The first 6.4 million Covid-19 vaccine doses may begin to ship out in the US as early as this weekend, after the Food and Drug Administration approves an emergency use authorization of the Pfizer/BioNTech vaccine. The EUA is expected to be imminent following the Thursday vote of an advisory committee, which recommended it in a 17-4-1 vote. Per Centers for Disease Control and Prevention guidance, these doses will be earmarked for front-line health care workers, as well as residents and staff of long-term care facilities.
The government estimates another 13.6 million people in these high-risk groups might be able to be vaccinated by the end of 2020, with the rest of the US population following in about the next six months.
Many experts, however, are concerned that the US has not adequately prepared for mass Covid-19 vaccination. “The logistics of vaccine administration and distribution are complex,” Stanley Kent, chief pharmacy officer for Michigan Medicine, wrote in an email to Vox. Especially for vaccines that have such stringent cold storage needs and require two precisely timed doses — during a pandemic that’s taking more than 2,000 lives a day on average.
The first, smaller rollout to health care workers will ultimately be a critical test of vaccine distribution and administration tactics — and a chance to make adjustments before the country tries to have hundreds of millions more people roll up their sleeves.
Health systems have been working quickly and furiously to figure out how to make these first doses go well. But there are substantial hurdles, from dealing with delicate vaccines to keeping track of the millions of people who get the shot and will need to return for a second one.
Although most of us will be waiting many more months until we might be able to get vaccinated, here are the important things to watch out for as the first health care workers get the Covid-19 vaccine in the US.
Getting the vaccine out of the freezers and to vaccinators
As the first Covid-19 immunization to be submitted to the FDA for emergency use authorization, the Pfizer/BioNTech vaccine is expected to be the first to receive this initial green light, followed by Moderna next week. But Pfizer/BioNTech’s vaccine has the most extreme temperature requirements, needing to be stored at minus 94 degrees Fahrenheit, and only viable for five days in standard refrigeration and six hours at room temperature. (And although slightly less sensitive, the Moderna vaccine still needs to be kept frozen at minus 4 degrees Fahrenheit until 30 days before it is used, and then needs to be refrigerated, until at most 12 hours before administration.)
Very few facilities have the medical-grade ultra-cold freezers needed to store the Pfizer/BioNTech vaccine, so it will be shipped to hub locations to be distributed — packed in dry ice — to hospitals, clinics, and other vaccination sites. This will take finely tuned planning to ensure that just the right number of vaccine doses make it to just the right place at just the right time.
“The challenges of redistribution are inventory management, getting the right number of doses to each administration site to minimize waste, and cold chain adherence,” Kent explained.
With these cold requirements, even simply removing the vaccine from the super-cold freezers could be a bottleneck, since it requires special gloves. And to keep freezers at the right temperature, they’re not supposed to be opened more than a couple of times a day and for no more than a minute at a time, NPR reported.
Doses are also not ready to give once they are out of the freezer. The vaccine vials Pfizer is sending out actually contain five doses of the vaccine — and need to be mixed with 1.8 ml of saline solution before being given. “Preparing the product for administration is a multi-step process, requiring thaw time, reconstitution, and drawing it up” into the syringe, Kavish Choudhary, director of inpatient and infusion pharmacy services at the University of Utah Health, explained. These are yet more logistical steps in the process that needs to be carefully plotted out and well staffed.
Finally, there is the issue of ensuring all the IT systems are in place to record each dose and recipient and report it to the state database within 24 hours. This will allow any adverse events to be reported and linked to a particular run of vaccine — but it is also how we will be able to know if and when someone has received one or both doses. Some health system administrators are still suggesting those receiving the vaccine keep the paper vaccination card they will receive and even take a picture of it with their phone, in case systems go down.
Ensuring all of these steps hold — and work together — is not only essential for the success of these first doses for the very highest-risk people, but also as we look at scaling way up to hundreds of millions of people in the first half of 2021.
An employee places blocks of dry ice inside a cooler at Capitol Carbonic, a dry ice factory, in Baltimore, Maryland, on November 20.Saul Loeb/AFP via Getty Images
Deciding who should get a vaccine — and finding them
There will not be nearly enough vaccine in the first shipments to vaccinate every health care worker (21 million people) or nursing home resident or staff (3 million people) in the country. (Custodial staff, people who deliver meals to patient rooms, and those who transport patients are among the many others in these groups.)
The federal government has decided to allocate doses based on state adult populations, rather than the number of potential recipients in each of the risk categories. This means not all states will be able to vaccinate the same proportion of their health care workforce right away (a pattern that is likely to reappear with other category-based allocations down the road).
There’s definitely a big focus on mapping if we have enough vaccine to cover high priority pops, like this planner.
Delivery – How many vaccinations can one heath worker deliver in a day? When are folks available to get vaccinated? – is also complex. https://t.co/1W99JwsmHv
— Amanda Makulec MPH (@abmakulec) December 3, 2020
So although health care workers are among those eligible for the first round of vaccines, states and health care systems will have to decide which ones can get it and when. (Further information in an emergency use authorization from the FDA could add additional clarification for whom to vaccinate first.)
Choudhary says they are “prioritizing healthcare workers that work in areas that have regular and frequent interactions with Covid-19 positive patients,” in an email to Vox. This includes some working in the ER, ICUs, medicine units, urgent care, and testing facilities. This will hopefully help more people stay healthier and preserve the capacity of these essential staff as pandemic hospitalizations spike — and it is an approach many health systems are taking.
Yale New Haven Health, which provides care to people across Connecticut, will be opening up appointments to their 30,000-plus employees in alphabetical order instead. There are a few reasons for this. First, it ensures a level of randomization that will make the process transparent and equitable. Second, the frontrunning vaccines are known to have occasional minor side effects, such as fever.
So by vaccinating employees based on name rather than unit or office, they can help avoid multiple people from a team being out for a day or two after the vaccine. “That is one logistical hurdle,” says Brita Roy, director of population health at Yale Medicine, who is also a co-chair of the health system’s Covid-19 vaccine task force.
Down the road, these sorts of more granular prioritization or organization strategies will become essential, as the number of people eligible on the general priority list balloon. And other organizations, such as food service companies, might need to take similar lessons on strategic and equitable scheduling.
It’s tricky, though, to schedule people for appointments — no matter the order — when you haven’t been told how many doses are available to give. As of earlier this week, some states had not yet informed systems how much of the vaccine they will get in the first weeks. “One of the biggest challenges is not knowing how many vaccine doses we will receive,” Kent said.
Roy agrees: Having prepared other details — from deep freezers to distribution — now, she says, “our biggest challenge is keeping up with what the allotment will be on a weekly basis … and designing around that.” Connecticut, for example, had to retabulate the numbers after the CDC announced that the first doses would be made available to residents and staff of long-term care facilities in addition to the health care workers it was already planning to vaccinate (meaning there would be fewer doses available for the latter group).
These shifts in quantities may continue to be a part of the vaccine administration landscape for months to come, forcing those planning the shots to quickly adjust their operations and scheduling.
Despite all these challenges, vaccinating health care workers is, in many ways, much simpler than reaching and scheduling members of the broader population for two doses. For one, many work for large hospitals or health systems that can use employee records to determine who should be getting the vaccine — and contacting them through the organization’s system.
Many vaccine hubs in health care settings, however, are also responsible for vaccinating workers outside of their system. Yale New Haven Health plans to set up sites to vaccinate health care workers from other hospitals and clinics that do not have ultra-cold storage to keep their own doses of the vaccine. This will require not only spinning up additional vaccination locations and distribution (“those will be a little delayed, maybe week two or three — we don’t have that nailed down exactly yet,” Roy says), but also getting in touch with those additional people.
Connecticut is helping provide some of the information about individuals who fit the priority category, but Yale New Haven Health will also need to establish communication with them and get them into the appointment system.
At Riverside Health in Virginia, Cindy Williams, vice president and chief pharmacy officer, explained to Vox in an email that their system has four of the state’s 25 facilities that can store the Pfizer vaccine, “giving us the ability to help distribute across physician practices and across the state at large,” she wrote. They plan to work with local health departments and other health care groups to reach other workers eligible for the vaccine. “I do believe that this experience will assist us in outreach to other populations as we move through the priority groups for vaccination,” she said.
Maximizing speed — and minimizing waste
Although nearly 6.5 million doses of the Pfizer/BioNTech vaccine might be available to ship the day after an emergency use authorization, there will be no way of getting all of those doses into top-priority arms in the following day or weeks. Health systems are carefully working out their logistics to maximize the number of workers they can vaccinate in a day, while also making the process as safe as possible. This is a challenge during a Covid-19 spike, and with cold temperatures in much of the country limiting how much can reliably be done outdoors.
Which means streamlining the administration process as much as possible, from getting all of a recipient’s information to ensuring each vaccinator has every supply they need on hand.
One simple requirement will be space. At University of Utah Health, Choudhary and others have been working closely with the facilities team to shuffle services around to clear room for vaccination locations to eventually vaccinate almost 20,000 health staff and students with two doses. These spots, he notes, will be in a clinic setting; “that way we have the appropriate equipment and personnel in place if we need to respond to an adverse reaction.”
During trials of the vaccines, participants were observed for 30 minutes after receiving the vaccine to monitor for side effects, a step that would add a big hurdle to the logistics of safely moving people through during a pandemic. But recent guidance says that administration sites will not necessarily need an observation period, Roy notes — although some might still have a brief one — so people should be able to flow through fairly quickly after receiving their shot.
At Michigan Medicine, they are planning to initially vaccinate several hundred of their employees a day, building up to 1,000 to 1,500 per day, Kent said.
All of this also needs to be carefully planned to minimize any potential waste of precious vaccine doses. Once a five-dose vaccine vial is opened, it has only a six-hour shelf life before it goes bad.
Yale New Haven Health is working with a modeler to assess how to maximize “throughput” while ensuring they stock precisely the right amount of vaccine doses. They, along with many systems, are drawing from their experience with flu shot clinics this year, having people sign up ahead of time and staggering appointments for safety. “We’re going to try to keep it pretty precise,” Roy says. “We want to make sure that as many appointments each day are filled as possible.”
Fine-tuning these logistics and procedures in this first group of recipients will be essential to ensuring the vaccine is safely and efficiently given to the general population. Choudhary begs patience for the outset of this unprecedented effort. “We recognize the need and urgency to get our staff vaccinated so we can turn our attention to the community and our patients. We are limited by our supply and our lack of familiarity with the product, but have the appropriate time, personnel, and resources,” he wrote.
Both the Pfizer/BioNTech and Moderna vaccines are designed to be given in two doses, spaced either 21 or 28 days apart (depending on the vaccine) to reach the high levels of protection against Covid-19 reported in early trial results. So making sure people get their second shot when they are supposed to, and that it is the correct brand, is crucial.
Even those overseeing vaccination of health care system employees in their own organization have concerns about ensuring people make it back for their second dose.
For that reason, some groups are scheduling the second visit in person when people receive their first dose. At other places, they’ve been so busy putting together a plan for the first dose, adherence is second on the list. “We have not yet talked a lot about that,” says Roy. “I have not yet heard of a contingency plan of what happens if someone goes beyond two to three days beyond their window,” she says.
And finally, there is the question of making sure a second dose will be available at just the right time, in the right place. The federal government has said it will hold second doses back from the first shipments of the Pfizer/BioNTech vaccine, in part because once it leaves super-cold storage, it can only be kept on dry ice for 15 days and refrigerated for another five, just missing the vaccine’s 21-day mark for second shots.
This means the main hubs should receive second doses in time to give them. But the delicate ballet of coordination, distribution, and administration will need to begin anew before recipients roll up their sleeves again.
There will be a lot that might go off the rails, from IT systems to supply chains. “All health systems will learn a significant amount during the initial weeks of distribution,” Kent said.
“Operationally, this is the first time I can think of that we’re trying to disseminate a vaccine all at the same time,” Roy says. Even with the annual flu shot push, only about half of the US population typically gets vaccinated. “But this is different,” she says. “We need 80 to 90 percent [of the US population]. Logistically, how do we do that?”
And much of that will come down not just to the physical logistics but also to messaging. Even for health care workers.
At Yale New Haven Health, Roy notes that she has heard “a fair amount of vaccine hesitancy in places where I wouldn’t have expected. And these are people who get their annual flu vaccine and whose children are up to date on all of their vaccines.” When it comes to a Covid-19 vaccine, she suspects that many health care workers are mostly wary of being the first ones — after trial participants — to get the shot. And they are likely aware that getting both doses of the vaccine will still not yet change the precautions they need to keep taking, such as wearing PPE (in part because we don’t yet know if the vaccine keeps people from carrying and spreading the virus — or just from developing the illness).
She worries that if these health care workers skip out on their chance to get the vaccine now, doses might not be available to allocate to these higher-risk folks again until summer, after other risk groups have been covered and when it is more broadly open to the general community.
To encourage more health care workers to get the vaccine right away, Roy says, “we will be doing some more messaging around the safety profile of the vaccine.” But she still worries. “The amount of hesitancy I heard surprised me.” Working through it, however, should provide learning opportunities for messaging ahead of wider rollouts among the general population.
This will be essential, because, as Roy notes, “We’re going to need to get to 80 to 90 percent vaccination rate to achieve herd immunity” in the US.
Every lesson we can learn from these early rollouts will be valuable in reaching a broader population as effectively and quickly as possible as more doses become available. And health care systems know eyes will be on them in the coming weeks.
This means even the best-laid plans might need to change quickly. “It’s going to be important to be responsive and be nimble and to continually learn, and make the process better as we go,” Roy says.
Will you help keep Vox free for all?
There is tremendous power in understanding. Vox answers your most important questions and gives you clear information to help make sense of an increasingly chaotic world. A financial contribution to Vox will help us continue providing free explanatory journalism to the millions who are relying on us. Please consider making a contribution to Vox today, from as little as $3.
Source by www.vox.com