key: cord-0940275-6l58anrr authors: Reiss, Dorit R; Caplan, Arthur L title: Considerations in Mandating a New Covid-19 Vaccine in the USA for Children and Adults date: 2020-05-08 journal: J Law Biosci DOI: 10.1093/jlb/lsaa025 sha: 80e672a9323ea45cbbb96260dce5586abe3c3918 doc_id: 940275 cord_uid: 6l58anrr nan School mandates have been a staple of United States policymaking since the 19 th century, and currently, all fifty states and the District of Columbia require vaccines for school. 5 Adult mandates are less common, and usually adopted in specific contextsfor example, the famous Jacobson case addressed a mandate for a smallpox vaccine in the context of an outbreak. 6 In another recent context, flu shot mandates are targeted at healthcare workers. 7 There is a large literature about school mandates, and a somewhat more limited literature on adult mandates, but there is less principled discussion of when is it appropriate to mandate a specific vaccine. Field and Caplan suggested an ethical framework to consider when school mandates ought to apply. 8 They suggested that a principled, neutral way to assess a vaccine mandate is to treat it as an intersection of competing values, and examine the factors that Autonomy focuses on the right of individuals to govern their own behavior, and requires both ability to comprehend the choice, the alternatives, the consequences, and freedom from outside limitations. Children generally have less autonomy than adults, because their capacity to make decisions is less. 9 The autonomy in question here is that of parents to make medical decisions for their childrenand that autonomy is more limited, since the primary focus is on the child's benefit, with the parent or guardian acting as their agent. 10 It is unclear what age COVID-19 vaccines will be recommended for, but if adolescents, there may be more of an argument for autonomyand in that case, it is worth considering not just a mandate, but the right of a minor to consent to a vaccine over parental opposition. 11 For adults, of course, the autonomy argument is stronger but not overwhelming depending on context. Healthcare workers sacrifice some of their autonomy by entering, voluntarily, a highly regulated service profession, where they accept certain requirements (and certain risks) in favor of their patients. 12 Some states, for example Rhode Island, have also enacted mandates for day I P T 5 care workers and various occupations including military service, off-shore oil work and some private employers require vaccination without exceptions except for medical reasons. 13 The argument for autonomy that an adult might invoke weakens as the risk to others by their non-participatory conduct increases: it is more justified to limit autonomy when its invocation harms others. COVID-19 (unlike influenza, which has more of a bi-modal distribution, where both the old and the very young are at greater risk), is both more contagious and far more lethal than influenza, though the risk of death and hospitalization increases with age. 14 While the risk to healthy children is less, healthy unvaccinated children who do not receive the vaccine can getand transmitthe virus both to vulnerable classmates for example, children with medical conditions that put them at high risk if they get COVID-19, and to high-risk teachers (such as the teacher, administrator or janitor who is over sixty years old, those who are immunocompromised or have conditions like diabetes or heart disease). 15 There may be additional risks not yet discoveredfor example, recent findings from UK suggest that COVID-19 may cause a severe but rare syndrome in children, though the data is yet too limited to be certain. 16 Adults can certainly infect others, too. In the hospital, there is a substantial risk for both healthcare workersnot just the healthcare workers themselves, discussed below, but also their 13 colleagues including cleaners, technicians, food preparation, first responders, transporters, security, parking, chaplains, social workers, and potentially vulnerable patients. 17 Given the risk to others and the need to keep the health system functioning, the argument for autonomy in any health care setting broadly understood seriously weakens. Mandates will surely be imposed with almost no if any exceptions. Beneficence involves acting for the benefit of othersincluding by preventing harm to them. A vaccine against COVID-19 would have some benefit for children, since some children get seriously ill from the disease, and rarely, children may die from it. 18 They may also suffer from long term harms yet to be established, as mentioned above. But most children are asymptomatic or mildly ill with COVID-19, so the known benefits directly to the children are limited (though real). Healthcare workers, in contrast, suffer disproportionally severe disease from COVID-19, and for adults generally, the risks and the corresponding benefits from a vaccine mandate increase with age. 19 On the other hand, utilitarianismacting for the benefit of the greatest number for society as a whole,-supports a COVID-19 mandate, as it supports other vaccine mandates. School mandates are very effective at increasing vaccines rates and reducing the risk of outbreaks. 20 Hospital mandates are also effective. 21 While data on adult mandates is limited since they have not often been used in recent times (though New York city imposed a temporary mandate for the measles, mumps and rubella (MMR) vaccine during its recent outbreak), data from other contexts suggest they increase rates. The current pandemic is causing harms in lives and suffering, and also economic harms as preventing loss of more life requires measures like sheltering at home, closing businesses and the closing of public spaces. Preventing these staggering costs is a huge social benefit. Once a vaccine is available, the justification for measures like shelter-at-home will decrease, but preventing harms will depend on vaccine use. A mandate will increase use, boost herd immunity and reduce costs. The only caveat is that the balance of costs and benefits depends on the safety of the vaccine. One concern is that the pressure to license and recommend a vaccine quickly, with perhaps less evidence then normally would be required by regulators, in the face of a disease causing extensive social upheaval, harms, and social fear, will lead to licensing of a vaccine that will be discovered to have unexpected risks, potentially even greater than the risks prevented. Usually testing a vaccine for licensing takes years; but at least one vaccine candidate has already skipped animal studies, moving straight to stage I trials. 22 surveillance. 26 Multiple oversight systems would have to fail to allow a mandate to apply to a vaccine whose risks outweigh its benefits. So while the discovery of a problem may be a possibility, it would require a combination of unlikely events, and for which the chances are very low. Further, since the 1980s the United States provided compensation for vaccine injuries using a no-fault system, in other words, in the rare cases of harms from a vaccine, recipients can be compensated without having to show negligence or a defect in the vaccine, making compensation more easily accessible than in the regular courts. 27 To be covered by the program, a vaccine needs to be recommended by ACIP for either children or pregnant women, so a COVID-19 vaccine licensed for adults only will not be covered without further legal change. 28 The compensation program is the easiest and most just way to handle the rare cases of vaccines harms, and having those cases covered under it would be an important complement to a mandate. Justice requires allocating scarce resources based on a principled, reasoned system. In the context of mandates, a precondition to a mandate is a system for providing access to the vaccine. For recommended vaccines, the Vaccines For Children program addresses many access issuesand again, vaccines are not generally mandated unless they are recommended. 29 In addition, in a recent article Shachar and Reiss pointed out that precedent and context also affect the reasonableness of adopting a vaccine mandate. 33 In the United States, school immunization mandates are a traditional, well established rule (though they are accompanied by exemptions), and quite a few were adopted in response to general public health needsthat was the driving force behind the smallpox school mandates in the 19 th century and the spread of measles mandates, for example, in the 1960-1970s. 34 This history, also supports a school mandate. Coming out of a large outbreak, and in the context of a country seeking to improve long-term safety from this highly lethal virus, this context supports one. Adult mandates, however, are no longer common, and have rarely be used (though New York City, experimenting with one, offers a recent precedent 35 ). Healthcare worker mandates are in betweensomewhat common, but far from universal. The current legal framework provides states extensive leeway to mandate school immunizations, and in the past, courts have refused to step into evaluating the specific vaccines mandated, leaving that decision, by implication, to the legislature. 36 In fact, the classic Jacobson case, in which the court upheld a vaccine mandate, expressly stated that the court is deferring to the legislature. 37 Since all vaccines currently mandated are recommended by an expert committee, ACIP, and subject to extensive professional monitoring, it's reasonable for courts to allow legislatures to choose among these expert-recommended vaccines. But after the initial smallpox mandates, there have not been cases challenging only the mandating of an individual vaccine. The COVID-19 vaccine can raise questions for child mandates because, as mentioned, the main benefits are likely to accrue to others than the children themselves. Adult mandates are trickier. Healthcare worker mandates will likely be constitutional, because healthcare workers work with a vulnerable population. 38 But they will be subject to federal antidiscrimination laws, and may be challenged if they do not offer a religious or medical exemption, though such challenges have not always not succeeded. 39 While Jacobson upheld an adult mandate, it has been a long time since Jacobson, and the question is less certain today. A detailed analysis of Jacobson's validity is beyond this paper, but is an important topic. 40 Finally, past experience suggests that enacting school mandates or tightening them in the United States is difficult but not impossible. 47 In short, depending on the features of the vaccine, there may be good ethical grounds to mandate a COVID-19 vaccine, as long as the risk is low, and access is readily available. Our jurisprudence suggests states will face few, if any, legal barriers in doing so, and the past political fights brought on by anti-vaccination groups are likely to be significantly weakened by the unparaled intensity of the COVID-19 crisis. Supporting the Health Care Workforce During the Covid-19 Global Epidemic COVID-19 Infection in Children, Online only: The Lancet Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention Exempting Schoolchildren from Immunizations: States with Few Barriers Had Highest Rates of Nonmedical Exemptions, 32 HEALTH AFF. 1282, 1289 (2013) (confirming the inverse relationship -between nonmedical exemptions rates and the complexity of exemption applications procedures‖) Processes for Obtaining Nonmedical Exemptions to State Immunization Laws, 91 AM Medical Exemptions to School Immunization Requirements in the United States-Association of State Policies with Medical Exemption Rates The National Vaccine Injury Compensation Program: Striking a Balance Between Individual Rights and Community Benefits National Vaccine Injury Compensation Program: Covered Vaccines How to Pay When are Vaccine Mandates Appropriate Manifold Restraints: Liberty, Public Health, and the Legacy of Jacobson v Massachusetts, 95 AJPH New York Declares Measles Emergency, Requiring Vaccination in Parts of Brooklyn. NYTimes Responding to the Childhood Vaccination Crisis: Legal Frameworks and Tools in the Context of Parental Vaccine Refusal. 63 BUFF First Do No Harm: Protecting Patients Rough Immunizing Health Care Workers, 26 Vaccination without Litigation -Addressing Religious Objections to Hospital Influenza-Vaccination Mandates 375 Influenza Mandates and Religious Accommodation: Avoiding Legal Pitfalls However, Jacobson is already in play in the COVID-19 jurisprudence and may change. In a recent blog post, scholars Wiley and Vladeck summarize their coming piece on the issue: Lindsay F. Wiley & Steve Vladeck COVID-19 Reinforces the Argument for -Regular‖ Judicial Review-Not Suspension of Civil Liberties-In Times of Ben Horowitz, A Shot in the Arm: What a Modern Approach to Jacobson v For other discussions, see: James Colgrove & Ronald Bayer, Manifold Restraints: Liberty, Public Health, and the Legacy of Jacobson v. Massachusetts, 95 AM Massachusetts at 100 Years: Police Power and Civil Liberties in Tension, 95 AM Stopping the Resurgence of Vaccine-Preventable Childhood Diseases: Policy, Politics and Law. (Forthcoming, ILL L. REV.), on file with author