Speaker 1: Welcome the prognosis. I'm Laura Carlson. It's day one and
Speaker 1: sixty six since coronavirus was declared a global pandemic. Today's
Speaker 1: main story using the blood plasma of recovered COVID patients
Speaker 1: to treat very sick ones. It's a promising experimental tool
Speaker 1: in the fight against the disease. But what should we
Speaker 1: make of today's decision by the White House to expand
Speaker 1: access to the treatment even before researchers fully understand it.
Speaker 1: But first, here's what happened in virus news today. After
Speaker 1: suffering one of Europe's earliest and fiercest outbreaks, Italy emerged
Speaker 1: as an unlikely role model for its handling of the pandemic.
Speaker 1: The country managed to reduce infections and fatalities dramatically in
Speaker 1: June and July after two months of strict lockdown, but
Speaker 1: as cases flare in Europe, Italy's success may now be
Speaker 1: in jeopardy. On Saturday, Italy recorded the most new cases
Speaker 1: since mid May. The intensity and duration of Italy's lockdown
Speaker 1: is widely seen as one of the reasons why cases
Speaker 1: continue to fall. After curbs started to be gradually lifted
Speaker 1: in early May, restrictions were maintained for a full six
Speaker 1: weeks after new infections peaked, and schools never reopened. Unlike
Speaker 1: in France or Germany, Hong Kong has confirmed the first
Speaker 1: known case of a coronavirus reinfection. A man was infected
Speaker 1: with the virus this month after recovering from an initial
Speaker 1: bout in April. Scientists say they found the second infection
Speaker 1: in the thirty three or old who had no symptoms
Speaker 1: when he was screened at an airport after returning from Europe.
Speaker 1: Researchers at the University of Hong Kong say they know
Speaker 1: it is a reinfection because they used genomic sequence analysis
Speaker 1: to prove that he had been reinfected by two different strains.
Speaker 1: The findings suggests there may not be long lasting immunity
Speaker 1: from the virus in those who recover. The South Korean
Speaker 1: government is deciding whether to raise social distancing restrictions to
Speaker 1: the highest level, as officials warn the country is at
Speaker 1: the risk of a quote massive nationwide outbreak. An additional
Speaker 1: three d and ninety seven new virus cases were reported
Speaker 1: on Sunday, the highest number since March seven. Jung Un Kyung,
Speaker 1: head of Korea's Centers for Disease Control and Preventions set
Speaker 1: at a briefing on Sunday that case is are rising
Speaker 1: in seventeen cities and provinces across the nation. And now
Speaker 1: for today's main story, President Donald Trump expanded access to
Speaker 1: a coronavirus treatment that involves blood plasma donated by people
Speaker 1: who have recovered from COVID nineteen. But while convalescent plasma
Speaker 1: as it's known, is a promising therapy, researchers don't yet
Speaker 1: fully understand how well it works. I spoke with Bloomberg's
Speaker 1: Michelle fake Cortez about what the announcement means and the
Speaker 1: concerns that agencies like the f d A are letting
Speaker 1: pressures from the White House rather than science guide their decisions.
Speaker 1: What is the promise of plasma as a treatment for
Speaker 1: COVID nineteen. Convalescent plasma is basically bringing in reinforcements to
Speaker 1: help someone who's newly infected with coronavirus fight it off.
Speaker 1: When you think about an infection, there is a pathogen
Speaker 1: that your body encounters and your immune system fights it
Speaker 1: off using antibodies. These antibodies remain in your blood and
Speaker 1: in your system for some extended period perhaps life long
Speaker 1: after you successfully fight off that infection. So think of
Speaker 1: these antibodies as your soldiers in your fight against the virus.
Speaker 1: What convalescent plasma does is it takes your blood, your antibodies,
Speaker 1: your fighters, and gives them to another person who's been
Speaker 1: newly infected, and it takes up the battle for them.
Speaker 1: So obviously there's all kinds of questions around it. What
Speaker 1: antibodies specifically do you need, Because the body makes a
Speaker 1: wide variety, at what point should you get the antibodies.
Speaker 1: If you've had the infection for a while, you've made
Speaker 1: your own antibodies, so maybe someone else's don't help, but
Speaker 1: perhaps early on in the infection they do. Has convalescent
Speaker 1: plasma been used before with other diseases. Convalescent plasma has
Speaker 1: been used for over a hundred years, and in fact,
Speaker 1: it won the first Nobel Prize for treatment of diphtheria.
Speaker 1: So it is a known quantity. That being said, because
Speaker 1: of the way viruses infections move, we don't yet have
Speaker 1: definitive proof that it works. There haven't been any clinical
Speaker 1: trials that have been completed that show that convalescent plasma
Speaker 1: actually does help you recover more quickly or lower mortality
Speaker 1: from any type of infection. Again, there's great hope that
Speaker 1: this does work, and we know that millions of people
Speaker 1: get blood transfusions all the time. So it's considered very
Speaker 1: very safe. Because it's safe, it doesn't have to be
Speaker 1: all that beneficial in order to make a difference in
Speaker 1: patients lives. Usually, when we're thinking about drugs, we have
Speaker 1: safety versus efficacy. In this case, we know there's not
Speaker 1: a safety risk. So even if it helps a little bit,
Speaker 1: if you're not hurting anybody, why not go forward. The
Speaker 1: bottom line is, though, we really want evidence, We really
Speaker 1: want proof that this product is going to benefit people.
Speaker 1: And what evidence is there that the use of convalescent
Speaker 1: plasma works with regard to COVID nineteen, The Mayo Clinic
Speaker 1: had a program that showed that people who received a
Speaker 1: high dose of convalescent plasma were thirty five percent less
Speaker 1: likely to die than those who received a lower dose
Speaker 1: of that plasma, but everyone in the trial received plasma.
Speaker 1: The way that it was talked about by the Trump
Speaker 1: administration and f d A Commissioner Han was that convalescent
Speaker 1: plasma itself reduced mortality by but because everybody did get
Speaker 1: the convalescent plasma. It wasn't the plasma itself that was
Speaker 1: making the difference. Likely it was the high dose antibodies
Speaker 1: versus the low dose antibodies. But again, there wasn't a
Speaker 1: clinical trial, so there are other things that could have
Speaker 1: been playing a role, other variables like how sick the
Speaker 1: patients were, how old the patients were, whether they got
Speaker 1: it early in their infection or late in their infection.
Speaker 1: So without those kind of controls, we really don't know
Speaker 1: how effective it was at all. And when you look
Speaker 1: at a thirty five percent reduction in mortality, that's a
Speaker 1: relative risk reduction. When you look at the actual numbers
Speaker 1: from the program that was done by the Mayo Clinic,
Speaker 1: we saw that people who had a high dose of
Speaker 1: antibodies were eight point nine percent likely to die. People
Speaker 1: who had a lower dose or thirteen point seven percent
Speaker 1: more likely to die. Now, while that is a thirty
Speaker 1: five percent decrease in depths, it doesn't mean that half
Speaker 1: of all the people didn't die. And it's those kind
Speaker 1: of nuances around statistical analysis and math that most people
Speaker 1: don't follow anyway, and so some of the details might
Speaker 1: get lost in translation. We've recently seen an emergency Use
Speaker 1: authorization issued with regard to convalescent plasma. Now, how does
Speaker 1: this exactly speed up the process of medical facilities and
Speaker 1: physicians acquiring and issuing this as a treatment for COVID nineteen?
Speaker 1: An expanded use authorization is essentially like an approval in
Speaker 1: that it allows hospitals and doctors to prescribe the therapy
Speaker 1: and to use it unilaterally. They don't have to enroll
Speaker 1: their patients in a clinical trial, they don't have to
Speaker 1: track their outcomes. They don't have to report any kind
Speaker 1: of an improvement or deceleration in their response to the therapy.
Speaker 1: They will have to tell the f d A if
Speaker 1: there's been any terrible side effects with it, but that's
Speaker 1: a generally pretty high bar. That's when you've had a
Speaker 1: serious adverse event. But these patients who are going to
Speaker 1: be getting plasma under the emergency Use authorization will get
Speaker 1: it just like people get any approved medicine. So how
Speaker 1: they ultimately do isn't going to be tracked by anyone,
Speaker 1: So we won't really know if they are better off
Speaker 1: than if they had just gotten standard of care. And
Speaker 1: will the emergency use authorization affected all the acquisition or say,
Speaker 1: the distribution of this convalescent plasma. It can be really
Speaker 1: tricky to get convalescent plasma. This isn't a product that's
Speaker 1: being made in a laboratory. You literally have to take
Speaker 1: it out of people's bodies, and there are a number
Speaker 1: of companies out there who do that. You've probably seen
Speaker 1: them on the side of the road in small little buildings,
Speaker 1: Biolife other places like that. Also, the American Red Cross
Speaker 1: and hospitals have set up their own plasma donation centers.
Speaker 1: So getting access to the plasma requires people to be
Speaker 1: willing to donate after they've already gone through an infection,
Speaker 1: So you have to know you've been infected, you have
Speaker 1: to be willing to donate, and you have to have
Speaker 1: a place to go to do the donation. But there's
Speaker 1: already a lot of demand for blood products in general,
Speaker 1: and donations have gone down, so the entire industry is
Speaker 1: actually already under pressure. Exactly how this emergency Use authorization
Speaker 1: is going to impact the industry isn't entirely clear. The
Speaker 1: hope is that it will make it easier for these
Speaker 1: organizations to gather the plasma and to distribute it widely
Speaker 1: across the country where it's needed. Is it likely that
Speaker 1: we are going to see more uses of the emergency
Speaker 1: use authorization in the future, for potentially, say the development
Speaker 1: of a COVID nineteen vaccine. Emergency use authorizations get products
Speaker 1: to patients markedly faster than any other kind of approach
Speaker 1: used by regulators. It's a critical tool during the pandemic
Speaker 1: because we don't really have time in a lot of
Speaker 1: cases to make sure we're dotting every eye and crossing
Speaker 1: every t so the standard is lower. It's just they
Speaker 1: want to make sure that it's safe and that it
Speaker 1: has some suggestion that there might be a benefit. But
Speaker 1: there is a broader issue here that is concerning a
Speaker 1: lot of people in the industry and in science and
Speaker 1: medicine in general. So the concern is that politics is
Speaker 1: entering into play here. Certainly, everyone is anxious, beyond measure
Speaker 1: to get new treatments and vaccines and testing tools out
Speaker 1: to the people, to the doctor so that we can
Speaker 1: get coronavirus under control. There are a lot of uncertainties ahead,
Speaker 1: and when we talk about something like a vaccine which
Speaker 1: will be given to people who are entirely healthy in
Speaker 1: hopes of averting an infection that they might not ever
Speaker 1: have anyway, the idea of giving something that is not
Speaker 1: truly vetted and truly safe is worrisome to a lot
Speaker 1: of people. And so the idea that maybe we're losing
Speaker 1: some of our confidence and some of our belief in
Speaker 1: our public health officials because they are racing to get
Speaker 1: new products two people quicker, so that perhaps they might
Speaker 1: be cutting some corners raises critical problems. Obviously, with the
Speaker 1: election coming up over the next couple of months, there
Speaker 1: has been perhaps an even increased pressure for the Trump
Speaker 1: administration to have a vaccine ready by that time. Is
Speaker 1: there an option or have we seen any likelihood that
Speaker 1: there may be a similar emergency use authorization or emergency
Speaker 1: order for a fast tract vaccine before November. There's almost
Speaker 1: no question that the first vaccines that become available for
Speaker 1: coronavirus will be made available through an emergency use authorization.
Speaker 1: Everyone expects that. Whether it's possible for that to happen
Speaker 1: before the election is still an open question. Almost all
Speaker 1: of the data we have so far suggests that the
Speaker 1: uncle trials will not be completed. Going back to the
Speaker 1: criteria of what regulators are going to act on when
Speaker 1: it comes to something like that. They don't have to
Speaker 1: have fully definitive proof, but they do need to have
Speaker 1: some guarantee that at least it's safe, and then a
Speaker 1: show's signs of promise. It is possible that there could
Speaker 1: be action before the election, but whether or not people
Speaker 1: are going to trust those findings and ultimately embrace the
Speaker 1: vaccine isn't known, and that's critically important for controlling coronavirus.
Speaker 1: If a vaccine works or it doesn't work, If people
Speaker 1: don't get it, it doesn't even matter. That was Michelle
Speaker 1: Fake Quartets, and that's it for our show today. For
Speaker 1: coverage of the outbreak from one twenty bears around the world,
Speaker 1: visit Bloomberg dot com slash coronavirus and if you like
Speaker 1: the show, please leave us a review and a radar
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Speaker 1: help more listeners fall our global reporting, The Prognosis Daily
Speaker 1: edition is produced by Topher Foreheads, Jordan Gaspure, Magnus Hendrickson
Speaker 1: and me Laura Carlson. Today's main story was reported by
Speaker 1: Michelle Fake Cortez. Original music by Leo Sidran. Our editors
Speaker 1: are Rick Shine and Francesca Levi. Francesco Levi is Bloomberg's
Speaker 1: head of podcasts. Thanks for listening.