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Speaker 1: Welcome to Prognosis. I'm Laura Carlson. It's day two hundred

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Speaker 1: and sixty eight since coronavirus was declared a global pandemic.

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Speaker 1: Today's main story this week, crucial decisions are coming that

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Speaker 1: will determine how soon Americans can start receiving a COVID

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Speaker 1: nineteen vaccine. We'll discuss everything you need to know about

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Speaker 1: what happens next, but first, here's what happened in virus

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Speaker 1: News today. Global coronavirus cases have topped sixty seven million

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Speaker 1: in the US. A record number of coronavirus patients are

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Speaker 1: in the hospital, and nearly two thousand people are being

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Speaker 1: hospitalized with the disease every day. According to data from

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Speaker 1: the Department of Health and Human Services, New York, North Carolina,

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Speaker 1: and Tennessee recorded the biggest increase in patients. New Mexico

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Speaker 1: has exceeded its ICU capacity. COVID nineteen cases now account

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Speaker 1: for at least one in five hospital patients in nine states.

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Speaker 1: Experts are warning about the winter holidays ahead. Anthony Fauci,

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Speaker 1: the top infectious disease expert in the US, warned that

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Speaker 1: the Christmas season could be even worse than Thanksgiving for

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Speaker 1: the outbreak the Christmas holiday is both longer and more challenging,

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Speaker 1: Fauci said in a CNN interview. And Scott Gottlieb, former

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Speaker 1: Commissioner of the U S Food and Drug Administration and

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Speaker 1: a FISER board member, believes the current wave of infections

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Speaker 1: in the US has yet to peak. On CBS's face

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Speaker 1: the Nation on Sunday, Gottlieb said COVID nineteen numbers are

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Speaker 1: expected to get worse over the next four to six weeks.

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Speaker 1: Infections are not likely to peek until the end of

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Speaker 1: December or into January. Deaths probably will peak in the

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Speaker 1: middle of January. Finally, there are signs the outbreak is

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Speaker 1: abating in parts of Europe. Italy's outbreak continues to slow. Today,

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Speaker 1: health officials reported the lowest daily new cases since October.

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Speaker 1: Italy make it its first three point four million doses

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Speaker 1: of the FISER bio en Tech COVID nineteen vaccine as

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Speaker 1: soon as January, a week earlier than expected. According to

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Speaker 1: the Italian newspaper Il Massa Gero and Now for today's

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Speaker 1: main story, the coming week could mark an early turning

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Speaker 1: point in the U S battle against COVID nineteen. An

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Speaker 1: advisory panel made up of top medical experts will meet

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Speaker 1: December tenth to help the Food and Drug Administration review

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Speaker 1: the drug for possible emergency authorization that would clear the

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Speaker 1: way to making it a top weapon against the virus.

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Speaker 1: I asked reporter Anna Edney to break down the next

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Speaker 1: steps in the approval process and help explain the reality

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Speaker 1: of making the vaccine available to the public, and I

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Speaker 1: was hoping you might provide us with some details about

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Speaker 1: exactly what's going to happen at this meeting. So the

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Speaker 1: meeting is so that the advisors to the Food and

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Speaker 1: Drug Administration can hear from the FDA staff themselves actually

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Speaker 1: as well as Visor about their UM look at the

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Speaker 1: clinical chrial data that Visor UM ended up with after

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Speaker 1: they they did a trial on about forty four thousand participants,

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Speaker 1: And so the FDA has taken a look at that data,

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Speaker 1: visors taking its own look UM. They're going to present

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Speaker 1: each of their own calculations to the advisory panel in

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Speaker 1: public so everybody can listen to it if they want

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Speaker 1: to UM, and then they're going to the panel of advisors.

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Speaker 1: They'll talk about UM that data, they'll discuss it. They're

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Speaker 1: often have a vote at the very end of the meeting.

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Speaker 1: I anticipate it will be a lengthy meeting UM, and

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Speaker 1: they'll they'll vote on something that will give an indication

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Speaker 1: to the FDA about whether they should authorize the vaccine

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Speaker 1: or not. And obviously we're talking on Monday. The meeting

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Speaker 1: is only a few days away. As far as the

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Speaker 1: timeline and materials, what's going to be made available leading

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Speaker 1: up to the meeting. So typically the way that these

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Speaker 1: advisory panel meetings work is the two days before they meet,

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Speaker 1: the Food and Drug Administration will release UM they're called

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Speaker 1: briefing documents. It's the f d a's review of the

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Speaker 1: clinical trial data. They'll release fiser's own briefing documents as well.

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Speaker 1: So this will be the first hint the public will

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Speaker 1: get UM into the agency's view of that data and

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Speaker 1: you know where they're leaning on it, where they have questions,

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Speaker 1: where they think there might be gaps in some of

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Speaker 1: the data, UM. And then so that will come likely

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Speaker 1: Tuesday morning, sometime around nine am. Typically they come out UM.

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Speaker 1: You know, at the same time the meeting would start

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Speaker 1: two days later, and then you know, the meeting happens

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Speaker 1: on Thursday, UM, probably all day long, and they'll be

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Speaker 1: that vote that I mentioned at the end. Most likely

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Speaker 1: we'll see in those briefing documents what exactly the questions

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Speaker 1: are for the panel that they'll discuss at the end,

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Speaker 1: and whether there is a vote that's asked for. So

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Speaker 1: as far as the experts and authorities that will be

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Speaker 1: at this meeting and the various opinions and recommendations that

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Speaker 1: will happen with regards to a vaccine candidate, does the

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Speaker 1: FDA have to accept these recommendations. They don't have to.

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Speaker 1: Very often. They do their usual you know, they're they're

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Speaker 1: in agreement, I would say most of the time with

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Speaker 1: the panel, um when it comes down to whether they

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Speaker 1: authorize or approve or reject um a drug or a vaccine,

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Speaker 1: and then there, um, you know, the final decision. The Commissioner,

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Speaker 1: Stephen Hahn has said he's leaving that up to Peter Marks,

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Speaker 1: who's the head of the agency center that oversees vaccines.

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Speaker 1: And that's really typical. You know, the Commissioner often does

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Speaker 1: not get involved in making those decisions unless there's something

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Speaker 1: that the Commissioner might want to over a role. It's

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Speaker 1: not something that I anticipate in this case, um, And

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Speaker 1: so I think you'll see career officials at the Food

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Speaker 1: and Drug Administration making any final decision on this, which

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Speaker 1: could come, you know, as soon as a day or

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Speaker 1: two after the meeting on Thursday. And that brings up

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Speaker 1: a good point as far as what happens after this

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Speaker 1: meeting in terms of the days and weeks after these

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Speaker 1: recommendations are made and after this panel meets. What we're

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Speaker 1: looking for during the panel is, you know, what are

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Speaker 1: the questions the FDA has. How complicated are those questions?

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Speaker 1: If they're pretty straightforward, If the data looks pretty straightforward, um,

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Speaker 1: and the FDI doesn't seem too conflicted, you know, we

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Speaker 1: might see an FDA decision on authorizing the vaccine within

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Speaker 1: a day or two. If it's if it looks like

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Speaker 1: there's a lot they're trying to work through. If they're

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Speaker 1: not quite sure about this vaccine or some some portion

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Speaker 1: of it, the safety or the avocacy, then that might

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Speaker 1: take a little bit longer. UM. Peter Marks, who had

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Speaker 1: the the agency center that has the handles vaccines he has,

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Speaker 1: you know, said it possibly could take weeks if there

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Speaker 1: if there are complications in the in the application for

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Speaker 1: the vaccine. Um. But whenever it does get authorized. If

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Speaker 1: it does, then UM operation work warp Speed officials have

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Speaker 1: said that they will expect to start distributing it within

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Speaker 1: twenty four hours. So that's probably about UM six point

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Speaker 1: four million doses right away and UM that'll that'll go

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Speaker 1: to healthcare workers and long term care residents, UM kind

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Speaker 1: of as the states see fit. So this this really

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Speaker 1: isn't the end of the process, but really perhaps just

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Speaker 1: one of the many starting points. Certainly, I think, you know,

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Speaker 1: even the vaccine makers will have more work to do.

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Speaker 1: They're not going to necessarily just abruptly and their clinical trials. UM.

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Speaker 1: The f d A is making their decision on these

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Speaker 1: vaccines UM that are getting emergency authorization based on two

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Speaker 1: months of safety data and typically for a full approval

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Speaker 1: UM they were they'd be looking for six months. So

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Speaker 1: they're gonna they're gonna want the the drugmakers to continue

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Speaker 1: doing these trials, to continue getting them information and and

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Speaker 1: seek out a full approval from the agency. UM. And

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Speaker 1: so there's still more work to be done. And then

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Speaker 1: you know, the States will be doing a lot of

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Speaker 1: work to try to get these vaccines out to people

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Speaker 1: and to you know, that's going to be a continuing

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Speaker 1: process well through the spring in the summer, and does

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Speaker 1: this in terms of the emergency use authorization for the

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Speaker 1: fighter and the bio and tech candidate. Will that potentially

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Speaker 1: make it more difficult for the other candidates under development

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Speaker 1: from other companies? It could in the sense that UM.

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Speaker 1: You know, when there are other companies like Johnson and

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Speaker 1: Johnson UM still trying to do clinical trials of their vaccines.

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Speaker 1: People that are in those trials, you know, about half

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Speaker 1: of them are getting a placebo. They're not getting the vaccine.

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Speaker 1: And if they feel they're getting the placebo, they're going

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Speaker 1: to think, you know, maybe I should drop out and

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Speaker 1: at the vaccine if they're eligible to get the vaccine.

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Speaker 1: So there are people at the f d A and

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Speaker 1: at companies trying to work through this. You know, do

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Speaker 1: they start switching these trials, you know, or start start

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Speaker 1: doing some trials based on comparing them to the vaccines

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Speaker 1: that are on the market rather than a pluce ebo. UM.

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Speaker 1: They're thinking about all of this, trying to make sure

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Speaker 1: that there can still be data gathered on the vaccines

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Speaker 1: as they're going. And you know, the other thing is

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Speaker 1: safety won't just be up to the company's to look at.

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Speaker 1: There will be a lot of people in the United States,

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Speaker 1: millions of people using these vaccines, will be getting the vaccines.

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Speaker 1: So there are at least half a dozen different federal

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Speaker 1: programs that will be tracking safety UM within the Department

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Speaker 1: of Health and Human Services, the Veterans Affairs Department, the

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Speaker 1: Department of Defense. They all track, you know, whether there

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Speaker 1: might be any rare side effects we don't see in

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Speaker 1: clinical trials because they're short and and not in a

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Speaker 1: lot of people. UM, whether anything rare might might crop

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Speaker 1: up that will still be looked as well as we

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Speaker 1: continue getting these That was Anna Edney, and that's it

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Speaker 1: for our show today. For coverage of the outbreak from

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Speaker 1: one BES around the world, visit Bloomberg dot com, slash

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Speaker 1: coronavirus and if you like the show, please leave us

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Speaker 1: a review and a rating on Apple Podcasts or Spotify.

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Speaker 1: It's the best way to help more listeners find our

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Speaker 1: global reporting. The Prognosis Daily edition is produced by Tophor

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Speaker 1: foreheads Jordan Gospoure, Magnus Hendrickson, and me Laura Carlson. Today's

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Speaker 1: main story was reported by Anna Edney. Original music by

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Speaker 1: Leo Sedrin. Our editors are Rick Shine and Francesco Levi.

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Speaker 1: Francesco Levi is Bloomberg's head of podcasts. Thanks for listening

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Speaker 1: The LAS