Covid-19 Vaccines: Ethical, Legal and Health Policy considerations regarding different responses to vaccine hesitancy

What is currently understood about the effect of Covid-19 vaccines on infection and transmission?

The public policy rationale and ethical justification for requiring an individual to be vaccinated is to prevent that individual from passing the virus on to others (i.e. transmission) and/or to ensure the continuity of critical public services such as healthcare, security or education. Therefore, it is important to understand both the efficacy of a vaccine in preventing symptomatic disease, as well as its effects on asymptomatic infection and transmission. To date, two vaccines against Covid-19 have been deployed in Switzerland, Pfizer/BioNTech and Moderna, both mRNA vaccines. Swissmedic granted authorization to these vaccines based on data that they protect the vaccinated individual against developing Covid-19 symptoms and severe illness.^[1] Prevention of symptomatic Covid-19 or severe disease was the primary endpoint of clinical trials for most vaccines.^[2] However, further data is being collected to understand the extent to which either of these vaccines prevents infection (asymptomatic and symptomatic) or transmission, and the evidence base is evolving.

For example, a US CDC study published in April 2021 found that mRNA vaccines reduced both symptomatic and asymptomatic infections by 90% in fully-vaccinated participants (>2 weeks after second dose) and 80% in partially-vaccinated participants (>2 weeks after first dose) in real-world conditions.^[3] A study conducted in England published in April 2021 found that the Pfizer/BioNTech vaccine reduced infections (asymptomatic and symptomatic) by 70% >21 days after the first dose, increasing to 85% >7 days after the second dose.^[4] A study conducted in Israel published in May 2021 found that the Pfizer/BioNTech vaccine was 95.3% effective at reducing infections (both symptomatic and asymptomatic), and that as population vaccination coverage increased, “marked and sustained declines” in incidence across all age-groups was observed, suggesting an overall dampening effect on transmission.^[5]

As of April 2021, the ECDC therefore already concluded that “Evidence from real-life usage of COVID-19 vaccines has confirmed these clinical trial findings and also showed high vaccine effectiveness against PCR-confirmed SARS-CoV-2 infection. Limited evidence indicates that fully vaccinated individuals, if infected, may be less likely to transmit SARS-CoV-2 to their unvaccinated contacts.  Uncertainty remains regarding the duration of protection in such cases, as well as possible protection against emerging SARS-CoV-2 variants.”^[6] The decrease of transmission of SARS-CoV2 by vaccinated individuals has since been confirmed.^[7] The Delta variant, however, shows signs of partial immune escape and rates of transmission of this variant by vaccinated individuals may not be decreased as much as with previous ones

Vaccine hesitancy and measures available to address it

Achieving population immunity, so that society is protected from future epidemics of SARS-CoV2 and resilient against re-introduction of the virus, will require a high proportion of the public to be vaccinated. The precise proportion required for population immunity is not currently known, as it depends on the efficacy of the vaccine(s), including for the prevention of infection and transmission, the transmissibility of the virus (which is evolving as novel variants emerge), and the duration of protection (which is not yet known).^[8] Vaccine hesitancy refers to attitudes of concern, preoccupation and skepticism towards vaccination.^[9] Defined by WHO as “the reluctance or refusal to vaccinate despite the availability of vaccines,” vaccine hesitancy (also known as vaccine resistance) was ranked as one of 10 priority threats to global health by WHO in 2019.^[10] While resistance to vaccination has existed as long as immunization programs, it has attracted increased attention in traditional and social media in recent years. “Vaccine hesitancy” is distinct from “underimmunization,” which is a behavior relating to different groups of the population: those who encounter access obstacles in getting vaccinated, those who refuse vaccines and some of those who are hesitant who are likely to delay or omit immunization.^[11] Indeed some of the vaccine hesitant are immunized.

In light of low compliance with H1N1 vaccination schemes in 2009 and of the relevance of vaccine hesitancy, studies regarding people’s attitudes towards Covid-19 vaccination are important. While some data are available, they are nonetheless related to the specific timing and context of the surveys. Attitudes toward COVID-19 vaccines may therefore change as both the pandemic, local epidemic, and vaccine development continue to evolve. There is also a spectrum of hesitancy, with some likely to refuse vaccination regardless of the circumstances while others are likely to change their views.

The University of Zurich’s Covid-Norms^[12] survey has been tracking public willingness to be vaccinated since Sept 2020. As of late July 2021, 74.9% of respondents indicated that they had already been vaccinated. In addition, 4.6% were “willing” to get vaccinated, 7.6% were undecided, and 12% “declining.” The proportion “willing”+”vaccinated” has increased steadily throughout 2021, with the proportion undecided and declining having decreased. A Sotomo survey in late October 2020, before safety and efficacy data on the frontrunner vaccines had been published in mid-November, found that only 49% of the population was willing to take a Covid-19 vaccine, with 26% undecided and 25% saying they would not.^[13] Willingness to be vaccinated against Covid-19 seems to have dropped steadily during 2020, then grew steadily in 2021 (see above). For example, a survey administered in September found 54% of the Swiss population willing to be vaccinated,^[14] and in June that 63% would be willing.^[15] In a study of 7 European countries, 74% were willing to be vaccinated in April 2020, which dropped to 68% in June.^[16]  Surveys have also found that the proportion of persons willing to be vaccinated increases with age, that men are more willing to be vaccinated than women, and that willingness was correlated with levels of trust in information provided by the authorities.^[17], ^[18] A study across 19 countries published in October 2020 found that younger people were more likely than older persons to get vaccinated if required by employer; higher acceptability among those with higher income and education; and higher acceptance in countries that had experienced high caseloads. Whether respondents or their families had been infected did not seem to affect acceptance rates.³⁰ There is variation across the population in vaccine hesitancy, and many of the factors associated with hesitancy cannot be changed by a strategy of the authorities. However, targeting communication to specific sub-populations that are more vaccine hesitant has been recommended.

Both the survey data cited above and previous experience with safe, effective vaccines such as those for measles suggest that hesitancy is not only related to the objective characteristics of specific vaccines, but to other social, cultural and normative factors. Switzerland is known to have large local differences in the willingness to get vaccinated.

Addressing vaccine hesitancy requires a holistic approach:

The WHO Technical Advisory Group on Behavioral Insights and Sciences for Health meeting in October 2020 concluded that three factors would increase Covid-19 vaccine uptake: “1. Creating an enabling environment – making vaccination easy, quick and affordable, in all relevant respects. 2. Harnessing social influences – especially from people who are particularly trusted by and identified with members of relevant communities. 3. Increasing motivation – through open and transparent dialogue and communication about uncertainty and risks, including around the safety and benefits of vaccination.”^[19]

These three aspects are complementary and each can be addressed in a variety of ways. For example:

Creating an enabling environment can include multiplying low-threshold access to vaccination, such as walk-in appointments or mobile vaccination clinics to sporting and cultural events, schools, religious institutions, town and village squares, free hotlines staffed by health care providers and other people who can be trusted to answer questions factually and with empathy, and home-based vaccination for those with low mobility or other access difficulties.

Harnessing social influences can include direct contact by health care providers to their patients, promoting vaccination and offering opportunities to ask questions, calls by faith-based and political leaders to their members, by social influencers to their audience, as well as encouraging vaccinated individuals to wear a visible sign to signal pride for their contribution.

Increasing motivation can include public recognition of the contribution of those who are vaccinated, communication about the benefits of vaccination such as protecting health, the economy, jobs, and reaching the end of the pandemic faster, and it can also include a variety of incentives to be vaccinated such as gifts, gift cards, lotteries, or even tax incentives. Since all of these measures provide either symbolic or concrete advantages to the vaccinated in order to raise motivation, they all risk either representing or encouraging stigmatization and in some cases discrimination of those who cannot be vaccinated. It is therefore important to recognize the existence of such individuals appropriately, for example by offering similar recognition and incentives in their case for other actions aiming to increase vaccination in the population as a whole. Incentives have been shown to be effective especially in motivating one-time behavior.^[20] They also have drawbacks, however. For example, incentives can send a counter-productive message that the incentivized behavior is not something individuals would want to do without the incentive, and some may conclude that it is risky and decide against it.^[21] Communication must therefore be very clear on the reality of the risk-benefit ratio for individuals targeted by incentives.

The WHO Technical Advisory Group on Behavioral Insights and Sciences for Health also highlighted that healthcare providers (HCPs) are a key group for targeted measures. HCPs themselves may be vaccine hesitant. At the same time, they are one of the most trusted sources of information and advice for patients. By engaging in motivational interviewing^[22] (“a collaborative method of interaction aimed at exploring people’s real reasons for hesitancy and strengthening their own motivation for change”^[23]) and making vaccination the default option (presumptive communication approaches), HCPs can play a critical role in addressing vaccine hesitancy.^[24],^[25]

Communication campaigns targeted at specific sub-groups may also be needed. Different groups may have different reasons for vaccine hesitancy – ranging from perceived lower risk from Covid-19 infection to fear of vaccine side effects, from mistrust in the healthcare system to religious beliefs.^[26] For this reason, trusted leaders and influencers in communities (rather than government officials or experts alone) may be more influential in shifting social norms within a group towards supporting vaccination. Lessons from previous efforts to address vaccine hesitancy can provide useful guidance.^[27]

Guidance for health authorities and practitioners has been developed on ways to improve communication regarding Covid-19 vaccines.^[28] Because positions regarding vaccination tend to crystallize tendencies for mutual oversimplification and distrust,^[29] our previous Policy Brief on “Responses to Corona Denial” is also relevant here.As vaccination campaigns progress, further evidence and research is expected to become available on vaccine hesitancy and ways to address it for Covid-19.

Effects of vaccine mandates: The academic literature on mandatory vaccination is based on policies related to childhood immunization or vaccination of healthcare professionals, with case studies mostly situated in high income countries, particularly the US. In a context of vaccine hesitancy, Italy and France recently made some childhood vaccinations mandatory. Fears have been expressed, however, that vaccine mandates might fuel political polarization and increase vaccine hesitancy. However, some data suggest that mandates can effectively increase vaccination rates.^[30] Evidence gathered from 32 studies (covering the period 1980 to 2015) in the United States and related to vaccination requirements to access childcare, schools and colleges found a median 18% increase in vaccination rates when vaccine mandates were implemented.^[31] A recent review of interventions aimed at improving vaccination rates concluded that, in high income countries, vaccine mandates are more likely to support uptake than measures aimed at modifying people’s attitudes towards vaccination.^[32] However, the literature’s focus on childhood immunizations limits its applicability to discussions about potential COVID-19 vaccine mandates, as these initially primarily concern adult populations. Factors specific to Covid-19 vaccines must be taken into account when considering vaccine mandates (as noted above).

While countries adjacent to Switzerland recently adopted vaccine mandates for childhood vaccines, public health professionals in Switzerland seem on the whole reluctant to do so, preferring to count on recommendations and individual responsibility.

In the next section, we address specific issues related to vaccine mandates.

What are vaccine mandates, and what are the ethical, legal and health policy considerations regarding vaccine mandates?

WHO outlined ethical considerations regarding Covid-19 vaccine mandates: necessity and proportionality to meet public objectives; sufficient evidence of vaccine safety, efficacy and effectiveness; sufficient supply; public trust; and ethical processes for decision-making.^[33] We address each of these in the following sections.

What are vaccine mandates?

A vaccine mandate is an authoritative requirement, for example by a government or employer, for an individual to be vaccinated. Vaccine mandates can vary widely along multiple dimensions,^[34] including for example: the groups subject to the mandate (from tightly-targeted groups to population-wide), the vaccines that are mandated, the types of sanctions for non-compliance (from non-existent to criminal), and the planned exemptions (from few to many, from easy to difficult to obtain). See Annex A for a discussion of the features of vaccine mandates.

What types of vaccine mandates are legally permissible in Switzerland?

The Swiss Epidemics Act, which came into force on January 1st 2016, makes it clear that vaccine mandates can only be considered for specific groups and cannot refer to the entire population. This Act mandates the Federal Office of Public Health (FOPH) to elaborate, in cooperation with the Cantons, national programs relating to vaccines (Art. 5 para. 1 lit. a Epidemics Act). The Confederation and the Cantons jointly are responsible for implementing such national programs (Art. 5 para. 2 Epidemics Act). The Epidemics Act provides a legal basis for the introduction of selective vaccine mandates. According to Art. 22 of the Act (Mandatory vaccinations), cantons are granted the authority to issue such mandates: “The Cantons may declare vaccinations mandatory for risk groups, particularly exposed persons, and for persons engaged in specific activities, provided that a serious threat is established.”^[35]

In a special epidemiological situation (in which the country still finds itself in July 2021), the Confederation is also granted such authority. It may, after consultation of the Cantons, “declare vaccinations mandatory for risk groups, particularly exposed persons, and for persons engaged in specific activities” (Art. 6 para. 2 lit. d Epidemics Act). While the authority to issue vaccine mandates constitutes an exclusive competence of the cantons in normal epidemic situations, the Confederation and the Cantons share concurrent competences in special situations. The Cantons may issue vaccine mandates “when a serious threat is established”, the Confederation may do so whenever the epidemiological situation is special (which implies a serious threat to health). The Epidemics law aimed at limiting the authority of vaccine mandates. They may only exist when – and as long as – a serious threat exists or when – and as long as – the country finds itself in a special epidemiological situation. When the Act was publicly discussed, the Federal Council made it clear that the Epidemics Act did not provide a legal basis for enforced vaccines (against the will of a person) and did not provide for criminal sanctions in case of non-compliance. The Council also made it clear that children who have not been vaccinated would not generally be banned from attending school, but only in case of an outbreak of the disease at the school. As for the consequences of vaccine mandates in the sphere of work, the Council referred to labour law and mentioned the possibility of non-vaccinated health workers to be temporarily transferred to less exposed workplaces.  (see FOPH, Das neue Epidemiegesetz, Fragen und Antworten, 2013).

The Epidemics Act raises a number of issues which merit examination. If selective vaccine mandates are justified by a situation, will the Confederation or the Cantons introduce the obligation? If the Confederation decided not to declare vaccines mandatory for specific groups, could individual cantons -or cantons acting jointly- still do so? If the Confederation does issue a vaccine mandate for specific groups, can the Cantons go beyond in terms of scope and/or sanctions? These are relevant questions that must be answered, but lie beyond the scope of this policy brief.

Covid-19 vaccine-specific considerations:

Consideration should be given to the specific features of Covid-19 vaccines and the context in which they would be deployed. Covid-19 vaccines have been developed in record time, condensing a multi-year process into 10-18 months. Phase III studies have enrolled tens of thousands of people, but longer-term data on safety, efficacy and real-world effectiveness is still needed now that new highly transmissible variants of concern are becoming dominant, and continue to be gathered. It will be unprecedented that so many people are vaccinated in such a short time with novel vaccines, which calls for vigilance and surveillance of adverse effects. Furthermore, as noted above, the effects of specific vaccines on infection or transmission are still actively being studied.

Human rights considerations:

An obligation to be vaccinated constitutes a restriction on personal freedom, guaranteed in Article 10 para. 2 of the Swiss Federal Constitution. Such a restriction is constitutional when the following conditions are simultaneously met:

1. The vaccine mandate is provided for by law. As the obligation to vaccinate constitutes a serious restriction to personal freedom (physical and psychological integrity), a formal legal basis, i.e. an Act adopted by the Federal Assembly or cantonal parliaments, is required;
2. The vaccine mandate must be justified by the public interest or by the protection of the rights and freedoms of others;
3. It must be proportionate;
4. It must leave the very essence of the right intact.

The first condition (i) is fulfilled by the Epidemics Act. The last condition (iv) excludes the possibility to physically force a person to get vaccinated. Forced medical treatment against the will of a person is only permitted under very restrictive conditions (and only when a person is deprived of liberty for health reasons).

The fulfillment of the second (ii) and third (iii) conditions must be evaluated based on the characteristics of the vaccine and the epidemic. Public interest and proportionality strongly depend on the effects of the vaccine and the context.

As noted above, since vaccines decrease the risk of both infection and transmission, there is a public interest in high vaccine coverage, as each vaccinated individual reduces the risk of harm not only to himself or herself but also to others. Even in this situation, however, a vaccine mandate is only justified if proportionate, i.e. if there is no less intrusive means to prevent the danger. The question arises as to whether the use of personal protective equipment (PPE) is an adequate replacement for vaccination. A mandate requires necessity and proportionality: this means that for a mandate to be justified, a vaccine must be not only effective and safe, but also be more effective than alternative measures such as PPE. The evidence base may not allow for easy comparisons. Vaccines are developed through randomized controlled trials with clearly quantified effects on the risk of symptomatic infection, and after vaccination, protection against infection does not rely on consistent behavior by the individual. In contrast, while evidence of the efficacy of PPE is strong,^[36] it is not generated through RCTs and also depends on constant availability of quality PPE and consistent correct use by the individual. The real-world effectiveness of PPE, in lieu of vaccination, for preventing symptomatic infection is likely to vary by workplace. The ethical acceptability of employees wearing PPE in lieu of vaccination while working in proximity to vulnerable populations would depend, in principle, on how well either intervention reduces the risk of infection or transmission. Although specific comparative data is not available, PPE is likely to be less effective than vaccination to prevent transmission of SARS-CoV2.

A mandate also requires that a vaccine no longer be considered experimental, since in this case mandatory vaccination would imply mandatory participation in research.^[37] This condition is fulfilled in Switzerland, where Swissmedic has granted authorization under the ordinary procedure to three Covid-19 vaccines. Although manufacturers are continuing full-length clinical trials for longer-term follow-up on each of them, these vaccines are no longer considered to be experimental. ^[38]

Considerations regarding general vaccine mandates:

Population wide-vaccine mandates are discussed in several countries. Justifications for such mandates are not to protect individuals themselves, but rather to decrease the risk of transmission to others, to protect the healthcare system from being overwhelmed by a surge of patients, and to protect individuals ineligible themselves to be vaccinated, or in whom vaccines may be less efficacious. Population-wide vaccine mandates are not permitted under Swiss law. The Swiss authorities have clearly stated that there will be no general Covid-19 vaccine mandate,^[39] and the National Advisory Commission on Biomedical Ethics has also advised against such a mandate.^[40]

Considerations regarding targeted vaccine mandates for some professional groups:

A targeted vaccine mandate for specific professional groups would be permitted under Swiss law. Justifications for considering such a mandate include ensuring continuity of services, and protecting those who depend on such services from transmission by professionals.

Ensuring adequate staffing for the continuity of essential public services, such as public safety, education, transport or healthcare, which would be threatened if significant numbers of employees were unable to work due to illness. While large numbers of employees could indeed become severely ill with Covid-19, however, thus far it does not appear to be the case that high numbers of police, teachers, health workers, military or other providers of essential services in the country have fallen ill to the extent that such services cannot be provided adequately.

In light of growing evidence regarding the effects of vaccines on the risk of infection and transmission, there is however a stronger case for vaccination of health professionals, who have a duty to protect patients, where no alternative measures are as effective as vaccination to protect their patients against the risk of nosocomial COVID-19. As of this writing, Italy and Greece have introduced such mandates for healthcare professionals, and France has announced that it will do so. A recent publication summarizing -and defending- the case for such specific mandates lists three arguments: heath workers’ specific duty to protect their patients, especially when vaccination has so few side effects, their general duty to protect the health of others, and the observation that mandates to be vaccinated against COVID19 are not the first vaccine mandate health professionals are subjected to, but rather an extension of a well-accepted practice.^[41] WHO’s ethical guidance suggests “Whether a mandate for health workers is necessary and proportionate (ethical consideration 1) and would not undermine trust (ethical consideration 5) might depend on the local context and should be investigated empirically before a mandate is considered for this population.”

In February 2021, the National Advisory Commission on Biomedical Ethics has also advised against such a mandate in its Summary and Recommendations regarding COVID19 vaccination,^[42] with a position based on some of the same arguments as that of the WHO:

“Vor dem Hintergrund ihrer Erwägungen empfiehlt die Kommission, von einem Impfobligatorium für bestimmte Bevölkerungsgruppen abzusehen. Derzeit ist lediglich eine Wirkung der Impfstoffe zum Selbstschutz der betroffenen Person nachgewiesen. Einen solchen Selbstschutz für bestimmte Personengruppen allgemein zu verordnen, wäre paternalistisch und nicht zu rechtfertigen. Auch wenn nachgewiesen werden könnte, dass die Impfung vor einer Weitergabe des Virus schützt, müsste der Nutzen eines Impfobligatoriums für bestimmte Gruppen, namentlich für das Gesundheitspersonal, sorgfältig gegen die damit verbundenen Nachteile abgewogen werden. Zwingend müssten mildere wirksame Methoden, etwa die Vornahme regelmässiger Schnelltests bei Nichtgeimpften, ausgeschöpft sein, bevor ein Obligatorium ins Auge gefasst wird. Auch müssen unerwünschte Folgeeffekte, etwa die Akzentuierung des Fachkräftemangels, in der Abwägung berücksichtigt werden, umso mehr, als das Gesundheitspersonal im Zuge der Pandemie bereits in hohem Mass gefordert ist und einen Einsatz zugunsten der Allgemeinheit leistet, dem grösste Wertschätzung gebührt. Ein Impfobligatorium für bestimmte Gruppen und insbesondere für das Gesundheitspersonal wird von der Kommission in dieser Hinsicht abgelehnt.”

In the Swiss context, it would be valuable to consider data on the extent and reasons underlying vaccine hesitancy among certain professional groups, such as health workers, teachers, or police forces. Measures should be developed to encourage an adequate willingness to be vaccinated within key professional groups and in consultation with their representatives. No individual can legally, or should, be vaccinated against his or her will. Nevertheless, health professionals and institutions have duties to protect patients and users, and no alternative measures are as effective as vaccination to do so. The Swiss Epidemics Act also provides a legal basis for the introduction of selective vaccine mandates by Federal or Cantonal authorities, including for specific professional groups. Decisionmakers including health and long-term care institution authorities can also mandate vaccination as a condition of employment (or the performance of certain functions) in settings where the risk of transmission is high, such as healthcare settings, care homes for the elderly, daycares or schools, if the risk to vulnerable members of the public warrant this decision. Careful planning, sometimes including regional coordination, will be needed to minimize disruptions if it is expected that significant numbers of employees may change or leave their jobs rather than be vaccinated. Any mandate should also have exemptions, such as for medical reasons, appropriately verified and regulated. Such mandates for specific professional groups must in any case be based in law, respect the principle of proportionality, and any sanctions imposed on those who refuse vaccination must also remain proportionate (for example, transfer to other functions rather than dismissal).

Private sector vaccine mandates:

The question also arises regarding the appropriateness of vaccine mandates adopted by private actors, such as private firms or private educational institutions. For example, Delta Airlines announced new employees would be required to be vaccinated against Covid-19.^[43] If a private firm is providing an essential public service that would be severely impacted by high levels of employee illness, as above, vaccine mandates may be justifiable. But if the rationale is to reduce costs related to employee illness, this may be considered by some to be disproportionate. The absence of a general vaccine mandate does not exclude employers to request their workforce to be vaccinated. If the employer is the state (e.g. a public hospital or home), such obligation must be based on law. In private settings, the obligation to be vaccinated can be introduced by means of private labour law. In such cases also, any specific mandate must be based in law, respect the principle of proportionality, and any sanctions imposed on those who refuse vaccination must also remain proportionate (for example, transfer to other functions rather than dismissal).