vaccines and testing tools out to the people, to the doctor so that we can
get coronavirus under control. There are a lot of uncertainties ahead, and when we talk about something like a vaccine which will be given to people who are entirely healthy in hopes of averting an infection that they might not ever have anyway, the idea of giving something that is not truly vetted and truly safe is worrisome to a lot
of people. And so the idea that maybe we're losing some of our confidence and some of our belief in our public health officials because they are racing to get new products two people quicker, so that perhaps they might be cutting some corners raises critical problems. Obviously, with the election coming up over the next couple of months, there has been perhaps an even increased pressure for the Trump
administration to have a vaccine ready by that time. Is there an option or have we seen any likelihood that there may be a similar emergency use authorization or emergency order for a fast tract vaccine before November. There's almost no question that the first vaccines that become available for coronavirus will be made available through an emergency use authorization. Everyone expects that. Whether it's possible for that to happen
before the election is still an open question. Almost all of the data we have so far suggests that the uncle trials will not be completed. Going back to the criteria of what regulators are going to act on when it comes to something like that. They don't have to have fully definitive proof, but they do need to have some guarantee that at least it's safe, and then a
show's signs of promise. It is possible that there could be action before the election, but whether or not people are going to trust those findings and ultimately embrace the vaccine isn't known, and that's critically important for controlling coronavirus. If a vaccine works or it doesn't work, If people don't get it, it doesn't even matter. That was Michelle
Fake Quartets, and that's it for our show today. For coverage of the outbreak from one twenty bears around the world, visit Bloomberg dot com slash coronavirus and if you like the show, please leave us a review and a radar on Apple Podcasts or Spotify. It's the best way to help more listeners fall our global reporting, The Prognosis Daily edition is produced by Topher Foreheads, Jordan Gaspure, Magnus Hendrickson and me Laura Carlson. Today's main story was reported by
Michelle Fake Cortez. Original music by Leo Sidran. Our editors are Rick Shine and Francesca Levi. Francesco Levi is Bloomberg's head of podcasts. Thanks for listening.