Sometime in the next months—before the end of the year, according to optimists, or more likely early in 2021—the United States will have a vaccine for Covid-19. We don’t know which formula will be first to the finish line. We don’t know if that vaccine will be released under an emergency use authorization or a standard new-drug approval. We don’t even know how many doses will be available. But one thing is certain: The task of getting the shot into arms falls to state governments and health departments. And because each state is different—in geography, density, income, and in the trust its residents do (or don’t) have in their leaders—each state is going to have to devise its own plan.
Our attempt to control the coronavirus, in other words, isn’t going to be one war. It’s going to be at least 50 separate battles—maybe 56, if you count Washington, DC, Puerto Rico, and the other US territories—fought on different terrain and different timelines, with variable supply lines and no clarity yet about who is going to pay for all the personnel.
It could be messy.
State and local health departments, and the organizations that advocate for them, are trying to be cheerful about the task, but officials are clearly worried. “This is unlike any other effort we've had to make in 100 years or so—maybe ever,” says Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials. “The closest we have ever come was the H1N1 flu, and in terms of vaccination, that was not the magnitude of Covid-19. So it's a wholly new planning process. And it's really difficult to plan when you don't have all the information you need.”
The planning process has already started. The Centers for Disease Control and Prevention released a 57-page “interim playbook” in mid-September that lays out, in detail, what the states should be doing now: creating committees, identifying vaccination sites, working out ordering and storage, creating systems to track who receives the shots, and building the workforce to handle all those tasks. The work specified in the playbook is not optional; the states have to perform it in order to show the feds they are prepared to receive the vaccine once it is approved.
And it’s a process that’s moving fast. The states’ first communication back to the CDC—the first version of their complete plan for recruiting vaccinators, receiving the vaccine, and motivating their citizens to take it—is due today, October 16, exactly one month after the playbook was published. Yet the states must submit those plans without access to crucial information: not just when the vaccine will arrive, but how many doses they will receive in the first round, how much will follow subsequently, and when those subsequent releases will begin.
“States don’t know how much of the first supply they will be allocated,” says Marcus Plescia, a physician who is chief medical officer at the Association of State and Territorial Health Officers, and who led a call with state health department leaders last week. “Because that hasn’t been determined, they don't know how to prioritize distribution.”
Two realities, not well publicized so far, underlie this decisionmaking. The first is that once a vaccine is approved, it is likely to arrive not all at once, but in tranches; a state’s initial allotment might be only a few thousand doses. The second is that any of the formulas are almost certain to require two shots, spaced 21 to 28 days apart, to be effective. So however many doses arrive in that first delivery, they probably can be used to protect only half that many people—which means the number of people allowed to come to the front of the line in any state might be pretty small.
Though there is not yet a federal directive on who goes first—that will come from the Advisory Committee on Immunization Practices in the days after the vaccine is approved—there are lots of opinions. The National Academies recommended this month that the very first recipients should be first responders and health care workers doing direct patient care, closely followed by elderly long-term-care residents, and people of any age with a chronic condition that puts them at high risk of infection. On the other hand, prominent public health academics wrote in an opinion piece in The Journal of the American Medical Association on Wednesday that racial and ethnic minorities should be among the first recipients, because those groups have endured higher rates of illness and death.
The CDC allows each jurisdiction to decide who its “critical populations” are, the people who most need protection because of their jobs or vulnerability. That might include health care and pharmacy personnel; people on whom local infrastructure depends, such as government workers, members of the military, medical supply makers, and mortuary operators; people confined to nursing homes or prisons; or members of groups who we already know are vulnerable, including tribal communities.
Each decision to prioritize a group involves making a choice about where to give people the vaccine: at their workplace, where they live, or at some third, not yet determined, site. “With our first responders, we can go to the firehouse and know we can find them there,” says Thomas Quade, the health commissioner for Geauga County in northeast Ohio. “For health care workers, that can be done at the institutions where they work.” For vulnerable communities or seniors, that calculus of who travels—the person or the shot—becomes a lot more complex.
But put a pin in that idea of where the vaccine gets delivered, because an equally important question has to be answered first: when. The timing of vaccine administration isn’t only a function of the date when the doses arrive in town. It’s also affected by when, or whether, a state can assemble enough health care workers to perform the injections.
The rules that allow people to administer shots aren’t uniform: All 50 states allow pharmacists to do them now (thanks to a federal push to expand access to flu vaccination), but many, for instance, prevent emergency medical technicians from doing the same task. To vaccinate their population, officials in some states may well need to tweak laws to expand practice standards. Or, more likely in the short term, they may need to write contracts to hire additional personnel.
That’s an unbudgeted cost—and states, unlike the federal government, are required to balance their budgets. It’s also a nerve-wracking calculation of timing. Write the contract too soon and the new hires may have nothing to do. Attempt it too late and health care workers may become a scarce commodity that states bid against each other to acquire, another version of the PPE death match they were forced to conduct in the spring.
Behind a potential shortage of vaccinators, there’s another workforce issue looming: the availability of IT workers. Anyone recruited to give vaccines needs to have their data entered into a new system that tracks simple information such as their name and medical license or credentials, verifies their electronic signature, and also records their assent to complex attestations about how they will handle and distribute the vaccine and keep records of the shots they administer. The system also needs to record the characteristics of the institution where the vaccinator works—hospital, pharmacy, clinic—and what its capacity is for storing and handling vaccines. (Storage is a whole separate issue. Put a pin in that, too.)
Built into the national planning is an absolute requirement that each state create a registry recording who receives a dose, and where and when, so as to send that data to the federal government within 24 hours. That demand is intended to give the feds near real-time visibility of where the vaccine is being used and where it is needed. It will also keep track of who received vaccines in case there are adverse reactions, a rare possibility that can’t be ignored. And it’s needed to sort out who has received their first dose and needs to be chased down for their second, a task complicated by the fact that both doses have to be of the same vaccine formula. Mixing two manufacturers’ vaccines won’t work.
States already have vaccine registries, of course, which track receipt of the childhood vaccines that kids must receive to be enrolled in school. Out of those registries, many states have built some form of adult vaccine tracking, as well—but that’s new. “States have varied levels of robustness of data,” says Claire Hannan, executive director of the Association of Immunization Managers, whose members head state vaccination programs. “We probably have less than a handful in which 95 percent of their adults have a record in their immunization information system.” Even in places where that capacity exists, the databases don’t have the fields to record the granular data being demanded of Covid-19 vaccine reporting. It would have to be built.
Because of historic underinvestment—state public health budgets have been persistently cut over years—the techs who could build them aren’t sitting in health departments now. Nor is there money to hire them. A cash infusion to ease state planning is included in the most recent Covid-19 stimulus bill, but the vote has been postponed until after the election. That pushes the arrival of any new funding until at least mid-November. Yet states are having to plan and hire now.
“I think our biggest point of vulnerability is this unbelievably complex matrix of interconnected information systems that everyone is expected to use, but that no one has yet seen, or started learning how to use and to figure out where the bugs are,” says Kelly Moore, a physician and former director of the Tennessee Immunization Program, now associate director of immunization education at the Immunization Action Coalition. “I have yet in my public health career to see an information system that worked perfectly out of the box.”
All of this is further complicated by the challenges posed by the vaccine candidates themselves. First, there’s the storage issue. All the leading candidates will be shipped frozen and must be held, at the end of the line, at subzero temperatures. For the Pfizer/BioNTech vaccine (Moore is on a Pfizer advisory board), the holding temperature is what is described as “ultra-cold”—60 to 80 degrees below zero Celsius, or down to –112 Fahrenheit—a level achievable only by lab freezers. Once thawed and opened, the vaccine can only be held for five days before it must be discarded. Pfizer has devised scaled-down shipping containers to keep the doses frozen as long as possible—but they are packed with dry ice, which must be replenished.
Even the competing Moderna vaccine, which still has to be held below zero (at –20 Celsius or –4 degrees Fahrenheit, just below the temperature of a home freezer), has storage limitations. Once thawed, it must be discarded after two weeks, for fear of contamination. But an equally big hurdle for both isn’t the cold chain: It’s the size of the vaccine shipment once it is thawed. If the number of people waiting for a vaccine—on a reservation, for instance, or in a small town’s nursing home—are fewer than the number of doses sent to them, those doses will be wasted, at a time when every dose will be precious.
“This is a real concern for states which have rural areas, where it is just not plausible to send them a package on dry ice and expect it to get used before it needs to be discarded,” Hannan says. “Program managers are asking, ‘Where do I get dry ice? How do I store it?’ It is stuff we have never done before.”
These challenges have planners thinking through when it will be practical to send the vaccine to the end of the line, to small towns or clinics. Hannan shakes her head imagining one health care worker being told, on 24 hours’ notice, to get in a car and carry the vaccine to clinics in each of five rural counties. This assumes that the residents of those counties can get to a clinic, and aren’t lacking a car or available transit or childcare. It may make sense—though no one has had the time yet to devise this—to plan bus caravans or similar transport to bring people to the shot instead.
The peril of wasting doses is guiding planners to identify locations where large numbers of people can gather safely; the more recipients arrive at once, the less wastage there is likely to be. In Ohio’s Geauga County, southeast of Cleveland and northeast of Akron, that’s likely to be the county fairground. “It’s massive,” Quade says. “We can get the cars off the road, have them line up, have people stay in their cars and hang their arms out the window.”
Operating the vaccination campaign once the formula arrives isn’t Quade’s biggest concern. What he’s anticipating—but isn’t sure how to plan for—is the distrust that is likely to precede it, and not only from people commonly opposed to vaccines. Since the spring, messages from the government and from science have been in conflict: over the usefulness of masks, the reliability of experimental drugs such as hydroxychloroquine, the possible death toll. “People were told that anyone who wanted a test could get one, and that’s never been the case,” he points out. “Credibility is in play here. I’m worried we’ll have people who are not willing to get the shot, either because they don’t trust the system or because they don’t trust the vaccine.”
Multiple polls have already shown that Americans are worried about the speed of vaccine development, reporting that half to two–thirds of respondents plan to wait to take the shot. Capturing that distrust, Senator Kamala Harris said in last week’s vice presidential debate that she would take the vaccine if leading federal scientist Anthony Fauci recommended it, but not if the White House did.
Communicating the presumed safety of the coronavirus vaccine will be much harder than it is for legacy ones, because the window to get out the message will be so short. It’s predicted that the Advisory Committee on Immunization Practices will meet within 24 hours of the Food and Drug Administration issuing whichever approval it chooses, possibly even that night, and doses will start shipping as soon as the ACIP rules. Those first doses are likely destined for health care workers, but these workers’ attitudes toward vaccination are not monolithic; every year, some proportion don’t accept the flu shot.
“We don't want to start promoting the vaccine before that because, right now, it's just a potential vaccine candidate,” Hannan says. “That’s the biggest worry for me, and the biggest challenge, that we’ll have a day or two to sell this vaccine. if your health care personnel are not accepting it right off the bat, that's a real uphill battle.”
Recommendations for communicating the reliability of the vaccine, whichever one arrives first, are included in the CDC’s playbook. “Communicate early about the safety of vaccines in general,” it urges, recommending that health departments seek the help of trusted community members such as teachers and church leaders. “Communicate transparently about Covid-19 vaccine risks.”
The US had a stubborn problem with vaccine acceptance even before the Trump administration made how people respond to Covid-19 a badge of political allegiance. In the end, planners worry that doubt over vaccines will hinder the coming vaccination campaign more than any logistical issues—making the strategy for conquering the virus, like any other battle plan, the first casualty of the fog of war.
Update 10-16-2020 3:38 PM EST: This story was updated to correct Thomas Quade's job title.