WEBVTT - Moderna Filles for Emergency Use Authorization From the FDA for Its Vaccine Candidate

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<v Speaker 1>It's Tuesday, December one. I'm Oscar Ramirors from the Daily

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<v Speaker 1>Dive podcast in Los Angeles, and this is reopening America.

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<v Speaker 1>Maderna has now become the second company to request emergency

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<v Speaker 1>use authorization from the FDA for their vaccine candidate. In

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<v Speaker 1>their latest findings, the vaccine is over effective against coronavirus

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<v Speaker 1>and very effective at preventing serious cases of the virus.

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<v Speaker 1>Karen wintrialb health reporter at USA Today joins us for

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<v Speaker 1>more as we get closer to vaccine approvals. Thanks for

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<v Speaker 1>joining us, Karen, Thanks for having me more good news

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<v Speaker 1>on the vaccine front. Every Monday, we've been getting these updates.

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<v Speaker 1>Maderna has become the second company to request emergency use

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<v Speaker 1>authorization from the FDA for its vaccine candidate. They release

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<v Speaker 1>some new findings in their latest press release. The effectiveness

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<v Speaker 1>of this is still above effective against COVID. So Karen

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<v Speaker 1>tell us a little bit more about what we learned

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<v Speaker 1>with these latest findings. So they total nine people in

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<v Speaker 1>their clinical trial out of thirty thousands have now gotten

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<v Speaker 1>COVID and of those a hundred ninety six half the

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<v Speaker 1>people in the thirty thousand person trial half got the

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<v Speaker 1>placebo and half got the active arm, the active vaccine.

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<v Speaker 1>Of a hundred and ninety six people who got COVID,

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<v Speaker 1>a hundred and eighty five of them had received the placebo,

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<v Speaker 1>only eleven had gotten the vaccines, and statistically speaking, that

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<v Speaker 1>just doesn't happen by chance, and so they are now

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<v Speaker 1>concluding that the vaccine is extremely effective. The other number

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<v Speaker 1>that's quite positive is that thirty of those participants got

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<v Speaker 1>very very ill with COVID. One of them even died,

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<v Speaker 1>But none of those thirty were in the vaccine arms,

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<v Speaker 1>so it does suggest that the vaccine protects against very

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<v Speaker 1>serious filness. Yeah, and they said that it was pretty

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<v Speaker 1>consistent across age groups, ethnicity, so that was also good.

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<v Speaker 1>No major side effects other than the ones we've talked

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<v Speaker 1>about before. You know, you feel a little crummed a

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<v Speaker 1>couple of days, maybe a low grade fever something, but

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<v Speaker 1>it lasts only a couple of days, so other than that,

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<v Speaker 1>it's all good news. They've been also saying a lot

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<v Speaker 1>about how effective it is at reducing severe cases as well.

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<v Speaker 1>It's not just that it prevents you from getting as well,

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<v Speaker 1>but if you do happen to get it, it most

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<v Speaker 1>likely won't be a severe case, and that was one

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<v Speaker 1>of the big concerns with these vaccine trials. They weren't

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<v Speaker 1>all specifically looking for severe cases, and there was a

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<v Speaker 1>concern that maybe it might help prevent mild cases and

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<v Speaker 1>not severe ones. But this seems to address that and

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<v Speaker 1>the conclusion is positive as far as we can tell.

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<v Speaker 1>One of the big questions that remains unanswered is the

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<v Speaker 1>long term effectiveness. I know, we're rushing this thing out

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<v Speaker 1>because we need it right away, so that's going to

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<v Speaker 1>be kind of determined at a later time, and you know,

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<v Speaker 1>if anything, you can still get a booster shot. They say,

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<v Speaker 1>when do they plan on approving all of this? I

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<v Speaker 1>think December tenth, the FDA Advisory Board is going to

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<v Speaker 1>talk about FISER and then a week later they'll talk

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<v Speaker 1>about MODERNA exactly. And we don't know how long the

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<v Speaker 1>FDA will take to issue its u A Emergency Use

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<v Speaker 1>authorization after that, but week that they'll move very quickly

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<v Speaker 1>on that, and it would be hard to imagine them

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<v Speaker 1>not approving it at this point. When it comes to

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<v Speaker 1>the amount of doses that are going to be ready

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<v Speaker 1>by the end of this year and next year, what

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<v Speaker 1>are we looking at they're hoping to have forty million

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<v Speaker 1>by the end of this year, which means vaccinating twenty

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<v Speaker 1>million Americans this calendar year. They're going to start with

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<v Speaker 1>healthcare workers, the people at most risk for catching COVID,

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<v Speaker 1>and the people who are sacrificing themselves to help the

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<v Speaker 1>rest of us. It looks like there's a meeting tomorrow

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<v Speaker 1>to confirm that, but those are likely to be the

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<v Speaker 1>first people in mind, then followed by nursing home residents

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<v Speaker 1>and others who are at risk. Next year, hopefully disguised

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<v Speaker 1>the limit both companies. Uh Viser says it can make

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<v Speaker 1>as much as a billion doses next year. They have

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<v Speaker 1>promised a hundred millions to the US, with some expansion possible.

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<v Speaker 1>Madarna has also promised a hundred million total to the US.

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<v Speaker 1>So theoretically, we really do need at least another one

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<v Speaker 1>or two vaccines, So hopefully some of the others coming

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<v Speaker 1>along behind them will also be effective. But theoretically we're

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<v Speaker 1>in pretty good shape, certainly in the US. Let's talk

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<v Speaker 1>a little bit about the confidence in vaccines, because you know,

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<v Speaker 1>we've been seeing polls a lot of people saying they

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<v Speaker 1>maybe not want to take the first batch of these

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<v Speaker 1>vacts scenes they want to wait a little while. But

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<v Speaker 1>we have to remind everybody. I know, this is going

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<v Speaker 1>very fast and it's being bolstered by operation work speed

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<v Speaker 1>and all that. But these are the gold standard of

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<v Speaker 1>vaccine trials. The first two that have gone through this already,

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<v Speaker 1>you know, Fiser and Maderna. They've done the extensive Phase

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<v Speaker 1>three trials and all that, so people should have some

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<v Speaker 1>confidence in this. They've followed the same practice. The only

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<v Speaker 1>reason they're asking for emergency use authorization instead of full

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<v Speaker 1>approval is if they're not following the people out. As

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<v Speaker 1>you mentioned, they're not following people out for two years,

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<v Speaker 1>which would be the standard. And again we'll find out

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<v Speaker 1>later if we need to add a booster shot to

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<v Speaker 1>get us to two years or not. But in general,

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<v Speaker 1>the vaccine trials have been held to exactly the same standards,

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<v Speaker 1>and they're very large trials. But Darrena's thirty thousand people,

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<v Speaker 1>Fiser's forty four thousands, so and the others are on

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<v Speaker 1>the same order of magnitude, so they really have tested

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<v Speaker 1>them and a lot of people safety. The FDA required

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<v Speaker 1>the companies to wait until at least half of the

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<v Speaker 1>participants had been out two months from their shot. Generally,

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<v Speaker 1>if you're going to have a bad reaction to the vaccine,

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<v Speaker 1>it's going to be in the first six weeks, so

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<v Speaker 1>eight weeks buy some time to make sure there are

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<v Speaker 1>no health problems, and at this point no major long

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<v Speaker 1>lasting health problems have emerged. So we have these two

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<v Speaker 1>main vaccine candidates right here in Moderna and fiser. Those

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<v Speaker 1>are m R n A vaccines, and then we also

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<v Speaker 1>have the other major one, the astra Zeneca vaccine, that

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<v Speaker 1>is also doing very well. At the same time. Right now,

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<v Speaker 1>there's some questions that have arisen over the Astrosenica vaccine.

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<v Speaker 1>The results that released some results last week, interim results

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<v Speaker 1>that raised a lot of questions. They found that for

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<v Speaker 1>the most part, the vaccine was six effective, which would

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<v Speaker 1>have sounded great the Asday was looking for only more

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<v Speaker 1>than fifty percent effective, But now that we have these

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<v Speaker 1>two options that are ninety plus percent effective, sixty doesn't

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<v Speaker 1>sound so great anymore. Um And they suggested that one

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<v Speaker 1>way of manipulating the doses might be more effective, but

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<v Speaker 1>that data was very small, so we need to wait

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<v Speaker 1>and see what happens with the rest of the trial,

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<v Speaker 1>all right, well, we'll see what happens next. Maybe Monday,

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<v Speaker 1>we'll get another updata as it's incoming. So well, okay

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<v Speaker 1>to find Karen winchild health reporter at USA Today. Thank

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<v Speaker 1>you very much for joining us. Thank you. I'm Oscar

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<v Speaker 1>Ramirez and this has been reopening America. Don't forget effort

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<v Speaker 1>today's big news stories. You can check me out on

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<v Speaker 1>the Daily Dive podcast every Monday through Friday, So follow

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<v Speaker 1>us on I Heart Radio or wherever you get your

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<v Speaker 1>podcast