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

more as we get closer to vaccine approvals. Thanks for joining us, Karen, Thanks for having me more good news on the vaccine front. Every Monday, we've been getting these updates. Maderna has become the second company to request emergency use authorization from the FDA for its vaccine candidate. They release some new findings in their latest press release. The effectiveness of this is still above effective against COVID. So Karen tell us a little bit more about what we learned

with these latest findings. So they total nine people in their clinical trial out of thirty thousands have now gotten COVID and of those a hundred ninety six half the people in the thirty thousand person trial half got the placebo and half got the active arm, the active vaccine.

Of a hundred and ninety six people who got COVID, a hundred and eighty five of them had received the placebo, only eleven had gotten the vaccines, and statistically speaking, that just doesn't happen by chance, and so they are now concluding that the vaccine is extremely effective. The other number that's quite positive is that thirty of those participants got

very very ill with COVID. One of them even died, But none of those thirty were in the vaccine arms, so it does suggest that the vaccine protects against very serious filness. Yeah, and they said that it was pretty consistent across age groups, ethnicity, so that was also good. No major side effects other than the ones we've talked about before. You know, you feel a little crummed a couple of days, maybe a low grade fever something, but it lasts only a couple of days, so other than that,

it's all good news. They've been also saying a lot about how effective it is at reducing severe cases as well. It's not just that it prevents you from getting as well, but if you do happen to get it, it most likely won't be a severe case, and that was one of the big concerns with these vaccine trials. They weren't all specifically looking for severe cases, and there was a concern that maybe it might help prevent mild cases and

not severe ones. But this seems to address that and the conclusion is positive as far as we can tell. One of the big questions that remains unanswered is the long term effectiveness. I know, we're rushing this thing out because we need it right away, so that's going to be kind of determined at a later time, and you know, if anything, you can still get a booster shot. They say,

when do they plan on approving all of this? I think December tenth, the FDA Advisory Board is going to talk about FISER and then a week later they'll talk about MODERNA exactly. And we don't know how long the FDA will take to issue its u A Emergency Use authorization after that, but week that they'll move very quickly on that, and it would be hard to imagine them

not approving it at this point. When it comes to the amount of doses that are going to be ready by the end of this year and next year, what are we looking at they're hoping to have forty million by the end of this year, which means vaccinating twenty million Americans this calendar year. They're going to start with healthcare workers, the people at most risk for catching COVID, and the people who are sacrificing themselves to help the

rest of us. It looks like there's a meeting tomorrow to confirm that, but those are likely to be the first people in mind, then followed by nursing home residents and others who are at risk. Next year, hopefully disguised the limit both companies. Uh Viser says it can make as much as a billion doses next year. They have promised a hundred millions to the US, with some expansion possible. Madarna has also promised a hundred million total to the US.

So theoretically, we really do need at least another one or two vaccines, So hopefully some of the others coming along behind them will also be effective. But theoretically we're in pretty good shape, certainly in the US. Let's talk a little bit about the confidence in vaccines, because you know, we've been seeing polls a lot of people saying they maybe not want to take the first batch of these vacts scenes they want to wait a little while. But

we have to remind everybody. I know, this is going very fast and it's being bolstered by operation work speed and all that. But these are the gold standard of vaccine trials. The first two that have gone through this already, you know, Fiser and Maderna. They've done the extensive Phase three trials and all that, so people should have some confidence in this. They've followed the same practice. The only reason they're asking for emergency use authorization instead of full

approval is if they're not following the people out. As you mentioned, they're not following people out for two years, which would be the standard. And again we'll find out later if we need to add a booster shot to get us to two years or not. But in general, the vaccine trials have been held to exactly the same standards,

and they're very large trials. But Darrena's thirty thousand people, Fiser's forty four thousands, so and the others are on the same order of magnitude, so they really have tested them and a lot of people safety. The FDA required the companies to wait until at least half of the

participants had been out two months from their shot. Generally, if you're going to have a bad reaction to the vaccine, it's going to be in the first six weeks, so eight weeks buy some time to make sure there are no health problems, and at this point no major long lasting health problems have emerged. So we have these two main vaccine candidates right here in Moderna and fiser. Those are m R n A vaccines, and then we also have the other major one, the astra Zeneca vaccine, that

is also doing very well. At the same time. Right now, there's some questions that have arisen over the Astrosenica vaccine. The results that released some results last week, interim results that raised a lot of questions. They found that for the most part, the vaccine was six effective, which would have sounded great the Asday was looking for only more than fifty percent effective, But now that we have these two options that are ninety plus percent effective, sixty doesn't

sound so great anymore. Um And they suggested that one way of manipulating the doses might be more effective, but that data was very small, so we need to wait and see what happens with the rest of the trial, all right, well, we'll see what happens next. Maybe Monday, we'll get another updata as it's incoming. So well, okay to find Karen winchild health reporter at USA Today. Thank you very much for joining us. Thank you. I'm Oscar Ramirez and this has been reopening America. Don't forget effort

today's big news stories. You can check me out on the Daily Dive podcast every Monday through Friday, So follow us on I Heart Radio or wherever you get your podcast