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nce We Have An Approved Covid-19 Vaccine, Then What?

TECH

Once We Have an Approved COVID-19 Vaccine, Then What?

It’s not as simple as snapping your fingers and getting herd immunity.

Here’s a thought experiment: after the RMS Titanic collided with an iceberg, it became necessary to allocate seats on the lifeboats; there were only about 700 places for the 2208 passengers. What if seats had been auctioned, with the price determined by supply and demand—i.e., by market forces? Clearly, the wealthiest would have crowded out the others. Instead, the Captain decided that women and children should take precedence. Of course, children had the most life to lose, but why women over men? Chivalry? We will likely never know.

The clinical results from the testing of different vaccines, which have been created using a variety of platforms, will inevitably vary in ways that we cannot foresee, and that will raise many questions.

A contemporary example of the limitations of purely free-market distribution models is quickly approaching, as one or more vaccines to prevent infection by the SARS-CoV-2 virus, which causes COVID-19, come to market. The situation is exceedingly complex in many ways, and the “solution” will inevitably involve elements of medicine, science, ethics, and politics.

The clinical results from the testing of different vaccines, which have been created using a variety of platforms, will inevitably vary in ways that we cannot foresee, and that will raise many questions. For example, how effective will the vaccines be for different demographic groups—particularly the elderly, who are most vulnerable to severe illness and death, but who mount a less vigorous immune response?

One thing seems clear, however: we have seen no enthusiasm from any quarter for allowing the price of the vaccine (i.e., market forces) to determine who should get priority in obtaining protection from COVID-19. But that still leaves many possible strategies to allocate what will inevitably be a scarce resource for some time—despite attempts to anticipate the conundrum and produce many millions of doses, beginning large-scale production even before safety and effectiveness have been demonstrated to a level acceptable to regulators. 

In several cases, this early production is being subsidized by the U.S. government. Its Operation Warp Speed aims to begin delivery of 300 million doses of an FDA-authorized, safe and effective vaccine for COVID-19 by the end of the year (an admirable but probably overly ambitious goal). As part of that initiative, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) jointly announced on July 7th a $1.6 billion agreement with Maryland-based Novavax Inc., to demonstrate commercial-scale manufacturing of the company’s COVID-19 investigational vaccine. By funding this manufacturing effort, the federal government will own the 100 million doses of investigational vaccine expected to result from those demonstration projects. On July 22nd, the feds announced a $1.95 billion deal with U.S.-based Pfizer Inc. and BioNTech for large-scale production and delivery of 100 million doses of an FDA-approved COVID-19 vaccine. Additional federal funding of COVID-19 vaccine development has gone to Massachusetts-based Moderna (almost half a billion dollars) and to British drugmaker AstraZeneca (more than $1 billion).

These and other similar initiatives are some of the U.S. government’s wisest “corporate welfare” subsidies within memory. They accelerate the realization of remedies to a societal calamity, without which progress would be much slower. Unfortunately, although they might mitigate some of the most difficult vaccine allocation choices, others will remain.

Medical distribution.

Medical distribution.

WHO IS “ESSENTIAL” AND WHO IS “MOST VULNERABLE?”

Triaging vaccine distribution raises many possible options concerning whom to prioritize and why. One obvious priority would be to vaccinate the “most vulnerable” populations. But how do we define vulnerability? By age and comorbidities, or, perhaps, by occupation or living situation (such as residents of nursing homes, or to people working in tight quarters like meatpacking plants). Or should “value to society in mitigating the pandemic” trump other considerations, with front-line medical personnel and staff at long-term care facilities going to the head of the line? Those whose work is both essential and hazardous? And how about those involved in keeping the food supply chain intact, such as farmworkers, truck drivers, and food-store workers? (The head of our line is starting to get pretty crowded.)

Triaging vaccine distribution raises many possible options concerning whom to prioritize and why.

Still, another question is to what extent the results of clinical trials should affect our priority-setting. For example, if a trial revealed that subjects with blood type A obtain the greatest benefit, should they get priority for that vaccine? What about various racial, ethnic, or gender groups that have a statistically higher incidence of mortality from COVID-19? For example, should Blacks be considered a higher priority for vaccination because they are dying from COVID-19 at a rate 2.5 times higher than whites? And what about the political considerations: should Americans automatically receive higher priority, simply because our government subsidized the development of the vaccine?

The allocation criteria could theoretically become a complex algorithm, perhaps something analogous to the National Association of EMS physicians SALT Mass Casualty Triage Algorithm, which sorts patients into three categories based on the severity of their condition and determines the interventions they should get and in what order. In the case of vaccination, on the basis of the variables mentioned above, individuals could be placed in a category of the appropriate category, and within the category, would then receive vaccine in random lottery order. Of course, such an approach would not eliminate value judgments or squelch controversy.

We hope that, to the extent possible, these decisions will be made based on medical evidence and plausible rationales rather than political interests. To return to our analogy, imagine if only members of one political party or British citizens were permitted on the Titanic’s lifeboats. (It was a British ship, after all.) In today’s hyper-partisan times, nothing seems too implausible or cynical.

Medical equipment.

Medical equipment.

SCIENCE, NOT PARTISAN PERFORMANCE, SHOULD DETERMINE VACCINE ALLOCATION DECISIONS

In order to muddle through (“resolve” would be too optimistic) these conundrums, the feds will receive formal advice from at least two sources. National Institutes of Health Director Francis Collins has asked the National Academy of Medicine to develop guidelines for who should get priority for the first doses of a coronavirus vaccine.

[N]o allocation scheme will please everyone, and despite all the attempts at rational analysis and planning, there will be unintended consequences.

A second panel, the Advisory Committee on Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention on vaccine issues, has also been tasked to formulate guidelines. Last month, the ACIP convened a meeting electronically to discuss “who counts as an essential worker, where teachers should fall in the priority list, vaccinations for pregnant women and whether race and ethnicity should factor into priority considerations.”

It remains to be seen how and who in the administration will reconcile two independently crafted sets of recommendations, and to what extent other parties will be allowed to participate in the process. In the end, the FDA could specify which groups get priority if it grants an emergency use authorization for a vaccine. That would be similar to the FDA’s having directed that Gilead Sciences remdesivir, a COVID-19 drug treatment, be used exclusively for “patients hospitalized with severe disease,” when regulators granted an emergency use authorization.

Questions will also arise about the cost of vaccines to consumers—and the posturing and virtue-signaling by politicians have already begun. In early June, before a vaccine was even on the horizon, Sen. Elizabeth Warren (D-MA) said in a statement, “We can’t allow American families—who are already struggling to make ends meet during this public health emergency—to be squeezed even further by companies out to make a quick buck.” And Sen. Patty Murray (D-WA) echoed her comrade, “We need to have confidence that no one is making billions in a back room somewhere.” These gratuitous broadsides are part of their ongoing disparagement of one of the nation’s most innovative and successful industries. (Thankfully, the major vaccine manufacturers seem to have accepted that the pandemic is not a time for profiteering. The deals vaccine makers have struck with the feds suggest the cost will be modest, in the range of $4-$37 per dose.)

Several things are certain, however. First, no allocation scheme will please everyone, and despite all the attempts at rational analysis and planning, there will be unintended consequences. Second, the vaccine debate will re-inflame the passions about drug pricing and drug companies’ profits. Finally, we can be sure the companies that are working furiously on therapies and vaccines to rescue the world from the throes of the worst pandemic in a century won’t receive any gratitude from progressive politicians.

The bottom line: insofar as it’s possible, the scientific and medical evidence should inform the allocation process.

Henry I. Miller, a physician and molecular biologist, is a Senior Fellow at the Pacific Research Institute. He was the founding director of the Office of Biotechnology at the FDA. Andrew I. Fillat spent his career in technology venture capital and information technology companies. He is also the co-inventor of relational databases. They were undergraduates together at M.I.T.

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