From Transport To Storage, How Vaccine Distribution Will Work : Consider This from NPR Distribution of the first doses of a coronavirus vaccine could be mere months away. But how that distribution will work remains a massive logistical puzzle that is still coming together piece by piece.

NPR's Selena Simmons-Duffin reports on how drug companies and the federal government are planning to ship and store vaccines that must remain frozen, some at temperatures that require special freezers.

NPR's Dina Temple-Raston outlines the federal government's $590 million plan to avoid shortages of crucial vials and syringes.

In participating regions, you'll also hear a local news segment that will help you make sense of what's going on in your community.

Email us at considerthis@npr.org.
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Vials, Cold Storage, Staggered Doses: The Challenges Of Vaccine Distribution

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Vials, Cold Storage, Staggered Doses: The Challenges Of Vaccine Distribution

Vials, Cold Storage, Staggered Doses: The Challenges Of Vaccine Distribution

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AUDIE CORNISH, BYLINE: Hi. It's Audie Cornish. And we here at CONSIDER THIS want to know what you think of the show. A short anonymous survey is open now. Go to npr.org/considerthissurvey to share your thoughts. That's npr.org/considerthissurvey. And thanks.

AILSA CHANG, HOST:

This week, America officially recorded 250,000 deaths from the coronavirus. The actual number is probably a lot higher. And as we all know, the only end in sight will come from a vaccine. It looks like several might be ready soon. In fact, Pfizer may ask the FDA for emergency use authorization for its vaccine as soon as Friday. But that doesn't mean anything if the vaccine can't actually make its way to you.

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PAUL MANGO: This is a really quite extraordinary, logistically complex undertaking.

CHANG: Paul Mango is the deputy chief of staff for policy at the Department of Health and Human Services.

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MANGO: And a lot of uncertainties right now. I think the message we want you to leave with is, we are prepared for all of those.

CHANG: Uncertainties like how will we keep track of who's getting vaccinated and when? You see, the two leading vaccines from Pfizer and Moderna are stored at different temperatures, and they require different preparation before they can be injected. Pfizer requires two doses, 21 days apart; Moderna - two doses, 28 days apart. And health care providers need to be sure that a patient getting the first dose of, say, the Pfizer vaccine doesn't accidentally get a dose of the Moderna vaccine because they're not interchangeable.

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GUS PERNA: What we're working with is all the states and their capabilities and capacities that they have. And what we've created is a system that integrates all that information into one.

CHANG: That's Gus Perna. He's the army general in charge of distribution and logistics for the government's vaccine program, otherwise known as Operation Warp Speed. And he told NPR this month the government will help states track dosing. And to try and avoid any confusion, the second dose would be shipped well after the first.

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PERNA: That way, there's no potential for them to over-administer, and it won't overwhelm their local storage capabilities. We'll hold it nationally, and then we'll distribute it as required.

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CHANG: CONSIDER THIS - vaccine distribution is going to be a massive puzzle of planning and logistics, and we are still months away from knowing exactly how that puzzle will all come together.

From NPR, I'm Ailsa Chang. It's Thursday, November 19.

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CHANG: It's CONSIDER THIS FROM NPR. A lot of the planning for a vaccine rollout is happening at the state level.

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NIRAV SHAH: Here's the level of planning we are at. We are way beyond where are our freezers and where's our dry ice. We did that weeks ago. We are now at the stage of, how many pairs and what sizes of ultracold dry-ice gloves do we need to be ordering?

CHANG: Officials like Dr. Nirav Shah, who's the director of the Maine Center for Disease Control and Prevention, have been working on their vaccine rollout plans for months.

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SHAH: Like, OK, we've got 17 people. What size are their hands? How many are mediums? How many are larges? How many are smalls? How many goggles do we need to be ordering?

CHANG: He told NPR this week that his state, hypothetically, could be ready to distribute the first vaccine doses as soon as next week.

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SHAH: Particularly to the highest-priority groups on our list - health care providers, first responders and others that we know we need to keep healthy so that they themselves can continue to care for patients and help us vaccinate others.

CHANG: But there's still more work to do before they're ready to vaccinate the general public, and it's not just about dry-ice gloves.

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SHAH: We need to be able to hire vaccinators. We need to be able to hire logistics teams to transport the vaccine and store it sometimes in ultracold environments. We need an IT system that can help us track who's received the vaccine and when to get their second dose. And we need to be able to instill confidence in the entire prospect.

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CHANG: And Shah says that requires more funding, not just in Maine but in other states. And because state revenue has taken a huge hit during this pandemic, Shah says the federal government needs to help. But there's no sign Congress will approve any additional funding this year.

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SHAH: We at the state level are ready to receive the baton, to have that baton passed to us, to begin the vaccination process. But without proper funding, it'll be like putting up tent poles without having the tent.

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CHANG: Now, state-level funding is not the only pressure point in the vaccine distribution process. The vaccine has to be able to get to those states in the first place. You heard Nirav Shah in Maine talk about dry ice. Well, that's because both of the leading vaccines from Pfizer and from Moderna need to be kept cold. And the Pfizer vaccine has to be kept really, really cold - like, colder than anything a conventional freezer could handle.

NPR's Selena Simmons-Duffin has been looking into how drug companies and the federal government are planning for that. Selena spoke to NPR's Steve Inskeep.

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SELENA SIMMONS-DUFFIN: Both of these vaccine candidates are what's called messenger RNA vaccines. And mRNA is very unstable. So to help explain what that means, here's an analogy. Think of the vaccine like a melty chocolate bar. To stabilize the vaccines, these drug companies used modified building blocks, or nucleosides - which would kind of be like changing the chocolate recipe so it's less melty - and then they coated it...

STEVE INSKEEP: And not on my 5-year-old's fingers quite as much. OK, go on. Go on.

SIMMONS-DUFFIN: (Laughter) Right. So then they coated it with something called lipid nanoparticles. Margaret Liu explained this to me. She's a vaccine researcher who chairs the board of the International Society for Vaccines.

MARGARET LIU: That formulation helps protect the RNA. It's kind of like putting your chocolate inside a candy coating and you have an M&M, so the chocolate doesn't melt.

SIMMONS-DUFFIN: So then the freezing is also done to protect the RNA and make the vaccine more stable. It's the same concept as freezing food so it doesn't spoil. Although only Pfizer's vaccine requires ultracold conditions. That is minus 70 degrees Celsius, which is extremely cold - colder than winter in Antarctica. And that presents challenges.

INSKEEP: Wow. Yeah. One of them would be a normal freezer. The other would be this extreme freezing situation. Why would that be?

SIMMONS-DUFFIN: Well, we don't really know. The data isn't public. All we have is these companies' statements. Moderna says that its vaccine can be distributed at minus 20 degrees Celsius, which is regular freezer temperature. Once it's thawed, it can be refrigerated for up to a month, and you can even leave it at room temperature for 12 hours. The Pfizer vaccine is more complicated because it has to be stored at ultracold temperatures, and the company will use specialty shipping containers that can be refreshed with dry ice. But once the vaccine's thawed, it only lasts in the refrigerator for five days.

INSKEEP: What are the implications of those freezing requirements?

SIMMONS-DUFFIN: So what this means is that immunization managers who are in each and every state are expecting they're likely going to get both of these vaccines, and they'll have to figure out where to send them - probably to different kinds of places. So Christine Finley is the vaccine manager in Vermont. She's still finalizing the state's vaccination plan. She told me it might make sense to send the Pfizer vaccine, which comes in huge quantities and requires the dry ice and the specialty freezers, to be sent to big population centers.

CHRISTINE FINLEY: If you have a large university where you're going to be able to reach a larger number of people, that would make sense that you might consider distributing your ultracold there. And then in areas where it might be more difficult to use up such a large order or they may not have the storage, you've now got another option.

SIMMONS-DUFFIN: She says especially at first when there are limited doses, they need and want as much stock of vaccine as they can get.

INSKEEP: When there are limited doses, they'll go - well, not to the general population at first, right?

SIMMONS-DUFFIN: Right. The first limited doses will go to frontline health workers - they're the people most at risk - and then other groups like seniors and people with conditions that make them more likely to get seriously sick. And the general public will get it likely many months after that, which is why public health experts are frantically trying to get the message across that people still need to social distance and hand-wash and wear masks, especially now that the virus is spreading so much across the country.

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CHANG: Selena Simmons-Duffin reports on health policy for NPR.

Now, distributing the vaccine is not just about temperature. To get the vaccine where it needs to go, it has to be put in specialized vials. And once the vials are delivered, individual doses need to be injected with a syringe. But public health officials have been concerned that there might not be enough glass vials and syringes to go around. So on Thursday, the Trump administration announced a $500 million Plan B. That's how much the government is loaning a Connecticut company that makes a new mass-produced vaccine injection device. NPR investigative correspondent Dina Temple-Raston has more.

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DINA TEMPLE-RASTON: That's the sound of a COVID-19 vaccine backup plan.

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TEMPLE-RASTON: It's a production line in Columbia, S.C., that's churning out a novel injection device that the Trump administration is counting on to help deliver the COVID-19 vaccine as early as this spring. The administration will add to its already hefty investment in a company called ApiJect Systems America and extend more than half a billion dollars to its effort to backstop the country's COVID-19 vaccine program.

JAY WALKER: Hi there. I'm Jay Walker, and I am the chairman of ApiJect Systems.

TEMPLE-RASTON: And you founded another company we've heard of, right?

WALKER: Yes, and I am best known as the founder of Priceline.com.

TEMPLE-RASTON: The founder of Priceline, the man who put William Shatner back on the map, is now producing a single-use, self-contained injection device that's designed to be an alternative to glass vials and syringes.

WALKER: We call it a syrette.

TEMPLE-RASTON: It's a little bigger than your thumb, and it looks a little like those single doses of eye drops that you get from the eye doctor. It has a hypodermic needle that you screw into the end like you do when you screw in a nozzle on a tiny bottle of Krazy Glue. Only in this case, it would carry any number of approved COVID vaccines. Walker said it's that effort that the U.S. International Development Finance Corp. is funding with a $590 million loan.

WALKER: The U.S. government is announcing a plan to support the biggest and fastest vaccine syringe filling factory - up to 3 billion doses a year.

TEMPLE-RASTON: That's billion with a B, even though the injection device has yet to be approved by the Food and Drug Administration, which worries Nicole Lurie.

NICOLE LURIE: So I think the challenge that I see is that it is a completely untested technology.

TEMPLE-RASTON: She served at the Department of Health and Human Services during the Obama administration.

LURIE: It's not clear to me what testing of the ApiJect product has been done to ensure that the materials inside the ApiJect containers don't interact with the components of the various vaccines.

TEMPLE-RASTON: The vaccine being produced by Moderna, for example, needs to be kept at arctic temperatures. Walker says the ApiJect devices can handle that, but the FDA has yet to certify that that's true. But then you can say that about a lot of the projects funded by the Trump administration to try to combat the virus. Tens of billions of taxpayer dollars have been spent to fund a roster of vaccines, some of which are bound to fail. The point is to try and find a solution.

DARIN ZEHRUNG: Yeah. My name is Darin Zehrung.

TEMPLE-RASTON: Darin Zehrung is the global program leader for medical devices at PATH, which is focused on improving global public health in developing countries.

ZEHRUNG: I've been at PATH 22 years.

TEMPLE-RASTON: He's been tracking ApiJect's progress for a while, and he says it's hired some people who are really good at prefilled technologies.

ZEHRUNG: From our perspective, a low-cost prefill is something that we've always been aiming towards for low- and middle-income countries.

TEMPLE-RASTON: He doesn't think the administration is making a particularly risky bet.

ZEHRUNG: I'm excited about what could be. I mean, we could truly have a low-cost, scaled-up prefilled system that could be used for a number of different, you know, drugs or vaccines, biologics that could benefit low- and middle-income countries.

TEMPLE-RASTON: ApiJect is getting a cash infusion. Now it needs FDA approval to become the backup plan the Trump administration is banking on.

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CHANG: That is NPR investigative correspondent Dina Temple-Raston.

It's CONSIDER THIS FROM NPR. I'm Ailsa Chang.

CORNISH: Once again, just a reminder that we want to hear what you think about CONSIDER THIS. A short, anonymous survey about CONSIDER THIS is open for a limited time at NPR.org/considerthissurvey. This is going to help us all so much and will give you a chance to help shape the future of the show. That's NPR.org/considerthissurvey. And thanks.

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