Monthly Review: COVID-19 Legal and Ethics Issues – August 9, 2021

Monthly Review: COVID-19 Legal and Ethics Issues – August 9, 2021

COVID-19 Vaccination Mandates

NOTE: Because this is now a once-a-month post, I’m including lots of links to other pieces of interest in the text. I strongly encourage you to explore the issues raised in these articles.

The largely unchecked spread of the Delta variant across the U.S. has led to a significant rise in business, university, school, and local government interest in the implementation of vaccine mandates. While high vaccination rates alone likely will not stop the Delta variant’s spread — masking, social distancing measures, testing (along with quarantine/isolation), strong ventilation policies will be necessary — vaccination against the Coronavirus has proven to significantly reduce not only the risks of an individual being hospitalized or dying due to Covid-19, but also the individual’s infectiousness should they catch the Delta strain of the virus.

Recently, the Department of Justice issued an opinion that the FDA’s Emergency Use Authorization regulatory structure does allow businesses and other entities to implement vaccination mandates as part of their safety protocols. This information has contributed to some entities that may have been waiting for the FDA to fully license the vaccines before mandating the vaccine to speed up their mandate timelines. Furthermore, while some states (like Indiana) have limited who may ask for proof of vaccination (aka “vaccine passports”), requiring that employees or others demonstrate that they have been vaccinated is not a violation of HIPAA (the Health Insurance Portability and Accountability Act).

Who Are the Unvaccinated?

When considering vaccination mandates, it’s important to understand who remains unvaccinated at this point, as outreach should be targeted to the particular needs and concerns raised within the vulnerable communities. 

In June 2021, The Kaiser Family Foundation published survey data on the U.S. unvaccinated population, and has found it to be “younger, less educated, more likely to be Republicans, people of color, and uninsured” than the vaccinated population.

While much of the media (and social media) focus has centered on the political divide between the unvaccinated and vaccinated, and on the share of the population that has declared itself anti-vaccination, Bryce Covert in the New York Times highlights how 75% of those who remain unvaccinated live in lower income families facing significant negative social determinants of health that, if addressed, might increase their ability and willingness to get a shot. These individuals not only have a higher likelihood to lack easy access to vaccination, but they also fear being fired for missing work if they or a family member had vaccine-related side effects, due to their employers not offering workplace benefits like paid sick leave, and are much more likely to lack consistent sources of nutritious food:

Those who aren’t yet vaccinated are much more likely to be food insecure, have children at home and earn little. About three-quarters of unvaccinated adults live in a household that makes less than $75,000 a year. They are nearly three times as likely as the vaccinated to have had insufficient food recently. Many of them have pressing concerns they can’t just put aside because they need to get a vaccination.

Access is far more widespread than it was at the beginning of the year. Many cities now offer multiple venues for getting it without needing an appointment. But about 10 percent of the eligible population still lives more than a 15-minute drive from a vaccine distribution location. And even if there’s a site down the road, it usually requires taking time off work — not just to get the shot but also potentially to recover from the side effects — arranging transportation and figuring out child care.

“Missing out on a few hours of work seems very easy to us, but in fact it could be the matter of having food for the family versus not,” said Ann Lee, the chief executive of the nonprofit Community Organized Relief Effort. For these people, when they’re weighing whether to get a vaccination or potentially forgo some wages, “the wages are going to win out.”

Those who are unvaccinated are also likely to work in essential jobs like agriculture and manufacturing that don’t allow them to step away from work. They work long hours and may prioritize time with their families or communities when they finally get a break. People who have multiple jobs may find it impossible to schedule a shot in between all of their shifts.

And yet 43 percent of the unvaccinated say they definitely or probably would get it or are unsure, according to Julia Raifman, an assistant professor at the Boston University School of Public Health.

The concerns about missing work due to vaccine side effects highlights another significant difference between the vaccinated and unvaccinated: according to a July 2021 analysis, most unvaccinated adults believed getting the vaccine was more dangerous to their health than the Coronavirus. These numbers may be declining in light of the dramatic spread of the Delta variant over the last few weeks; however, it does highlight how changes in public health policy, practices, and communication may be necessary to improve vaccination uptake. Furthermore, putting a mandate in place may shift the individual’s risk assessment, leading them to see the combination of risk to themselves from Covid and the risk to their job status from staying unvaccinated in the face of a workplace mandate as higher than the risks of getting the shot.

Soft vs Hard Mandates

Second, it’s important to note that “vaccine mandate” is not a one-size-fits-all policy proposition. Many institutions, including the federal government, are putting in place so-called “soft mandates.” This type of mandate subjects those who refuse vaccination to additional safety protocols, such as regular testing (which may be an out-of-pocket cost for the unvaccinated), social distancing at work, and mask wearing in office settings (although the CDC is now recommending that all individuals working or entering into public indoor spaces in locations with significant community Delta variant spread mask up). The effectiveness of these policies will depend in large part on how rigorously the workplace enforces the additional burdens they are placing on those who remain unvaccinated. 

Hard mandates — those that require individuals to be vaccinated or be fired — are more likely to be adopted by entities that expect significant interaction between those who would fall under their policies and vulnerable populations. For example, health care systems, nursing homes, universities, airlines, even Walmart, Disney, and news organizations like CNN have announced having hard mandates in place for some of their employees. 

Last week, the California Department of Public Health announced a first-in-the-nation policy requiring all paid and unpaid workers in health care facilities, including hospitals, nursing facilities, psychiatric hospitals, clinics and doctor’s offices, dialysis centers, residential substance use treatment centers, and at least a half-dozen other facilities, be vaccinated by September 30. Oregon’s governor has announced similar plans.

Exemptions

These measures are likely to significantly raise community vaccination rates; however, the significant variability in policy adoption means that vaccination protection will vary dramatically from place to place. In most places, individuals subject to vaccine mandates will have the option to pursue exemptions based on medical and/or religious grounds. The breadth and rigor of enforcement around these exemption policies will have an effect on their effectiveness in protecting the environment where the mandate is put in place. Some institutions, such as health care systems and nursing homes (and even universities) may legally be permitted to have policies in place with very low tolerances for exemptions, as allowing exemptors to remain on site may put that individual and others at significant risk. As we’ve seen with childhood immunizations, places that put extremely broad or unenforceable Nonmedical Exemption standards in place, such as the ethical exemption adopted by Indiana University, run the risk that their vaccine policy will be ineffective, as they will be undermined by those who feel it is easier to opt out than to contribute to protecting their community from dangerous infectious diseases. Furthermore, the imposition of mandates has also increased the chances that people may seek out fraudulent means of proving their vaccination status (like fake vaccine cards), rather than actually getting the shot(s). As I stated in the Guardian newspaper last week, while vaccine mandates are ethical and legal in the midst of a dangerous infectious disease outbreak, making it as easy as possible for people to say yes to getting the vaccination can minimize the use of such work-arounds. 

The debate over vaccine mandates (as well as mask mandates) is likely to be especially vigorous in places such as school systems, where significant shares of the student population may remain ineligible for vaccination.

Are Mandates Justified?

Last fall, I co-authored an article in the New England Journal of Medicine outlining 6 trigger points for ethically and legally structuring Covid-19 vaccination mandates. While the piece originally focused on state governments, I believe the framework may also be useful in justifying mandates put in place by the entities listed above considering hard mandates. Those criteria are:

  1. Covid-19 is not adequately contained in the state.
  2. The Advisory Committee on Immunization Practices has recommended vaccination for the groups for which a mandate is being considered.
  3. The supply of vaccine is sufficient to cover the population groups for which a mandate is being considered.
  4. Available evidence about the safety and efficacy of the vaccine has been transparently communicated.
  5. The state has created infrastructure to provide access to vaccination without financial or logistic barriers, compensation to workers who have adverse effects from a required vaccine, and real-time surveillance of vaccine side effects.
  6. In a time-limited evaluation, voluntary uptake of the vaccine among high-priority groups has fallen short of the level required to prevent epidemic spread.

At this point, just about everywhere in the country, I believe the data supports a determination that all 6 criteria have been met (although, as noted above, more could be done, either at the individual business or the state policy level, to ensure paid time off and job protections for workers for side effects from vaccination suffered by themselves or their family).

Or, as my colleague Larry Gostin stated in this piece in the Scientific American last week, “Vaccine Mandates Are Lawful, Effective and Based on Rock-Solid Science.”

|2021-08-09T09:54:22-04:00August 9th, 2021|COVID-19 Literature|0 Comments

About the Author: Ross Silverman

Ross Silverman
Ross D. Silverman, JD, MPH, is Professor of Health Policy and Management at Indiana University Fairbanks School of Public Health and Professor of Public Health and Law at Indiana University McKinney School of Law in Indianapolis. He is a member of the IU Centers on Health Policy and Bioethics. His research focuses on public health and medical law, policy, and ethics, and law's impact on health outcomes and vulnerable populations. He also serves as Associate Editor on Legal Epidemiology for Public Health Reports, the official journal of the Office of the U.S. Surgeon General and the U.S. Public Health Service. His most recent Covid-19 publications include: "Ensuring Uptake of Vaccines Against SARS-CoV-2" in the New England Journal of Medicine (with MM Mello & SB Omer), and "Covid-19: control measures must be equitable and inclusive" in BMJ (with ZD Berger, NG Evans & AL Phelan)

Get Involved with Indiana CTSI