WEBVTT - A Turning Point Week Ahead

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

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<v Speaker 1>and sixty eight since coronavirus was declared a global pandemic.

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<v Speaker 1>Today's main story this week, crucial decisions are coming that

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<v Speaker 1>will determine how soon Americans can start receiving a COVID

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<v Speaker 1>nineteen vaccine. We'll discuss everything you need to know about

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<v Speaker 1>what happens next, but first, here's what happened in virus

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<v Speaker 1>News today. Global coronavirus cases have topped sixty seven million

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<v Speaker 1>in the US. A record number of coronavirus patients are

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<v Speaker 1>in the hospital, and nearly two thousand people are being

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<v Speaker 1>hospitalized with the disease every day. According to data from

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<v Speaker 1>the Department of Health and Human Services, New York, North Carolina,

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<v Speaker 1>and Tennessee recorded the biggest increase in patients. New Mexico

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<v Speaker 1>has exceeded its ICU capacity. COVID nineteen cases now account

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<v Speaker 1>for at least one in five hospital patients in nine states.

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<v Speaker 1>Experts are warning about the winter holidays ahead. Anthony Fauci,

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<v Speaker 1>the top infectious disease expert in the US, warned that

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<v Speaker 1>the Christmas season could be even worse than Thanksgiving for

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<v Speaker 1>the outbreak the Christmas holiday is both longer and more challenging,

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<v Speaker 1>Fauci said in a CNN interview. And Scott Gottlieb, former

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<v Speaker 1>Commissioner of the U S Food and Drug Administration and

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<v Speaker 1>a FISER board member, believes the current wave of infections

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<v Speaker 1>in the US has yet to peak. On CBS's face

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<v Speaker 1>the Nation on Sunday, Gottlieb said COVID nineteen numbers are

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<v Speaker 1>expected to get worse over the next four to six weeks.

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<v Speaker 1>Infections are not likely to peek until the end of

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<v Speaker 1>December or into January. Deaths probably will peak in the

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<v Speaker 1>middle of January. Finally, there are signs the outbreak is

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

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<v Speaker 1>health officials reported the lowest daily new cases since October.

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<v Speaker 1>Italy make it its first three point four million doses

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<v Speaker 1>of the FISER bio en Tech COVID nineteen vaccine as

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<v Speaker 1>soon as January, a week earlier than expected. According to

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<v Speaker 1>the Italian newspaper Il Massa Gero and Now for today's

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<v Speaker 1>main story, the coming week could mark an early turning

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<v Speaker 1>point in the U S battle against COVID nineteen. An

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<v Speaker 1>advisory panel made up of top medical experts will meet

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<v Speaker 1>December tenth to help the Food and Drug Administration review

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<v Speaker 1>the drug for possible emergency authorization that would clear the

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<v Speaker 1>way to making it a top weapon against the virus.

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<v Speaker 1>I asked reporter Anna Edney to break down the next

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<v Speaker 1>steps in the approval process and help explain the reality

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<v Speaker 1>of making the vaccine available to the public, and I

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<v Speaker 1>was hoping you might provide us with some details about

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<v Speaker 1>exactly what's going to happen at this meeting. So the

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<v Speaker 1>meeting is so that the advisors to the Food and

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<v Speaker 1>Drug Administration can hear from the FDA staff themselves actually

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<v Speaker 1>as well as Visor about their UM look at the

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<v Speaker 1>clinical chrial data that Visor UM ended up with after

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<v Speaker 1>they they did a trial on about forty four thousand participants,

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<v Speaker 1>And so the FDA has taken a look at that data,

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<v Speaker 1>visors taking its own look UM. They're going to present

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<v Speaker 1>each of their own calculations to the advisory panel in

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<v Speaker 1>public so everybody can listen to it if they want

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

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

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<v Speaker 1>often have a vote at the very end of the meeting.

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<v Speaker 1>I anticipate it will be a lengthy meeting UM, and

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<v Speaker 1>they'll they'll vote on something that will give an indication

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<v Speaker 1>to the FDA about whether they should authorize the vaccine

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<v Speaker 1>or not. And obviously we're talking on Monday. The meeting

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<v Speaker 1>is only a few days away. As far as the

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<v Speaker 1>timeline and materials, what's going to be made available leading

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<v Speaker 1>up to the meeting. So typically the way that these

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<v Speaker 1>advisory panel meetings work is the two days before they meet,

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<v Speaker 1>the Food and Drug Administration will release UM they're called

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<v Speaker 1>briefing documents. It's the f d a's review of the

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

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<v Speaker 1>So this will be the first hint the public will

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<v Speaker 1>get UM into the agency's view of that data and

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<v Speaker 1>you know where they're leaning on it, where they have questions,

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<v Speaker 1>where they think there might be gaps in some of

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<v Speaker 1>the data, UM. And then so that will come likely

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<v Speaker 1>Tuesday morning, sometime around nine am. Typically they come out UM.

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<v Speaker 1>You know, at the same time the meeting would start

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<v Speaker 1>two days later, and then you know, the meeting happens

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<v Speaker 1>on Thursday, UM, probably all day long, and they'll be

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<v Speaker 1>that vote that I mentioned at the end. Most likely

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<v Speaker 1>we'll see in those briefing documents what exactly the questions

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<v Speaker 1>are for the panel that they'll discuss at the end,

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<v Speaker 1>and whether there is a vote that's asked for. So

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<v Speaker 1>as far as the experts and authorities that will be

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<v Speaker 1>at this meeting and the various opinions and recommendations that

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<v Speaker 1>will happen with regards to a vaccine candidate, does the

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<v Speaker 1>FDA have to accept these recommendations. They don't have to.

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<v Speaker 1>Very often. They do their usual you know, they're they're

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<v Speaker 1>in agreement, I would say most of the time with

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<v Speaker 1>the panel, um when it comes down to whether they

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<v Speaker 1>authorize or approve or reject um a drug or a vaccine,

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<v Speaker 1>and then there, um, you know, the final decision. The Commissioner,

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

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<v Speaker 1>who's the head of the agency center that oversees vaccines.

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

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<v Speaker 1>not get involved in making those decisions unless there's something

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<v Speaker 1>that the Commissioner might want to over a role. It's

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<v Speaker 1>not something that I anticipate in this case, um, And

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<v Speaker 1>so I think you'll see career officials at the Food

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<v Speaker 1>and Drug Administration making any final decision on this, which

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<v Speaker 1>could come, you know, as soon as a day or

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<v Speaker 1>two after the meeting on Thursday. And that brings up

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<v Speaker 1>a good point as far as what happens after this

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<v Speaker 1>meeting in terms of the days and weeks after these

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<v Speaker 1>recommendations are made and after this panel meets. What we're

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<v Speaker 1>looking for during the panel is, you know, what are

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<v Speaker 1>the questions the FDA has. How complicated are those questions?

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<v Speaker 1>If they're pretty straightforward, If the data looks pretty straightforward, um,

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<v Speaker 1>and the FDI doesn't seem too conflicted, you know, we

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<v Speaker 1>might see an FDA decision on authorizing the vaccine within

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<v Speaker 1>a day or two. If it's if it looks like

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<v Speaker 1>there's a lot they're trying to work through. If they're

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<v Speaker 1>not quite sure about this vaccine or some some portion

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<v Speaker 1>of it, the safety or the avocacy, then that might

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<v Speaker 1>take a little bit longer. UM. Peter Marks, who had

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<v Speaker 1>the the agency center that has the handles vaccines he has,

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<v Speaker 1>you know, said it possibly could take weeks if there

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<v Speaker 1>if there are complications in the in the application for

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<v Speaker 1>the vaccine. Um. But whenever it does get authorized. If

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<v Speaker 1>it does, then UM operation work warp Speed officials have

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<v Speaker 1>said that they will expect to start distributing it within

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<v Speaker 1>twenty four hours. So that's probably about UM six point

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<v Speaker 1>four million doses right away and UM that'll that'll go

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<v Speaker 1>to healthcare workers and long term care residents, UM kind

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<v Speaker 1>of as the states see fit. So this this really

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<v Speaker 1>isn't the end of the process, but really perhaps just

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<v Speaker 1>one of the many starting points. Certainly, I think, you know,

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<v Speaker 1>even the vaccine makers will have more work to do.

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

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<v Speaker 1>The f d A is making their decision on these

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<v Speaker 1>vaccines UM that are getting emergency authorization based on two

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<v Speaker 1>months of safety data and typically for a full approval

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<v Speaker 1>UM they were they'd be looking for six months. So

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<v Speaker 1>they're gonna they're gonna want the the drugmakers to continue

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<v Speaker 1>doing these trials, to continue getting them information and and

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<v Speaker 1>seek out a full approval from the agency. UM. And

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<v Speaker 1>so there's still more work to be done. And then

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<v Speaker 1>you know, the States will be doing a lot of

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<v Speaker 1>work to try to get these vaccines out to people

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<v Speaker 1>and to you know, that's going to be a continuing

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<v Speaker 1>process well through the spring in the summer, and does

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<v Speaker 1>this in terms of the emergency use authorization for the

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<v Speaker 1>fighter and the bio and tech candidate. Will that potentially

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<v Speaker 1>make it more difficult for the other candidates under development

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<v Speaker 1>from other companies? It could in the sense that UM.

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<v Speaker 1>You know, when there are other companies like Johnson and

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<v Speaker 1>Johnson UM still trying to do clinical trials of their vaccines.

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<v Speaker 1>People that are in those trials, you know, about half

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<v Speaker 1>of them are getting a placebo. They're not getting the vaccine.

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<v Speaker 1>And if they feel they're getting the placebo, they're going

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<v Speaker 1>to think, you know, maybe I should drop out and

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<v Speaker 1>at the vaccine if they're eligible to get the vaccine.

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<v Speaker 1>So there are people at the f d A and

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<v Speaker 1>at companies trying to work through this. You know, do

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<v Speaker 1>they start switching these trials, you know, or start start

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<v Speaker 1>doing some trials based on comparing them to the vaccines

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<v Speaker 1>that are on the market rather than a pluce ebo. UM.

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<v Speaker 1>They're thinking about all of this, trying to make sure

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<v Speaker 1>that there can still be data gathered on the vaccines

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

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

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<v Speaker 1>There will be a lot of people in the United States,

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<v Speaker 1>millions of people using these vaccines, will be getting the vaccines.

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<v Speaker 1>So there are at least half a dozen different federal

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<v Speaker 1>programs that will be tracking safety UM within the Department

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<v Speaker 1>of Health and Human Services, the Veterans Affairs Department, the

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<v Speaker 1>Department of Defense. They all track, you know, whether there

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<v Speaker 1>might be any rare side effects we don't see in

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<v Speaker 1>clinical trials because they're short and and not in a

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<v Speaker 1>lot of people. UM, whether anything rare might might crop

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<v Speaker 1>up that will still be looked as well as we

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<v Speaker 1>continue getting these That was Anna Edney, and that's it

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<v Speaker 1>for our show today. For coverage of the outbreak from

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<v Speaker 1>one BES around the world, visit Bloomberg dot com, slash

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<v Speaker 1>coronavirus and if you like the show, please leave us

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<v Speaker 1>a review and a rating on Apple Podcasts or Spotify.

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<v Speaker 1>It's the best way to help more listeners find our

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<v Speaker 1>global reporting. The Prognosis Daily edition is produced by Tophor

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

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<v Speaker 1>main story was reported by Anna Edney. Original music by

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<v Speaker 1>Leo Sedrin. Our editors are Rick Shine and Francesco Levi.

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<v Speaker 1>Francesco Levi is Bloomberg's head of podcasts. Thanks for listening

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<v Speaker 1>The LAS