Mandating COVID-19 Vaccines VIEWPOINT

Opinion

Lawrence O. Gostin, JD Severe acute respiratory syndrome coronavirus 2 breaks. Strengthening the rigor of the application pro- O’Neill Institute for (SARS-CoV-2) vaccines hold promise to control the pan- cess and enforcement are associated with improved vac- National and Global demic and help restore normal social and economic life. cination rates.3 Adult vaccine mandates are rare, but at Health Law, The US Food and Drug Administration (FDA) has granted least 16 states require influenza or hepatitis B vaccina- Georgetown University, Washington, DC. Emergency Use Authorization (EUA) for 2 messenger tions for postsecondary education. Given the rarity of RNA vaccines and will likely issue full biologics licenses adult mandates, states are unlikely to enact mandatory Daniel A. Salmon, in the coming months. Anticipating vaccine scarcity,the COVID-19 vaccinations for the adult population, espe- MPH, PhD Advisory Committee on Immunization Practice (ACIP) cially in the absence of long-term safety data. Institute for Vaccine published guidance on vaccine priorities. Safety, Johns Hopkins Bloomberg School of DataforthevaccinesgrantedanEUAreportedlydem- Health Care Facilities | Health care workers are at in- Public Health, onstrate 95% efficacy,but even highly effective vaccines creased risk of contracting infectious diseases and trans- Baltimore, Maryland. cannot curb the pandemic without high population cov- mitting to vulnerable populations. Consequently,health erage and maintenance of other mitigation strategies. care institutions must institute infection control proto- Heidi J. Larson, PhD London School of Recent data from 1676 adults surveyed November 30 to cols, and many require health care workers to receive the Hygiene & Tropical December 8, 2020, found that when a COVID-19 vaccine influenza vaccination. These institutions owe both le- Medicine, London, isapprovedandwidelyavailable:34%wouldgetitassoon gal and ethical duties to staff and patients to ensure a United Kingdom. as possible; 39% would wait; 9% would only get it if re- safe environment. Additionally, because vaccines pre- quired for work or school; 15% would definitely not get it. vent hospitalizations, their wide use in health care set- Blackpersons,athighriskofinfectionandhospitalization, tings may reduce worker shortages. Even among health arelesslikelytoreportvaccineintentwithonly20%report- workers, however, SARS-CoV-2 vaccine mandates could Viewpoint page 534 ingtheywouldgetthevaccinesoonand52%intendingto be counterproductive, given the stress of working dur- wait.1 Intent to vaccinate has changed substantially over ing a pandemic. Offering nonmedical exemptions could Multimedia time and is likely to continue to evolve. In this Viewpoint, reduce health worker concerns over mandates. we examine whether vaccine mandates would be lawful andethicalandwhethertheycouldboostvaccineuptake. Businesses | In a recent Yale CEO survey of 150 execu- tives, 71% supported companies requiring COVID-19 From EUAs to BLA Approvals vaccines.4 The Equal Employment Opportunity Com- MandatingCOVID-19vaccinesunderanEUAislegallyand mission (EEOC) has ruled that businesses can compel ethically problematic. The act authorizing the FDA to is- employees to submit to SARS-CoV-2 tests as a condi- sue EUAs requires the secretary of the Department of tion of employment. Recently, the agency determined Health and Human Services (HHS) to specify whether in- that employers can require COVID-19 vaccines and bar dividuals may refuse the vaccine and the consequences employees from the workplace if they refuse.5 The for refusal. Vaccine mandates are unjustified because an Occupational Safety and Health Administration earlier EUA requires less safety and efficacy data than full issued guidance permitting employers to require influ- Biologics License Application (BLA) approval. Individu- enza vaccinations. The EEOC, however, requires em- als would also likely distrust vaccine mandates under ployers to grant medical exemptions and offer reason- emergency use, viewing it as ongoing medical research. able accommodations based on religion or disability.6 Businesses will rely on high vaccine coverage to fa- Should SARS-CoV-2 Vaccines Be Mandatory? cilitateareturntonormaloperatingpractices.Sectorsrang- Once SARS-CoV-2 vaccines receive a BLA, policy making from food service and transportation to the arts and ers must determine to which, if any, populations man- sports have been economically harmed by public health dates should apply. Vaccine mandates could be im- restrictions, as well as by consumer reluctance to risk posed in multiple sectors, each with their own legal and SARS-CoV-2 exposure. In many settings, like meatpack- ethical considerations. ing plants, there is high occupational risk of virus transmission.Businesseshaveanethicalandlegaldutytokeep State Mandates |SinceJacobsonvMassachusetts(1905), their workers and customers safe. Thus, businesses that Corresponding the judiciary has consistently upheld vaccination man- requirein-personattendance,catertovulnerablecustom- Author: Lawrence O. dates. All states require childhood vaccines as a condi- ers, or both may consider mandates with accommoda- Gostin, JD, O’Neill tion of school entry, which are demonstrated to main- tions for medical, religious, or disability reasons. Institute for National and Global Health Law, tain high coverage and prevent vaccine-preventable 2 Georgetown University diseases. All states grant medical exemptions, and 45 Postsecondary Education | Colleges and universities will Law Center, 600 states and Washington, DC, grant religious exemp- also need high vaccine coverage to safely reopen in- New Jersey Ave NW, tions, with 15 states also allowing philosophical exemp- person learning. Sitting in a crowded classroom for long Washington, DC 20001 (gostin@georgetown. tions. Vaccine exemptions often cluster geographically durations poses a high risk of transmission. Postsecond- edu). and socially and are associated with a higher risk of out- ary institutions have often been loci for vaccination

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campaigns, and many have required influenza vaccines during the risk settings could require proof of vaccination as a condition of ser- COVID-19 pandemic. It is foreseeable that institutions of higher edu- vice, such as in long-distance travel (plane, rail, bus), restaurants, and cation may require SARS-CoV-2 vaccines for students, faculty, and entertainment (sports, movies, theater). While states might be con- staff as part of fall 2021 reopening plans. stitutionally barred from requiring vaccines to participate in religious worship,itisconceivablethatsomechurches,synagogues,ormosques Primary and Secondary Education | Returning to in-person child edu- might consider such conditions for congregants. cation is a vital social goal, given rising achievement gaps between Local or state governments could also require vaccination as a high- and low-income students as well as parental needs to return condition of service. To ensure safety, research must first ascertain to the workforce. At-home schooling is suboptimal for student learn- whether vaccines prevent infection or only prevent disease. The du- ing and can cause increased mental distress in households. There ration of immunity from vaccines is also unknown. Beyond gaps in arealsopublichealthjustificationsforsafelyreopeningschools.While scientific knowledge, so-called “immunity passports” face logisti- COVID-19 is generally less severe among children, older children are cal challenges, including implementing a novel policy approach in a source of disease transmission. Teachers, moreover, are vulner- the US. Any certification or immunity passport, moreover, should able to SARS-CoV-2, including serious disease. Requiring SARS- be explicit about what is being attested to and avoid guarantees of CoV-2 vaccines of schoolchildren and teachers and staff could en- protection against COVID-19.8 If scientific and logistical challenges able students to safely return to in-person education. can be overcome, linking vaccinations as a condition of providing ser- School mandates for COVID-19 vaccines could occur, as an addi- vice could be an effective incentive for vaccination. tiontoACIP-recommendedchildhoodvaccinations.Yetmandatesare not warranted until the FDA licenses a vaccine with reliable data on Acceptance and Implementation vaccine safety and efficacy among school-aged children. Even after Legal mandates signal clear policy support for immunizations, which phase 3 vaccine studies among children are completed and after full can also increase resources for a vaccine infrastructure. Yet man- vaccine licensure is obtained, postmarketing safety monitoring is es- dates can undermine public support, creating a backlash and even sential to fully characterize the risks. In 2006, the Association of Im- reducing vaccine uptake. Mandates may be useful in the future, but munization Managers (AIM) advised, “School and child care immuni- their implementation among any population that does not widely zation requirements must be used sparingly, approached cautiously, support vaccination could be counterproductive. The purpose of risk and considered only after an appropriate vaccine implementation communication is to inform decision-making, respecting individual period.”7 At that time, AIM also recommended broad public and pro- choice.Mandatesfundamentallyalterthisdynamicbyoverridingper- fessional support for any vaccine prior to implementing mandates. sonal autonomy.Furthermore, although employers, health care, and Costs and vaccine supplies must also be at acceptable levels. educational institutions can monitor conformance with mandates, there are no clear mechanisms to enforce population-wide vacci- Vaccination as a Condition of Service nation requirements. Businesses have a duty to safeguard their customers and often im- Immunization coverage sufficient to achieve community im- pose safety precautions as a condition of providing services to cus- munity will reap enormous health, social, and economic benefits. tomers. During the pandemic, many businesses have required masks Limited vaccine mandates with public support, in special high-risk and distancing for consumers. Even before the pandemic, custom- or high-value settings, and with longer-term safety data can be part erscouldnotentercertainpremisesinpossessionofafirearmorother of a comprehensive package of interventions to return society to pre- hazardous substance. It is foreseeable that businesses in certain high- pandemic life.

ARTICLE INFORMATION November 15, 2016. Accessed December 16, 2020. email&utm_name=&utm_source=govdelivery&utm_ Published Online: December 29, 2020. https://www.cdc.gov/vaccines/imz-managers/ term= doi:10.1001/jama.2020.26553 laws/state-reqs.html 6. Bellon T. US employers could mandate a Conflict of Interest Disclosures: Dr Salmon 3. Phadke VK, Bednarczyk RA, Salmon DA, COVID-19 vaccine, but are unlikely to do so–experts. reported receiving grants from Walgreens and Omer SB. Association between vaccine refusal and Reuters. December 2, 2020. Accessed December Merck and personal fees from Merck and Janssen. vaccine-preventable diseases in the United States. 16, 2020. https://www.reuters.com/article/us- Dr Larson reported receiving grants from Merck JAMA. 2016;315(11):1149-1158. doi:10.1001/jama.2016. health-coronavirus-vaccine-companies/u-s- and GlaxoSmithKline and honoraria from Merck for 1353 employers-could-mandate-a-covid-19-vaccine-but- serving on a vaccine confidence advisory board and 4. Virtual Yale CEO summit: finding common are-unlikely-to-do-so-experts-idUSKBN28C2LL from GlaxoSmithKline for speaking at staff training ground across a divided land. Yale School of 7. Association of Immunization Managers. Position sessions. No other conflicts were reported. Management. December 15, 2020. Accessed statement: school and child care immunization December 16, 2020. https://som.yale.edu/event/ requirements. 2006. Accessed December 16, REFERENCES 2020/12/virtual-yale-ceo-summit-finding-common- 2020. https://cdn.ymaws.com/www. 1. Hamel L, Kirzinger A, Muñana C, Brodie M. ground-across-divided-land-getting-your- immunizationmanagers.org/resource/resmgr/files/ KFF COVID-19 vaccine monitor. Kaiser Family workforce-shareholders-customers-and- aimpositionstatement.pdf Foundation. Posted December 15, 2020. Accessed communities-back-to-business 8. Cash-Goldwasser S, Kardooni S, Cobb L, Bochner December 16, 2020. https://www.kff.org/ 5. What you should know about COVID-19 and the A, Bradford E, Shahpar C. Immunity passports. coronavirus-covid-19/report/kff-covid-19-vaccine- ADA, the Rehabilitation Act, and other EEO Laws. COVID-19 Science Review. Posted December 15, monitor-december-2020/ December 16, 2020. Accessed December 19, 2020. 2020. Accessed December 16, 2020. https:// 2. Centers for Disease Control and Prevention. https://www.eeoc.gov/wysk/what-you-should- preventepidemics.org/covid19/science/weekly- State vaccination requirements. Last reviewed know-about-covid-19-and-ada-rehabilitation-act- science-review/december-5-11-2020/ and-other-eeo-laws?utm_content=&utm_medium=

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