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Viewpoint
December 29, 2020

Mandating COVID-19 Vaccines

Author Affiliations
  • 1O’Neill Institute for National and Global Health Law, Georgetown University, Washington, DC
  • 2Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 3London School of Hygiene & Tropical Medicine, London, United Kingdom
JAMA. Published online December 29, 2020. doi:10.1001/jama.2020.26553

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic and help restore normal social and economic life. The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for 2 messenger RNA vaccines and will likely issue full biologics licenses in the coming months. Anticipating vaccine scarcity, the Advisory Committee on Immunization Practice (ACIP) published guidance on vaccine priorities.

Data for the vaccines granted an EUA reportedly demonstrate 95% efficacy, but even highly effective vaccines cannot curb the pandemic without high population coverage and maintenance of other mitigation strategies. Recent data from 1676 adults surveyed November 30 to December 8, 2020, found that when a COVID-19 vaccine is approved and widely available: 34% would get it as soon as possible; 39% would wait; 9% would only get it if required for work or school; 15% would definitely not get it. Black persons, at high risk of infection and hospitalization, are less likely to report vaccine intent with only 20% reporting they would get the vaccine soon and 52% intending to wait.1 Intent to vaccinate has changed substantially over time and is likely to continue to evolve. In this Viewpoint, we examine whether vaccine mandates would be lawful and ethical and whether they could boost vaccine uptake.

From EUAs to BLA Approvals

Mandating COVID-19 vaccines under an EUA is legally and ethically problematic. The act authorizing the FDA to issue EUAs requires the secretary of the Department of Health and Human Services (HHS) to specify whether individuals may refuse the vaccine and the consequences for refusal. Vaccine mandates are unjustified because an EUA requires less safety and efficacy data than full Biologics License Application (BLA) approval. Individuals would also likely distrust vaccine mandates under emergency use, viewing it as ongoing medical research.

Should SARS-CoV-2 Vaccines Be Mandatory?

Once SARS-CoV-2 vaccines receive a BLA, policy makers must determine to which, if any, populations mandates should apply. Vaccine mandates could be imposed in multiple sectors, each with their own legal and ethical considerations.

State Mandates

Since Jacobson v Massachusetts (1905), the judiciary has consistently upheld vaccination mandates. All states require childhood vaccines as a condition of school entry, which are demonstrated to maintain high coverage and prevent vaccine-preventable diseases.2 All states grant medical exemptions, and 45 states and Washington, DC, grant religious exemptions, with 15 states also allowing philosophical exemptions. Vaccine exemptions often cluster geographically and socially and are associated with a higher risk of outbreaks. Strengthening the rigor of the application process and enforcement are associated with improved vaccination rates.3 Adult vaccine mandates are rare, but at least 16 states require influenza or hepatitis B vaccinations for postsecondary education. Given the rarity of adult mandates, states are unlikely to enact mandatory COVID-19 vaccinations for the adult population, especially in the absence of long-term safety data.

Health Care Facilities

Health care workers are at increased risk of contracting infectious diseases and transmitting to vulnerable populations. Consequently, health care institutions must institute infection control protocols, and many require health care workers to receive the influenza vaccination. These institutions owe both legal and ethical duties to staff and patients to ensure a safe environment. Additionally, because vaccines prevent hospitalizations, their wide use in health care settings may reduce worker shortages. Even among health workers, however, SARS-CoV-2 vaccine mandates could be counterproductive, given the stress of working during a pandemic. Offering nonmedical exemptions could reduce health worker concerns over mandates.

Businesses

In a recent Yale CEO survey of 150 executives, 71% supported companies requiring COVID-19 vaccines.4 The Equal Employment Opportunity Commission (EEOC) has ruled that businesses can compel employees to submit to SARS-CoV-2 tests as a condition of employment. Recently, the agency determined that employers can require COVID-19 vaccines and bar employees from the workplace if they refuse.5 The Occupational Safety and Health Administration earlier issued guidance permitting employers to require influenza vaccinations. The EEOC, however, requires employers to grant medical exemptions and offer reasonable accommodations based on religion or disability.6

Businesses will rely on high vaccine coverage to facilitate a return to normal operating practices. Sectors ranging from food service and transportation to the arts and sports have been economically harmed by public health restrictions, as well as by consumer reluctance to risk SARS-CoV-2 exposure. In many settings, like meatpacking plants, there is high occupational risk of virus transmission. Businesses have an ethical and legal duty to keep their workers and customers safe. Thus, businesses that require in-person attendance, cater to vulnerable customers, or both may consider mandates with accommodations for medical, religious, or disability reasons.

Postsecondary Education

Colleges and universities will also need high vaccine coverage to safely reopen in-person learning. Sitting in a crowded classroom for long durations poses a high risk of transmission. Postsecondary institutions have often been loci for vaccination campaigns, and many have required influenza vaccines during the COVID-19 pandemic. It is foreseeable that institutions of higher education may require SARS-CoV-2 vaccines for students, faculty, and staff as part of fall 2021 reopening plans.

Primary and Secondary Education

Returning to in-person child education is a vital social goal, given rising achievement gaps between high- and low-income students as well as parental needs to return to the workforce. At-home schooling is suboptimal for student learning and can cause increased mental distress in households. There are also public health justifications for safely reopening schools. While COVID-19 is generally less severe among children, older children are a source of disease transmission. Teachers, moreover, are vulnerable to SARS-CoV-2, including serious disease. Requiring SARS-CoV-2 vaccines of schoolchildren and teachers and staff could enable students to safely return to in-person education.

School mandates for COVID-19 vaccines could occur, as an addition to ACIP-recommended childhood vaccinations. Yet mandates are not warranted until the FDA licenses a vaccine with reliable data on vaccine safety and efficacy among school-aged children. Even after phase 3 vaccine studies among children are completed and after full vaccine licensure is obtained, postmarketing safety monitoring is essential to fully characterize the risks. In 2006, the Association of Immunization Managers (AIM) advised, “School and child care immunization requirements must be used sparingly, approached cautiously, and considered only after an appropriate vaccine implementation period.”7 At that time, AIM also recommended broad public and professional support for any vaccine prior to implementing mandates. Costs and vaccine supplies must also be at acceptable levels.

Vaccination as a Condition of Service

Businesses have a duty to safeguard their customers and often impose safety precautions as a condition of providing services to customers. During the pandemic, many businesses have required masks and distancing for consumers. Even before the pandemic, customers could not enter certain premises in possession of a firearm or other hazardous substance. It is foreseeable that businesses in certain high-risk settings could require proof of vaccination as a condition of service, such as in long-distance travel (plane, rail, bus), restaurants, and entertainment (sports, movies, theater). While states might be constitutionally barred from requiring vaccines to participate in religious worship, it is conceivable that some churches, synagogues, or mosques might consider such conditions for congregants.

Local or state governments could also require vaccination as a condition of service. To ensure safety, research must first ascertain whether vaccines prevent infection or only prevent disease. The duration of immunity from vaccines is also unknown. Beyond gaps in scientific knowledge, so-called “immunity passports” face logistical challenges, including implementing a novel policy approach in the US. Any certification or immunity passport, moreover, should be explicit about what is being attested to and avoid guarantees of protection against COVID-19.8 If scientific and logistical challenges can be overcome, linking vaccinations as a condition of providing service could be an effective incentive for vaccination.

Acceptance and Implementation

Legal mandates signal clear policy support for immunizations, which can also increase resources for a vaccine infrastructure. Yet mandates can undermine public support, creating a backlash and even reducing vaccine uptake. Mandates may be useful in the future, but their implementation among any population that does not widely support vaccination could be counterproductive. The purpose of risk communication is to inform decision-making, respecting individual choice. Mandates fundamentally alter this dynamic by overriding personal autonomy. Furthermore, although employers, health care, and educational institutions can monitor conformance with mandates, there are no clear mechanisms to enforce population-wide vaccination requirements.

Immunization coverage sufficient to achieve community immunity will reap enormous health, social, and economic benefits. Limited vaccine mandates with public support, in special high-risk or high-value settings, and with longer-term safety data can be part of a comprehensive package of interventions to return society to prepandemic life.

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Article Information

Corresponding Author: Lawrence O. Gostin, JD, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, 600 New Jersey Ave NW, Washington, DC 20001 (gostin@georgetown.edu).

Published Online: December 29, 2020. doi:10.1001/jama.2020.26553

Conflict of Interest Disclosures: Dr Salmon reported receiving grants from Walgreens and Merck and personal fees from Merck and Janssen. Dr Larson reported receiving grants from Merck and GlaxoSmithKline and honoraria from Merck for serving on a vaccine confidence advisory board and from GlaxoSmithKline for speaking at staff training sessions. No other conflicts were reported.

References
1.
Hamel  L, Kirzinger  A, Muñana  C, Brodie  M. KFF COVID-19 vaccine monitor. Kaiser Family Foundation. Posted December 15, 2020. Accessed December 16, 2020. https://www.kff.org/coronavirus-covid-19/report/kff-covid-19-vaccine-monitor-december-2020/
2.
Centers for Disease Control and Prevention. State vaccination requirements. Last reviewed November 15, 2016. Accessed December 16, 2020. https://www.cdc.gov/vaccines/imz-managers/laws/state-reqs.html
3.
Phadke  VK, Bednarczyk  RA, Salmon  DA, Omer  SB.  Association between vaccine refusal and vaccine-preventable diseases in the United States.   JAMA. 2016;315(11):1149-1158. doi:10.1001/jama.2016.1353PubMedGoogle ScholarCrossref
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Virtual Yale CEO summit: finding common ground across a divided land. Yale School of Management. December 15, 2020. Accessed December 16, 2020. https://som.yale.edu/event/2020/12/virtual-yale-ceo-summit-finding-common-ground-across-divided-land-getting-your-workforce-shareholders-customers-and-communities-back-to-business
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What you should know about COVID-19 and the ADA, the Rehabilitation Act, and other EEO Laws. December 16, 2020. Accessed December 19, 2020. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws?utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term=
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Bellon  T. US employers could mandate a COVID-19 vaccine, but are unlikely to do so–experts. Reuters. December 2, 2020. Accessed December 16, 2020. https://www.reuters.com/article/us-health-coronavirus-vaccine-companies/u-s-employers-could-mandate-a-covid-19-vaccine-but-are-unlikely-to-do-so-experts-idUSKBN28C2LL
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Association of Immunization Managers. Position statement: school and child care immunization requirements. 2006. Accessed December 16, 2020. https://cdn.ymaws.com/www.immunizationmanagers.org/resource/resmgr/files/aimpositionstatement.pdf
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Cash-Goldwasser  S, Kardooni  S, Cobb  L, Bochner  A, Bradford  E, Shahpar  C. Immunity passports. COVID-19 Science Review. Posted December 15, 2020. Accessed December 16, 2020. https://preventepidemics.org/covid19/science/weekly-science-review/december-5-11-2020/
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    4 Comments for this article
    EXPAND ALL
    Mandating Covid-19 Vaccination
    Kent Savage, MHA | Retired Healthcare Executive
    In a freedom-based society such as the United States of America (USA), mandating vaccinations of any kind is contraindicated. Why would a healthcare professional ever suggest such a thing? It is because of the politicization of the pandemic in our American culture. We can attribute this to a President who has created more controversy over the pandemic than Woodrow Wilson who downplayed the 1918 influenza pandemic. The current President, like President Wilson with influenza, downplayed Covid-19 and then became sick with the virus. The difference is that the current President recovered rather quickly apparently causing him to believe Covid-19 was relatively benign unlike Mr. Wilson who became violently ill for some time.

    What does this have to do with vaccinations today? The President and his followers tend to believe him without question so about 48% of the population believe Covid-19 is predominantly benign. How could any reasonable healthcare professional believe that mandated vaccination would even begin to be successful in a reasonable timeframe when 48% of Americans will likely refuse to take it? Even if the refusal was near 25%, the intended result would not occur in a suitable timeframe.

    The best way to ensure maximum vaccination exposure is through public discussion that convinces the 48% that while the President may have had minimal health issues from Covid-19 a large number of people do and could easily include you, your children, your parents and your grandparents. We need continued examples of the safety of the vaccination and to have the reactions so closely reported in the press to be put into context.

    For example, 3 out of even 100,000 people having side effects makes the probability of having side effects almost non-existent while having 90,000 or so out of 100,000 develop immunity a significant goal attainment in eradicating this pandemic. We also need every healthcare worker and healthcare organization to demonstrate ZERO defects in administering the vaccine so that we stop hearing about those who were overdosed.

    Demonstrating, very directly, how the benefits outweigh the risks of vaccination by roughly 30,000:1 is a compelling argument for voluntarily receiving the vaccine. Other methods to improve voluntary vaccination include making it simple: minimal health history prior to vaccination (only information that is relevant to known allergies, etc.), large choice of vaccination locations, requiring all insurers to cover the 100% of the cost without unending documentation (yes, it's apparently free except to those with insurance), no requirement of a licensed provider's order, and the choice as to whether to get it or not.

    This is how we vaccinate the greatest percentage of people: "keep it simple." Free will is an inherent right of all mankind. Gentle, persistent and encouraging rhetoric helps people make the right choice, not mandates. I am not impressed with medical proselytizing nor with believing our healthcare system is always working in the best interests of society (a topic for another time). Consider the nature of flawed human decision-making. My grandfather had a very appropriate saying for this situation: "you can bring a horse to water but you can't make it drink." Mandates will not work in our current social environment. Find another, more appropriate approach.
    CONFLICT OF INTEREST: None Reported
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    Expectations and Anxieties About the COVID-19 Vaccine in Japan
    Takuma Hayashi, MBBS, D.M.Sci., GMRC, PhD | National Hospital Organization Kyoto Medical Center
    In Europe and the United States, vaccination against COVID-19 began in early December 2020. In Japan as well the start of vaccination against COVID-19 is expected. The Japanese Society of Infectious Diseases provides medical information to the Japanese people regarding the efficacy and safety of the COVID-19 vaccines which are currently being used overseas. In order for the Japanese people to judge the necessity of COVID-19 vaccination, the Japanese Society for Infectious Diseases on December 28 posted a proposal (1st edition) on their website. In the future, the content of the proposal regarding the COVID-19 vaccine will be updated from time to time as the situation of the COVID-19 vaccine changes in Japan and overseas.

    The proposal (1st edition) comprises sections on
    • Status of COVID-19 vaccine development worldwide
    • Medical features of each COVID-19 vaccine
    • Mechanism of action of mRNA vaccines and viral vector vaccines
    • How to evaluate the efficacy of COVID-19 vaccine
    • Efficacy in clinical trials of three vaccines (Pfizer's BNT162b2, Moderna's mRNA-1273, AstraZeneca's ChAdOx1)
    • Adverse events after the first and second vaccinations
    • Priority vaccination target in Japan
    • Precautions for COVID-19 vaccination
    In recent years the Japanese people have developed a negative attitude about vaccination. In Japan, in comparison with other countries, a special situation is continuing in relation to HPV vaccination. Serious symptoms have been observed after vaccination with the HPV vaccine, and the causal relationship between HPV vaccination and the serious symptoms continues to be disputed in Japan. Due to this dispute, many Japanese people do not accept HPV vaccination. From that experience, the number of Japanese people who wish to receive the COVID-19 vaccine is about 60% of all Japanese people, even if the COVID-19 infection continues to spread. In order for many Japanese peoples to be vaccinated with the COVID-19 vaccine, the Japanese government must transparently publicize any causal relationship between vaccination and adverse events and enhance medical support for serious medical conditions.
    CONFLICT OF INTEREST: None Reported
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    EUA Standards are not less than normal BLA
    Eric Harris, PhD | Retired neuroscientist
    Gostin et al. state that "an EUA requires less safety and efficacy data than full Biologics License Application (BLA) approval." Are there FDA regulations or guidances that support that statement? FDA's Q&A about COVID-19 vaccines state the following: "COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer."
    CONFLICT OF INTEREST: None Reported
    Mandatory Coronavirus Vaccinations
    Andrea Gardner, Registered Nurse | Retired
    This isn't a political issue. Vaccine-hesitant individuals come from all walks of life. Some believe all vaccinations are harmful. Others are skeptical because of past harmful actions, and will carry those ideas with them for this vaccine. Those harmed by a pharmaceutical such as diethylstilbestrol might think that until something is proven to be both safe and effective they might wait for more data to come forth prior to getting theirs.

    These vaccines are brand new. In reality we know very little about them. They received EUA only; they are not licensed. I am very uncomfortable
    with Dr. Fauci's recent suggestion that he might advise getting more people vaccinated once but holding off on the second dose. We don't really know how well the vaccines work with the two vaccinations given on time. If I can't get them as directed by the manufacturer, I will wait until I can. There's too much at stake. We don't even know how long any protection will last.

    Let's encourage the public to be vaccinated. Many groups are anxious for the vaccine to be available to them as soon as possible. My daughter in law, who is a nurse, was among the first in her hospital be vaccinated, having signed up prior to EUA approval. Most of my friends and former colleagues are waiting for their chance to get it. We older folks who are in good health lead busy, active, lives. I want to have my grandchildren back in my home. I want to return to my civic and social activities, and travel. Politics doesn't enter into my decision. Let's not malign a group with which we don't agree; that won't help anything.
    CONFLICT OF INTEREST: None Reported
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