Speaker 1: Welcome to Prognosis. I'm Laura Carlson. It's day two d
Speaker 1: and one since coronavirus was declared a global pandemic. Today's
Speaker 1: main story headlines about new vaccine candidates drop nearly every day,
Speaker 1: But because the development process is moving at superspeed, there's
Speaker 1: a lot we just can't know about the new crop
Speaker 1: of potential inoculations. But first, here's what happened in virus
Speaker 1: news today. German Chancellor Angela Merkel is warning that the
Speaker 1: country may see a coronavirus surge by Christmas. Merkel said
Speaker 1: today that Germany will face more than nineteen thousand new
Speaker 1: COVID nineteen cases a day by the end of December
Speaker 1: if the current trend in infections isn't halted. The country
Speaker 1: recorded about eleven thousand cases last week. Merkel told leaders
Speaker 1: of her party that the country must act quickly to
Speaker 1: avoid the same rapid rise in cases as neighboring countries
Speaker 1: such as France, which has been reporting an average of
Speaker 1: about twelve thousand cases each day. Moscow has started to
Speaker 1: reopen temporary hospital wards after daily coronavirus infections in the
Speaker 1: Russian capital Sword. The capital is the epicenter of the
Speaker 1: virus in Russia. City Hall ordered eight Moscow hospitals to
Speaker 1: re equip themselves to handle patients by early next week.
Speaker 1: According to the inter Facts news service, Moscow began demobilizing
Speaker 1: its temporary wards in late May. Finally, Hong Kong's latest
Speaker 1: coronavirus wave is showing signs of subsiding after months of
Speaker 1: social distancing measures. The country posted single digit increases in
Speaker 1: cases for seven of the last eight days. That has
Speaker 1: pushed the rolling seven day average daily infection rate down
Speaker 1: to about five the lowest since the end of June.
Speaker 1: And now for today's main story, the race for a
Speaker 1: COVID nineteen vaccine entered a new phase. Recently, four different
Speaker 1: vaccine candidates developed by Moderna, Fiser, bio ent Tech, and
Speaker 1: Johnson and Johnson entered final stage trials, with two others
Speaker 1: close behind. But we won't know exactly how these four
Speaker 1: vaccines work for months. I spoke to reporter Robert Langrath
Speaker 1: about what we can and more importantly, what we can't
Speaker 1: know about a vaccine developed at breakneckt speed give us
Speaker 1: a broad overview of some of the major differences among
Speaker 1: the front runners right now in the race to develop
Speaker 1: a COVID nineteen vaccine. Yeah, so there are a variety
Speaker 1: of different vaccines that are now in the final state
Speaker 1: trials in the United States for COVID nineteen. Two of
Speaker 1: the vaccine front runners are so called a messenger RNA vaccines.
Speaker 1: And those two vaccines that use that very new technology
Speaker 1: messenger RNA are the ones from maderna US biotech company
Speaker 1: and from the big drug giant Fightser, and they are
Speaker 1: both very far along and testing and could have results
Speaker 1: early results from a phase three trial trials plural in
Speaker 1: a month or so. They're both two shot vaccines. Most
Speaker 1: of the first vaccines are two shot vaccines, meaning you'll
Speaker 1: get you'll need to take two shots of the vaccine
Speaker 1: spread out over three or four weeks in order to
Speaker 1: potentially have some protection from the virus. And then the
Speaker 1: third vaccine that's in final stage trial now in the
Speaker 1: US is a vaccine that's based on a cold virus
Speaker 1: called adnovirus that is from astro Zenica and University of Oxford,
Speaker 1: and that that cold virus based vaccine. It's based on
Speaker 1: a monkey cold virus that basically can't replicate in the
Speaker 1: body but helps bring in the coronavirus spike protein in
Speaker 1: and in the fourth vaccine in final stage trials in
Speaker 1: the US that is also based on adnovirus, a type
Speaker 1: of common cold virus. And again, UH, this is one
Speaker 1: that's been altered so it cannot replicate in the body.
Speaker 1: And that's the J and J vaccine, and that just
Speaker 1: began final stage trial in the United States and other
Speaker 1: countries on sixty people. And the big difference with this
Speaker 1: vaccine is that J and J says and may be
Speaker 1: able to have efficacy with just one shot. So this
Speaker 1: is gonna be the first attempt at a single vaccine
Speaker 1: UH in the United States. And the advantages of a
Speaker 1: single shot vaccine is of course just practical distribution and
Speaker 1: immunization mass immunization advantages. Okay, So among these four front runners,
Speaker 1: obviously everyone is keen for the same goal that their
Speaker 1: vaccine is effective. But in terms of the trials that
Speaker 1: are going on right now, how exactly does one prove
Speaker 1: that a vaccine is effective. So all these trials are
Speaker 1: a placebo controlled trials where a participants healthy volunteers in
Speaker 1: the trials are randomly assigned to either get the vaccine
Speaker 1: or a placebo shot, and then they're basically followed after
Speaker 1: they get their shots for weeks and months to see
Speaker 1: how many patients that got the real vaccine got the
Speaker 1: coronavirus COVID nineteen versus how many patients they got the
Speaker 1: bacebo vaccine at the coronavir IRUs. And the hope is
Speaker 1: UH that these vaccines will reduce the incidents of symptomatic
Speaker 1: COVID nineteen by at least half. That's the hope. That's
Speaker 1: the goal of the trials are hoping to do more
Speaker 1: than half, but the kind of half is sort of
Speaker 1: the minimum, the bare minimum that the Food and Recondministration
Speaker 1: has said it would accept. There's some controversy over whether
Speaker 1: the trials, in a rush to get results, in a
Speaker 1: race to get sooner, are including UH and counting in
Speaker 1: the trials, you know, patients with you know, relatively mild
Speaker 1: or moderate cases and not focusing enough on the more
Speaker 1: severe cases and the kinds we all want to prevent,
Speaker 1: the hospitalizations and I see you visits and the deaths UH,
Speaker 1: and that kind of data will take much longer to collect.
Speaker 1: But what they may get early on in the trials,
Speaker 1: they may get a sense of, you know, how it
Speaker 1: prevents UH somewhat milder cases and mild moderate cases and
Speaker 1: may not know as much about what it does in
Speaker 1: terms of preventing hospitalizations or I SeeU visits, because those,
Speaker 1: of course are very severe events we want to prevent,
Speaker 1: but they're much rarer. And how about how these studies
Speaker 1: can account for, say, diverse populations that a vaccine will
Speaker 1: be effective, and say the elderly or communities of color,
Speaker 1: how is that taken into account. Maderna actually slowed down
Speaker 1: one of the company's Maderna actually said it slowed down
Speaker 1: enrollment of its trials a little bit in order to
Speaker 1: make sure, you know, increased minority representation. I made an
Speaker 1: effort to do that now. Of course, another issue is
Speaker 1: that the coronavirus, as everyone knows now, is you know,
Speaker 1: most severe in the elderly, and that's where you know,
Speaker 1: most of the deaths are occurring. Is what I don't
Speaker 1: think anyone wants is a vaccine that does a great
Speaker 1: job offending mild cases and young people, but you still
Speaker 1: have the deaths and elderly people. That's, you know, a
Speaker 1: nightmare scenario. I don't think anyone wants. So they're trying
Speaker 1: to enroll those people, and we don't just won't know
Speaker 1: yet when the early results come out, you know, how
Speaker 1: much we'll have in terms of detailed results in older people,
Speaker 1: we may you know, not have all that information because
Speaker 1: if the trials, you know, are stocked based on kind
Speaker 1: of early results and symptomatic cases in the large your
Speaker 1: population the trial, it may not have those kind of
Speaker 1: all important subsets to how well does the vaccine do
Speaker 1: an elderly population. Let's talk about accountability. You mentioned the
Speaker 1: requirements of the FDA has put out. What kind of
Speaker 1: data do these drug makers have to provide to say
Speaker 1: that their vaccine is reliable and safe and ready to
Speaker 1: be used. Yeah, well, they certainly have to provide a
Speaker 1: data to the FDA, and there's sort of there's sort
Speaker 1: of a basic minimum requirement that the vaccines be at
Speaker 1: least you know, effective and preventing symptomatic COVID. But how
Speaker 1: do you define the symptoms and how mild a case
Speaker 1: do you kind of include for a point of counting.
Speaker 1: The FISER trials is I would say the most controversial
Speaker 1: among researchers because it includes for the purposes of counting
Speaker 1: coronavirus cases for its primary goal cases and with patients
Speaker 1: have a positive test and just one symptom, so that
Speaker 1: could include you know, a lot of my potentially a
Speaker 1: lot of milder cases, and they could declare a success
Speaker 1: based on that. And then some top researchers are worried
Speaker 1: they might declare success based on you know, mostly milder
Speaker 1: moderate cases and not have many cases that are severe,
Speaker 1: and we won't know how well it works in the
Speaker 1: all important severe cases. So there's a great worry about that.
Speaker 1: But one of the consultants we talked to estimated that
Speaker 1: neither FISER number DIRTA would be likely to have results
Speaker 1: in the more severe kind of hospitalization type cases. Really
Speaker 1: until February, they won't have you know, data, clear cut
Speaker 1: data on that. And it looks like other early results
Speaker 1: may come out as soon potentially as soon as the
Speaker 1: end of October for FISER and probably more like November
Speaker 1: sometime for MODERNA, So you know, it looks like there
Speaker 1: could be decision made on an emergency authorization of vaccine
Speaker 1: based on some of the kind of early results in
Speaker 1: the trial. And it's not really clear how much we're
Speaker 1: gonna know about whether the vaccine early on really prevents
Speaker 1: the severe cases severe complications. It's just it's really unclear
Speaker 1: at this point. So what are the risks of pushing
Speaker 1: through an experimental treatment too fast? Yeah. One one big
Speaker 1: issue with any vaccine UH as safety, right, because there's
Speaker 1: a big, big difference between a vaccine that might be
Speaker 1: given to millions of healthy people, including younger people who
Speaker 1: aren't at severe resee complications. So there's a big difference
Speaker 1: between a vaccine like that's given to very healthy people
Speaker 1: and a drug that's given to coronavirus patients already in
Speaker 1: the ICU. UH. And so in terms of side effects, UH, generally,
Speaker 1: you know, researchers want a lot a lot of data
Speaker 1: on safety. The question is, you know, how much is enough? Uh.
Speaker 1: These trials are large. You know, there are thirty thousand
Speaker 1: people or more, and so that means at least, say
Speaker 1: fifteen thousand people get the vaccine, fifteen thousands get the placebo.
Speaker 1: But in the past, vaccines have been felled, are even
Speaker 1: recalled for pretty rare side effects. These things can pop
Speaker 1: up and then you know, they may be you know,
Speaker 1: things that could occur, even severe events that could occur,
Speaker 1: even like one in ten thousand and so the researchers
Speaker 1: I talked to said that you know, based on a
Speaker 1: trial with thirty patients, we may know about things that
Speaker 1: happen you know, one in a few thousand, we may
Speaker 1: not know about you know, rarer events, a rarer adverse
Speaker 1: events that could happen because of vaccine, you know, until
Speaker 1: later on to more and more people start using it.
Speaker 1: Uh So, you know, safety is something that really needs
Speaker 1: to be looked at, you very carefully. And already there's
Speaker 1: has been this controversy with the Astrosennica vaccine over a
Speaker 1: possible neurologic adverse effects that we're seen in one patient
Speaker 1: in the UK that Assnica says in University Oxfors says
Speaker 1: aren't related to the vaccine. But that's led to the
Speaker 1: trial being on hold in the US while the US
Speaker 1: authorities trying to get more information about what happened in
Speaker 1: this case. What will we be able to know about
Speaker 1: how effective that vaccine is and perhaps more importantly, what
Speaker 1: won't we know? These trials are basically essentially going to show,
Speaker 1: you know, short term efficacy, because that's that's all we're
Speaker 1: gonna have. We're not going to have much information on
Speaker 1: how long does the protection last, and of course that's
Speaker 1: a really key factor. To now is you know, how
Speaker 1: how how long are these vaccines gonna work? And we're
Speaker 1: just not going to have that information early on. And
Speaker 1: of course, the history of coronavirus is the cold, common
Speaker 1: cold coronavirus and other ones, is that the immunity to
Speaker 1: them is your fades over time, over you know, months
Speaker 1: to a year or more, a fade. That's why you
Speaker 1: keep getting common colds again and again and again. Uh
Speaker 1: So there is a precedent for coronavirus is an immunity
Speaker 1: you know, not lasting a long period of time. And
Speaker 1: that's a really key question. It's like, are you gonna
Speaker 1: need to be reimmunized like a once every six months,
Speaker 1: once a year and nobody knows that and we're not
Speaker 1: going to know that when the vaccine comes out. All
Speaker 1: we're really going to have is relatively short term ethicsly
Speaker 1: data that hey, so far, for a couple of months,
Speaker 1: this thing, you know, seems to work or at least partially.
Speaker 1: So that's a really key question that we just there's
Speaker 1: no way we're gonna be able to know that what
Speaker 1: a vaccine has brought out, especially if it's brought out
Speaker 1: early on this fall, based on pretty short term follow
Speaker 1: up that was Robert Langrath, and that's it for our
Speaker 1: show today. For coverage of the outbreak from one hundred
Speaker 1: and twenty bureaus around the world, visit bloomberg dot com
Speaker 1: slash Coronavirus and if you like the show, please leave
Speaker 1: us a review and a rating on Apple Podcasts or Spotify.
Speaker 1: It's the best way to help more listeners find our
Speaker 1: global reporting. The Prognosis Daily Edition is produced by Topher
Speaker 1: foreheads Jordan Gaspure, Magnus Henrickson and me Laura Carlson. Today's
Speaker 1: main story was reported by Robert Langreth. Original music by
Speaker 1: Leo Sidrin. Our editors are Rick Shine and Francesco Levi.
Speaker 1: Francesca Levi is Bloomberg's head of podcasts. Thanks for listening.