people waiting in a line.

How the Government Can Prevent Individuals from Using Wealth to Cut the Vaccine Line

Cross-posted from COVID-19 and The Law, where it originally appeared on January 27, 2021. 

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Since the Food & Drug Administration granted emergency use authorization for the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna in December 2020, there have been many debates on vaccine allocation and prioritization.

As noted by Harvard Law School Professor Glenn Cohen in a recent interview with Annie Kapnick for the COVID-19 and The Law series, the issue of vaccine distribution is “complicated” because of competing factors decision-makers must consider. The relative weights placed on these factors has led to very different prioritization schemes. Initially, the Centers for Disease Control and Prevention (CDC) recommended a hybrid plan that appeared to prioritize individuals who were most likely to contract the virus (e.g., first responders, grocery store workers) over individuals most vulnerable to severe symptoms or death from the virus if contracted (e.g., individuals over the age of 65 not in long-term care facilities). In the United Kingdom, the prioritization groups were primarily based on vulnerability. Similarly, when looking more narrowly at the various plans being implemented at the state level in the United States, there are high degrees of variation.

This post does not seek to evaluate the merits of these or other specific vaccine allocation plans. Rather, it will address a risk that all plans likely face: the potential of individuals using their wealth and access to “cut the line” and be vaccinated ahead of schedule.
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Person smoking cigarette.

Should Smokers be Prioritized for COVID Vaccine?

Cross-posted from Harvard Law Today, where it originally appeared on February 2, 2021. 

By Jeff Neal

Should smoking be among the pre-existing health risks that qualify people for priority access to the COVID-19 vaccine? In a Zoom interview with Harvard Law Today, public health expert Carmel Shachar J.D./M.P.H. ’10 says the answer is yes. 

CDC guidelines, which most states are following as they launch mass vaccination programs, say people with certain underlying medical conditions that put them at greater risk for hospitalization or death if they contract COVID-19 (also known as co-morbidities) should receive access to the vaccine before the general population. In Massachusetts, these individuals will be eligible to receive the vaccine in Group 4 of Phase 2 of the state’s vaccination rollout plan. But many have been surprised to see smoking listed among the qualifying conditions, alongside cancer and heart disease.

Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, says that smoking is often the result of structural and biological factors that make it more prevalent in historically marginalized communities, and that denying priority access for smokers would reinforce existing inequities. More practically, she says, “every time a person gets vaccinated, it’s good for the community.” 

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Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Recent Organ Procurement Organization Regulations Will Save Lives

By Matthew Wadsworth

Thirty-three Americans die every day for lack of an organ transplant. As the CEO of an organ procurement organization (OPO) — one of the network of 57 government contractors responsible for organ recovery across the country — this is what I think about every day: how to help the 3,000 people waiting in my home state of Ohio and the more than 100,000 others around the country who wake up each morning hoping they get a call that a transplant is available.

Fortunately, the U.S Department of Health and Human Services (HHS) recently published new, pro-patient regulations to bring baseline accountability to OPOs. While some of my peers have opposed the reform effort, I see it as long overdue.

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Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

How to Encourage Organ Donation

By James W. Lytle

Last week, Bill of Health published a Q&A with Phil Walton, the Project Lead for Deemed Consent Legislation with the National Health Service Blood and Transplant Division, and Alexandra Glazier, the President/CEO of the New England Donor Services.

In the first part of this conversation, Walton and Glazier described the various frameworks undergirding organ donor registries in their home countries. Walton detailed the “deemed consent” or “opt-out” registry employed by Wales and England, while Glazier detailed the opt-in, prompted choice framework in the U.S.

In this second installment, Walton and Glazier discuss strategies to encourage organ donation, regardless of the opt-in or opt-out framework. The conversation also touched on health disparities and strategies to address them.

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COVID-19 fake news concept illustration.

COVID-19 Vaccine Misinformation and the Anti-Vaccine Movement

By Dorit Rubinstein Reiss

The anti-vaccine movement is aggressively working to promote misinformation about COVID-19 vaccines, up to and including promoting fake claims of deaths from vaccines. We need to be aware of its efforts, and be prepared to respond.

It’s worth emphasizing that this blog post is focused on the anti-vaccine movement, not people with concerns about vaccines (the “vaccine hesitant”).

In relation to COVID-19, anti-vaccine activists have aggressively promoted misinformation from the start of the pandemic.

In March 2020, anti-vaccine activists incorrectly alleged – by misrepresenting a study – that flu vaccines increase COVID-19 risks. In June, anti-vaccine activist Del Bigtree described COVID-19 as a “cold,” blamed those who died for their own deaths, and called on his followers to “catch that cold.”

And from the beginning, anti-vaccine activists were committed to the ideas that COVID-19 vaccines would not work, would be dangerous, and would be promoted by a nefarious global conspiracy. They continue to spread these allegations, for example, using the fact that there are liability protections for COVID-19 vaccines to imply the vaccines are dangerous. Liability protections for COVID-19 vaccine manufacturers are real; but they are not evidence that the vaccines are unsafe.

This post will focus on one type of misinformation: alleged deaths from COVID-19 vaccines.

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hospital equipment

Balancing Health Care Rationing and Disability Rights in a Pandemic

By Yolanda Bustillo and Rachel Perler

Amid the present surge of the coronavirus pandemic, it is crucial that disability rights are a factor in the development of triage protocols.

During the last week of December, the CDC recorded a record of 225,269 new coronavirus cases and 118,948 total hospitalizations. Health care systems across the country have predicted that they soon may face shortages of ventilators, personal protective equipment (PPE), and other limited resources.

In Utah, for example, hospital administrators have implemented informal triage protocols that prioritize patients based on health status, clinical factors, and the time sensitivity of their needed procedures. Hospitals in California have similarly begun rationing care.

If these dire circumstances worsen, hospital systems may apply triage protocols that deviate from best practices and impermissibly discriminate against people with disabilities.

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adult and child hands holding red heart, organ donation concept image.

Opt-in vs. Opt-out Organ Donation Schemes: Evidence from the US and UK

By James W. Lytle

We need to encourage organ donation. In the U.S. alone, even with a record number of about 40,000 transplants in 2019 and some progress made towards closing the gap, approximately 108,000 Americans are on the waiting list.

In considering the best way to increase organ donation, much of the debate has focused on how to make organ donor registries more successful: nothing facilitates the prospect for organ donation more than knowing that a potential donor has already indicated their intention to donate.

Should registries, like those in the U.S., require people to elect to join (the “opt-in” approach) or should they presume consent to organ donation and register everyone except those who explicitly “opt-out,” as is the case in certain other countries?

I asked two transplant professionals, one from the U.S. and one from Wales, to help consider this question and related issues involving organ donation.

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organ transplant

New Regulations for Organ Procurement Organizations Pose Concerns

By Alexandra Glazier

The United States has one of the highest organ donation and transplant rates in the world. A poorly crafted regulatory change could disrupt our world-leading system and put patients at risk.

Recently, new performance regulations for organ procurement organizations (OPOs) were promulgated by CMS in the last stretch of the Trump Administration, which should be reviewed by the incoming Biden Administration.

While there is widespread support for reform to the system of organ donation and transplantation, including consensus that changes to the CMS metrics measuring OPO performance are warranted, there are significant differences in opinion on how that can be accomplished best.

Bipartisan groups and delegations of both Democrats and Republicans, donor families, the medical community, and donation and transplant professionals as well as OPOs have raised a range of concerns about specific aspects of the proposed and final regulations, making suggestions on how the regulations could be improved to achieve the goal of transplanting more patients.

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Vial and syringe.

What to Know About the COVID-19 Vaccine Dosing Debate

By Dorit Rubinstein Reiss

Faced with limited COVID-19 vaccine doses and the ever-mounting toll and strain of the pandemic, a new debate has emerged as to the best strategy for allocating the vaccines.

Both COVID-19 vaccines authorized for emergency use in the U.S., which are produced by Pfizer/BioNTech and Moderna, have been studied under two-dose clinical trials. The two-dose regime is thought to accord a more robust immune response against COVID-19.

In the U.K., however, due to concerns about the shortage of COVID-19 vaccines, the government has deviated from established protocols. First, it decided to delay (but not omit) the administration of the second dose of the available vaccines, in order to increase the number of people getting at least one dose; second, it decided to allow mixing and matching of doses across vaccine types.

The United States is considering following the U.K. and moving to give more first doses, at the cost of delaying completion of the series.

Experts are sharply divided on whether that is a good or bad idea.

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