The first 6.4 million doses of Covid-19 vaccine may be shipped this weekend in the US after the Food and Drug Administration approved an emergency clearance for the Pfizer / BioNTech vaccine. The EEA is expected to stand immediately after an advisory committee vote on Thursday recommended it in a 17-4-1 vote. According to guidelines from the Centers for Disease Control and Prevention, these doses are intended for frontline health workers as well as residents and long-term care workers.
The government estimates that an additional 13.6 million people in these risk groups can be vaccinated by the end of 2020. The rest of the US population will follow suit in roughly the next six months.
However, many experts are concerned that the US has not adequately prepared for mass vaccination with Covid-19. "The logistics of vaccine administration and distribution are complex," Stanley Kent, Michigan Medicine's chief pharmacy officer, wrote in an email to Vox. Especially for vaccines that have such high requirements for cold storage and require two precisely matched doses – during a pandemic in which an average of more than 2,000 people per day are killed.
The first, smaller rollout for healthcare workers will ultimately be a critical test of vaccine distribution and administration – and a chance to make adjustments before the country tries to get hundreds of millions more up its sleeves.
Health systems have worked fast and furiously to figure out how those first doses can work well. But there are significant hurdles from dealing with sensitive vaccines to tracking the millions of people who get the shot and have to come back for a second.
While most of us will wait many months before we can get vaccinated, here are the important things to keep in mind when the first health care workers get the Covid-19 vaccine in the United States.
Get the vaccine from the freezers and to the vaccines
The Pfizer / BioNTech vaccine is expected to be the first to receive this first green light as the first Covid-19 immunization to be submitted to the FDA for emergency approval, followed by Moderna next week. However, Pfizer / BioNTech's vaccine has the most extreme temperature requirements. It must be stored at minus 94 degrees Fahrenheit and can only be kept for five days in standard refrigeration and six hours at room temperature. (Although the Moderna vaccine is slightly less sensitive, it must be frozen at minus 4 degrees Fahrenheit for up to 30 days before use, and then refrigerated for no more than 12 hours before administration.)
Very few facilities have the medical grade ultra-cold freezers required to store the Pfizer / BioNTech vaccine. Therefore it is delivered to hub locations and packed in dry ice distributed to hospitals, clinics and other vaccination centers. This requires fine-grained planning to ensure that exactly the right number of vaccine doses arrive in the right place at the right time.
"The challenges with redistribution are inventory management, the right number of cans in each administrative location to minimize waste, and maintaining the cold chain," said Kent.
With these cold demands, simply removing the vaccine from the super cold freezers can even be a bottleneck as it is required special gloves. And to keep the freezers at the correct temperature, they shouldn't be opened more than a few times a day and for more than a minute, NPR reported.
Cans are also not ready to give when they are out of the freezer. The vaccine bottles that Pfizer sends out actually contain five doses of the vaccine – and must be mixed with 1.8 ml of saline before administration. "Preparing the product for administration is a multi-step process that requires thawing, reconstitution, and preparation," said Kavish Choudhary, director of inpatient and infusion pharmacies at the University of Utah Health. These are further logistical steps in this process that must be carefully planned and well staffed.
Ultimately, the problem is to ensure that all IT systems are in place to record every dose and recipient and report it to the status database within 24 hours. In this way, adverse events can be reported and associated with a specific vaccination course. However, it can also be used to determine if and when someone received one or both doses. Some health system administrators still suggest that those who receive the vaccine keep the paper vaccination card they receive and even take a picture of it with their phone in case the systems fail.
Making sure that all of these steps persist – and work together – is critical not only to the success of those first doses for the people at greatest risk, but also, as we did in the first half of up to hundreds of millions of people can scale 2021.
An employee places blocks of dry ice in a cooler at Capitol Carbonic, a dry ice factory in Baltimore, Maryland, on Nov. 20.
Saul Loeb / AFP via Getty Images
Decide who should get a vaccine – and find it
There won't be nearly enough vaccines in the initial shipments to vaccinate all healthcare workers (21 million people) or nursing homes or employees (3 million people) in the country. (Supervisors, people delivering meals to patient rooms, and people transporting patients are among the many others in these groups.)
The federal government decided to assign the dosage based on the adult population of the state, rather than the number of potential recipients in each country the risk Categories. This means that not all states will be able to immediately vaccinate the same proportion of their health care workers (a pattern that is likely to recur later in other category-based assignments).
There is definitely a huge focus on mapping when we have enough vaccines to cover high priority pops like this planner.
Delivery – How many vaccinations can a health worker give in a day? When can people get vaccinated? – is also complex. https://t.co/1W99JwsmHv
– Amanda Makulec MPH (@abmakulec) December 3, 2020
Although health workers are among those eligible for the first round of vaccination, states and health systems must decide which ones to get them and when. (More information in an emergency FDA clearance could add additional clarification of who to vaccinate for first.)
Choudhary said in an email to Vox that they are "prioritizing healthcare workers who work in areas that regularly and frequently interact with Covid-19 positive patients." This includes some work in the emergency room, intensive care units, medical units, emergency care and testing facilities. Hopefully this will help more people stay healthier and maintain the capacity of these important staff as the number of pandemic hospital stays increases – and this is an approach that many health systems are taking.
Yale New Haven Health, which serves people across Connecticut, will instead open appointments for more than 30,000 employees in alphabetical order. There are several reasons for this. First, it ensures a level of randomization that makes the process transparent and fair. Second, the front running vaccines are known to occasionally have minor side effects such as fever.
By vaccinating employees by name rather than unit or office, they can prevent multiple people from a team from being absent a day or two after vaccination. "It's a logistical hurdle," said Brita Roy, director of population health at Yale Medicine, who is also the co-chair of the health system's Covid-19 vaccine task force.
In the future, these more detailed prioritization or organizational strategies will be crucial, as the number of people on the general priority list comes into question. Other organizations, such as For example, food service companies may need to learn similar lessons from strategic and fair planning.
However, it is difficult to schedule people for appointments – regardless of the order – unless you have been told how many doses are available. As of earlier this week, some states hadn't informed the systems about how much vaccine they would receive in the first few weeks. "One of the biggest challenges is not knowing how many doses of vaccine we're going to get," said Kent.
Roy agrees: After preparing other details – from freezers to distribution – she now says, "Our biggest challenge is keeping up with the weekly allocation … and making it happen." Connecticut, for example, had to retab 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 health care workers who should already be vaccinated (which means it would be ) fewer doses available for the latter group).
These volume shifts could also be part of the vaccine management landscape in the coming months, forcing those planning the shots to adjust their amounts quickly Operations and Planning.
Despite all of these challenges, vaccinating health care workers is in many ways much easier than reaching and planning members of the wider population for two cans. For one, many work for large hospitals or health systems who can use employee data to determine who should get the vaccine – and contact them through the organization's system.
However, many health vaccination centers are also responsible for vaccinating workers outside of their system. Yale New Haven Health plans to set up vaccination sites for health care workers from other hospitals and clinics that do not have ultra-cold storage to keep their own vaccine doses. This not only requires splitting up additional vaccination sites and distributing them ("these will be a bit delayed, maybe in the second or third week – we haven't specified that yet," says Roy), but also contacting these additional people.
Connecticut will help provide some information about people who are in the priority category, but Yale New Haven Health must also establish communication with them and put them on the appointment system.
At Riverside Health, Virginia, Cindy Williams, vice president and chief pharmacy officer, told Vox in an email that her system has four of the 25 state facilities that can store Pfizer vaccine. "With this we can support distribution to doctor's offices and across the state," she wrote. They plan to work with local health departments and other health groups to reach out to other workers who are eligible for the vaccine. "I believe this experience will help us reach other populations as we move through the priority groups for vaccination," she said.
Maximize speed – and minimize waste
Although nearly 6.5 million doses of the Pfizer / BioNTech vaccine may be available for shipment the day after an emergency clearance, there is no way to get all of those doses into high priority arms the next day or in the following weeks. Health systems are carefully working out their logistics to maximize the number of workers they can vaccinate in a day while making the process as safe as possible. This is a challenge during a Covid-19 spike and with cold temperatures across much of the country limiting how much can be reliably done outdoors.
This means streamlining the administrative process as much as possible, from collecting all of a recipient's information to making sure that every vaccine has all the supplies it needs.
A simple requirement will be space. At the University of Utah Health, Choudhary and others worked closely with the facility team to mix the services to make room for vaccination sites and eventually vaccinate nearly 20,000 health workers and students with two doses. He notes that these posts will be in a clinic. "This way we have the appropriate equipment and personnel when we need to respond to an adverse response."
During the vaccine trials, participants were observed 30 minutes after receiving the vaccine to monitor side effects. This would seriously hinder the logistics of safely moving people during a pandemic. However, recent guidance says that administrative sites don't necessarily need an observation period, Roy said – although some may still have a short one – so people should be able to flow through relatively quickly after receiving their shot.
At Michigan Medicine, they plan to vaccinate several hundred of their employees a day initially, building up to 1,000 to 1,500 a day in the process, Kent said.
All of this also needs to be carefully planned to minimize possible waste of valuable vaccine doses. Once a five-dose vaccine bottle is opened, it only has a shelf life of six hours before it goes bad.
Yale New Haven Health is working with a modeler to evaluate how to maximize "throughput" while ensuring that just the right amount of vaccine doses are on hand. Together with many other systems, they are drawing on their experience with flu prevention clinics this year by registering in advance and making staggered appointments for safety reasons. "We're going to try to be pretty accurate," says Roy. "We want to make sure that as many appointments as possible are taken every day."
Fine-tuning these logistics and procedures in this first group of recipients is critical to ensure that the vaccine is safely and efficiently delivered to the general population. Choudhary asked for patience to begin this unprecedented effort. “We recognize the need and urgency to vaccinate our staff so that we can focus our attention on the community and our patients. We are limited by what we offer and our lack of familiarity with the product, but we have the time, staff and resources to do so, ”he wrote.
Both the Pfizer / BioNTech and Moderna vaccines are designed to be given in two doses 21 or 28 days apart (depending on the vaccine) in order to achieve the high level of protection against Covid-19 indicated in early trial results . Hence, it is crucial that people get their second shot when they should and that it is the right brand.
Even those overseeing the vaccination of health care workers in their own organization have concerns about making sure people return for their second dose.
Because of this, some groups plan the second visit in person when people get their first dose. Elsewhere, they've been so busy putting together a schedule for the first dose that compliance is second on the list. "We haven't talked much about it yet," says Roy. "I haven't heard of a contingency plan for what happens if someone goes beyond their window for more than two to three days," she says.
Finally, the question arises whether a second dose is available in the right place at exactly the right time. The federal government has announced that it will withhold the second doses of the first shipments of the Pfizer / BioNTech vaccine, also because after leaving the super-cold warehouse it can only be kept on dry ice for 15 days and refrigerated for another five days. only missed the vaccine's 21-day mark for second shots.
This means that the major nodes should receive second doses in time to give them. However, the delicate ballet of coordination, distribution, and management has to start over before recipients roll up their sleeves again.
From IT systems to supply chains, a lot may get out of hand. "All health systems will learn a significant amount in the first few weeks of distribution," said Kent.
"In operational terms, this is the first time I've thought of trying to spread a vaccine at the same time," says Roy. Even with the annual flu shot, only about half of the US population is typically vaccinated. "But that's different," she says. “We need 80 to 90 percent (of the US population). How do we do it logistically? "
And a lot of that will be down to not just physical logistics, but messaging as well. Also for healthcare workers.
At Yale New Haven Health, Roy notes that she has "heard some vaccine reluctance in places 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 healthcare workers tend to be cautious about being the first to get the shot, after the test takers. And they are likely aware that getting both doses of the vaccine doesn't change the precautions they need to keep, like wearing PPE (in part because we don't yet know if the vaccine will stop people from doing that Virus to carry and spread – or just from developing the disease).
She fears that if these health care workers miss their chance to get the vaccine now, it may not be until the summer after other risk populations have been covered and if it remains open that doses will again be available to those at higher risk Can be assigned to the general community.
To encourage more healthcare workers to get the vaccine right away, Roy says, "We'll continue to improve the vaccine's safety profile." But she still worries. "The hesitation I heard surprised me." However, the editing should provide an opportunity to learn about messaging before a broader introduction to the general population.
This will be essential as Roy states that "we need to get 80 to 90 percent vaccination rates to get herd immunity" in the US.
Any lesson we can learn from these early rollouts will be valuable in reaching a wider population as effectively and quickly as possible once more doses become available. And the health systems know they will be kept an eye on in the coming weeks.
This means that even the best of plans may need to change quickly. "It will be important to be responsive and agile, to learn continuously, and to improve the process over time," says Roy.
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