With dozens of viable candidates pushing through clinical trials, it is possible that a COVID-19 vaccine could be available as early as October of this year. Once approved, the nation faces another set of challenges, as the vaccine moves from a theoretical concept to a mass-produced, commercially available product.
Producing, distributing, administering and inoculating the public against COVID-19 is shaping up to become the top supply chain challenge of the pandemic. What follows are four considerations for a successful vaccination program, and Premier’s recommendations for how each should be managed.
1. National Prioritization for Who Gets Vaccinated First
No matter which vaccine is approved, initial quantities will be limited. In an environment of scarcity, an equitable prioritization plan is necessary to define the segments of the population that should get vaccinated first. There is widespread agreement that frontline healthcare workers caring for the most vulnerable patients need to be at the front of the line.
But which population is next? Initial estimates provided by the Centers for Disease Control and Prevention (CDC) indicate that early production will only total between 1-2 million doses, and there are 17 million healthcare workers in the U.S. Which of these workers get vaccinated first? And at what point do we start vaccinating beyond healthcare workers and start reaching those most vulnerable patients themselves?
These are all questions being evaluated by the federal government and public health workers. However, a formal segmentation of populations, with defined triggers that signal readiness to move to second- and third-tier groups, has not been approved. Confusing the issue is duplication: multiple arms of the federal government are working on the same prioritization issues, creating a lack of clear authority on which agency has the final say. And adding even more complexity is the fact that multiple vaccines may be approved at once, which will require several prioritization plans, depending on which vaccine is most efficacious for each population group.
Particularly in the early days of vaccination, a clear national plan will be required to maximize the impact and save the greatest number of lives – with a secondary goal of ensuring the public understands rationed choices and does not feel unfairly deprived. This is not a task that can be kicked to the states for a patchwork of solutions, or even worse, to healthcare providers themselves to decide with little, confusing or contradictory guidance.
2. Dynamic Allocation Based on Hotspots and Priority Populations
In previous mass vaccination efforts such as the 2009 outbreak of H1N1, the federal government allocated vaccines to each state equally, based on their populations. From there, states were responsible for allocating to the priority groups.
While this playbook may appear impartial, following it in this instance will inevitably lead to shortages in some communities while others sit on an unfair cache of supply. For one, priority vaccine candidates are not evenly distributed across the states; if those aged 65 and up are to be among the first for vaccination, Puerto Rico counts nearly 21% of its residents as older than 65, while Utah reports about half that number.
In addition, COVID-19 infection rates aren’t affecting states equally, with hotspots like Hawaii reporting nearly a 20% increase in active cases over the past week, whereas New York now has an infection rate of less than 1%.
Rather than taking the “peanut butter approach” and spreading vaccines equally, the nation will need a more dynamic allocation strategy. The government should allocate vaccines in greater proportion to emerging hotspots, stopping the spread in communities where science shows it’s metastasizing. Secondary prioritization should be given to states with higher percentages of priority vaccination candidates, like those aged 65 and over. Not only is this method more equitable, it’s also more effective, as it ensures that burning fires are put out first.
Plans should also take into consideration that a percentage of people may be unwilling to get vaccinated – or choose to sit out the first vaccine to market – and be able to make nimble adjustments based on changing evidence, new facts and emerging issues.
3. Potential Subzero Distribution, Storage and Handling Plan
The nation also will need a distribution plan that ensures the vaccine is safely and efficiently transported to communities across the country, which takes time and coordination. To put this into perspective, flu vaccines are mature and have established distribution pathways, and it still takes three months for all vaccines to reach providers. For a new vaccine that could experience problems in manufacturing, the timetables will be longer.
Currently, McKesson Corporation has been tapped to create the distribution plan for the government-owned vaccines. It’s probable (and recommended) that McKesson will partner with other national and regional distributors in a hub-and-spoke model to ensure the greatest possible capacity.
Assuming this is true, distribution capacity will exist – in theory. Questions remain, however, about the storage and handling requirements. At least one vaccine candidate must be frozen at temperatures of
-70° C, with a very short shelf life outside that temperature range, making them challenging to scale.
First, there are very few distributors that can store, long-haul transportation options that can ship or provider sites that can stock vaccines at that temperature. Given this, distribution partners and administration sites will need special plans to ensure they are not only equipped with the vaccine, but also with the freezing capabilities.
Companies making frozen vaccines are working to ensure that their products can be stored at warmer temperatures, evaluating running their own distribution channel direct to administration sites and are considering providing the administration sites with their own freezing storage systems. Regardless, planning should begin now to understand freezer capabilities in the supply chain, gaps and where additional capacity could be tapped.
4. Accurate and Methodical Patient Tracking
In the case of the COVID-19 vaccines, nearly all require administration of two doses within a prescribed window of time. Because multiple vaccines may be approved at once, this presents a significant challenge. Not only do providers need to ensure that all patients return and receive their second dose within the time window, but they must ensure patients receive the same vaccine they did on the first visit.
In addition, there is another, larger issue at play. Historic adherence to multi-dose vaccine regimes is low, typically about 30 percent or less. Failure to receive the second dose essentially means that the first dose was wasted – something that we can ill afford during this time of scarcity.
To overcome these challenges, patients and the vaccine they receive will need to be linked together – preferably in an electronic health record – and providers will need automated technologies to guide immediate follow-up in the event of a missed second appointment.
However, standing in the way of this vision is the fact that patients can be improperly linked to the wrong medical records up to 20 percent of the time due to missing demographic or other identifiers. Particularly as vaccines start to be administered to millions of individuals, a unique patient ID would avoid this problem and improve overall accuracy.
However, there currently exists an arcane federal ban on the creation of unique patient IDs. To deal with the problem of patient data matching, Congress should pass legislation that overrides this ban to ensure that patients are linked to the correct first-dose vaccine. Such records will be vital to monitor:
- The patients who have been vaccinated
- Their clinical results, to adjust treatment for improved outcomes and faster recovery
- The number of people who failed to receive their second dose, a data point central to understanding the success of the vaccination program, progress toward herd immunity and forward-looking manufacturing demand
Like most facets of this pandemic, the administration of the COVID-19 vaccine will likely be anything but straightforward.
The next few weeks will be critical for players across the healthcare industry and federal agencies to work together, develop a strategic and equitable plan, and communicate to states, healthcare providers and millions of Americans. With the right forethought, the nation’s vaccination plan could extricate us from the rough waters that have engulfed us since January – and position us on the path to resiliency.