WEBVTT - FDA Says Moderna Vaccine Is Safe and Effective, Clearing Way for Approval

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<v Speaker 1>It's Wednesday, December six. I'm Oscar Ramiras 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>We are on track to get the second coronavirus vaccine

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<v Speaker 1>approved by the end of the week. On Tuesday, the

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<v Speaker 1>FDA confirmed that Maderna's two dose vaccine is safe and effective.

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<v Speaker 1>In the first week of its rollout, about six million

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<v Speaker 1>doses will be shipped out. The government also bought another

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<v Speaker 1>one million doses from Maderna for a total of two

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<v Speaker 1>hundred million at a cost of three point two billion dollars.

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<v Speaker 1>Sarah Overmall, healthcare reporter at Politico, joins us for more

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<v Speaker 1>good vaccine news. Thanks for joining us, Sarah, Yeah, happy

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<v Speaker 1>to be here. It seems we're on the same track

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<v Speaker 1>as we were last week with the Fiser vaccine. The

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<v Speaker 1>FDA has cleared the path for the second coronavirus vaccine

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<v Speaker 1>to be approved. This is the one from Maderna. It's

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<v Speaker 1>very similar to the Fiser vaccine. The FDA panel will

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<v Speaker 1>go through it, make recommendations, and hopefully over the weekend

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<v Speaker 1>and early next week we'll already be seeing shots at

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<v Speaker 1>Ministered of the Maderna vaccine. So Sarah tell us a

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<v Speaker 1>little bit about what the FDA panel has said about

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<v Speaker 1>this vaccine. They basically said it's safe and effective. This

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<v Speaker 1>is basically deja vu for last week, so the Fiser vaccine.

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<v Speaker 1>It was authorized by FDA last week on very similar data,

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<v Speaker 1>which is why we are pretty confident about the trajectory

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<v Speaker 1>for this MODANA one. We expect that after expert Advisory

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<v Speaker 1>Panel meets on Thursday, the FDA could be authorizing it

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<v Speaker 1>as soon as Friday morning, as it did with Fiser,

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<v Speaker 1>and then we will have a CDC panel meeting over

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<v Speaker 1>the weekend to talk about recommendations for who this goes

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<v Speaker 1>to first. But because they are really similar vaccines, they

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<v Speaker 1>have a very similar technology called Messenger RNA. They also

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<v Speaker 1>have almost identical effective dis rates, we can expect some

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<v Speaker 1>of these same things. There are some important distinctions for

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<v Speaker 1>the moderna want, especially with certain populations that they have

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<v Speaker 1>different data for. For instance, it shows that it's more

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<v Speaker 1>factive and younger people than it is in people over

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<v Speaker 1>the age of sixty five. That could be a really

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<v Speaker 1>important distinction. As we roll these doses out and find

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<v Speaker 1>out that maybe the Fiser one is more ideal for

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<v Speaker 1>nursing homes, and the Modena one might be more ideal

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<v Speaker 1>for people who work in high exposure areas but aren't

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<v Speaker 1>necessarily as old as somebody who's in ay, more vulnerable situations.

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<v Speaker 1>So these are the things we're going to find out

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<v Speaker 1>over the next few days. But you're right, we could

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<v Speaker 1>as of next week have millions more doses to be

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<v Speaker 1>shipping out across the country. The initial round of doses

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<v Speaker 1>are obviously limited. How many doses are we going to

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<v Speaker 1>be able to see go out in the first push,

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<v Speaker 1>So they're actually will be more of the Nodanna doses

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<v Speaker 1>out in the first push than there were of these

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<v Speaker 1>FISER ones. Government officials have said that nearly six million

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<v Speaker 1>will be put out into more than three thousand sites

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<v Speaker 1>next week if we do have this authorize, which we're

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<v Speaker 1>expected to. That's in comparison to two point nine million

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<v Speaker 1>doses from FISER that are going out as we speak,

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<v Speaker 1>and two point nine allion from Guisor that have been

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<v Speaker 1>held back for a second dose. So between the two

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<v Speaker 1>of them, each has promised twenty million doses a piece

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<v Speaker 1>this month, which is forty millions total, but they all

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<v Speaker 1>are two dose regiments. You can think of this as

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<v Speaker 1>twenty million very high made people getting doses this month.

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<v Speaker 1>There was some criticism with the government's action on the

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<v Speaker 1>Fiser vaccine for not buying that extension or extra doses,

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<v Speaker 1>But on this case with the Moderna vaccine, the US

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<v Speaker 1>did exercise their right to buy a hundred million additional

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<v Speaker 1>doses of the Maderna vaccine. Tell us a little bit

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<v Speaker 1>about that and then the costs associated with it, because

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<v Speaker 1>this one is a little more closely tied to Operation

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<v Speaker 1>Warp Speed. The government gave Maderna more money to develop

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<v Speaker 1>this whole thing exactly, and so they had options with

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<v Speaker 1>both of those pharmaceutical companies to buy one hundred million

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<v Speaker 1>doses originally, but the option to buy hundreds of millions

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<v Speaker 1>more with each of them. The Christism lately has been

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<v Speaker 1>that they did not exercise that option when they could

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<v Speaker 1>have with Fiser, so they had an option to buy

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<v Speaker 1>up to five hundred million doses from them, and according

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<v Speaker 1>to side there, they offered that to the government multiple

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<v Speaker 1>times and the government didn't take them up on that,

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<v Speaker 1>and so they moved on. They have signed multiple different

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<v Speaker 1>agreements with other countries in the world. I mean, you

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<v Speaker 1>think about the entire world wants these highly effective vaccines,

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<v Speaker 1>so kind of to them that loss, or to shore

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<v Speaker 1>up our supplies here in the United States. The United

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<v Speaker 1>States announced late last week that they would buy a

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<v Speaker 1>hundred million more of the Modanna vaccine, and that brings

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<v Speaker 1>its total costs with Modanna to three point two billion dollars,

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<v Speaker 1>which is eye popping. But when you think about how

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<v Speaker 1>much this company, which has never actually mass produced a

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<v Speaker 1>vaccine or products ever before Modanna, this is going to

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<v Speaker 1>be their first authorized products. This is a huge undertaking.

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<v Speaker 1>That's why there's so much money going towards this. So

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<v Speaker 1>you can think about this as the US trying to

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<v Speaker 1>shore up its supplies in this arena. It also has

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<v Speaker 1>multiple other agreements out there with six manufacturers total to

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<v Speaker 1>get if everything goes right, nine billion doses. That might

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<v Speaker 1>seem like a lot, like way too much for the US,

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<v Speaker 1>but we don't know how many of those are going

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<v Speaker 1>to work. We even just learned last week that another

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<v Speaker 1>vaccine from Snophi and Glackslow Smith Klein is going to

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<v Speaker 1>be delayed until the end of one because they didn't

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<v Speaker 1>get really good results. So this is why the US

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<v Speaker 1>is betting so big. Yeah, and the MODERNA vaccine for

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<v Speaker 1>its part, is easier to ship and store than the

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<v Speaker 1>fiser one is, so you know, maybe this vaccine will

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<v Speaker 1>make it into rural areas a little more easily. So

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<v Speaker 1>there's benefits, you know, in pros and cons to each

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<v Speaker 1>one kind of on this. So at least a good

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<v Speaker 1>thing that they bought up a bunch of those extra orders.

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<v Speaker 1>And the last thing I wanted to ask real quick

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<v Speaker 1>was just about how much the moderna vaccine protects. There's

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<v Speaker 1>been things made that it can reduce severe effects of coronavirus.

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<v Speaker 1>They're hoping obviously that it will reduce transmission rates, but

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<v Speaker 1>that's kind of what the focus was of their study

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<v Speaker 1>as well, and just how effective this would be. So

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<v Speaker 1>that was something we learned in the Food and Drug

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<v Speaker 1>Administration's briefing documents tuesday morning, was that not only is

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<v Speaker 1>this effective broadly, but there's a suggestion that after the

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<v Speaker 1>first dose it might even have curbed infections. And you

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<v Speaker 1>might think that's pretty obvious, that's what vaccine you're supposed

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<v Speaker 1>to do, But we don't actually know yet how effective

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<v Speaker 1>vaccines would be as preventing transmission, which is kind of

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<v Speaker 1>the ultimate goal. We don't want people to have to

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<v Speaker 1>get sick in the first place. This indicates that the

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<v Speaker 1>Modanna vaccine might be able to do that. And then,

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<v Speaker 1>like you said, with severe COVID illness, there are really

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<v Speaker 1>promising results from Nemoderna vaccine. There were thirty severe illnesses

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<v Speaker 1>in the PLACEBA arm and none in the vaccine arm.

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<v Speaker 1>That's great news. So we actually have between this advisor

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<v Speaker 1>two really promising candidates first out of the gate. We

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<v Speaker 1>kind of couldn't expect for better, to be honest, So

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<v Speaker 1>now it's you know, it's the challenge of getting this

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<v Speaker 1>out to people, getting it to the people who need

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<v Speaker 1>it most right away, and meeting the demand that we

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<v Speaker 1>know we're going to have. And Dena's as an author

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<v Speaker 1>in the world. Sarah Overmall, healthcare reporter at Politico, thank

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<v Speaker 1>you very much for joining us. Oh wait, thank you

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<v Speaker 1>for having me. I'm Oscar Ramirez and this has been

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<v Speaker 1>reopening America. Don't forget effort today's big news stories. You

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<v Speaker 1>can check me out in the Daily Dive podcast every

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<v Speaker 1>Monday through Friday, So follow us on I Heart Radio

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<v Speaker 1>or wherever you get your podcast.