Updated at 1 pm, to include comment from the White House and the Department of Health and Human Services
Even the most effective, safest coronavirus vaccine won't work to curb the spread of the virus unless a large number of people get immunized. And getting a vaccine from the manufacturers all the way into people's arms requires complex logistics — and will take many months.
Now, public health officers across the country are rushing to finish up the first draft of plans for how to distribute a coronavirus vaccine if and when it is authorized, and they're grappling with a host of unknowns as they try to design a system for getting the vaccine out to everyone who wants it.
The Centers for Disease Control and Prevention gave state immunization managers only 30 days to draft a comprehensive COVID-19 vaccine distribution plan. Friday is the day those plans are due.
The timing of vaccine research and planning is politically fraught with the presidential election a few weeks away. When the CDC announced the October deadline last month, critics worried that political pressure was tainting the process, since President Trump has repeatedly promised a vaccine will be ready soon.
"If you listen to the White House, [vaccine distribution] could be just a matter of weeks away," New York Gov. Andrew Cuomo told reporters on Thursday. He and Arkansas Gov. Asa Hutchinson sent a letter to Trump on behalf of the National Governors Association asking for a meeting to talk through the many unanswered questions about the process.
"We need to know: What is the plan? What does the federal government do, what do you expect the states to do? When does it start? Who funds it?" Cuomo said. "Let's figure it out now because this virus has been ahead of us every step of the way — it's about time this country catches up."
In a written response to the governors on Friday, Trump administration official Douglas Hoelscher said the White House has already provided states with several opportunities to discuss plans for vaccine distribution, and that a meeting with Health and Human Services Secretary Alex Azar was being arranged.
Planning fast with changing expectations
For dozens of public health officials across the country, the process over the past month has been like "herding a lot of cats," says Claire Hannan, director of the Association of Immunization Managers. "It's really cramming three to six months worth of strategic discussions ... into 30 days," she says.
States need to lay the groundwork for distribution now, says James Blumenstock, vice president for pandemic response and recovery for the Association of State and Territorial Health Officials. That means deciding who's in charge of responsibilities such as ordering supplies, signing up vaccine providers, training staff, and running mass vaccination clinics and outreach campaigns, he explains. They'll also need a data management system to track who received an initial vaccine dose and to remind them to come back for their second dose.
"We have been working feverishly over the past few weeks," says Decrecia Limbrick, assistant director of the Department of Health in Houston, which is one of several large cities that receives funding directly from the CDC. "I think we're ready to submit a plan — a 'Version 1' of a plan."
Then there are conflicting messages from the Trump administration. "Originally there had been talk about hurrying up and getting your plan done because the vaccine will be ready before the election," says Kris Ehresmann, director of infectious disease for Minnesota's Department of Health. When the Food and Drug Administration recently said that vaccine trials must allow two months after the last experimental dose is administered, that guidance "changes the timeline" again.
"It's pretty much like being in a continuous earthquake," she adds. "The ground is constantly moving."
Despite the tight timeline, "all jurisdictions appear to be on target to meet the [Friday] deadline," Michael Pratt, spokesperson for the U.S. Department of Health and Human Services, wrote in a statement to NPR. "Once received at CDC, we will conduct a review of the draft plans and provide feedback to jurisdictions in the next two weeks. The team reviewing each plan will include CDC and [Department of Defense] staff."
Pratt noted that CDC has been holding weekly conference calls with immunization managers, and has already "answered nearly 400 distinct questions from states."
Overcoming logistical hurdles
Nobody knows which vaccine will be authorized first, when that will happen, which populations it will be authorized for, and how many initial doses will be available.
Adding to this uncertainty is the likelihood that the first coronavirus vaccines will be extremely challenging to handle. The CDC playbook notes that the vaccines will likely require cold chain storage (possibly "ultra-cold" storage, which is colder than Antarctica), must be given in two doses a certain number of days apart, and could have a minimum order of 1,000 doses.
"For routine vaccines, [providers] will order 10 doses at the time or 20 doses at a time," explains Michigan Department of Health and Human Services immunization director Bob Swanson. "It makes it more difficult to think about — how are we going to use a thousand doses for at risk populations across a rural county?"
Initially, the focus will be on the priority groups who will be first in line to get immunized. The specifics of who that will be are still getting worked out by a CDC advisory committee, although front-line health workers will almost certainly be at the top of the list. There are also concerns about distributing the vaccine equitably to communities that, for instance, speak different languages or are difficult to reach, especially at first when doses are limited.
As immunization managers look ahead to the coming year, different places around the country face a range of challenges.
Then there are seasonal issues. During a North Dakota winter, freezing temperatures and snowfall make outdoor drive-through clinics untenable, says Molly Howell, North Dakota's immunization program manager, so they're considering using warehouses or sporting venues for mass vaccination campaigns so that people can gather indoors while maintaining physical distance. "Those are some of the ways that we're trying to be creative about vaccinating people safely during the pandemic," she says.
In Houston, officials are thinking ahead to the complications of the hot and humid summer. "If we get those hot days, we want to obviously ensure that we maintain the integrity of the vaccine," says Limbrick of the Houston Department of Health, and they have to think about taking care of the medical staff who have to administer the vaccine in those conditions.
"After [health officials] push that button on Friday afternoon, on Saturday morning, they're going to continue to work on their planning efforts going forward over the days and weeks and months ahead," says Blumenstock of ASTHO. And when the first vaccine is authorized, "it's going to be close to a yearlong effort," he says, to immunize everyone across the country who wants to be vaccinated.
Finding the money to execute plans
CDC Director Robert Redfield told Congress last month that states are going to need about $6 billion to distribute vaccines.
"This is going to take substantial resources," Redfield told lawmakers. "The time is now for us to be able to get those resources out to the state[s]."
On Thursday, ASTHO and the Association of Immunization Managers wrote a letter formally requesting $8.4 billion from Congress for these efforts.
The letter notes that so far the CDC has distributed $200 million to states, territories and a few large cities to fund the vaccine planning process — but it describes this sum as "merely a down payment." And with the election looming, the chances of a new COVID-19 relief bill getting through the legislature anytime soon are dim.
"The funding I don't have control over, but I do have control over how we're going to get vaccines out when they're available," says Swanson. "And I will tell you, public health is strong, and public health works hard, and immunizations are public health's bread and butter."
Michigan has received $5.9 million so far, and Swanson says that money has gone to getting the state's immunization registry up to speed, and to local health departments for staffing.
The lack of clarity about funding troubles Dr. Kelly Moore, associate director of immunization education at the Immunization Action Coalition and the former director of Tennessee's immunization program.
States need additional funds to be able to carry out the plans they're submitting to the CDC, she says. "They need to be able to invest in manpower, in I.T. systems and in the people to use them," she explains, adding that those who are brought in to run the vaccination campaigns from other parts of the health department like STD clinics and family planning will also need to be backfilled.
"A lot of things need to be paid for with these billions of dollars," she says. "Even the best laid plans can't be executed if you don't have the resources to do so."
RACHEL MARTIN, HOST:
We all talk a lot about when a vaccine for the coronavirus will be developed. But an equally important step - once it's developed, I mean, you've got to figure out how to distribute it. Later today, U.S. states have to submit their COVID vaccine distribution plans to the Centers for Disease Control. This is to show that they have worked out how they're going to get a potential vaccine to citizens in their state. NPR's Pien Huang is with us now to talk about it. Hi, Pien.
PIEN HUANG, BYLINE: Hi, Rachel.
MARTIN: So you've been talking to state health officials. I mean, do they have these distribution plans? Have they worked this out?
HUANG: Yeah, in a sense. My co-reporter, Selena Simmons-Duffin, and I, we've been hearing from state departments all over the country from California to Texas, North Dakota, Michigan, Virginia, Florida. And they only had 30 days to do it. So back on September 16, the CDC gave them a playbook for vaccine distribution and said that they were to tailor it to their own states, the plans for how to get the vaccines out to their people. And they've been racing to pull it together. It's been described to me as anxiety-inducing, frustrating and also really exciting to be doing the work that will help get the vaccine out and, hopefully, help end this pandemic. I talked to Claire Hannan, who's head of the Association of Immunization Managers.
CLAIRE HANNAN: You know, it's really cramming three to six months' worth of strategic discussions with the task force, with stakeholders, into 30 days.
HUANG: She says the process, for many, has been like herding a lot of cats. In Minnesota, Kris Ehresmann is director of infectious disease at the state health department. She says the document they'll submit does address all the CDC's requirements, but it's far from final.
KRIS EHRESMANN: We've kind of described it as framing up a house. So we're going to keep adding to it, obviously, as we get more and more information. But right now, we've kind of just built a frame.
HUANG: Ehresmann says the information that still needs to be added are big keystones like which vaccines will actually be approved and how many doses will be available. But even without knowing those specifics, there is a lot of problem-solving that can be started now. Some of the vaccines may need to be stored in super cold temperatures, much colder than your home freezer. Molly Howell, immunization program manager for the state of North Dakota, says that's a logistical problem they're thinking through.
MOLLY HOWELL: So the storage container that the ultra-low cold chain vaccine comes in can maintain temperatures for up to 10 days if it's unopened. If the container is opened, then you have to kind of recharge it with dry ice every so often.
HUANG: North Dakota has bought some ultra-cold freezers and is trying to figure out how to get or make their own dry ice so they can get the vaccine out to people who live in rural communities. In Texas, the state is starting to get hospitals, doctors' offices and pharmacies registered to give out the vaccine when it is available. Decrecia Limbrick, who's assistant health department director in Houston, says they're considering all the different scenarios for vaccination down to the weather. It can get really hot and humid in Houston.
DECRECIA LIMBRICK: If we should get those hot days, we want to make sure that we maintain the integrity of the vaccine. But also, when you think about individuals potentially having to work in those conditions, just making sure that we take care of the workforce as well.
HUANG: In Virginia, Christy Gray runs the immunization division at the department of health. She says they ran a simulation to see how their plan works in different conditions.
CHRISTY GRAY: Let's just poke all kinds of holes in it. Let's take it for a ride and see how can we improve it, you know? Are there things we haven't thought of?
HUANG: Submitting these first plans to the CDC is a milestone. But Jim Blumenstock, from the Association for State and Territorial Health Officials, says it's just the very beginning.
JIM BLUMENSTOCK: Planning is just that. It's not execution. When the whistle blows and we start this campaign, it's going to be, you know, close to a year-long effort.
MARTIN: Pien, I mean, this has all got to be expensive, right? Where's the funding coming from?
HUANG: Well, Blumenstock says money is the other big missing piece to these plans. And last month, CDC Director Robert Redfield told Congress that states are going to need up to $6 billion to distribute vaccines. Yesterday, Blumenstock's organization, along with the Association of Immunization Managers, formally asked Congress for 8.4 billion. So far, the money has not been approved by Congress. And it's actually not very clear when a COVID package might get through. The election and politics are really complicating things at the moment.
MARTIN: (Laughter) Right. OK. So states are going to submit their plans. Then what happens?
HUANG: Well, the National Governors Association sent a letter to the president yesterday. It was cosigned by the heads of the NGA, Democrat Andrew Cuomo from New York and Republican Asa Hutchinson from Arkansas. And it basically said, we need to talk. We really want this vaccine campaign to roll out smoothly. But it takes a lot more than just the cost of a vaccine.
You know, states have to put up data systems to track who's getting it, to remind them to come back for second doses. They have to buy gloves and syringes and dispose of medical waste. And they also have to hire and train a lot of temporary staff to carry out that work. So the governors have asked the president for a meeting to discuss what the federal government is doing versus states and how it will all get paid for.
MARTIN: So meanwhile, the U.S. is approaching the 8 million mark for the total number of known COVID cases, which is just staggering. Can you just tell us what's happening with the virus right now?
HUANG: Yeah, absolutely. I mean, new case counts are rising across much of the country. And right now, the highest risk hot spots are in parts of the West and Midwest. You know, in North Dakota, in South Dakota, Montana and Wisconsin, the case numbers per capita are really soaring. And hospitals in these states are filling up.
A field hospital actually opened up this week at the state fair park in Milwaukee to take in overflow patients. And a month ago, the U.S. was seeing about 35,000 new cases a day. Now that number has climbed to over 50,000. The CDC reportedly told governors this week that one of the reasons for the surge in cases is because of small household gatherings, you know, groups of people coming together in homes without masks.
MARTIN: NPR's Pien Huang. Thanks for your reporting.
HUANG: Thanks for having me. Transcript provided by NPR, Copyright NPR.