Speaker 1: Welcome to Prognosis. I'm Laura Carlson. It's day two hundred
Speaker 1: and sixty eight since coronavirus was declared a global pandemic.
Speaker 1: Today's main story this week, crucial decisions are coming that
Speaker 1: will determine how soon Americans can start receiving a COVID
Speaker 1: nineteen vaccine. We'll discuss everything you need to know about
Speaker 1: what happens next, but first, here's what happened in virus
Speaker 1: News today. Global coronavirus cases have topped sixty seven million
Speaker 1: in the US. A record number of coronavirus patients are
Speaker 1: in the hospital, and nearly two thousand people are being
Speaker 1: hospitalized with the disease every day. According to data from
Speaker 1: the Department of Health and Human Services, New York, North Carolina,
Speaker 1: and Tennessee recorded the biggest increase in patients. New Mexico
Speaker 1: has exceeded its ICU capacity. COVID nineteen cases now account
Speaker 1: for at least one in five hospital patients in nine states.
Speaker 1: Experts are warning about the winter holidays ahead. Anthony Fauci,
Speaker 1: the top infectious disease expert in the US, warned that
Speaker 1: the Christmas season could be even worse than Thanksgiving for
Speaker 1: the outbreak the Christmas holiday is both longer and more challenging,
Speaker 1: Fauci said in a CNN interview. And Scott Gottlieb, former
Speaker 1: Commissioner of the U S Food and Drug Administration and
Speaker 1: a FISER board member, believes the current wave of infections
Speaker 1: in the US has yet to peak. On CBS's face
Speaker 1: the Nation on Sunday, Gottlieb said COVID nineteen numbers are
Speaker 1: expected to get worse over the next four to six weeks.
Speaker 1: Infections are not likely to peek until the end of
Speaker 1: December or into January. Deaths probably will peak in the
Speaker 1: middle of January. Finally, there are signs the outbreak is
Speaker 1: abating in parts of Europe. Italy's outbreak continues to slow. Today,
Speaker 1: health officials reported the lowest daily new cases since October.
Speaker 1: Italy make it its first three point four million doses
Speaker 1: of the FISER bio en Tech COVID nineteen vaccine as
Speaker 1: soon as January, a week earlier than expected. According to
Speaker 1: the Italian newspaper Il Massa Gero and Now for today's
Speaker 1: main story, the coming week could mark an early turning
Speaker 1: point in the U S battle against COVID nineteen. An
Speaker 1: advisory panel made up of top medical experts will meet
Speaker 1: December tenth to help the Food and Drug Administration review
Speaker 1: the drug for possible emergency authorization that would clear the
Speaker 1: way to making it a top weapon against the virus.
Speaker 1: I asked reporter Anna Edney to break down the next
Speaker 1: steps in the approval process and help explain the reality
Speaker 1: of making the vaccine available to the public, and I
Speaker 1: was hoping you might provide us with some details about
Speaker 1: exactly what's going to happen at this meeting. So the
Speaker 1: meeting is so that the advisors to the Food and
Speaker 1: Drug Administration can hear from the FDA staff themselves actually
Speaker 1: as well as Visor about their UM look at the
Speaker 1: clinical chrial data that Visor UM ended up with after
Speaker 1: they they did a trial on about forty four thousand participants,
Speaker 1: And so the FDA has taken a look at that data,
Speaker 1: visors taking its own look UM. They're going to present
Speaker 1: each of their own calculations to the advisory panel in
Speaker 1: public so everybody can listen to it if they want
Speaker 1: to UM, and then they're going to the panel of advisors.
Speaker 1: They'll talk about UM that data, they'll discuss it. They're
Speaker 1: often have a vote at the very end of the meeting.
Speaker 1: I anticipate it will be a lengthy meeting UM, and
Speaker 1: they'll they'll vote on something that will give an indication
Speaker 1: to the FDA about whether they should authorize the vaccine
Speaker 1: or not. And obviously we're talking on Monday. The meeting
Speaker 1: is only a few days away. As far as the
Speaker 1: timeline and materials, what's going to be made available leading
Speaker 1: up to the meeting. So typically the way that these
Speaker 1: advisory panel meetings work is the two days before they meet,
Speaker 1: the Food and Drug Administration will release UM they're called
Speaker 1: briefing documents. It's the f d a's review of the
Speaker 1: clinical trial data. They'll release fiser's own briefing documents as well.
Speaker 1: So this will be the first hint the public will
Speaker 1: get UM into the agency's view of that data and
Speaker 1: you know where they're leaning on it, where they have questions,
Speaker 1: where they think there might be gaps in some of
Speaker 1: the data, UM. And then so that will come likely
Speaker 1: Tuesday morning, sometime around nine am. Typically they come out UM.
Speaker 1: You know, at the same time the meeting would start
Speaker 1: two days later, and then you know, the meeting happens
Speaker 1: on Thursday, UM, probably all day long, and they'll be
Speaker 1: that vote that I mentioned at the end. Most likely
Speaker 1: we'll see in those briefing documents what exactly the questions
Speaker 1: are for the panel that they'll discuss at the end,
Speaker 1: and whether there is a vote that's asked for. So
Speaker 1: as far as the experts and authorities that will be
Speaker 1: at this meeting and the various opinions and recommendations that
Speaker 1: will happen with regards to a vaccine candidate, does the
Speaker 1: FDA have to accept these recommendations. They don't have to.
Speaker 1: Very often. They do their usual you know, they're they're
Speaker 1: in agreement, I would say most of the time with
Speaker 1: the panel, um when it comes down to whether they
Speaker 1: authorize or approve or reject um a drug or a vaccine,
Speaker 1: and then there, um, you know, the final decision. The Commissioner,
Speaker 1: Stephen Hahn has said he's leaving that up to Peter Marks,
Speaker 1: who's the head of the agency center that oversees vaccines.
Speaker 1: And that's really typical. You know, the Commissioner often does
Speaker 1: not get involved in making those decisions unless there's something
Speaker 1: that the Commissioner might want to over a role. It's
Speaker 1: not something that I anticipate in this case, um, And
Speaker 1: so I think you'll see career officials at the Food
Speaker 1: and Drug Administration making any final decision on this, which
Speaker 1: could come, you know, as soon as a day or
Speaker 1: two after the meeting on Thursday. And that brings up
Speaker 1: a good point as far as what happens after this
Speaker 1: meeting in terms of the days and weeks after these
Speaker 1: recommendations are made and after this panel meets. What we're
Speaker 1: looking for during the panel is, you know, what are
Speaker 1: the questions the FDA has. How complicated are those questions?
Speaker 1: If they're pretty straightforward, If the data looks pretty straightforward, um,
Speaker 1: and the FDI doesn't seem too conflicted, you know, we
Speaker 1: might see an FDA decision on authorizing the vaccine within
Speaker 1: a day or two. If it's if it looks like
Speaker 1: there's a lot they're trying to work through. If they're
Speaker 1: not quite sure about this vaccine or some some portion
Speaker 1: of it, the safety or the avocacy, then that might
Speaker 1: take a little bit longer. UM. Peter Marks, who had
Speaker 1: the the agency center that has the handles vaccines he has,
Speaker 1: you know, said it possibly could take weeks if there
Speaker 1: if there are complications in the in the application for
Speaker 1: the vaccine. Um. But whenever it does get authorized. If
Speaker 1: it does, then UM operation work warp Speed officials have
Speaker 1: said that they will expect to start distributing it within
Speaker 1: twenty four hours. So that's probably about UM six point
Speaker 1: four million doses right away and UM that'll that'll go
Speaker 1: to healthcare workers and long term care residents, UM kind
Speaker 1: of as the states see fit. So this this really
Speaker 1: isn't the end of the process, but really perhaps just
Speaker 1: one of the many starting points. Certainly, I think, you know,
Speaker 1: even the vaccine makers will have more work to do.
Speaker 1: They're not going to necessarily just abruptly and their clinical trials. UM.
Speaker 1: The f d A is making their decision on these
Speaker 1: vaccines UM that are getting emergency authorization based on two
Speaker 1: months of safety data and typically for a full approval
Speaker 1: UM they were they'd be looking for six months. So
Speaker 1: they're gonna they're gonna want the the drugmakers to continue
Speaker 1: doing these trials, to continue getting them information and and
Speaker 1: seek out a full approval from the agency. UM. And
Speaker 1: so there's still more work to be done. And then
Speaker 1: you know, the States will be doing a lot of
Speaker 1: work to try to get these vaccines out to people
Speaker 1: and to you know, that's going to be a continuing
Speaker 1: process well through the spring in the summer, and does
Speaker 1: this in terms of the emergency use authorization for the
Speaker 1: fighter and the bio and tech candidate. Will that potentially
Speaker 1: make it more difficult for the other candidates under development
Speaker 1: from other companies? It could in the sense that UM.
Speaker 1: You know, when there are other companies like Johnson and
Speaker 1: Johnson UM still trying to do clinical trials of their vaccines.
Speaker 1: People that are in those trials, you know, about half
Speaker 1: of them are getting a placebo. They're not getting the vaccine.
Speaker 1: And if they feel they're getting the placebo, they're going
Speaker 1: to think, you know, maybe I should drop out and
Speaker 1: at the vaccine if they're eligible to get the vaccine.
Speaker 1: So there are people at the f d A and
Speaker 1: at companies trying to work through this. You know, do
Speaker 1: they start switching these trials, you know, or start start
Speaker 1: doing some trials based on comparing them to the vaccines
Speaker 1: that are on the market rather than a pluce ebo. UM.
Speaker 1: They're thinking about all of this, trying to make sure
Speaker 1: that there can still be data gathered on the vaccines
Speaker 1: as they're going. And you know, the other thing is
Speaker 1: safety won't just be up to the company's to look at.
Speaker 1: There will be a lot of people in the United States,
Speaker 1: millions of people using these vaccines, will be getting the vaccines.
Speaker 1: So there are at least half a dozen different federal
Speaker 1: programs that will be tracking safety UM within the Department
Speaker 1: of Health and Human Services, the Veterans Affairs Department, the
Speaker 1: Department of Defense. They all track, you know, whether there
Speaker 1: might be any rare side effects we don't see in
Speaker 1: clinical trials because they're short and and not in a
Speaker 1: lot of people. UM, whether anything rare might might crop
Speaker 1: up that will still be looked as well as we
Speaker 1: continue getting these That was Anna Edney, and that's it
Speaker 1: for our show today. For coverage of the outbreak from
Speaker 1: one BES around the world, visit Bloomberg dot com, slash
Speaker 1: coronavirus and if you like the show, please leave us
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Speaker 1: It's the best way to help more listeners find our
Speaker 1: global reporting. The Prognosis Daily edition is produced by Tophor
Speaker 1: foreheads Jordan Gospoure, Magnus Hendrickson, and me Laura Carlson. Today's
Speaker 1: main story was reported by Anna Edney. Original music by
Speaker 1: Leo Sedrin. Our editors are Rick Shine and Francesco Levi.
Speaker 1: Francesco Levi is Bloomberg's head of podcasts. Thanks for listening
Speaker 1: The LAS