Multiple U.S. Decision-Making Entities Complicate Task Of Allocating Coronavirus Vaccines

Priority setting of health care services and technologies in limited supply isn’t easy in the best of times. It’s even harder during a pandemic. In the case of Covid-19, multiple, sometimes competing, decision-making entities at the federal, state, and local levels may complicate the task of allocating coronavirus vaccines once they become available.

Several coronavirus vaccines in development have demonstrated encouraging results in Phases I and II, and have now begun Phase III. If all goes well, Food and Drug Administration (FDA) approval may ensue by the end of the year for one or more vaccines. It’s also possible that the FDA will issue an emergency use authorization at some point this fall, prior to potential approval.

Already, several manufacturers have plans to mass-produce vaccine doses. Pfizer and BioNTech, for example, have entered an agreement with the Department of Health and Human Services and the Department of Defense for the production and nationwide delivery of 100 million doses of coronavirus vaccine, should the vaccine be approved.

As production of vaccines is scaled up, it’s imperative that non-arbitrary medical criteria are used to set priorities for an equitable allocation of vaccines. It’s likely that healthcare workers get first dibs, followed by other first responders, people employed in the food supply chain and other essential goods and services, as well as teachers and school administrators.

Subsequently, as authorities allocate available supplies of vaccine, it’s important to weigh individual and population risks, owing to age and underlying health conditions: For example, assigning priority to vaccinating the elderly residing in nursing homes, and prioritizing sub-populations with higher incidences of diabetes, hypertension, and cardiovascular disease. This may imply the need to prioritize vaccination of Native, Latin, and African Americans, who face a much greater risk of getting infected by coronavirus and having severe Covid-19 disease.

Who gets to make these critical decisions? Well, this is where it gets confusing.

The Advisory Committee on Immunization Practices (ACIP), a panel that has made recommendations on vaccination policy to the Centers for Disease Control and Prevention (CDC) for decades, will play a key role.

But, Operation Warp Speed may also have a say in how vaccines get distributed. The public–private partnership was established by the Trump Administration to facilitate the development, manufacturing, and distribution of coronavirus vaccines, therapeutics, and diagnostics. It’s not known what exact role Operation Warp Speed will play in terms of distribution. Officials in the Department of Health and Human Services that oversees the partnership have said they want a vaccine distribution system ready by November. Precisely how Operation Warp Speed and ACIP will work together to achieve this goal is unclear.

At the same time, in July, the National Academies of Sciences, Engineering, and Medicine (NASEM) named a federal advisory expert panel to develop a framework to determine vaccination priorities. Evidently, ACIP is working with NASEM to develop a distribution plan. NASEM just released draft guidelines on initial priorities for vaccine distribution. Federal officials haven’t explained how this plan will differ from the one Operation Warp Speed and ACIP are working on.

Besides distribution of vaccines, expert panels will need to communicate to the public the need for widespread vaccination, as sufficient uptake is crucial to achieve herd immunity. Here, it’s vital that authorities find effective ways to address large numbers of vaccine-hesitant Americans. In a recent survey, only 42% of Americans say they'll get vaccinated.

The task of priority setting won’t be easy. And, lessons must be drawn from prior mistakes made in depleting the national stockpile of protective personnel equipment, extending unevenly distributed relief funds to hospitals, and haphazardly allocating remdesivir following its emergency use authorization.

To illustrate, the federal government’s formula for distributing Covid-19 aid through the CARES Act to hospitals has exacerbated already existing inequalities. Paradoxically, the formula used to allocate the $50 billion to providers who operate in the Medicare program favors hospitals with the highest share of private insurance revenue as a percentage of total net patient revenue. As a result, money is flowing disproportionately to hospitals with the most revenue, not the most need.

Also, the Covid-19 treatment remdesivir has been in short supply in some locales, as allotment of the treatment to hospitals by federal and state authorities hit early snags, leaving some hospitals without adequate supply. Notably, North Carolina wasn't allotted any remdesivir through early July, despite having a significant Covid-19 patient caseload.

So far, this article has only focused on U.S. vaccine distribution. Given that the novel coronavirus is a global pandemic, it’s important to acknowledge that any approved vaccine is a public good. This is not only due to the global nature of the pandemic, but also because development (and manufacturing in some instances) of vaccines by multinationals is in large part being funded by governments.

The rising tide of nationalism in recent years may imply, however, that certain governments may not view vaccines as public goods. In fact, it’s more probable that beggar-thy-neighbor policies will be instituted, in a world governed at times by a zero-sum game philosophy. The U.S. is a case in point, as the Trump Administration has declared it will not join a global effort to equitably distribute vaccine doses across nations.

In the U.S., the federal government will determine vaccination priorities, hopefully in close coordination with state and local authorities. With multiple entities involved in coronavirus vaccine allocation, each with its own vested interests, there may, however, be confusion as to who will make the final decisions and on what basis. Besides the need to carefully coordinate decisions, it's essential that non-arbitrary medical criteria apply for allocation algorithms.

And, once governments have completed the task of vaccine priority-setting, state and local government leaders will have to identify accessible vaccination sites in both urban and rural areas, and proactively engage with communities with ongoing messaging campaigns designed to encourage vaccination.