COVID-19 vaccines

Vaccination is a public health strategy that has shown benefits for the world population, as seen with the eradication of smallpox and the control of infections such as poliomyelitis and measles (⁹,¹³). It cannot be overlooked that, compared to other vaccines available for different infectious diseases, the vaccine against COVID-19 has some particularities.

Vaccines against COVID-19 have different mechanisms of action (through messenger RNA, protein subunits, and vectors), whose main purpose is the development of immunity in the organism without contracting the disease, stimulating defense cells such as memory T lymphocytes and B lymphocytes (¹⁴). Pioneer pharmaceutical companies in the development of vaccines such as Pfizer, at the end of November 2020, reported that the vaccine had an efficacy of up to 95% in preventing complications of the disease. For its part, the Moderna laboratory reported a vaccine efficacy of 94.5%; while Russian manufacturers confirmed efficacy of more than 90% for the Sputnik vaccine. This could be interpreted theoretically as meaning that out of every 100 people vaccinated with these biologics, between 90 and 95 will be protected against presenting severe symptoms of the disease (¹⁵). A study published in the New England Journal of Medicine reported that the efficacy of the Pfizer vaccine, between the first and second dose, was 52% (with a 95% confidence interval between 29.5% and 68.4%). After the seventh day following the second dose, efficacy increased to 95% (¹⁶).

For their part, Doroftei et al. (¹⁷) published in March 2021 a general review of the efficacy of the vaccines available up to that time against COVID-19. After reviewing 19 relevant published articles, the authors concluded that Pfizer-BioNTech, Moderna, and Sputnik V had greater than 90% efficacy. In addition, they reported that the Moderna, Sputnik V, and Oxford-AstraZeneca vaccines have also shown fewer serious adverse reactions. Convidicea, Johnson & Johnson, Sinopharm, Covaxin, and Sinovac vaccines were analyzed for their immunogenicity. The authors concluded that the aforementioned vaccines are efficient and safe regardless of age and sex, apart from being well tolerated by the recipients.

It is important to wait cautiously for the follow-up of vaccinated subjects to better observe both the efficacy of the vaccine and the safety measured against the main adverse effects in the medium and long term. In this context, it is understandable that there is reluctance among the population to be immunized with these biologics, which some still call "experimental" vaccines. Would it be valid to raise the question of whether the application of a vaccine in a pandemic or a state of functional emergency, in this case, SARS-CoV-2, should be mandatory?

Some regulatory background on vaccination

In the United States, the 14th Amendment to the Constitution states that no state may enact laws that restrain or deprive any person of life, liberty, or property without due process of law. The Supreme Court recognizes that this amendment protects U.S. citizens from arbitrary legislative action, but that does not mean that laws with a legitimate government purpose cannot be enacted to be declared constitutional. In addition, the Supreme Court has recognized the "police power" in each state, which grants authority to the state to enact health ordinances, including quarantine and vaccination to protect public health and safety (¹⁸).

On the other hand, in Spain vaccination is considered voluntary. However, the Vaccine Advisory Committee reported on the website of the Spanish Academy of Pediatrics that some situations allow the competent public authorities to impose forced vaccination, and one of these exceptional cases is the occurrence of epidemics, following Organic Law 4 of June 1, 1981, which allows action in states of alarm, exception. and siege (¹⁹).

In Colombia, the general vaccination schedule is aimed at all children under five years of age. Adults are vaccinated against specific diseases, such as yellow fever or tetanus. In addition, vaccination for seasonal influenza (²⁰) and pneumococcus (²¹) is offered free of charge to at-risk groups (especially the elderly), since these agents are responsible for prevalent respiratory diseases in the population and are associated with significant morbidity and mortality in this age group. However, except for the immunizations included in the Expanded Plan of Immunization (²²), vaccination in this territory is neither free nor mandatory.

It seems only logical that for the employment of health care workers, immunological antecedents should be verified (either through a vaccination card or by measuring antibody concentrations for specific diseases such as chickenpox or hepatitis B); however, it is likely that if these immunizations are not accredited (for various reasons, including refusal to receive a vaccine), this would constitute a reason for discrimination in the job selection process.

It is important to remember that Colombia is considered a social state governed by the Political Constitution of 1991, article 16 of which states that "All persons have the right to the free development of their personality with no limitations other than those imposed by the rights of others and the legal order." This is coupled with Article 18, according to which "freedom of conscience is guaranteed. No one shall be reprimanded on account of his convictions or beliefs, nor compelled to reveal them, nor forced to act against his conscience" (²³).

From these perspectives, concerns arise as to whether in the case of the COVID-19 vaccine in this country: should vaccination be a mandatory requirement? Could the immunological and vaccination status generate some type of discrimination among those who are already employed or who aspire to be employed? Would residents in Colombian territory be obliged to receive the immunization or could they object to freedom of conscience?

Autonomy

Siurana (²⁴) states that "The word autonomy comes from Greek and means self-government." Article five of the 2005 UDBHR emphasizes respect due to the individual's decision-making capacity and the need to protect the rights and interests of those who cannot exercise their autonomy (¹²).

For Serge (²⁵), in the chapter "Individual autonomy" of the Latin American Dictionary of Bioethics, autonomy is an ethical principle that is part of the theory of principlism, proposed by Beauchamp and Childress. The latter author indicates that the principles within bioethical theories are intended to support the norms that guide ethical judgments, but they must also be consistent with the "feeling," i.e., Serge states that the "ethical position emerges from the perception of a phenomenon that happens within each of us" (²⁵); however, the autonomy construct, says Serge, is a recent conquest that began during the European Enlightenment. This principle, which denotes the importance of respect and recognition that individuals may think and feel differently, could even become an ideal for modern society, in which respect for identity and free will have become fundamental notions of bioethics.

Although some have felt that their autonomy has been violated during this pandemic by some restrictions such as the limitation of free movement, Chia and Oyeniran (²⁶) indicate that the draconian isolation and quarantine measures that were initiated in the first half of 2020 were necessary as a consequence of the rapid spread of the virus. They recall that in 2003, in the SARS outbreak, these same measures were useful to curb the disease. The authors argue that in this context autonomy plays an important role in the face of the "autonomous reflection" of self-government and the limits that individual autonomy must signal in the face of the benefit of others.

Should individuals who claim their legitimate right to autonomy to refuse vaccination be subject to moral criticism? Has the country historically discriminated against individuals who do not accept public health measures such as immunization?

It is important to bring up a scenario of mandatory vaccination in Colombia. For example, unemancipated individuals under five years of age must receive the immunizations scheduled for their age with the authorization of their caregivers. The Constitutional Court (²⁷) indicated that the non-vaccination of minors is considered a violation of the right to health of children and adolescents. Consequently, the competent authority (family defender, family commissioner, or police inspector) may initiate a process of re-establishment of rights. On the other hand, at present, adults, in general, do not have any obligation to be vaccinated in Colombian territory.

In favor of autonomy, public and private institutions should optimize the processes of comprehensive care for candidates to be immunized against COVID-19. The UDBHR (¹²), in its sixth and eleventh articles, refers to the importance of carrying out the "free, express and informed" consent of any person who is going to receive a medical intervention such as immunization and, in turn, invites to "avoid discrimination or stigmatization" of the individual to ensure respect for human dignity.

Justice

The UDBHR (¹²) mentions the importance of "fair and equitable treatment of human beings" in the tenth article of the 2005 declaration. This principle of justice is, in turn, complemented by the fifteenth principle, which cites the "Sharing of benefits" so that all individuals can have access to scientific and technological knowledge and progress.

Siurana (²⁴) quotes Beauchamp and Childress to clarify that justice does not mean that everyone should receive the same; rather, he states that this principle appeals to "equitable and appropriate treatment in light of what is due to a person". Therefore, in the face of the ethical dilemma posed by the notion of obligatory COVID-19 vaccination, one can appeal to Beauchamp and Childress' concept of distributive justice, which refers to "the impartial, equitable and appropriate distribution in society, determined by justified norms that structure the terms of social cooperation" (²⁴).

Since immunization is a strategy that favors community health, and from the principle of justice, the national government must guarantee vaccination to all inhabitants of the national territory without discrimination of any kind. On the official page of the Colombian Ministry of Health and Social Protection, the Government informed that it has purchased "enough vaccines to immunize, with the complete scheme, 40.5 million people. This is approximately 70 million doses of vaccines, of which 51.5 million will be received through direct agreements with producers and the rest through the COVAX mechanism" (⁶).

For Pinto Bustamante et al. (⁸), the "cardinal principle" that should guide the allocation of immunization prioritization is "the intrinsic value of people, their dignity." The distribution and availability of COVID-19 vaccines have become one of the major global determinants of infection control and pandemic-associated mortality. This measure also represents a fundamental reason for economic and social reactivation; therefore, when public and private sectors are expected to join efforts so that vaccination can be administered in Colombia with celerity and equity, it is when the principle of justice becomes more valid.

Responsibility

The UDBHR (¹²), in its fourteenth article, mentions the importance of health promotion by the government and all sectors of society concerning "Social responsibility and health," which, together with article 13, called "Solidarity and cooperation," puts on the table the importance of cooperative work and solidarity among human beings. This, together with Article 13, entitled "Solidarity and cooperation", brings to the table the importance of cooperative work and solidarity among human beings. Could it be understood that all members of society have an inescapable responsibility for the welfare of other individuals? What responsibility should be attributed to official institutions in the vaccination process in a pandemic?

According to Battin et al. (²⁹), in the context of infectious diseases, such as COVID-19, the patient should be understood as a "victim and vector" who has a potential risk of becoming ill, but also of participating in the chain of contagion so that others like him become ill, and given the risk of lethality that this disease represents, the principle of responsibility is fundamental when facing the crisis caused by the pandemic. For Battin et al. (²⁹), the individual agency from the feminist perspective demonstrates that human beings need to establish social, cultural, and biological ties for the free development of their personality, but this situation also represents a responsibility for the "social location" of each citizen and the repercussions of their actions concerning others.

It is striking that scenes of social disobedience to the health measures proposed by governments to control COVID-19 infection rates are observed daily in the world's media. The simple use of a mask or social distancing has become a challenge for public health and authorities in this pandemic.

Siqueira (³⁰) proposes the principle of responsibility, according to Hans Jonas, through a categorical imperative: "Act in such a way that the effects of your action are compatible with the permanence of an authentically human life on Earth," with a preventive rather than punitive perspective on the consequences of the agent's decisions. Siqueira (³⁰) quotes again Jonas to recall his thesis: "The responsibility of the human being with himself is inseparable from that which he must have with all others. It is a solidarity that connects him to all men and to nature that surrounds him."

However, responsibility does not only have to do with the individual agency or the private sphere. Consuegra-Fernández (⁷) questions the responsibility of governmental entities concerning the growing strength of anti-vaccine movements. This author suggests that the multifactorial origin of distrust among citizens regarding public policies (such as vaccination) in times of crisis should be studied in-depth and claims the importance of the participation of the scientific community in the transparent and neutral dissemination of knowledge. Perceptions of inequity in the distribution of health resources or even logistical difficulties in the timely administration of vaccines in the national territory may become other factors favoring reluctance towards immunization against COVID-19 in Colombia.

From this perspective, responsibility would require compliance with all available strategies currently available to halt the advance of COVID-19, including vaccination, risk management, transparency, and fairness in informing the population. Could this be a sufficient argument to support the mandatory application of the biologic in Colombia?

The common good

The UDBHR (¹²) suggests some mechanisms to apply the principles mentioned in the declaration. It proposes that "decision making and treatment of bioethical issues" be discussed in spaces of dialogue and discussion not only in public debate, but also in instances such as ethics committees, and urges governments to assess and manage the risks related to medical practices and related technologies for the common good of society.

From the perspective of Mill's utilitarianism (³¹), the actions of each human being, individual or collective, should be focused on the benefit of the greatest number of individuals involved, to maximize the utility of this action. In the case of a Latin American country, it seems that the notion of mandatory vaccination is a real option for the control of the COVID-19 pandemic. According to a well-known news media, the Brazilian Supreme Court "almost unanimously endorsed mandatory vaccination" (³²). Although it seems that no one will be forced to receive this intervention, national authorities could sanction citizens who choose not to be immunized. This situation already has some historical antecedents, since in past decades Brazil, as well as other countries of the European Community, have tried to mitigate the impact of the tuberculosis epidemic with compulsory immunization with BCG vaccine in the child population.

Moreover, the immigration policy of many countries requires vaccination (e.g. yellow fever) for foreigners to enter their territory. On March 9, 2021, China announced to the world the official launch of a "digital passport" that allows verification of the health status of travelers, as to whether they have had the SARS-CoV-2 disease or have already been vaccinated for this microorganism (³³). In the same sense, the European Commission approved the project to request the Digital Green Pass (also known as COVID-19 vaccination passport) to travelers wishing to enter the 27 member countries of the European Union as of July 1, to "allow movements within the continental bloc, without the need to submit to restrictions, to anyone who has been vaccinated against COVID-19, has a negative test for the virus, or has recently recovered from the disease" (³⁴).

Against this backdrop, it is only fair to question whether, in the face of a possible greater good of society, vaccination against COVID-19 could come to be considered mandatory, at least in some populations that offer social care services and are not only more at risk of acquiring the disease, but also of transmitting it. Is it possible, from Engelhardt's perspective (³⁵), that an agreement could be reached between "moral strangers" so that through widespread vaccination the devastating impact of this disease on health, the economy, and the very development of society could also be mitigated?

The notion of obligatory vaccination

The arguments that can support the notion of mandatory immunization against COVID-19 are diverse and relevant. From the point of view of distributive justice, individuals will receive what they need and deserve, i.e., mandatory vaccination could articulate the governmental duty to offer strategies in favor of the health of citizens with the duty of the social rule of law to guarantee the general welfare of the community, since the control of the pandemic allows for the economic and social recovery of the population. Moreover, from a utilitarian perspective, the mandatory administration of the vaccine would prioritize the common good or the good of the majority.

Chia and Oyeniran (²⁶) expose the ethical debate on the supremacy between the concept of human health and the notion of individual rights, arguing that public health ethics differs from clinical ethics in that it promotes the prioritization of the "common good" over the protection of individual autonomy. For their part, Reiss and Caplan (³⁶) raise an example to denote the greater good when referring to the vaccination of health personnel and the armed forces, who by accepting their mission in society cede some of their individual autonomy in favor of their profession. The authors strongly consider that vaccination in this group of people should be mandatory, for their own and society's safety.

Colombian authorities have reported on several occasions on civil disobedience concerning biosecurity measures, such as the use of masks and social distancing. Moros (³⁷) indicates that from the "self-determination theory" it is usual for citizens to be reluctant to control external interventions (even governmental) and it has been observed that, in particular, young people show defiant behaviors in the face of mobility restrictions and generate risks to their integrity and that of other citizens.

In such a scenario of civil disobedience, the notion of mandatory immunization could lessen the effect of the pandemic. Giubilini and Jain (³⁸), senior researchers at the Uehiro Centre for Practical Ethics at Oxford University, argue that leaving everything to the conscience of individuals is insufficient and suggest that vaccination should be mandatory. They argue that "Being vaccinated drastically reduces the risk of seriously harming or killing others." Likewise, these researchers assert that mandatory immunization against COVID-19 fairly distributes the responsibility for achieving herd immunity because it "ensures that the risks and burdens of vaccination are evenly distributed among the population." They also support other less restrictive measures, highlighting the importance of information campaigns to promote the benefits of this public health measure to the public. Vaccination will not be the only measure to curb the infection rate, but it could be an additional strategy to biosecurity measures with the potential to mitigate new epidemiological peaks of infections and deaths associated with this disease.

The optional notion of vaccination

Against the optional notion of vaccination for SARS-CoV-2, it is possible to argue from a principled perspective the need to respect the autonomy of citizens. It is reasonable to consider that individuals in full use of their mental capacities can make the decision to be vaccinated or not, based on their preferences and deepest beliefs, but also the reflective exercise of the consequences of their decision. Citizens who reject the obligatory nature of vaccination could appeal to articles 16 and 18 of the Political Constitution of Colombia (¹⁴), already mentioned, to establish rights of tutelage to protect their right of free will.

In the case of children, adolescents, and persons incapable of giving their consent, it would be more complex to face this optional condition of the vaccine, due to the paternalistic tendency of medicine and legislation, since the decision will depend on third parties. In the Colombian State, the legal framework favors the making of this type of decision by the guardians or legal representatives, who must receive all the corresponding medical information, evaluating the context of each individual against the potential risks and benefits to record their approval according to their best interest (³⁹).

The right to non-maleficence cannot be disregarded. Although the vaccine does not imply voluntary harm to the individual, since it is an experimental vaccine, some may consider that the current options do not have the ideal guarantees compared to the safety and efficacy evaluated in others previously developed for other pathologies. The decision of some citizens not to receive the vaccine, at least for now, until they see better performance in phase IV (commercialization and mass administration) could be reasonable. It would be valid for other individuals to state their preference not to receive the vaccine in the face of potential side effects ranging from pain in place of administration to the risk of anaphylaxis (⁶).

For González-Melado and Di Prieto (⁴⁰), the compulsory vaccination option that some governments may opt for reflects the problems of the ethical models on which health policies and their implementation are based. The authors propose building health policies on a "first-person" ethical model, based on responsibility, to favor the transformation from normative ethics to the ethics of responsible behavior.

Reiss and Caplan (³⁶), for their part, indicate that the debate on the application of mandatory vaccines should be approached neutrally, trying to evaluate the commonalities between citizens' values and the pros and cons of the social benefit in each particular circumstance.

Pinto Bustamante et al. (⁸) quote Diego Gracia when they refer that the key to balanced decision making, which respects "individual freedoms and the common interest," is the weighing of conflicts between ethical values and extreme courses of action. Consequently, risk communication strategies, comprehensive counseling, and the quality of the informed consent process emerge as a fundamental point to accompany the optional choice for vaccination against COVID-19. These authors state that autonomous decision-making regarding the process of accepting immunization should be based, as in any informed consent process, on clear and truthful information communicated assertively to citizens considered candidates to receive this public health measure.