法律翻译 | 疫苗强制接种对于提高美国新冠疫苗接种率的意义

译者 | 高兴，香港大学LL.M.

审稿 | LYJ，新加坡国立大学LL.M.

          曾梓栩，外交学院 法本

排版 | 陈远航，美国西北大学LL.M.

责编 | 陈远航，美国西北大学LL.M.

Introduction

前言

Many high-income countries have rapidly pivoted from hard decisions about who may receive  COVID-19 vaccines, due to shortages, to equally hard decisions about who must receive them. As lasting containment of COVID-19 remains elusive, many nations—from Costa Rica, to Austria,  to Turkmenistan—are turning to vaccination mandates of various kinds.[1] Mandates, however, are controversial in many countries. Austria’s proposed mandate for adults, for example, provoked mass protests. Some objectors argue mandates represent undue encroachment on individual liberty. Some other objectors maintain that mandates will not be an effective policy for COVID-19 because many individuals will seek to evade them, and mandates might erode support for other public health measures such as mask wearing.

许多高收入国家已迅速从疫苗短缺时期决定对谁可以接种新冠疫苗，转向决定谁必须接种疫苗，这两种决定同样困难。由于仍难以长久遏制新冠肺炎，从哥斯达黎加、奥地利到土库曼斯坦，许多国家正转向各种疫苗强制接种（vaccination mandates）。然而，强制接种在许多国家都是有争议的。例如，奥地利提出的针对成年人的强制接种，就引发了大规模抗议。一些反对者认为，强制接种是对个人自由的不正当侵犯。其他一些反对者坚称，强制接种并不是防控新冠的有效举措，因为很多人会试图规避该政策，而且强制接种可能会削弱人们对戴口罩等其他公共卫生措施的支持。

In this Viewpoint we consider the likely effectiveness of policies that require COVID-19 vaccines in improving vaccine uptake and reducing disease in the USA, in view of the evidence from past vaccination mandates and distinctive aspects of COVID-19. Two dimensions of effectiveness in improving uptake are relevant: (1) target-group effectiveness (the extent to which a mandate improves uptake of vaccines in the group covered by the policy) and (2) population effectiveness (the extent to which mandate policies improve vaccination coverage in the US population).

本文认为，鉴于过去疫苗强制接种和新冠疫苗的特殊性，我们审视了新冠疫苗对于美国在扩大疫苗接种率和减少疾病方面可能产生的有效性。与之相关的是提高疫苗接种率的有效性的两个方面：（1）对于目标人群的有效性（疫苗强制接种在多大程度上提高了政策所涵盖群体的疫苗接种率）和（2）对于全体人群的有效性（疫苗强制接种在多大程度上提高了美国人民的疫苗接种率）。

By vaccination mandate, we refer to requirements issued by government or private educational institutions or employers that condition access to an important benefit (typically school or  employment) on having received a vaccine, unless an exemption applies. Exemptions can be available on religious or philosophical grounds; as legal matter, they must also be provided for valid medical contraindications. Compulsory vaccinations—requirements that carry civil or criminal penalties for non-compliance—are rare. We distinguish both mandatory and  compulsory vaccination from policies that merely require unvaccinated individuals to submit to  alternative measures to prevent spreading disease to others, such as undergoing testing for disease.

我们这里所说的疫苗强制接种，是指政府、私立教育机构或雇主颁布的要求，这些要求将接种疫苗作为获得重大福利（通常是上学或就业）的前提条件，除非适用接种豁免。豁免可以出于宗教或哲学原因；同样，作为法律问题，一些患有医学禁忌症的人群也应该可以适用豁免。强制接种（违反者将受到民事或刑事的处罚的政策）并不常见。我们将义务接种、强制接种政策与仅仅要求未接种疫苗的个人采取替代措施预防疾病传播的政策区分开来，后者例如进行疾病检测。

Evidence for the effectiveness of vaccination mandates

疫苗强制接种的有效性的证据

Substantial evidence shows that vaccination mandates in the USA performed well on both  dimensions of effectiveness before the COVID-19 epidemic. Cross-state comparisons show that  states’ school-entry mandates (eg, for pertussis and measles) are effective in improving vaccination coverage among schoolchildren and greatly reduced disease outbreaks in the USA. [2][3]This has already led two states (California and Louisiana) and the District of Columbia to adopt COVID-19 vaccination mandates for schoolchildren.

大量证据表明，在新冠流行之前，美国的疫苗强制接种在两个方面的有效性上都表现良好。对不同州的数据进行比较可以表明，各州的入学强制接种（school-entry mandate）（如百日咳和麻疹）可以有效提高学生（schoolchildren）的疫苗接种覆盖率并大幅减少美国的疾病爆发。基于此，加利福尼亚州、路易斯安那州、哥伦比亚特区对学生采取了疫苗强制接种措施。

（图片来源于网络）

The stringency and enforcement of school-entry mandates matter. States that have eliminated personal-belief or religious exemptions (while maintaining medical exemptions) have lower exemption rates and higher vaccination rates.[2][3] Further, outbreaks of vaccine-preventable disease have disproportionately occurred in areas with higher exemption rates.[2][3][4] Such evidence has prompted California, Connecticut, Maine, Mississippi, New York, Washington, and West Virginia to remove religious or personal-belief exemptions from some or all vaccination requirements.[5] Likewise, states that impose burdensome procedural requirements to obtain exemptions—such as counselling, annual reapplication, notarisation, or clergy attestation—have lower exemption rates and lower risk of disease outbreak.[2][3] Vaccination mandate laws with gaps or loopholes (eg, delayed effective date) have prompted strategic behaviour among vaccine objectors.[6] Mandate laws can also provoke controversy related to the specific targets of the vaccine. For example, the attempt to require adolescents to receive human papillomavirus vaccines following the first vaccine approval in 2006 sparked heated debate. Some people questioned requiring a vaccine for a virus that is not transmitted through casual contact, even though the virus can cause six different types of cancer. The perception that the vaccine manufacturer was involved in political efforts to adopt mandates created additional controversy.

入学强制接种要求的严格性和强制性非常重要。不适用个人信仰或宗教豁免（同时保持医疗豁免）的州的豁免率较低，且疫苗接种率较高。此外，疫苗可预防的疾病的暴发不成比例地发生在豁免率较高的地区。这些证据促使加利福尼亚州、康涅狄格州、缅因州、密西西比州、纽约州、华盛顿州和西弗吉尼亚州取消了宗教或个人信仰的接种豁免。有的州则颁布了豁免所需的繁琐的程序规定，比如咨询、每年重新申请、公证或神职人员认证，这些州接种豁免率较低，疾病爆发的风险也相对较低。疫苗强制接种规定中存在的漏洞（例如，生效日期延迟）已使得反对疫苗者采取了相应策略。强制接种法律也可能引发有关疫苗具体目标的争议。例如，在2006年第一针人类乳头瘤病毒疫苗获得批准后，青少年被要求接种的尝试就引发了激烈的争论。一些人质疑，尽管这种病毒会导致六种不同类型的癌症，但他们却要为一种不能通过偶然接触传播的病毒接种疫苗。有种说法认为是疫苗制造商在其中采用政治手段推动疫苗的强制接种，这种观点又引发了另一种争议。

Compared with childhood vaccination mandates, less evidence is available concerning mandates for adults. Many states and universities require college students to be up to date on meningitis and other vaccines, but there is little reliable information about how such requirements have affected vaccine uptake or disease outbreaks. Facility and state policies requiring influenza vaccination for health-care workers significantly increase vaccination rates, decrease inpatient influenza diagnoses, and reduce influenza mortality for long-term care residents and the general population.[7][8]

与儿童疫苗强制接种相比，关于成人疫苗强制接种的数据较少。许多州和大学要求大学生了解脑膜炎和其他疫苗的最新情况，但关于这些要求如何影响疫苗接种率或疾病爆发的可靠信息很少。为医疗工作者接种流感疫苗而配套的设施和相关政策显著提高了疫苗接种率，减少了流感住院的病人数量，并降低了长期照护人群和普通人群的流感死亡率。

There are growing reports (albeit not systematic evaluations) that COVID-19 vaccination mandates for health-care workers, emergency first responders, federal workers, school staff, university students and staff, and other groups have garnered high levels of compliance.[9][10] Among US adults vaccinated from June to September, 2021, 35% report that a major reason they got vaccinated was to participate in recreational activities that required proof of vaccination and 19% said their employer’s requirement was a major reason.[11]

越来越多的报告（尽管不是系统的评估）表明，医疗工作者、急救人员、联邦工作人员、学校员工、大学师生以及其他群体对于疫苗强制接种表现得非常顺从。在2021年6月至9月接种疫苗的美国成年人中，35%的人报告说他们接种疫苗的主要原因是为了参加需要接种疫苗证明的娱乐活动，19%的人称主要原因是其雇主的要求。

Considerations that might reduce the effectiveness of COVID-19 vaccination mandates

可能降低新冠疫苗强制接种有效性的因素

Several aspects of the COVID-19 pandemic create uncertainty as to whether COVID-19   vaccination mandates will produce outcomes as favourable as those of school-entry mandates for other vaccines, particularly for population-wide effectiveness.

新冠大流行的几个特征导致我们无法确定疫苗强制接种是否会产生与其他入学强制接种的疫苗一样有利的结果，特别是对全体人群的有效性。

Resistance to COVID-19 vaccination mandates is markedly higher than for other vaccination mandates.[12] Political polarisation and propagation of vaccine scepticism by conservative media and political leaders have fostered anti-vaccine views among an unusually high proportion of the population in some areas of the country.[13] For both adults and children, this resistance jeopardises the target-group and population effectiveness of COVID-19 vaccination mandates. Further, government requirements could strengthen anti-vaccine sentiment generally,[14] add fuel to organised campaigns to roll back other mandates (which have already resulted in proposed legislation in some states), and reduce acceptance of other vaccines.

对疫苗强制接种的抵触要明显多于强制接种的其他疫苗。保守派媒体和政治领导人的两极化政治以及疫苗怀疑论的传播，使得一国某些地区有异常高的人口比例产生了反对疫苗的观点。对于成人和儿童，这种抵触情绪危及强制接种疫苗的目标人群和全体人群的有效性。此外，政府的相关强制性规定会增强对疫苗的抵触情绪，助长有组织的活动取消其他强制接种（这已经导致了一些州拟颁布法律），并降低对其他疫苗的接受度。

Another source of mandate resistance in the USA is the view that those who have been infected with the virus do not need vaccination, thereby making mandates less essential. Evidence  suggests that the immunity produced by natural infection varies by individual, and that people   with previous infection benefit from vaccination.[15] New variants further undercut the case for the adequacy of previous infection[16] (although they could also mean reduced vaccine effectiveness, at least until vaccines can be reformulated).

（图片来源于网络）

在美国，抵触强制接种的另一个原因是，有观点认为已经感染过病毒的人不需要接种疫苗，因此强制接种并不是那么必要。有证据表明，自然感染产生的免疫因人而异，曾感染新冠的人接种疫苗也是有好处的。新的病毒变种进一步削弱了曾经感染就不需要接种疫苗的论断。（尽管它们也可能意味着，至少在疫苗能够重新配制之前，疫苗的有效性会降低）。

Except for entities subject to federal regulation, COVID-19 vaccination mandates remain the responsibility of states, localities, and businesses. Ideological divides mean that mandates will be differentially adopted across the country. Areas with the lowest vaccination rates are least likely to mandate vaccination. Some states have adopted laws prohibiting some or all COVID-19  vaccination mandates.[17] This phenomenon does not affect target- group effectiveness, but does weaken the population effectiveness of mandates.

除受联邦监管的实体外，疫苗强制接种仍由各州、地方和企业负责。意识形态上的分歧意味着，在全国范围内采用强制接种的程度不同。疫苗接种率最低的地区最不可能强制接种疫苗。一些州已经通过法律，禁止部分或全部新冠疫苗的强制接种。这种现象并不影响强制接种对目标群体的有效性，但确实削弱了对全体人群的有效性。

Some potential COVID-19 vaccination mandates would be challenging to enforce, undercutting both target-group and population effectiveness. No strong levers exist for enforcing a general-population mandate for adults. The main available mechanism—a civil fine—is regressive, would be very difficult to implement, and might intensify political opposition. College attendance, loans, and government benefits could be conditional on COVID-19 vaccination, but most people in the USA are not students. Many government benefits (eg, Medicaid coverage and unemployment benefits) support vulnerable populations. Withholding them could undercut pandemic control and health equity.

将一些潜在的疫苗强制接种规定付诸实施是具有挑战性的，这将削弱疫苗对目标人群和全体人群的有效性。并没有强有力的施压来强制对成年人执行普通人群的规定。现有的主要可用的机制——民事罚款——是倒行逆施的，不仅难以实行，而且可能加剧政治性抗议。大学入学率、贷款和政府福利可能以新冠疫苗的接种为条件，但大多数美国人并不是学生。许多政府福利金（如医疗保险和失业救济金）都支持弱势群体。用需要接种疫苗来限制这些福利的领取可能会削弱对流行疾病的控制和卫生公平性。

In contrast, employer-based vaccination requirements are relatively straightforward to enforce through adverse employment consequences. A few large US employers have terminated   hundreds of workers for non- compliance.[18] Of course, employer-based mandates do not reach everyone. Moreover, employers’ cooperation in enforcing them is not universal. Employers who disagree with vaccination requirements, face pushback from labour unions, or are unwilling to lose workers in a tight labour market might not insist on vaccination. Workforce concerns have led some school districts and correctional institutions to add a testing alternative to vaccination.

相比之下，通过把疫苗强制接种与不利的就业后果联系起来，雇主推广疫苗强制接种的方式相对容易执行。一些美国大型雇主以不遵守规定为由解雇了数百名员工。当然，雇主推广的强制接种并不能适用于所有人。此外，雇主在执行这些措施方面的合作意愿并不一致。那些不同意接种疫苗的、面临工会抵制疫苗的，或不愿在紧张的劳动力市场中失去员工的雇主可能不会坚持要求员工接种疫苗。对劳动力的担忧导致一些学区和惩教机构增加了一种接种疫苗的测试性替代方法。

School-entry mandate rely on mechanisms (eg, administrative review of student registration data or completion of state reporting requirements) that function best at the start of the academic year. Imposing such mandates mid-year would mean that unvaccinated students could be moved to remote learning programmes or forced to find another district that is willing to accept them in the middle of a school grade—an undesirable prospect given the educational disruption children have already endured. This enforcement problem eases with the advent of a new academic year.

入学强制接种，依靠的是在学年开始时发挥最大作用的机制（如对学生注册数据的行政审查或完成州的报告要求）。在学年中实施这样的规定意味着未接种疫苗的学生会被转移到远程学习项目，或者被迫找另一个愿意接受他们在学段中途转学的地区——这将中断孩子们已接受的教育，导致不良的前景。随着新学年的到来，这一实行上的问题将会有所缓解。

As to the ultimate impact of school mandates on COVID-19 spread, in areas with high vaccination coverage for adults and adolescents, the marginal reduction in cases from school mandates compared with voluntary vaccination coupled with universal mask wearing might be modest. Mandates for adults can help lessen the need for school-entry mandates by reducing community prevalence. However, as mask mandates are lifted and childhood COVID-19 vaccines receive full government approval, the case for adding COVID-19 to the list of vaccines required for school entry will strengthen. Full licensure, which requires submission of additional evidence of vaccine effectiveness and safety beyond the relatively small clinical trials supporting emergency use authorisation, is possible by the start of the 2022–23 academic year.

（图片来源于网络）

至于入学强制接种（school mandates）对新冠传播的最终影响，在成人和青少年疫苗接种覆盖率高的地区，与自愿接种疫苗并普遍佩戴口罩相比，入学强制接种引起的病例减少可能并不明显。对成人的强制规定可以通过降低社区的疫情流行率来帮助减少对入学强制接种的需要。然而，随着口罩令（mask mandates）的解除、儿童新冠疫苗获得政府的全面批准，将出现更多将新冠疫苗列入入学所需疫苗清单的情况。除了支持紧急使用授权的相对较小的临床试验之外，疫苗全面许可需要提交关于疫苗有效性和安全性的额外证据。到2022-23学年开始时，可能会获得全面许可。

A final enforceability concern relates to legal challenges. COVID-19 vaccination mandates adopted by both public and private organisations are being heavily litigated, with the decisions issued to date sending confusing signals about their legality. On Jan 13, 2022, the Supreme Court invalidated a federal requirement that large employers mandate vaccines, adopting a surprisingly narrow view of federal authority, but upheld a federal mandate for health-care facility employees. Lower court decisions, too, have sent conflicting messages about legal requirements for both federal and state mandates. Individuals and organisations subject to mandates could delay compliance in the belief that it will ultimately not be needed, thereby jeopardising target-group effectiveness. State and local governments and other organisations might not adopt mandates until the legal issues are resolved, reducing population effectiveness. Indeed, some employers pulled back from mandate plans in the wake of the Supreme Court decisions even though those decisions had no bearing on what private employers can require.

最后一个可执行性问题与法律上的挑战有关。公共和私营组织采用的疫苗强制接种正在引发大量诉讼，迄今为止发布的决定令人对其合法性感到困惑。2022年1月13日，最高法院宣布要求大型雇主强制接种疫苗的联邦规定无效，出乎意外地限制联邦权力，但维持了针对医疗机构雇员的联邦规定。下级法院的裁决也释放出关于联邦和州强制接种法律的相互矛盾的信息。应被强制接种的个人和组织可能会延期接种，因为他们相信最终不再会推行强制接种疫苗，而这将损害疫苗对目标人群的有效性。在法律问题得到解决前，州政府、地方政府、其他组织可能不会采取任何强制措施，这会降低疫苗对全体人群的有效性。事实上，在最高法院的裁决后，一些雇主不再遵守强制接种的规定，尽管这些裁决对私人雇主的要求并没有影响。

Because safety is the main concern among people in the USA who have not yet been vaccinated against COVID-19,[19] the target-group effectiveness of vaccination mandates— and political support for adopting mandates—are closely linked to assuring the public that the vaccines are safe. Post-licensure safety data can improve confidence that the expected benefits of a vaccine outweigh its risks. During COVID-19, widespread administration in adults has quickly generated a large evidence base supporting the vaccines’ safety, including evidence from active-surveillance studies.[20] Although initial signals of vaccine safety for children have been favourable, the evidence base is still evolving. Additional analyses on the risk of adverse events should be conducted using active-surveillance data before school-entry mandates are implemented.

由于疫苗的安全性是美国尚未接种新冠疫苗之人的主要担忧，疫苗强制接种的目标群体有效性以及对采用强制要求的政治性支持都与向公众保证疫苗的安全性密切相关。获得许可后的安全数据可以让人们更加相信疫苗的预期收益大于其风险。在新冠期间，疫苗在成人中的广泛使用，已经迅速产生了支持疫苗安全性的大量证据基础，其中包括来自主动监测研究的证据。尽管儿童疫苗安全的初步信号是有利的，但证据基础仍在不断发展。在实施入学强制接种之前，应使用主动监测数据对不良反应的风险进行另外的分析。

Public communication of studies showing the vaccines’ safety has been suboptimum. Media reports have given greater prominence to vaccines’ association with specific adverse events than to their overall favourable benefit-to-risk ratio. These problems could reduce compliance with  COVID-19 vaccination mandates in the absence of a concerted, sophisticated effort at public education.

对证明疫苗安全性的研究进行的公共宣传一直不够理想。媒体在报道中更多地强调了疫苗与特定不良反应的关系，而不是其总体上有利的收益和风险比。如果在公众教育方面缺少一致的、精心的部署，这些问题可能会导致人们不遵守疫苗强制接种的规定。

（图片来源于网络）

Conclusions

结论

COVID-19 vaccines have shown higher effectiveness in preventing infection with some variants than others, but their great value in preventing severe illness and death is clear.[21] Mandates can play a role in promoting uptake of these vaccines. Our review supports several specific conclusions.

尽管新冠疫苗预防某些变种的感染效力不如其他变种，但它们在预防严重疾病和死亡方面的巨大价值仍非常明显。强制接种可在促进疫苗接种率方面发挥作用。我们通过讨论得出了几个具体的结论。

First, abundant evidence shows that school-entry mandates have been highly effective in  improving uptake of childhood vaccines. Second, the current evidence regarding the safety of COVID-19 vaccines in adults is sufficient to support mandates. Third, because of distinctive implementation challenges, the effectiveness of adult COVID-19 vaccination mandates in increasing vaccination uptake might be lower than the very high effectiveness of school-entry mandates observed for other vaccinations in the past. Therefore, mandate policies cannot be the only approach, especially given the ongoing legal uncertainties surrounding them. Fourth, COVID-19 vaccine requirements will probably be most effective when enforced by employers  and educational institutions. Fifth, consideration of school-entry mandates should follow review of real-world safety data and full licensure of the vaccines for children, which could come as soon as the start of the 2022–23 school year.

首先，大量证据表明，入学强制接种在提高儿童疫苗接种率方面非常有效。其次，目前关于成人使用新冠疫苗的安全性的证据足以支持强制接种。第三，由于在实行层面存在独特的挑战，成人疫苗强制接种在增加疫苗接种率方面的有效性可能低于过去对入学强制接种的高有效性。因此，强制政策不可能是唯一的办法，特别是考虑到这些政策在法律层面的不确定性。第四，雇主和教育机构执行强制接种新冠疫苗可能最为有效。第五，在2022-23学年开始时尽快执行：在审查现实世界的安全数据和儿童疫苗的全面许可之后考虑入学强制接种。

Finally, active surveillance for adverse events following immunisation and clear, sophisticated communication of findings to the public are essential for effective vaccination policies,  including mandates. Imposing mandates does not remove the need for effective messaging to overcome vaccine hesitancy. Giving appropriate emphasis to the major headline of the accreting vaccine safety studies—the vaccines are indeed safe—can create more fertile soil for  vaccination mandates to take root.

最后，对接种后的不良反应进行主动监测并向公众披露明确、复杂的调查结果，对于包括强制接种在内的、有效的疫苗接种政策至关重要。实行强制接种并不能取代有效的信息披露以消除疫苗犹豫。适当强调加强疫苗安全性研究的主要目的——证明疫苗确实是安全的——可以更好地为疫苗强制接种提供沃土。