Early results from the two leading US Covid-19 vaccine trials are expected in November, in what will likely be a major milestone in the race to end the pandemic.

The final leg of the race, however, will be actually getting people vaccinated.

The US Centers for Disease Control and Prevention (CDC) has offered guidance on jurisdictions’ plans, and has given them a deadline of November 1 to be ready to roll out a potential vaccine (a timeline administration officials assert is unrelated to the November 3 election).

Will health departments be ready to distribute a vaccine by then?

“Probably not, if you mean completely ready,” says William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, who also serves as a consultant to the Tennessee Department of Health. “Are they working hard? Absolutely.”

No matter when it commences, a nationwide vaccine administration effort will require a massive workforce of health professionals (who are already in short supply and are often already working on other Covid-19 responses). It also may require costly medical-grade freezers to keep vaccine doses at supercold temperatures — or lots and lots of dry ice. And it needs a robust new data management system to track who gets which vaccine when and where, particularly if vaccines require multiple doses to be effective, and if there ends up being more than one approved vaccine.

The trouble is, states and local health departments have not received funding from Congress to make any of this happen. This “makes it nearly impossible to do what you need to be doing at this stage of the game if your go date is November 1,” says Adriane Casalotti, head of government affairs for the National Association of City and County Health Officials (NACCHO).

Like many things in the pandemic, it didn’t have to be this way, she says. “This is one of the few areas of Covid-19 where we can plan in advance, where we don’t have to build the plane while flying it.” She adds that although their group has been asking the federal government for support for distribution since early vaccine research began, “now it’s late.”

To be sure, there will not be enough vaccine to immunize 328 million people right away, which simplifies logistics somewhat. And many experts are expecting it will be the end of this year or the beginning of 2021 before the first doses are available. (Health and Human Services Secretary Alex Azar recently said there might be enough doses to vaccinate health care workers, first responders, and seniors by the end of January, with some doses arriving sooner.)

But even with a relatively modest beginning (and we’re still talking about tens of millions of people), public health workers want to make sure they have plans and systems in place, rather than rushing to meet a deadline, Schaffner points out. “The government is antsy about getting things started, but most health departments are saying, ‘Whether I start vaccination this week or next week doesn’t matter so much because this is going to be going on for eight months,’” he says.

Let’s take a closer look at the challenges facing the vaccine rollout and how the government could help things get on track sooner rather than later.

Health experts say they need billions of dollars to be ready; the federal government hasn’t promised any money

State health departments were asked in late September to submit their proposed vaccine rollout plans to the CDC by October 16. For this task, the federal government distributed $200 million, which was split among the states, major metropolitan areas, and US territories.

Not only did this mean relatively little funds for each of the 64 jurisdictions (states, territories, and major cities), Casalotti notes, but it also did not guarantee any funding would reach the thousands of smaller local health departments around the country, which is where much of the on-the-ground work of preparing to get people vaccinated will take place.

More importantly, the government has yet to promise any money to support actually building out these plans and helping the health organizations be ready when the vaccines are.

A well-coordinated, well-supported effort by health departments to vaccinate the US population will likely cost at least $8.4 billion, according to an October 1 letter NACCHO sent to Congress requesting that much be appropriated for the effort. And other public health groups, including the Association of State and Territorial Health Offices (ASTHO), agree.

CDC Director Robert Redfield put the number slightly lower, but still in the billions. In a congressional subcommittee meeting in mid-September, Redfield said the CDC would need $6 billion to help states and localities adequately prepare to distribute a potential vaccine.

But the federal government still has not said if it will fund the effort, or how much it will allocate to vaccine distribution and administration.

“That needs to change soon, or that’s going to be a limiting step,” says Marcus Plescia, chief medical officer for ASTHO. “It’s great that we have an opportunity to plan for some element of the Covid-19 response, because so far we’ve just been reacting.”

Health officials are hoping a new, broad Covid-19 relief package, approved by Congress, will include funds earmarked specifically for vaccine distribution readiness. And soon. “That would mean we could finally be really prepared, and we could finally get a step ahead of things,” Plescia says.

If the federal government doesn’t step up, would states and localities be able to? Experts we spoke with agree that the funds need to come from the top. The first reason for this is logistical. With local and state budgets tapped out from pandemic response and lost revenue — and unable to run deficits — the federal government remains the only level of government that could bankroll this effort.

The second reason has to do with equity. “We’ve seen throughout the pandemic response when we’re not working as a nation, it’s really hard for us to make any ground,” Casalotti says. For a vaccine rollout to be most effective, it needs to be supported at a national level, she notes. “People travel, and what happens across state borders can directly impact your community. The virus doesn’t care about jurisdictional boundaries.”

If states and localities are left to somehow support vaccine deployment, the results are going to be uneven, and likely accentuate disparities the pandemic has already laid bare, she says.

“It really has to come from federal sources,” concludes Plescia.

Major unknowns remain, making preparations even more difficult

Planning a national vaccine rollout is a sizable ask, but it is also happening in the midst of major continued uncertainties — and not just about funding. This has left state and local health departments scrambling to prepare as best they can. “They’re not only planning, but they have to plan for several different contingencies,” Schaffner says.

One big unknown is which vaccine or vaccines will be approved and distributed first. This matters in part because many have different requirements, such as extreme cold chains. If health departments need to keep vaccine doses in storage way below zero, as some front-running candidates require, that will necessitate medical-grade freezers.

“You’re not going to find those freezers in pharmacies and doctors’ offices,” Schaffner says. Nor are they “something you can just run down to the hardware store and buy,” Casalotti adds.

So if thousands of vaccine locations around the country are ordering these freezers at the same time — on an expedited timeline — it is possible there could be a shortage.

Or if there is not a shortage, they could follow the path many other pandemic specialty supplies have: With such a sudden increase in demand, there could also be a drastic price increase. This would throw another wrench in even the best-laid plans. It’s quite possible, Casalotti says, for example, that health departments could already have established how many freezers they will need, and where they will procure them, but then encounter a new price, many times higher due to the surge in demand.

The federal government has the ability to step in and prevent this sort of price gouging. Although “we haven’t seen those tools deployed” in previous instances of this during the pandemic, Casalotti says.

Click Here:

Pfizer’s vaccine candidate, which is among those leading the race to approval, requires temperatures of about -94 degrees Fahrenheit (and even then is only stable there for about 10 days). To address this challenge in distribution, it has devised a freezer alternative, in which the vaccine vials can be stored in specially designed boxes filled with dry ice. Although these boxes will need to have their dry ice replenished during storage, which means that “all of our states have been spending a lot of time sorting out their dry ice supplies,” Plescia says.

Even this workaround might not prove to be a solution for everyone. Dry ice isn’t readily available everywhere, such as in some US territories, notes Plescia. And a shortage in the carbon dioxide supply has made it hard for some dry ice makers to keep up with demand. So Plescia hopes that even if a vaccine requiring drastic cold storage is approved first, a less temperamental one will not be far behind.

Another big unknown is precisely who will get the vaccine first and when. The CDC’s Advisory Committee on Immunization Practices, which Schaffner also helps advise, is working on finalizing this rubric for who will get the vaccine first. But they might not be able to complete their work until it’s known what vaccine or vaccines will be approved.

Many expect that health care workers and first responders will be first to receive an approved vaccine, which aligns with an assessment put out by the National Academy of Medicine in September and the CDC’s interim playbook for states. (President Trump, at an October 16 stop in Florida, claimed inaccurately that “seniors will be the first in line for the vaccine.” The CDC has listed those 65 and older — along with others at higher risk for severe Covid-19, and essential workers — in the second half of the first phase for vaccination, although this could change based on the results of the ongoing vaccine trials.)

Vaccinating health workers first would also give those working on vaccine distribution a slightly gentler start. As Plescia notes, this population would generally be easy to reach and follow up with through their employers, and tend to be in favor of vaccinations in general.

If this prioritization group does come first, he is optimistic about the possibility of health departments being equipped to provide these early doses when they become available. “I think being ready for that is not overly ambitious, and as we roll that out, we start to learn more and gives us a little more time to be ready to do it in community settings — those are the things that are going to require more capacity and more planning, and just more people,” he says.

What distribution might look like after that is fuzzier, making it hard for health departments to plan logistics, but also communication.

Local health departments are eager for the federal government to take on the job of clear messaging once these priority groups get established.

If local health departments are in charge of telling their communities who gets priority for the vaccine, “that’s just putting local health departments in a really hard position as people are looking at who is at the front of the line and who is at the back of the line,” Casalotti says. And animosity toward health departments has already been building, resulting in reluctance to participate in contact tracing efforts and even, in some cases, threats of violence, she notes.

So she asks for “clear messages from the top that we’re all in this together, and not everyone is in prioritization group 1 — and that’s okay because we, as a nation, are all going to get through this.”

Health departments will need time to get staff and systems up and running

One clear challenge in being ready to vaccinate millions of people as quickly as possible is having enough well-trained workers to give those shots. Hiring people to give shots in a public health setting is challenging even in the best of times, Casalotti says. The pay tends to not be that great and the hours can be hard. Not only that, but much of this available workforce has already been hired out to other much-needed positions, like those in hospitals, she notes.

There are also procedural considerations. “In most governmental structures, you can’t get a million dollars on Monday and hire people on Friday,” Schaffner says. “You have to go through a laborious administrative process to post openings, make sure they are available to everybody, interview applicants — and this all takes time.” And after they get hired, they still need to be trained before they can get to work.

Public health departments and other locations will also likely need to acquire additional ancillary supplies, such as PPE and other items that are already in high demand in the midst of the pandemic and flu season.

“We can be all ready to go and have planned perfectly and have our people in place and our capacity built, and then we run out of PPE,” Plescia says. He worries about that, he says, because “that supply still doesn’t seem to be secure.” And shortages, as we saw earlier in the pandemic, lead to unequal distribution, in which larger and wealthier states can procure more supplies.

There is also the little-discussed — but critical — issue of data infrastructure. As a country, we have a patchwork method for tracking vaccinations. For most adult vaccines, only the patient and office or clinic receive records about a given dose. (As Schaffner jokes, “When my father-in-law lived in New Hampshire, and spent time in Tennessee, then spent winters in Florida, I was his vaccine registry, I told his doctors. It worked fine for my father-in-law, but I can’t do that for everybody.”) Even pediatric vaccinations are usually logged just on a state-level basis. (And still the CDC encourages parents and caretakers to be in charge of tracking their child’s vaccines themselves.)

So the idea of states and localities tying into a robust national vaccine tracking program — and on short order — is daunting, but crucial. Especially with many leading candidate vaccines requiring multiple doses, and different time spans between doses.

And this information will have to flow easily among vaccine administration sites across the country in close to real-time. “We have to have a good ability to track people and know who got the initial dose, and we need to be able to do that across state lines,” Plescia says. “If someone got the first dose in Florida and moves to South Carolina, we need to see what they got.” Even beyond that sort of rapid record look-up, health workers will also need a way to get in touch with people to remind them to get their second dose in the right time frame, he says. One candidate vaccine has a 21-day space between doses; another is 28 days.

“It would be good to go ahead and have the funding so we can start building those systems,” Plescia says.

And not only that, Casalotti says, “we need time to make sure those systems are interoperable, and to train the users in how to employ them. And, frankly, we don’t have the time.”

“The marathon continues”

For many health departments, support from the federal government can’t come soon enough. Despite asking the federal government for vaccine distribution guidance and funding since this spring, Casalotti says they have still wound up behind the eight-ball. “We have ended up in a position where we no longer have the luxury of time. Now we’re behind.”

Additionally, many local health departments still hadn’t recovered from the budget cuts of the 2008 recession, and now a number of them have faced further budget reductions and have had to furlough staff. “That is certainly not what you want to be doing when you know you’re going to be in the middle of a pandemic,” she says.

In the meantime, the CDC has been directed to transfer $300 million from its budget to the public affairs office at its parent agency, the Department of Health and Human Services, Redfield said in a September 16 Senate subcommittee hearing. At least $250 million of that has been allotted for a massive public relations campaign “to defeat despair and inspire hope,” with the bulk of the funds to be used before January.

Some of this could be used toward general vaccine safety education and information, but experts are dubious that will be the case. “I haven’t seen that this program would be addressing this issue,” Casalotti says.

She asks for support from the federal government in reminding people that even after the first round of vaccine doses is distributed, the pandemic lifestyle will be here to stay for most people for quite a while. “The marathon continues, and we’re all running it whether we want to or not.”

Other public health experts are also looking to the federal government for a unified message and response. “This is a pandemic; it’s a national issue,” Schaffner says. “We have not had a coherent, sustained response to Covid-19 from the beginning. Every public health person I know of thinks we need it. This has to be largely directed and funded from a federal level. This is akin to disaster assistance. Sure, the locals go to work, but you really have to deal with this from a federal level. This is a hurricane that’s hit all 50 states.”

Katherine Harmon Courage is a freelance science journalist and author of Cultured and Octopus! Find her on Twitter at @KHCourage.