Speaker 1: It's Tuesday, December one. I'm Oscar Ramirors from the Daily
Speaker 1: Dive podcast in Los Angeles, and this is reopening America.
Speaker 1: Maderna has now become the second company to request emergency
Speaker 1: use authorization from the FDA for their vaccine candidate. In
Speaker 1: their latest findings, the vaccine is over effective against coronavirus
Speaker 1: and very effective at preventing serious cases of the virus.
Speaker 1: Karen wintrialb health reporter at USA Today joins us for
Speaker 1: more as we get closer to vaccine approvals. Thanks for
Speaker 1: joining us, Karen, Thanks for having me more good news
Speaker 1: on the vaccine front. Every Monday, we've been getting these updates.
Speaker 1: Maderna has become the second company to request emergency use
Speaker 1: authorization from the FDA for its vaccine candidate. They release
Speaker 1: some new findings in their latest press release. The effectiveness
Speaker 1: of this is still above effective against COVID. So Karen
Speaker 1: tell us a little bit more about what we learned
Speaker 1: with these latest findings. So they total nine people in
Speaker 1: their clinical trial out of thirty thousands have now gotten
Speaker 1: COVID and of those a hundred ninety six half the
Speaker 1: people in the thirty thousand person trial half got the
Speaker 1: placebo and half got the active arm, the active vaccine.
Speaker 1: Of a hundred and ninety six people who got COVID,
Speaker 1: a hundred and eighty five of them had received the placebo,
Speaker 1: only eleven had gotten the vaccines, and statistically speaking, that
Speaker 1: just doesn't happen by chance, and so they are now
Speaker 1: concluding that the vaccine is extremely effective. The other number
Speaker 1: that's quite positive is that thirty of those participants got
Speaker 1: very very ill with COVID. One of them even died,
Speaker 1: But none of those thirty were in the vaccine arms,
Speaker 1: so it does suggest that the vaccine protects against very
Speaker 1: serious filness. Yeah, and they said that it was pretty
Speaker 1: consistent across age groups, ethnicity, so that was also good.
Speaker 1: No major side effects other than the ones we've talked
Speaker 1: about before. You know, you feel a little crummed a
Speaker 1: couple of days, maybe a low grade fever something, but
Speaker 1: it lasts only a couple of days, so other than that,
Speaker 1: it's all good news. They've been also saying a lot
Speaker 1: about how effective it is at reducing severe cases as well.
Speaker 1: It's not just that it prevents you from getting as well,
Speaker 1: but if you do happen to get it, it most
Speaker 1: likely won't be a severe case, and that was one
Speaker 1: of the big concerns with these vaccine trials. They weren't
Speaker 1: all specifically looking for severe cases, and there was a
Speaker 1: concern that maybe it might help prevent mild cases and
Speaker 1: not severe ones. But this seems to address that and
Speaker 1: the conclusion is positive as far as we can tell.
Speaker 1: One of the big questions that remains unanswered is the
Speaker 1: long term effectiveness. I know, we're rushing this thing out
Speaker 1: because we need it right away, so that's going to
Speaker 1: be kind of determined at a later time, and you know,
Speaker 1: if anything, you can still get a booster shot. They say,
Speaker 1: when do they plan on approving all of this? I
Speaker 1: think December tenth, the FDA Advisory Board is going to
Speaker 1: talk about FISER and then a week later they'll talk
Speaker 1: about MODERNA exactly. And we don't know how long the
Speaker 1: FDA will take to issue its u A Emergency Use
Speaker 1: authorization after that, but week that they'll move very quickly
Speaker 1: on that, and it would be hard to imagine them
Speaker 1: not approving it at this point. When it comes to
Speaker 1: the amount of doses that are going to be ready
Speaker 1: by the end of this year and next year, what
Speaker 1: are we looking at they're hoping to have forty million
Speaker 1: by the end of this year, which means vaccinating twenty
Speaker 1: million Americans this calendar year. They're going to start with
Speaker 1: healthcare workers, the people at most risk for catching COVID,
Speaker 1: and the people who are sacrificing themselves to help the
Speaker 1: rest of us. It looks like there's a meeting tomorrow
Speaker 1: to confirm that, but those are likely to be the
Speaker 1: first people in mind, then followed by nursing home residents
Speaker 1: and others who are at risk. Next year, hopefully disguised
Speaker 1: the limit both companies. Uh Viser says it can make
Speaker 1: as much as a billion doses next year. They have
Speaker 1: promised a hundred millions to the US, with some expansion possible.
Speaker 1: Madarna has also promised a hundred million total to the US.
Speaker 1: So theoretically, we really do need at least another one
Speaker 1: or two vaccines, So hopefully some of the others coming
Speaker 1: along behind them will also be effective. But theoretically we're
Speaker 1: in pretty good shape, certainly in the US. Let's talk
Speaker 1: a little bit about the confidence in vaccines, because you know,
Speaker 1: we've been seeing polls a lot of people saying they
Speaker 1: maybe not want to take the first batch of these
Speaker 1: vacts scenes they want to wait a little while. But
Speaker 1: we have to remind everybody. I know, this is going
Speaker 1: very fast and it's being bolstered by operation work speed
Speaker 1: and all that. But these are the gold standard of
Speaker 1: vaccine trials. The first two that have gone through this already,
Speaker 1: you know, Fiser and Maderna. They've done the extensive Phase
Speaker 1: three trials and all that, so people should have some
Speaker 1: confidence in this. They've followed the same practice. The only
Speaker 1: reason they're asking for emergency use authorization instead of full
Speaker 1: approval is if they're not following the people out. As
Speaker 1: you mentioned, they're not following people out for two years,
Speaker 1: which would be the standard. And again we'll find out
Speaker 1: later if we need to add a booster shot to
Speaker 1: get us to two years or not. But in general,
Speaker 1: the vaccine trials have been held to exactly the same standards,
Speaker 1: and they're very large trials. But Darrena's thirty thousand people,
Speaker 1: Fiser's forty four thousands, so and the others are on
Speaker 1: the same order of magnitude, so they really have tested
Speaker 1: them and a lot of people safety. The FDA required
Speaker 1: the companies to wait until at least half of the
Speaker 1: participants had been out two months from their shot. Generally,
Speaker 1: if you're going to have a bad reaction to the vaccine,
Speaker 1: it's going to be in the first six weeks, so
Speaker 1: eight weeks buy some time to make sure there are
Speaker 1: no health problems, and at this point no major long
Speaker 1: lasting health problems have emerged. So we have these two
Speaker 1: main vaccine candidates right here in Moderna and fiser. Those
Speaker 1: are m R n A vaccines, and then we also
Speaker 1: have the other major one, the astra Zeneca vaccine, that
Speaker 1: is also doing very well. At the same time. Right now,
Speaker 1: there's some questions that have arisen over the Astrosenica vaccine.
Speaker 1: The results that released some results last week, interim results
Speaker 1: that raised a lot of questions. They found that for
Speaker 1: the most part, the vaccine was six effective, which would
Speaker 1: have sounded great the Asday was looking for only more
Speaker 1: than fifty percent effective, But now that we have these
Speaker 1: two options that are ninety plus percent effective, sixty doesn't
Speaker 1: sound so great anymore. Um And they suggested that one
Speaker 1: way of manipulating the doses might be more effective, but
Speaker 1: that data was very small, so we need to wait
Speaker 1: and see what happens with the rest of the trial,
Speaker 1: all right, well, we'll see what happens next. Maybe Monday,
Speaker 1: we'll get another updata as it's incoming. So well, okay
Speaker 1: to find Karen winchild health reporter at USA Today. Thank
Speaker 1: you very much for joining us. Thank you. I'm Oscar
Speaker 1: Ramirez and this has been reopening America. Don't forget effort
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