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Mandating COVID-19 Vaccines for PALTC Staff: The Ethical Argument

      Vaccine mandates have been a prickly issue in this country since the smallpox vaccine initiatives in the early 20th century. That’s not surprising, of course. America, a country that generally holds individual freedoms to be mainly inviolable, has a hard time constraining those freedoms in the interest of the common good. Despite this, public health mandates such as childhood vaccines, masking, and travel restrictions have been considered ethical as long as they satisfy three criteria: the risk of allowing unfettered individual choice must represent a significant danger to society, the benefit of the mandate must be high, and, finally, the risk to the individual in complying with the mandate must be low.
      Public health mandates such as childhood vaccines, masking, and travel restrictions have been considered ethical as long as they satisfy three criteria: the risk of allowing unfettered individual choice must represent a significant danger to society, the benefit of the mandate must be high, and, finally, the risk to the individual in complying with the mandate must be low.

      Precedent for Success

      Take the measles vaccine: in 1963, as in previous years, measles would sweep through the United States infecting anywhere between 3 and 4 million individuals, resulting in about 500 deaths. With the development of the first measles vaccine that year and the following revisions through 1967, measles prevalence dropped precipitously. Furthermore, it became apparent that the states that adopted robust vaccination programs had a fraction of the expected morbidity and mortality.
      Due to the effectiveness and the safety of the vaccine, measles vaccination led the charge in modern immunization initiatives. The risk was clear, the benefit was obvious, and safety concerns were satisfied. By the early 1980s, all 50 states had mandated measles vaccination — by then included in the measles, mumps, and rubella (MMR) vaccine series — for public schools and licensed childcare centers.

      Short of Expectations

      In February 2021, the Centers for Disease Control and Prevention published findings from a survey of over 11,000 skilled nursing facilities showing an alarmingly low rate of COVID-19 vaccine acceptance: 77% of residents had received at least one dose of the Pfizer or Moderna vaccine, but fewer than 38% of staff had done so (MMWR Morb Mortal Wkly Rep 2021;70:178–182). In my state, a recent survey conducted by the Virginia Department of Health showed some improvement over these numbers, but in some areas of the state fewer than 50% of staff have accepted and completed the two-dose series of either Pfizer or Moderna (unpublished data).
      Our robust hope at the beginning of the Pharmacy Partnership for Long-Term Care Program was that after such a horrible pandemic, COVID-19 vaccine acceptance would be nearly universal among both residents and staff. With continued vaccine hesitancy among frontline staff, however, is it time to consider a COVID-19 vaccine mandate for all workers in the post-acute and long-term care setting?

      Mandating Ethically

      To make an ethical case for mandatory vaccination, we must satisfy three criteria: the risk of allowing individual choice (vaccine rejection) must be high, the benefit of the mandate must be high, and the risk to the individual of receiving the vaccine must be low. The risk of vaccine refusal is clear, even more so than with measles in 1963: measles killed 500 across the entire United States each year, but COVID-19 has killed over 131,000 in long-term care settings alone. Although most of our residents were fully vaccinated in February, the unvaccinated persons who have been admitted since then, coupled with an alarmingly persistent COVID-19 prevalence throughout the country, puts frail elders at risk for a fourth wave of COVID-19 infections and deaths.
      Importantly though, it would be unethical to mandate a public health measure that has no clear benefit. Do the vaccines truly reduce the risk of COVID-19 infection in elders in nursing homes? We were unable to answer that question in December. The participants in the phase 3 clinical trials for the Pfizer and Moderna vaccines were much younger than nursing home residents. Would the amazing efficacy seen in those 60,000 younger individuals translate into effectiveness among our patients? With four additional months of data now available and almost 1.5 million residents fully vaccinated, the answer appears to be a resounding yes.
      An early study of skilled nursing facility residents in Connecticut showed that the Pfizer vaccine was as effective in long-term care residents as it had been in the participants in the phase 3 clinical trials (MMWR Morb Mortal Wkly Rep 2021;70:396–401). More recently, a study released by the American Healthcare Association and the National Center for Assisted Living showed a sharp decrease in outbreaks in facilities that had completed both vaccination clinics (with either Pfizer or Moderna) compared with those who had not started vaccination clinics (M. Domi, et al., “Nursing Home Resident and Staff Covid-19 Cases After the First Vaccination Clinic,” Center for Health Policy Evaluation in Long-Term Care, Feb. 2021; https://bit.ly/3u5iVfI). Other data are being compiled, but the results thus far indicate that the Pfizer and Moderna vaccines have been reliably effective in reducing morbidity and mortality in long-term care settings from COVID-19.

      Potential for Harm

      Finally, it would be unethical to implement a public health measure that has substantial potential to harm the individual. This was the most critical issue in vaccine hesitancy in December and January. At that time, we knew about the reported side effects of fatigue, headaches, and myalgias, but were there more dangerous side effects that would only become evident later? The Pfizer and Moderna studies only involved 66,000 individuals — a large enough population for an Emergency Use Authorization, yes, but could we honestly and confidently extrapolate the data to not only satisfy frontline staff but demand that they receive the vaccine? Absolutely not. To do so would have assumed safety that simply was not documented and would have unfairly disregarded the very valid concerns of our frontline staff.
      Fortunately, we are in a much better position to evaluate this situation in April than we were in December. Over 920 million doses of the various vaccines have been given worldwide, so we now have far more data about the potential side effects of both the Pfizer and Moderna vaccine. The data, fortunately, have been consistent with those of the phase 3 trials: the side effects are bothersome but not dangerous.
      It is important to recognize that safety data are not as encouraging for other vaccines. The risk of cerebral venous thrombosis from the Johnson & Johnson (Janssen) vaccine, although rare, was notable enough to prompt a pause on administration earlier in April. Many of our frontline workers are women between the ages of 18 and 48, the demographic who might be most impacted by this side effect. We must keep in mind any vaccine mandate should only include vaccines that we can confidently recommend to our staff as safe and effective. As a result, vaccine mandates, in my opinion, are most ethically sound only when they include vaccines with full Food and Drug Administration approval, a process that is underway for the Pfizer vaccine as of this writing.

      Keeping Things in Perspective

      There is precedent for mandating COVID-19 vaccination for all PALTC staff. Autonomy is an essential ethical principle, but not an absolute one. When and if full FDA approval is given to any COVID-19 vaccine, the case can be made that we have satisfied the ethical criteria necessary to implement a vaccine mandate. There will still be many frontline workers who disagree with vaccine mandates; and mandates need to be implemented in light of a recent poll showing that 54% of Black Americans don’t trust the health care system (M.A. Fletcher, “New Poll Shows Black Americans See a Racist Health Care System Setting the Stage for Pandemic’s Impact,” The Undefeated (ESPN)/Kaiser Family Foundation (KFF), Oct. 15, 2020; https://bit.ly/3eI6K1V).
      In the end, however, our elders must be the demographic that takes precedence. If we can align ourselves with one aim, it is to provide the best possible life for those living under our care. Universal COVID-19 vaccination is only one part of this effort, but an essential one.
      Dr. Wright is chair of the Society’s Ethics Committee. He received his PhD and MD from VCU Medical School in Richmond, VA, and holds a master’s degree in theological studies from Union Presbyterian Seminary as well as a certificate in bioethics from Loyola University, Chicago. He is founder of HomecomingRVA.org, a group of healthcare professionals dedicated to providing a new way of life for those living with dementia.

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