FDA Says Moderna Vaccine Is Safe and Effective, Clearing Way for Approval - podcast episode cover

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

Dec 16, 20207 min
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Episode description

We are on track to get the second coronavirus vaccine approved by the end of the week. On Tuesday, the FDA confirmed that Moderna’s two-dose vaccine is safe and effective. In the first week of its rollout about 6 million doses will be shipped out. The government also bought another 100 million doses from Moderna for a total of 200 million at a cost of $3.2 billion. Sarah Owermohle, health care reporter at Politico joins us for more good vaccine news.

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Transcript

Speaker 1

It's Wednesday, December six. I'm Oscar Ramiras from the Daily Dive podcast in Los Angeles, and this is Reopening America. We are on track to get the second coronavirus vaccine approved by the end of the week. On Tuesday, the FDA confirmed that Maderna's two dose vaccine is safe and effective. In the first week of its rollout, about six million

doses will be shipped out. The government also bought another one million doses from Maderna for a total of two hundred million at a cost of three point two billion dollars. Sarah Overmall, healthcare reporter at Politico, joins us for more good vaccine news. Thanks for joining us, Sarah, Yeah, happy to be here. It seems we're on the same track as we were last week with the Fiser vaccine. The FDA has cleared the path for the second coronavirus vaccine

to be approved. This is the one from Maderna. It's very similar to the Fiser vaccine. The FDA panel will go through it, make recommendations, and hopefully over the weekend and early next week we'll already be seeing shots at Ministered of the Maderna vaccine. So Sarah tell us a little bit about what the FDA panel has said about this vaccine. They basically said it's safe and effective. This is basically deja vu for last week, so the Fiser vaccine.

It was authorized by FDA last week on very similar data, which is why we are pretty confident about the trajectory for this MODANA one. We expect that after expert Advisory Panel meets on Thursday, the FDA could be authorizing it as soon as Friday morning, as it did with Fiser, and then we will have a CDC panel meeting over the weekend to talk about recommendations for who this goes to first. But because they are really similar vaccines, they

have a very similar technology called Messenger RNA. They also have almost identical effective dis rates, we can expect some of these same things. There are some important distinctions for the moderna want, especially with certain populations that they have different data for. For instance, it shows that it's more factive and younger people than it is in people over the age of sixty five. That could be a really

important distinction. As we roll these doses out and find out that maybe the Fiser one is more ideal for nursing homes, and the Modena one might be more ideal for people who work in high exposure areas but aren't necessarily as old as somebody who's in ay, more vulnerable situations. So these are the things we're going to find out over the next few days. But you're right, we could as of next week have millions more doses to be shipping out across the country. The initial round of doses

are obviously limited. How many doses are we going to be able to see go out in the first push, So they're actually will be more of the Nodanna doses out in the first push than there were of these FISER ones. Government officials have said that nearly six million will be put out into more than three thousand sites next week if we do have this authorize, which we're

expected to. That's in comparison to two point nine million doses from FISER that are going out as we speak, and two point nine allion from Guisor that have been held back for a second dose. So between the two of them, each has promised twenty million doses a piece this month, which is forty millions total, but they all are two dose regiments. You can think of this as twenty million very high made people getting doses this month.

There was some criticism with the government's action on the Fiser vaccine for not buying that extension or extra doses, But on this case with the Moderna vaccine, the US did exercise their right to buy a hundred million additional doses of the Maderna vaccine. Tell us a little bit about that and then the costs associated with it, because this one is a little more closely tied to Operation

Warp Speed. The government gave Maderna more money to develop this whole thing exactly, and so they had options with both of those pharmaceutical companies to buy one hundred million doses originally, but the option to buy hundreds of millions

more with each of them. The Christism lately has been that they did not exercise that option when they could have with Fiser, so they had an option to buy up to five hundred million doses from them, and according to side there, they offered that to the government multiple times and the government didn't take them up on that, and so they moved on. They have signed multiple different

agreements with other countries in the world. I mean, you think about the entire world wants these highly effective vaccines, so kind of to them that loss, or to shore up our supplies here in the United States. The United States announced late last week that they would buy a hundred million more of the Modanna vaccine, and that brings its total costs with Modanna to three point two billion dollars,

which is eye popping. But when you think about how much this company, which has never actually mass produced a vaccine or products ever before Modanna, this is going to be their first authorized products. This is a huge undertaking. That's why there's so much money going towards this. So you can think about this as the US trying to shore up its supplies in this arena. It also has multiple other agreements out there with six manufacturers total to

get if everything goes right, nine billion doses. That might seem like a lot, like way too much for the US, but we don't know how many of those are going to work. We even just learned last week that another vaccine from Snophi and Glackslow Smith Klein is going to be delayed until the end of one because they didn't get really good results. So this is why the US

is betting so big. Yeah, and the MODERNA vaccine for its part, is easier to ship and store than the fiser one is, so you know, maybe this vaccine will make it into rural areas a little more easily. So there's benefits, you know, in pros and cons to each one kind of on this. So at least a good thing that they bought up a bunch of those extra orders. And the last thing I wanted to ask real quick

was just about how much the moderna vaccine protects. There's been things made that it can reduce severe effects of coronavirus. They're hoping obviously that it will reduce transmission rates, but that's kind of what the focus was of their study as well, and just how effective this would be. So that was something we learned in the Food and Drug Administration's briefing documents tuesday morning, was that not only is this effective broadly, but there's a suggestion that after the

first dose it might even have curbed infections. And you might think that's pretty obvious, that's what vaccine you're supposed to do, But we don't actually know yet how effective vaccines would be as preventing transmission, which is kind of the ultimate goal. We don't want people to have to get sick in the first place. This indicates that the Modanna vaccine might be able to do that. And then, like you said, with severe COVID illness, there are really

promising results from Nemoderna vaccine. There were thirty severe illnesses in the PLACEBA arm and none in the vaccine arm. That's great news. So we actually have between this advisor two really promising candidates first out of the gate. We kind of couldn't expect for better, to be honest, So now it's you know, it's the challenge of getting this out to people, getting it to the people who need it most right away, and meeting the demand that we know we're going to have. And Dena's as an author

in the world. Sarah Overmall, healthcare reporter at Politico, thank you very much for joining us. Oh wait, thank you for having me. I'm Oscar Ramirez and this has been reopening America. Don't forget effort today's big news stories. You can check me out in the Daily Dive podcast every Monday through Friday, So follow us on I Heart Radio or wherever you get your podcast.

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