U.S. Vaccine Distribution Strategy is a Mess

here's what happened in Virus News Today. Food and Drug Administration Commissioner Stephen Hahn said that the recent pauses in several clinical trial else are a necessary step to making sure any COVID nineteen vaccine or therapy will be safe. In an interview with Bloomberg Today, Hans said that recent stops to clinical studies of vaccines and antibody treatments by Johnson and Johnson, Eli Lily and Astra Zeneca are normal.

The system, he said, is designed this way to identify safety issues and protect participants, but also to find the right treatments and vaccines. In the end, a surge in coronavirus infections in the US is threatening the very survival of hospitals just when the country needs the most. Hundreds of facilities were already on shaky financial ground before the virus, and the impact of caring for COVID patients has put hundreds more in jeopardy. The pandemic sidelined profitable elective procedures

and pushed up costs to keep patients and staff safe. Meanwhile, hospitals are losing the privately insured patients they depend on as millions of Americans lose their jobs and their employer sponsored coverage. The American Hospital Association estimates the pandemic will cost US hospitals more than three hundred and twenty three

billion dollars by the end of the year. The industry group is asking Congress for an additional one hundred billion dollars and full forgiveness of loans made under Medicare's Accelerated Payment Program, among other requests for relief. Finally, i Ran announced a travel ban to and from five major cities, including the capital Tehran, over an extended holiday weekend, as part of measures to curb COVID spread. The restriction comes into effect tomorrow, amid a record spike in the country's

coronavirus fatalities and rising new cases. And now for today's main story, States are racing the clock to meet a Friday deadline. That's when the federal government says they must submit their plans to distribute a vaccine once an effective one is ready. But Angelica Levita reports that they're putting together the strategies effectively blindfolded. State health officials have no clue which vaccine they will be distributing, nor when or

even if a vaccine will be forthcoming. I talked to Angelica today about the problems with this state by state strategy in terms of getting the US ready for a COVID nineteen vaccine. What's the significance of this Friday oct The states are required to submit their plans to the CDC detailing how they plan to distribute and administer COVID

nineteen vaccines. And so these plans are outlines because obviously, right now it's hard to give exact specifics on how you'll distribute a vaccine that you don't know what the storage requirements will be, when it will be here, how much of it you'll have. So the CDC gave states a playbook to use to help prepare these plans. And so the states will use those use that playbook to compile their rough plans and share those with the CDC.

Now this this might sound a bit obvious, but how exactly can states plan for a vaccine that doesn't exist yet? That's not at all obvious. This is a big question that states and other experts that I've spoken to talk about. And states have done this before. They help vaccinate people every single year for flu shots. They've been involved with the H one N one pandemic, so this is not

new to them, so they know how to run mass vaccination. However, this one, of course, is different because the scale will be much larger, and like you said, we don't know which vaccines, if any, will be approved when and what the requirements will be. So they're using their previous experiences and taking the mass vaccination plans that they already have, refreshing them and planning really scenarios. So and some of the plans um they'll talk about if this happens, we

will do this, and here is what we're thinking. Now this is to be determined. So these are really blueprints, we can call them. They have a lot of details based on their previous experience and what we know of the vaccine candidates look like, but there are still tvds that they need to figure out. And you mentioned this CDC playbook. Are there any hard and fast requirements that is in this playbook that all the states have to

adhere to. So the states are using the information that is provided in the playbook to form their proposals here their plans, and so there are some things that they will have to do. So, for example, there are reporting requirements that say, you know, they dictate how often they need to be communicating with the CDC to make sure that all of the states are sharing their information about how many people are getting vaccinated, who's getting vaccinated with what,

how many supplies they have. So those are some of the requirements that all of the states are really required to do. However, the other things are more of guidelines

about um and that's where things can get tricky. So, based on what we know now, there will be different priority groups, so essential workers, healthcare workers, and the CDC recommends that the states figure out how many of these populations are in their states, but that can obviously vary based on what types of healthcare workers you're talking about. How do you define essential workers? You know, essential worker

might be different in New York City versus Arkansas. As one person told me, so these are some of the variations that they are working through. So it sounds like there might be fifty potential different plans in terms of distribution and priorities. That sounds like it might create serious issues. I was just wondering, maybe if you could unpack a little bit, what might be some problems that arise in terms of how one state's plan might differ from another

state's plan. Right, And that's a really good question. And one person I talked to had mentioned that the issue here that states are facing right now is that it's really a top down approach where the federal government is saying, here the requirements we need from you, when really it should be a bottom up approach, if that makes sense. So this is obviously a local effort um, and so there should be some variation here because priorities in one

state might be different than another state. So that's natural. However, the CDC and Operation Warp Speed are asking for all these answers to these questions that might really vary state

by state. Naturally there will be some differences here. Um. But then one of the big questions about the differences and the plans are with data, because all of these states already have their own data reporting systems to track vaccines, and the CDC is offering its own version for them to use and hope in hopes of creating more of a federal database, But some states don't want to use that. They say, we have our own. It's hard enough to get providers to enroll in that. We're just getting them

comfortable with reporting UM into this new system. We're not adding another system. So we're already seeing some of this tension between the state and federal effort, and then of course that creates differences among all of the different states and how exactly they'll do this. There does seem to be a natural tension there that states might report a higher population of you know, frontline healthcare workers than another

state and receive than more vaccine than another state. Are are we looking at that kind of potential situation where states might have to justify receiving more amounts of the vaccine before another state. So the state officials I spoke to said that they are not yet sure how the allocation, meaning how many doses they will receive, will be determined in the past, where H one N one, for example,

it was equal. Every state got the same amount, at least at first, and there's questions of whether it will be different this time, especially because they are required to estimate the sizes of those different populations that you mentioned, the essential workers healthcare workers, so there is an open

question of how much they'll receive. And that's why I think now the CDC is asking, hey, can you please estimate these different populations and can you give us Can you give us an idea of how many of these people are in your state and how that information will be used. We're not really sure yet, at least from what I've heard. Just looking at one other potential logistical hurdle, it seems that most of the vaccines in development currently

are two shot vaccines, requiring two doses. Essentially, that would seem to add additional logistical hurdles in terms of getting both shots. There is a lot of discussion about that hurdle because I think the idea is that at the beginning, it might be easier if you have if you're vaccinating healthcare workers. Let's say I'm a hospital, I call in all of my emergency room staff let's say hypothetical, and I know who they are, they work for me, I

can track them tell them to come back. So I think at the beginning it might be a little bit easier. But there are real questions of what happens once you start broadening the scope of this um and so people are thinking a lot about that. How do you make sure that you prompt people to come back and you track which vaccine they received, Because that's another important factor here is we don't know how these vaccines will work

when they're used together. We know, of course, the manufacturers are studying how their vaccine performs when you get multiple doses, but they're not studying how getting their dose for the first shot and then another vaccine for your second dose, how that will perform. So that's another big issue here that people are talking a lot about. And finally, so this Friday is only a few days away, the states

will submit their plans. What happens next. So the people I spoke to from the different states say that they assume this is a big assumption that these plans will really be drafts, because the idea was that these states were supposed to submit their plans early in the event that we had a vaccine available in early November, which, based on the new guidelines from the f d A,

is all but certain that will not happen. So now I think people are breathing a little bit easier, thinking they have more time to refine these plans as they answer the outstanding questions. So the idea, at least among the States is that they will have time to take a breath, review the plans and see how they need to refine them. From here. That was Angelica Levito, and

that's it for our show today. For coverage of the outbreak from one and twenty bureaus 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 top foreheads Jordan Gospore, Magnus Hendrickson and me Laura Carlson. Today's main story was reported by Angelica Levito.

Original music by Leo Sedrin. Our editors are Rick Shine and Francesca Levi. Francesco Levi is Bloomberg's head of podcasts. Thanks for listening, L