Navigating Organizational Mandatory COVID-19 Vaccination Policy

A year after the COVID-19 virus began ravaging the world in late 2019, vaccines became available for emergency use in the United States and a few other countries. Half of the U.S. population was fully vaccinated by fall 2021. However, those who are vaccine-hesitant continue to dominate the media, hampering virus mitigation efforts.

During a pandemic, healthcare organizations must establish a safe environment for healthcare workers and patients. Therefore, policies that effectively introduce protective precautions and boost vaccination acceptance are critical.

In a perfect and rational society, everyone would be vaccinated — not due to mandate, but because they want to promote the public good. Such an idealistic conceptual framework is merely a consideration and does not apply to the legal argument to support an organization’s authority to mandate.

Historic Review

Which level of government should administer the order to vaccinate or quarantine during a pandemic? Since Thomas Jefferson’s presidency, the federal government has guaranteed the distribution of effective vaccines; decisions regarding mandates have been left to state and local governments.(1) During a pandemic, the federal powers to mandate are derived from the Commerce Clause of the U.S. Constitution, which states Congress has the power to regulate commerce among foreign countries and states. Congress can also regulate the requirement for foreigners entering the U.S. The ability to legally mandate vaccinations for public health is derived from the state’s general police powers.

Many mandatory vaccination and quarantine principles have been upheld in court, and many mandatory vaccination programs have successfully prevented transmittable diseases from devastating the public.(2) For example, in one of the many lawsuits filed after the mandatory smallpox vaccination law enacted in 1809, the court recognized it is within the state’s police powers to protect the population’s health and safety.(3) The court was not convinced that mandatory vaccination programs violated individual rights and noted that the liberty secured by the Constitution of the United States is not absolute and wholly free from all restraint.(4)

Compulsory vaccination programs vary by state. Many states provide exemptions based on medical, religious, or philosophical reasonings. Nevertheless, organizations’ compulsory vaccination attempts continue to meet legal challenges in court.(5) To date, legal challenges to the COVID-19 vaccine mandate in Texas (Bridges, et al. v. Houston Methodist Hospital, et al.)(6) and Indiana (Ryan Klaassen, et al. v. The Trustees of Indiana University)(7) were struck down by the court, which found that the 14th Amendment permits organizations “to pursue a reasonable and due process of vaccination in the legitimate interest of public health.” Although exemptions apply, several states have mandatory vaccination programs for healthcare workers.

During the H1N1 influenza pandemic in 2009, vaccination compliance against the viruses was meager.(8) The state of New York amended its regulations to mandate the vaccination with exceptions only for existing medical conditions. However, a state judge issued a temporary restraining order to suspend the mandate, which prompted the governor to eventually abandon the requirement that healthcare providers receive the influenza vaccine.(9) The unvaccinated were required to wear a mask.

Without state regulations, the vaccination of healthcare providers depends on the ethics and goodwill of the providers in the form of responsibility and natural duty to prevent the spread of viruses among themselves and their patients. However, a healthcare organization can require an annual vaccination protocol to renew employment and professional practice privileges. The policies can vary according to organizational tolerance or avoidance of legal challenges and consequences.

Attitude of the Public and the Governing Bodies

Organizations’ power to mandate vaccination is minimal, and they can incur negative repercussions for instituting a mandate. Although all 50 states and the District of Columbia have mandated vaccinations for healthcare workers against certain vaccine-preventable diseases, they generally allow exceptions.(10) The vaccines currently subjected to government mandates were licensed under a Biological License Application (BLA)(11); however, the Food and Drug Administration (FDA) has not yet licensed the COVID-19 vaccines under BLA due to their emergency status. Under the construct, even the states’ police power is not enough to challenge the protection of individual rights over public health and safety concerns when arguing in high-level courts.

While a growing number of people are being vaccinated against the COVID-19 virus, some people use politics and misconceptions about the vaccines as arguments against it.(12) Presently, the World Health Organization does not support the mandate for vaccination and prefers to promote campaigns and make precaution information readily available to the public.(13) Some countries, such as Indonesia, posted strict punishment for noncompliance. International and U.S. authorities, however, are hesitant to support such enforcement.

As vaccines become more readily available, healthcare organizations’ responsibility is to initiate effective policies to protect employees and ensure patients’ safety from the virus.

From Problem to Policy

Healthcare organizations are accustomed to addressing problems that are well-defined or guided by regulatory agencies, resolving them through best practices and standard operating procedures. However, COVID-19 is a complicated and complex problem and there are still many unknown public health implications.

During the COVID-19 pandemic, healthcare organizations’ problems are not limited to operational and economic challenges; the organizations also must protect stakeholders’ mental and physical safety.(14) Experts have taken a reactionary approached to the virus, requiring masking and restricting public activities and size of gatherings.(15) Exploratory, iterative, and adaptive thinking are necessary to develop a vaccination program, mandatory or voluntary, for hospitals and medical organizations to implement.(16)

Policy innovation is often at odds with normative structure and culture. In the healthcare environment, these challenges involve medical providers’ technical and professional knowledge as well as their life experiences, political leanings, religious beliefs, and skepticism. Technical issues are easy problems to address; policy innovation requires constant negotiation with people in the system.(17) Healthcare leaders must manage resistance, empathize with stakeholders’ interests, communicate a clear goal to generate a shared value, and align the goal to stop viruses from spreading in the organization and community.

As depicted in Figure 1, policy design of a COVID-19 vaccination program requires iterative testing.(18) Learning from failure is as important as learning from success. Policy design or redesign needs to be technical and politically supportable. It is essential to carefully consider and analyze all the influencing factors and evaluate for different options. When communicating decisions to stakeholders, the information should be concise, compelling, and relevant to their interests.

Figure 1. Fishbone diagram to depict the development of COVID-19 vaccination program

Authority for a Vaccination Mandate

Despite federal authority to impose vaccination requirements in immigration and military service, no federal law requires vaccination for the general public. Under the broad and flexible Public Health Service Act (PHSA), the court can and is authorized to grant the Secretary of Health and Human Services (HHS) the authority to delegate to the Centers for Disease Control and Prevention (CDC) the enforcement of regulations to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States or from one state to another.(19)

In this case, the CDC may issue regulations mandating vaccination to stop the transmission of COVID-19. However, the Constitution and other generally applicable statutory requirements, such as the Administrative Procedure Act and the Religious Freedom Restoration Act of 1993 (RFRA), would constrain the CDC’s exercise of this authority.

Under the Constitution’s Spending and Commerce Clauses, Congress has the power to introduce terms and requirements as conditions under which states and administrative agencies receive funding. Thus, Congress can apply its authority to encourage states to enact a vaccination mandate in exchange for funding needed to protect the public from COVID-19.

The Commerce Clause also grants Congress the power to regulate the channels of interstate commerce, instrumentalities of or persons or things in interstate commerce, and activities that substantially affect interstate commerce. These powers enable Congress to enact laws aimed to protect the public from contagion that poses health concerns.

However, even if a vaccine mandate falls within Congress’s enumerated powers, other constitutional provisions may constrain governmental action. In public health regulations, the key constraints are those grounded in federalism and the protection of individual rights.

In April 2020, the Office for Civil Rights at the U.S. Department of Health and Human Services issued guidance to allow covered entities and their business associates to disclose protected health information to health information exchanges for reporting to public health authorities engaged in public health activities. It is hopeful that, with more data available to researchers, the direction and strength of vaccination policies can be clarified to improve these programs.

Healthcare Organization Vaccination Goal

Healthcare organizations must set a clearly defined vaccination goal that is technically ready, politically supportable, and practically implementable. To launch a successful vaccination campaign, the organization needs to educate employees about how to protect themselves personally and how to maintain a sustainable working environment.

Making vaccinations readily accessible and ensuring employees time off from work to get vaccinated can help employees overcome possible vaccination reluctance. In addition, because healthcare providers are concerned they might bring the virus home, it is beneficial to consider providing the vaccine to the employee’s family members as well. Organizational leaders should lead by example and be among the first to be vaccinated.

An organization’s support of its vaccination programs and campaigns is critical to the program’s success. The organizational leaders should manage all aspects of the initiative, initiating protocols, designing and implementing programs, and providing access. The organization’s capability to measure the rate of vaccination and vaccination refusal is vital to the campaign. The declination rate helps organizations identify hesitant individuals or groups in need of more interventions to overcome barriers to vaccination.

Organizations must identify influential informal leaders in the organization who support vaccination. These influencers can inspire and motivate others to be vaccinated, for example by including them at events and on vaccination campaign posters.

Frontline healthcare workers are among the most likely to contract the virus and need to be protected; however, a team of researchers led by Wharton’s Sigal Barsade recently released a report that showed merely 40% of healthcare providers received the COVID-19 vaccine.(20) Barsade explained that vaccine hesitancy is related to how healthcare providers feel psychologically about the vaccination process in their organization.

Medical professionals are more likely to comply after listening to peers than to authority figures. Healthcare organizations should encourage healthcare workers and their family members to advocate vaccination to community members’ confidence and mitigate hesitancy. In addition, because healthcare providers are influenced by research, providing scientific evidence can encourage them to accept the vaccine.

There is still no sure way to ensure vaccination among healthcare providers. Therefore, hospitals must impose alternative policies such as social distancing, periodic testing, and mask wearing for those unwilling to get the vaccine.

Conclusions

The COVID-19 pandemic is the deadliest healthcare challenge the medical profession has faced in the past century. Ideally, managing the complex global pandemic requires a seamless collaboration of the world community. Unfortunately, the effort is disrupted by political mongering and blame games. It is disheartening to witness the failure of global cooperation to fight against the common enemy, the COVID-19 virus, leading to the loss of millions of lives and threatening the survival of billions.

Furthermore, the U.S. media is continuously flooding the public with politically driven misinformation and undecisive guidance, resulting in public confusion and hesitation to receive vaccines or adhere to the precautionary protocols.

Mass vaccination aims to administer enough vaccines to reach herd immunity. Achieving the goal depends on a rational plan that includes the assurance of vaccine availability and a comprehensive communication campaign to distribute information regarding the risks and benefits of vaccination.

Vaccines effectively protect healthcare providers and the vulnerable public from suffering a symptomatic and potential deadly COVID-19 infection. However, the vaccine’s status has remained an emergency use authorization under Section 564 of the Federal Food, Drug, and Cosmetic Act. The vaccine’s status continues to be a barrier for vaccine detractors and a source of endless debate among experts, politicians, and conspiracy theorists.

As The U.S. government has taken reluctant steps to make vaccination mandatory, everyone needs to understand the risk of declining vaccination rates. People can choose not to take the vaccine, but freedom is not without consequences. If that is their choice, they have a responsibility to stay away from others to minimize their health risks.

So far into the pandemic, the healthcare industry’s mandate of COVID-19 vaccinations is not expected at federal or state levels. For healthcare organizations to sustain their operations and avoid the risks of mandated vaccination, developing a vaccination campaign is a complex and uneasy process.

There are laws and regulations to comply with and emotional misinformation challenges to navigate. A massive campaign with a soundly designed educational strategy is necessary to initiate such a program. A sensitive innovation requires solid political support from both stakeholders and authorities. Developing advocate “messengers” to disseminate the vaccine’s benefits and broadcast the ethical and professional responsibility in the organization is critical to motivating internal stakeholders to get vaccinated.

Lastly, an organization’s policy implementation has to be well-reviewed and monitored. In time, redesigning the approach to vaccination may be necessary as the COVID-19 pandemic will stay for a long hold. Therefore, precautionary measures and aggressive vaccination campaigns are still the best approaches to coping with the pandemic before the global vaccine mandate is possible.

References

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