A Turning Point Week Ahead

in the US. A record number of coronavirus patients are in the hospital, and nearly two thousand people are being hospitalized with the disease every day. According to data from the Department of Health and Human Services, New York, North Carolina, and Tennessee recorded the biggest increase in patients. New Mexico has exceeded its ICU capacity. COVID nineteen cases now account for at least one in five hospital patients in nine states.

Experts are warning about the winter holidays ahead. Anthony Fauci, the top infectious disease expert in the US, warned that the Christmas season could be even worse than Thanksgiving for the outbreak the Christmas holiday is both longer and more challenging, Fauci said in a CNN interview. And Scott Gottlieb, former Commissioner of the U S Food and Drug Administration and a FISER board member, believes the current wave of infections

in the US has yet to peak. On CBS's face the Nation on Sunday, Gottlieb said COVID nineteen numbers are expected to get worse over the next four to six weeks. Infections are not likely to peek until the end of December or into January. Deaths probably will peak in the middle of January. Finally, there are signs the outbreak is abating in parts of Europe. Italy's outbreak continues to slow. Today, health officials reported the lowest daily new cases since October.

Italy make it its first three point four million doses of the FISER bio en Tech COVID nineteen vaccine as soon as January, a week earlier than expected. According to the Italian newspaper Il Massa Gero and Now for today's main story, the coming week could mark an early turning

point in the U S battle against COVID nineteen. An advisory panel made up of top medical experts will meet December tenth to help the Food and Drug Administration review the drug for possible emergency authorization that would clear the way to making it a top weapon against the virus.

I asked reporter Anna Edney to break down the next steps in the approval process and help explain the reality of making the vaccine available to the public, and I was hoping you might provide us with some details about

exactly what's going to happen at this meeting. So the meeting is so that the advisors to the Food and Drug Administration can hear from the FDA staff themselves actually as well as Visor about their UM look at the clinical chrial data that Visor UM ended up with after they they did a trial on about forty four thousand participants, And so the FDA has taken a look at that data,

visors taking its own look UM. They're going to present each of their own calculations to the advisory panel in public so everybody can listen to it if they want to UM, and then they're going to the panel of advisors. They'll talk about UM that data, they'll discuss it. They're often have a vote at the very end of the meeting. I anticipate it will be a lengthy meeting UM, and they'll they'll vote on something that will give an indication to the FDA about whether they should authorize the vaccine

or not. And obviously we're talking on Monday. The meeting is only a few days away. As far as the timeline and materials, what's going to be made available leading up to the meeting. So typically the way that these advisory panel meetings work is the two days before they meet, the Food and Drug Administration will release UM they're called briefing documents. It's the f d a's review of the clinical trial data. They'll release fiser's own briefing documents as well.

So this will be the first hint the public will get UM into the agency's view of that data and you know where they're leaning on it, where they have questions, where they think there might be gaps in some of the data, UM. And then so that will come likely Tuesday morning, sometime around nine am. Typically they come out UM. You know, at the same time the meeting would start two days later, and then you know, the meeting happens on Thursday, UM, probably all day long, and they'll be

that vote that I mentioned at the end. Most likely we'll see in those briefing documents what exactly the questions are for the panel that they'll discuss at the end, and whether there is a vote that's asked for. So as far as the experts and authorities that will be at this meeting and the various opinions and recommendations that will happen with regards to a vaccine candidate, does the FDA have to accept these recommendations. They don't have to.

Very often. They do their usual you know, they're they're in agreement, I would say most of the time with the panel, um when it comes down to whether they authorize or approve or reject um a drug or a vaccine, and then there, um, you know, the final decision. The Commissioner, Stephen Hahn has said he's leaving that up to Peter Marks, who's the head of the agency center that oversees vaccines.

And that's really typical. You know, the Commissioner often does not get involved in making those decisions unless there's something that the Commissioner might want to over a role. It's not something that I anticipate in this case, um, And so I think you'll see career officials at the Food and Drug Administration making any final decision on this, which could come, you know, as soon as a day or

two after the meeting on Thursday. And that brings up a good point as far as what happens after this meeting in terms of the days and weeks after these recommendations are made and after this panel meets. What we're looking for during the panel is, you know, what are the questions the FDA has. How complicated are those questions?

If they're pretty straightforward, If the data looks pretty straightforward, um, and the FDI doesn't seem too conflicted, you know, we might see an FDA decision on authorizing the vaccine within a day or two. If it's if it looks like there's a lot they're trying to work through. If they're not quite sure about this vaccine or some some portion of it, the safety or the avocacy, then that might

take a little bit longer. UM. Peter Marks, who had the the agency center that has the handles vaccines he has, you know, said it possibly could take weeks if there if there are complications in the in the application for the vaccine. Um. But whenever it does get authorized. If it does, then UM operation work warp Speed officials have said that they will expect to start distributing it within

twenty four hours. So that's probably about UM six point four million doses right away and UM that'll that'll go to healthcare workers and long term care residents, UM kind of as the states see fit. So this this really isn't the end of the process, but really perhaps just one of the many starting points. Certainly, I think, you know, even the vaccine makers will have more work to do.

They're not going to necessarily just abruptly and their clinical trials. UM. The f d A is making their decision on these vaccines UM that are getting emergency authorization based on two months of safety data and typically for a full approval UM they were they'd be looking for six months. So they're gonna they're gonna want the the drugmakers to continue doing these trials, to continue getting them information and and seek out a full approval from the agency. UM. And

so there's still more work to be done. And then you know, the States will be doing a lot of work to try to get these vaccines out to people and to you know, that's going to be a continuing process well through the spring in the summer, and does this in terms of the emergency use authorization for the fighter and the bio and tech candidate. Will that potentially make it more difficult for the other candidates under development from other companies? It could in the sense that UM.

You know, when there are other companies like Johnson and Johnson UM still trying to do clinical trials of their vaccines. People that are in those trials, you know, about half of them are getting a placebo. They're not getting the vaccine. And if they feel they're getting the placebo, they're going to think, you know, maybe I should drop out and at the vaccine if they're eligible to get the vaccine. So there are people at the f d A and

at companies trying to work through this. You know, do they start switching these trials, you know, or start start doing some trials based on comparing them to the vaccines that are on the market rather than a pluce ebo. UM. They're thinking about all of this, trying to make sure that there can still be data gathered on the vaccines as they're going. And you know, the other thing is safety won't just be up to the company's to look at.

There will be a lot of people in the United States, millions of people using these vaccines, will be getting the vaccines. So there are at least half a dozen different federal programs that will be tracking safety UM within the Department of Health and Human Services, the Veterans Affairs Department, the Department of Defense. They all track, you know, whether there might be any rare side effects we don't see in clinical trials because they're short and and not in a

lot of people. UM, whether anything rare might might crop up that will still be looked as well as we continue getting these That was Anna Edney, and that's it for our show today. For coverage of the outbreak from one BES around the world, visit Bloomberg dot com, slash coronavirus and if you like the show, please leave us a review and a rating on Apple Podcasts or Spotify. It's the best way to help more listeners find our global reporting. The Prognosis Daily edition is produced by Tophor

foreheads Jordan Gospoure, Magnus Hendrickson, and me Laura Carlson. Today's main story was reported by Anna Edney. Original music by Leo Sedrin. Our editors are Rick Shine and Francesco Levi. Francesco Levi is Bloomberg's head of podcasts. Thanks for listening The LAS