By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow
In the middle of a record number of COVID-19 infections and deaths—and continued evidence of racial disparities in the pandemic’s effects—December brought some good news to the fight against the pandemic: the FDA’s emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna vaccines and the ensuing nationwide rollouts. The record-breaking vaccine development timeline and the videos of healthcare workers receiving early vaccines are worth celebrating. But the subsequent distribution has been tragically slow—echoing distribution challenges for COVID-related goods ranging from PPE to diagnostics. On Dec. 29, Dr. Leana Wen noted that at the initial vaccination rate, it would take 10 years to vaccinate the roughly 80% of Americans needed to achieve herd immunity. According to Bloomberg’s vaccine tracker, as of today, fewer than 10 million vaccines have been administered in the United States. States are still sitting on nearly two-thirds of the doses they have received, and the federal government is holding half the U.S. supply in reserve. In this post we explain what went wrong and how policymakers can correct course for COVID-19 and avoid such disasters in the future.
Why has the U.S. vaccine rollout been so slow?
We have previously discussed challenges to scaling vaccine manufacturing, which is an important factor in the rollout of these vaccines. But right now, the rate-limiting step is not manufacturing—it’s distribution and administration, including maintaining the cold chain, training healthcare workers on how to thaw and prepare doses, setting up vaccination clinics, and administering the distributed doses to eligible people. States (following the recommendations of the Advisory Committee on Immunization Practices) have typically chosen to offer the first doses to health care personnel and residents of long-term care facilities. In theory, this is supposed to be the simplest stage of the vaccine rollout—as Dr. Saad Omer noted, “[t]his is the part where we’re supposed to know where people are.” These populations are identifiable and reachable in ways that the general public are not—and so vaccine distribution and administration will only get more difficult from here.
Although there are many factors driving our slowness in distributing and administering the vaccine, two problems loom large: a lack of resources and a lack of federal coordination. States and local governments were allocated just $340 million to prepare for the vaccine rollout, an amount that is highly inadequate. As the Commonwealth Foundation noted, funding is needed for states to “set up cold storage systems, public education and partnership initiatives, arrangements for local vaccine administration with diverse populations and conditions, transport to move the vaccine to the points of administration required to reach all Americans, and information systems to track who has received particular vaccines, and critically, to make sure recipients return for required second doses.” Hiring and training additional staff, purchasing the specialized freezers needed for cold chain management—these important tasks all require funding. And with public health departments already stretched thin by nearly a year of combatting the pandemic—particularly when coupled with the current surge in cases—states needed more resources earlier on.
But an even more significant problem has been the lack of coordination from the federal government, which Dr. Ashish Jha has called a “failure of national leadership.” To be sure, the CDC did send vaccine distribution guidance to public health officials in all states and the largest U.S. cities at the end of August, telling them to prepare for vaccine distribution beginning as soon as late October or early November. But more was needed.
Consider a problem that was entirely foreseeable (and foreseen): getting consent to administer the vaccine from residents in long-term care facilities. Because many residents may not be able to make their own medical decisions (due to the presence of dementia or Alzheimer’s disease, for instance), facilities must often track down the resident’s designated medical decisionmaker, often a family member or attorney, and ask that decisionmaker for consent. Repeating this process for a large fraction of a facility’s residents is an onerous one that can take days or weeks. As a result of this time lag, advocates argue that this process should have been started even before the vaccines received FDA authorization for marketing. But the federal government did not engage in the interagency coordination that would have been needed to do this ahead of time. As a result, even though HHS Secretary Azar publicly said that all nursing home residents could be vaccinated by Christmas, in many states vaccination in long-term care facilities did not even begin until after Christmas.
What can policymakers do to improve COVID-19 vaccine distribution?
To speed up vaccinations—perhaps the only solution to ending the pandemic—there are several targets for policy interventions. First, money. After incessant delays, Congress has finally passed, and President Trump signed, a new stimulus package that includes coronavirus relief. That package includes $8 billion for vaccine distribution (not including $20 billion allocated for vaccine purchases to make them “available at no charge for anyone who needs it”)—a marked increase from the measly $340 million allocated earlier. The federal government could do even more, such as increasing Medicare reimbursements for those paying for the vaccine. For anyone balking at these expenditures, it’s worth pointing out that the pandemic is adding $10 billion per day to the deficit and that around 2.4 million Americans contracted COVID-19 between authorization of the Pfizer-BioNTech vaccine and the relief package’s enactment—roughly 40,000 of whom will die.
The second policy intervention is improving coordination. To begin with, the federal government—which, for better or worse, has controlled vaccine allotments—should provide more than a few days’ notice of vaccine shipments. Dr. Ashish Jha has suggested the federal government should “provid[e] more direct logistical support” for vaccination sites, including “ensuring that they had the physical infrastructure, the staffing and the IT infrastructure they need to proceed.” This includes providing more guidance to local authorities regarding when they should proceed to the next priority phase, what to do with soon-perishing but unused doses, and—as has been debated recently—expanding distribution within a particular phase. The state of Illinois, for example, recently announced plans to lower the age cutoff for its Phase 1B distribution from 75 years old to 65—in contravention of federal guidelines. Part of the motivating factor behind the drop was equity: because Black and Hispanic Illinoisans tend to die of COVID at younger ages than their white counterparts, Governor Pritzker made the move to “overcome the structural inequalities that have allowed COVID-19 to rage through our most vulnerable communities.” The move also comes against a backdrop of the Governor’s sharp criticism of federal vaccine-coordination efforts.
Third, and relatedly, for those individuals eager to get a vaccine who are not in one of the initial priority groups, state and county health officials could provide substantially more transparency regarding vaccine distribution, including where vaccinations are likely to be administered; how the state or county plans on moving from one priority phase to the next; and how potential patients can go about staying informed about when they will be eligible to receive the vaccine. The sum total of public information from the Los Angeles County Department of Public Health, for example, says only “Some groups in Los Angeles County are already being vaccinated….It is likely to be available to the general public in Spring/Summer 2021. Please talk to your doctor or sign up for email updates to find out when vaccine will be available to you.” Even without guaranteed allotments of vaccines or good coordination from the federal government, content-less statements like these will do little to augment the public’s confidence in getting a shot—or figuring out how to do so—even when available.
Fourth, policymakers should immediately start working on addressing vaccine hesitancy. Right now, it appears that demand outstrips supply, but at some hospitals 40% or more of frontline healthcare workers have declined a shot. Vaccine hesitancy will also make achieving herd immunity difficult: a December survey by the Kaiser Family Foundation found that 27% of the public probably or definitely would not get a COVID-19 vaccine even if free and deemed safe by scientists. Among Black adults, this number rises to 35%, including a fair portion who say they don’t trust vaccines in general and that they aren’t confident that COVID-19 vaccine development has taken the needs of Black people into account. Overcoming the history of medical exploitation of Black Americans should be a particular policy priority, especially given the dire difference in COVID-19 mortality between Black and non-Black Americans and high-profile incidents such as the recent death of Dr. Susan Moore.
How can the federal government improve vaccine distribution institutions going forward?
The first step to improvement is to recognize that vaccines are not vaccinations, and that each step of developing and deploying a new biomedical technology is costly. Operation Warp Speed provides a successful model of how the public sector can speed development and manufacturing by, among other things, de-risking costs, facilitating collaboration and regulatory approval, and providing knowledge infrastructure. But if the government is going to take full charge of the vaccine, it must facilitate dissemination as well.
While the federal government isn’t the only potential actor here—public health has long been a state bailiwick—the long-term dismantling of state public health infrastructures and the rather disparate state responses to the pandemic, in general, the federal government seems to be the single entity that could (if functioning well) make the biggest difference next time. On that score, the federal government could improve vaccine distribution going forward in at least two different ways: taking direct action on its own or creating incentives for the private sector.
On the direct front, the federal government has substantial resources that could be devoted to solving “last mile” problems. The United States Public Health Service (PHS; the part of HHS that includes the FDA, CDC, and NIH) also includes the Commissioned Corps, a uniformed service of federal public health employees. Outside the PHS, the military has expertise and experience in logistical operations including large-scale distribution, especially in coordination with the national guard.
An alternative, indirect approach is to focus on a funding structure that better incentivizes vaccination by the private sector. The private sector, including pharmacies, employers, and hospitals, already oversees the administration of many vaccines each year (notably the annual flu vaccine). But in a pandemic situation with limited supply, urgent timing, and complex logistics, careful coordination with manufacturers and others administering the vaccine is essential. Manufacturers could potentially play a coordinating role, but lack incentives to do so. Currently, incentives for development (e.g., for drug manufacturers) are wholly distinct from incentives for administration (e.g., pharmacy chains or hospitals getting reimbursed). The federal government could link these incentives; for instance, it could provide manufacturers a reward per patient vaccinated rather than simply for receiving vaccine approval or manufacturing a certain number of doses.
The optimal approach may be a mixture of both types of incentives, such as a combination of private sector coordination and efforts at a centralized federal infrastructure. Both the public and private sector are subject to failures, and not all eggs should be put in one basket. Coordinated redundancy is not only acceptable in a pandemic, it is desirable. Accordingly, policymakers shouldn’t be afraid of spending too much on vaccine distribution or development—even under low-end estimates of social value, the billions spent on COVID-19 vaccine development so far are only a small fraction of this value. Part of the reason this pandemic has been as devastating as it has been was insufficient vaccine development funding prior to the pandemic. Providing adequate rewards at each stage of the vaccine pipeline will help us do a better job with the next outbreak.
This post is part of a series on COVID-19 innovation law and policy. Author order is rotated with each post.
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