WEBVTT - FDA Advisers Back Novavax Vaccine for Authorization

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<v Speaker 1>It's Wednesday, June eight. I'm Oscar Ramrrors 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>Vaccine experts advising the FDA have endorsed a new COVID

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<v Speaker 1>vaccine made by Novavax, saying that the shots benefits outweigh

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<v Speaker 1>any risk associated with it. The vaccine will still need

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<v Speaker 1>full approval before coming on the market, but it will

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<v Speaker 1>be the first one available using more traditional protein based technology.

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<v Speaker 1>Liz s Lee White, reporter at the Wall Street Journal,

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<v Speaker 1>joins for what to know about its effectiveness and concerns.

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<v Speaker 1>Thanks for joining us, Liz, Thanks for having me. Well,

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<v Speaker 1>let's talk about some interesting developments on the covid front.

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<v Speaker 1>We could be getting another vaccine on the market. This

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<v Speaker 1>one's by Novavax. There's a few little differences on this one,

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<v Speaker 1>but what we just saw was vaccine experts advising the

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<v Speaker 1>FDA basically endorsing this, saying that the benefits of this

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<v Speaker 1>new vaccine outweigh some of the risks that have been

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<v Speaker 1>associated with it so far. So tell us about what

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<v Speaker 1>was going on with the FDA, and then we'll get

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<v Speaker 1>into some details about this particular vaccine. As I mentioned,

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<v Speaker 1>it's a little different from the ones that we have

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<v Speaker 1>so far right now, Yeah, that's right. The f d

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<v Speaker 1>A has an outside advisory group that looks at every

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<v Speaker 1>you know, big vaccine like this, and the advisors today said,

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<v Speaker 1>vote of twenty one to zero with one abstention, that

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<v Speaker 1>they thought the vaccine safety profile looked good and they

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<v Speaker 1>thought the effectiveness. The FDA review said that the vaccine

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<v Speaker 1>was effective against COVID nineteen. So now there will be

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<v Speaker 1>if the FDA itself and CDC sign off, another option

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<v Speaker 1>on the table for people looking to get vaccinated. Now,

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<v Speaker 1>this vaccine has also been in development for quite some time,

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<v Speaker 1>but there was a lot of manufacturing related delays things

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<v Speaker 1>like that that kind of kept it off the table

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<v Speaker 1>a little bit longer. But this shot specifically, you know,

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<v Speaker 1>the two main vaccines that we're using right now are

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<v Speaker 1>the one by Fiser and the one by Maderna. Their

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<v Speaker 1>m RNA vaccines have relatively newer technology on this side

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<v Speaker 1>of things and is a more traditional protein based vaccine technology.

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<v Speaker 1>Tell us a little bit about that. That's right. The

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<v Speaker 1>platform that this vaccine uses is the same type that

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<v Speaker 1>is used by the shingles vaccine or hepatitis d vaccine

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<v Speaker 1>UM and it's been around since the around the nineteen seventies,

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<v Speaker 1>and so you know, there's the thought that there are

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<v Speaker 1>some folks out there who are more hesitant to get

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<v Speaker 1>the relatively new m R and a technology who might

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<v Speaker 1>be um you know, have been waiting around for novavax

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<v Speaker 1>to come onto the scene. It works in a different way. Basically,

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<v Speaker 1>instead of provoking the body to make its own coronavirus

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<v Speaker 1>spike protein version, which then stimulates the NEN system, the

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<v Speaker 1>protein based vaccine sends a bit like an own its

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<v Speaker 1>own version of a coronavirus book by protein to the body,

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<v Speaker 1>which stimulates the immune response. Yeah, and that's the hope, right.

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<v Speaker 1>I guess there's a lot of people that could be

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<v Speaker 1>allergic to some of the other vaccines too, and this

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<v Speaker 1>could be an option for them too. Obviously, it's really

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<v Speaker 1>just to provide more options on the on the table

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<v Speaker 1>for all of this. We have about of the population

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<v Speaker 1>that's fully vaccinated, which is pretty good. A lot of

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<v Speaker 1>other people have already been infected with it too, so

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<v Speaker 1>they have some of that natural immunity and those natural antibodies.

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<v Speaker 1>So on that side of things, we're doing pretty good.

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<v Speaker 1>But you're right, the big question would be will this

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<v Speaker 1>convince others that have been hesitant to take it so far? Now,

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<v Speaker 1>there were some cases of heart inflammation, some of the

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<v Speaker 1>things that we heard associated with other vaccines that were

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<v Speaker 1>also mixed in with this NOA vax one. So what

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<v Speaker 1>did we hear on that front? Right? The FDA pointed

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<v Speaker 1>to six what it called concerning cases of myocarditis or

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<v Speaker 1>paracarditis cases that they found there was some reason to

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<v Speaker 1>suggest that there may be some causality there with the vaccine,

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<v Speaker 1>since that they were all, you know, within a short

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<v Speaker 1>period of time after vaccination, and they were in young men,

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<v Speaker 1>that kind of thing. So the FDA kind of highlighted

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<v Speaker 1>that to advisers and it's briefing documents and said, you know,

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<v Speaker 1>we didn't see any of these signals with the mRNA

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<v Speaker 1>vaccines ahead of time. We saw them after authorization when

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<v Speaker 1>they were on the market and a ton of people

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<v Speaker 1>are using them. So they talked about that today and

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<v Speaker 1>they kind of said, well, you know, it's possible that

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<v Speaker 1>as we see more people take novavax the rates will

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<v Speaker 1>be pretty much the same as that the mRNA vaccines.

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<v Speaker 1>And then also just a scientists, they really wanted to

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<v Speaker 1>see more information on why this risk was coming about.

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<v Speaker 1>Is it something about the spike routine, about COVID itself,

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<v Speaker 1>or is there something to do with the platforms of

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<v Speaker 1>the vaccine. That's still an unknown. What's important I think

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<v Speaker 1>for people who just tune in occasionally to know it's

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<v Speaker 1>it's still really rare to have the myocard itist events

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<v Speaker 1>happen calling vaccination. And most of the cases have totally

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<v Speaker 1>resolved and like everyone recovered, h I mean six cases,

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<v Speaker 1>I mean out of it's got to be out of

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<v Speaker 1>the thousands right out of their from their clinical trials. Yeah,

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<v Speaker 1>as you mentioned little cases, but that's an interesting notion.

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<v Speaker 1>You know, who knows if it's the spike protein that's

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<v Speaker 1>causing this heart inflammation. As we know throughout going through

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<v Speaker 1>the pandemic, you know a lot of people that it

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<v Speaker 1>affects everybody in different ways, but inflammation is one of

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<v Speaker 1>those key things that really throws people's bodies for a loop.

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<v Speaker 1>So that'd be interesting to see if they ever do

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<v Speaker 1>find what that correlation could be. And you know, just

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<v Speaker 1>to end on this right, some of the people that

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<v Speaker 1>you did speak to for this, you know they did

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<v Speaker 1>say still say, hey, you know, I'm glad this new

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<v Speaker 1>one is coming up. Like the quote from the person

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<v Speaker 1>who spoke to they said, you know, this is the

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<v Speaker 1>first version of this vaccine, but to me, this is

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<v Speaker 1>kind of the second version of this traditional technology. We've

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<v Speaker 1>had some other stuff on the market. Now maybe I

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<v Speaker 1>could be ready. So the hope is that's something new

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<v Speaker 1>coming on board could spur some other people to still

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<v Speaker 1>get vaccinated. Yeah, yeah, I've seen. I've gotten even more

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<v Speaker 1>emails from readers saying the same thing since my story

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<v Speaker 1>came out this morning. So we'll be interesting. There's not

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<v Speaker 1>really good data on how many of those people are

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<v Speaker 1>out there, but we'll see. All right, we'll see and

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<v Speaker 1>we'll track this a long as it if it eventually

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<v Speaker 1>gets approved. Liz s Lee White, reporter at the Wall

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<v Speaker 1>Street Journal, thank you very much for joining us. Thanks

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

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<v Speaker 1>reopening America. Don't forget that. For today's big news stories,

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

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<v Speaker 1>every Monday through Friday, so follow us on I Heart

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