COVID-19 vaccines: How Structural Factors Can Vitiate Patient Autonomy and Dictate Vaccine Choice

Since SARS-COV-2, the causative agent of Coronavirus Disease 2019 (COVID-19), was first identified, reported global infections have well surpassed over one hundred and fifty million people, and millions of individuals have succumbed to the disease. To date, several COVID-19 candidate vaccines have been granted emergency use designation by multiple drug regulatory agencies and are being deployed, globally. To ensure that everyone enjoys of the highest attainable standard of health and achieves the full realization of their right to health, states are obliged to prevent and control epidemics. Mass immunization – characterized as delivering immunizations to a large number of people at one or more locations in a short interval of time – has proven to be a successful strategy for preventing the spread of many infectious diseases. Besides providing protection at the individual level, mass immunization programs also aim for vaccine-induced herd or population immunity – that is, immunizing a large proportion of the population to protect the non-vaccinated, immunologically naïve, and immunocompromised individuals by reducing the percentage of vulnerable hosts to a level below the transmission threshold. The attainment of vaccine-induced population immunity will depend on the procurement of effective vaccines and their widespread uptake. Vaccine uptake, in turn, depends on a potential vaccinee exercising their right to health and autonomously embracing vaccination. However, while voluntariness lies at the heart of autonomous decision-making, several structural factors could vitiate self-determination.   

Structural factors and patient autonomy

At the broadest level, structural factors are the political, economic, social and environmental conditions and institutions at national, regional and international levels that influence the overall environment in which individuals, families and communities are situated and which shape their beliefs, decisions and behaviours. Geopolitics, conflicts, political systems, sovereignty, governance, respect for human rights, and the rule of law, count as examples of structural factors. In the field of health ethics, the principle of autonomy has been characterised as ‘self-rule that is free from both controlling interference by others and from limitations, such as inadequate understanding, that prevent meaningful choice.’ The notion of autonomy is epitomized by the argument that ‘free people must be free to make bad decisions—and to enjoy the rewards or suffer the consequences.’ The legal doctrine of informed consent upholds the principle of autonomy by requiring clinicians to inform mentally competent patients of all relevant therapeutic and prophylactic alternatives and to respect the patient’s choices in that regard. While multiple COVID-19 candidate vaccines have been granted emergency use authorization in various settings, structural factors are dictating their access at a grassroots level. As a result, patients are being denied their autonomous right to access a vaccine of their choice.

How geopolitics dictates vaccine procurement and impacts on patient autonomy

Geopolitical factors are depriving hundreds of millions of people of their right to autonomy in regard to COVID-19 vaccine choice. Hamstrung by decades of United States (US) sanctions, Cuba has strived for self-sufficiency in relation to vaccine production. Cuba has accordingly not imported any COVID-19 vaccines through bilateral deals with foreign vaccine developers, nor has the country sought COVID-19 vaccines through the COVAX facility. Instead, Cuba is developing at least four homegrown COVID-19 vaccines and trialling the vaccines domestically, and in Iran and Venezuela. However, the hardening of US sanctions during the Trump presidency has made Cuban procurement of raw ingredients necessary for vaccine production, more difficult. Venezuela is procuring Russian COVID-19 vaccines because US sanctions against the country have ruled out the procurement of certain vaccine candidates. Similarly, while Iran’s Supreme Leader has barred the importation of vaccines from the US and the United Kingdom (UK) because of mistrust of Western powers, Iranian politicians have simultaneously urged the US to lift sanctions against Iran to enable the country to import COVID-19 vaccines. While such sanctions formally exempt the importation of food, medicine, and other humanitarian supplies, Iranian health workers and sanctions experts have claimed that US sanctions are resulting in lost oil revenue for the country, and preventing the importation of pharmaceuticals and medical supplies, including raw materials and equipment needed to manufacture medicines domestically. Oil revenue losses due to sanctions has left Iran with less financial resources to effectively tackle the COVID-19 pandemic. Iran has also claimed that foreign and multilateral lending institutions have been deterred or blocked from concluding agreements with the country, including in relation to humanitarian initiatives For instance, in March 2020, during Iran’s first wave of COVID-19, the US blocked Iran’s request for an emergency $5 billion International Monetary Fund (IMF) loan aimed at helping the country respond to the COVID-19 pandemic. In December 2020, Iran reported that all methods by the country to transfer funds to secure vaccines through the COVAX facility for COVID-19 vaccines were unsuccessful because foreign assets had been frozen and monetary transfers involving Iran required permits from the Office of Foreign Assets Control of the US Treasury, by virtue of US sanctions. As a result, Iran has procured Russian, Chinese, and Indian vaccines, and is simultaneously trialling Cuban and homegrown candidate vaccines. However, notwithstanding Iran’s Supreme Leader barring the deployment of US and UK vaccines in the country, Iran is scheduled to receive more than 4 million doses of AstraZeneca vaccines through the COVAX facility.

National pride, geopolitical tensions, and mistrust are also potentially depriving people in some settings of their autonomous right to access a vaccine of their choice, including those developed by countries deemed to be ‘rivals’. While there are documented cases of drug regulators restricting or permitting access to health interventions based on domestic politics, and not on science (including in settings such as the US), global geopolitics can also dictate access to healthcare interventions. US officials are unlikely to procure and deploy state-sponsored Chinese or Russian candidate vaccines because of mistrust and transparency concerns. China and Russia are only deploying their own respective domestically-produced vaccines, despite US and European vaccines demonstrating superior efficacy. China has been accused of attempting to discredit western vaccines, and indirectly pressuring foreign expats (for example, foreign workers and students registered at Chinese institutions) to take its vaccines by announcing in mid-March 2021 that the country would facilitate the processing of visa applications if applicants had been vaccinated with Chinese vaccines.

Geopolitical factors are also dictating vaccine procurement and disbursement between countries that develop and manufacture vaccines, and those that do not. For example, Pakistan finds itself in a challenging position because of historical tensions with India. In what could be viewed as national pride trumping national interest, Pakistan has not approached Indian vaccine manufacturers to procure COVID-19 vaccines, despite India producing billions of vaccine doses for countries, globally. Ironically, Pakistan will indirectly receive millions of vaccine doses sourced from India through the COVAX facility. Conversely, while India has donated millions of doses of domestically-produced vaccines to neighbouring countries and globally, as part of a goodwill ‘vaccine diplomacy’ effort to counter the influence of China, Pakistan has been a notable omission in the list of regional beneficiaries. Instead, China has filled the philanthropy void by donating millions of doses of Chinese vaccines to Pakistan as part of the Chinese government’s vaccine diplomacy efforts. Pakistan is also separately procuring and deploying Chinese vaccines, despite high levels of scepticism amongst Pakistanis towards Chinese COVID-19 candidate vaccines. Pakistani officials were forced to defend the country’s deployment of Chinese candidate vaccines after the Pakistani President was infected with COVID-19 soon after being vaccinated with a Chinese vaccine.

Taiwan offers another example of how geopolitical tensions can impact on vaccine procurement and patient autonomy. On the back of high levels of mistrust of Chinese vaccines amongst Taiwanese nationals, the Taiwanese government has indicated that it is prepared to help its diplomatic allies buy COVID-19 vaccines, conditional upon Taiwanese funding not being used to procure Chinese vaccines. Concurrently, Taiwan has accused China of trying to pressure the Paraguayan government into severing diplomatic ties with Taiwan in return for Paraguay receiving millions of vaccine doses from China. In arguably the ultimate display of vaccines being used as geopolitical currency, Israel allegedly secretly purchased Russian vaccines for the Syrian government, to facilitate the release of prisoners held by the Syrian regime. While Syria’s first tranche of vaccines through the COVAX facility are being deployed in specific areas of the country and subject to independent monitoring by monitors deployed by WHO and UNICEF, the alleged Israeli-sourced Russian vaccines were used by the Syrian regime to launch the government’s COVID-19 vaccination campaign, leading to concerns that many individuals in government-controlled and rebel-held areas would be deprived of vaccines without international oversight. In all the above situational contexts, geopolitics is dictating vaccine procurement and supply at the macro level, and indirectly vitiating autonomy at the individual level.

How corporate self-interest and sovereign fiscal constraints dictates COVID-19 vaccine procurement at the macro level and undermines personal autonomy at the grassroots level

As was the case with HIV, COVID-19 has become an intellectual property battleground. On 2 October 2020, South Africa and India petitioned the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council at the World Trade Organisation (WTO) to waive certain provisions of the TRIPS Agreement for the prevention, containment, and treatment of COVID-19, until the majority of the world’s population has access to effective vaccines and has developed immunity to COVID-19. Specifically, South Africa and India were advocating for intellectual property waivers that would temporarily suspend certain vaccine technology patent monopoly protections during the COVID-19 pandemic, thus enabling countries with vaccine manufacturing capabilities to access a candidate’s “recipe” (including the active ingredients as well as other substances) and manufacturing protocols, to enable domestic companies to produce generic versions of the vaccines. Such measures are permitted under the TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health, which affords countries the right to grant compulsory licenses, the freedom to determine the grounds upon which compulsory licences are granted, and to determine what constitutes a national emergency or other circumstances of extreme urgency. South Africa and India’s initiative found strong support from the Director-General of the WHO, Tedros Ghebreyesus, who argued: ‘If a temporary waiver to patents cannot be issued now, during these unprecedented times, when will be the right time?’ While India and South Africa’s initiative was criticised as lacking an evidentiary base, and the pharmaceutical industry argued that temporary patent waivers would harm innovation and entrepreneurship, and damage the industry, significantly, temporary patent waivers for COVID-19 vaccines also found support from the Director-General of the WTO, Ngozi Okonjo-Iweala, who also touted broadening COVID-19 vaccine access through technology transfers within the framework of multilateral rules through licensing agreements between patent holders and generics manufacturers. On 5 May 2021, the US government announced its support for waiving intellectual property protections for COVID-19 vaccines, noting “…extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures.” However, patent waivers will not translate to instantaneous vaccine access as there are practical challenges to scaling-up vaccine production related to manufacturing capabilities, technology transfer (the patent holder has to supply technical know-how and personnel), skills development, regulation, and quality control.

If a country does not issue compulsory licenses to enable domestic production of COVID-19 vaccines, realising the right to health through vaccine access will largely be determined by a country’s ability to mass-produce foreign vaccines to meet local (and foreign) demand through voluntary licensing agreements (as is the case with India), developing homegrown vaccines by necessity (as is the case with some countries that are subject to economic sanctions, such as Cuba and Iran), and/or a country’s financial capability to enter into bi-lateral and multilateral financing and procurement mechanisms to access the COVID-19 vaccine market. Such mechanisms include global-level Advance Market Commitments (AMCs), such as that of the COVAX facility, regional procurement mechanisms (such as those under the auspices of the European Commission (Advanced Market Agreements [AMAs] and the African Union [Advanced Procurement Commitments [APC]), and/or direct contracts between country authorities and vaccine developers / manufacturers, sometimes concurrent to procurement through AMAs, AMCs, and APCs. Current COVID-19 candidate vaccines differ widely in terms of cost per dose, and is an important factor in determining vaccine procurement. By 1 April 2021, of all vaccine doses administered globally, approximately 75% had gone to only 10 countries. Moreover, while 83% of vaccines administered globally had been administered in high-income and upper-middle-income countries, only 0.1 percent of doses had been administered in low-income countries. AMCs have been touted as providing assurances of future demand and financing, thus serving as a “pull” mechanism to incentivise manufacturers to invest in development and manufacturing of COVID-19 vaccines. It has been argued that AMCs can also serve as “push” funding, whereby public sector funds directly finance expanded vaccine manufacturing, securing critical raw materials and equipment, and transferring technology from developers to manufacturers. However, APAs can hold risks as countries risk getting locked into purchasing inferior or cost-ineffective products that could divert scarce resources from more optimal COVID-19 responses, including superior vaccines. Proponents of this view argue that if all or most available funding flows to the first market entrant, the second or third entrants may be boxed out of the market—even if their product is of better value or more efficacious. Such factors highlight how a country’s lack of domestic / regional vaccine production capability, and its financial ability to enter AMCs and AMAs, can impact on vaccine access at the grassroots level.

How sovereignty and governance impacts COVID-19 vaccine procurement and personal autonomy

A variety of vaccine procurement modalities apply globally. Sovereignty – defined for the purpose of this work as the decision-making authority of a government or non-state entity – is crucial to vaccine procurement. In settings such as Brazil, all levels of government and the private sector are permitted to procure COVID-19 vaccines directly from developers and manufacturers. In the Philippines, the private sector is permitted to purchase vaccines for private sector employees, provided half the supply is donated  to the government. Private sector vaccine procurement raises critical issues, including who pays for the vaccine: government (which level?), private sector employer, health insurer, civil society, or recipient? Moreover, who decides prioritisation and the vaccination schedule for target populations? Government, private sector, or civil society? Can two or more parallel systems operate? Should pricing be regulated? India offers an example of a country where the private sector is permitted to independently procure COVID-19 vaccines, but where pricing is capped at a quarter of the rate that vaccine manufacturers said they would sell to the private sector. Some have criticised the Indian government’s decision to cap vaccine prices, arguing that market forces should determine pricing. However, if people who are willing to pay higher prices to be vaccinated (especially in settings where universal vaccination coverage applies), such individuals could get vaccinated ahead of prioritisation frameworks established by policymakers. This will lead to affluent people getting vaccinated before poor people and potentially accessing more effective vaccines that have not been procured by the government because of fiscal constraints. Some have argued that allowing market forces to dictate pricing could also drive up prices, tempt manufacturers to prioritize higher-paying private sector purchasers, and lead to an increase in fraud and black market activity. Kenya offers an example of a country where private sector procurement was suspended on fears that the country was at risk of counterfeit vaccines and price gouging. Barring or dissuading a country’s private sector from procuring vaccines could also be motivated by fears that ineligible private sector clientele could ‘queue-jump’ over eligible individuals with less means. Such a situation is playing out in Pakistan, where private sector COVID-19 vaccine procurement is now permitted. There, most private sales of COVID-19 vaccines are taking place in large cities, such as Karachi, and vaccines are largely inaccessible to poorer residents in more rural areas. Such outcomes have major ethical and equity implications. In all such instances, sovereignty (central / state/provincial /local government /shared mandates / private sector) and governance (clinical guidance / prioritisation frameworks) will impact on equity and personal autonomy at the grassroots level.

The authority to procure vaccines, however, does not necessarily translate to time-sensitive access. Orders from the private sector are not prioritized by vaccine manufacturers. Further, the cost per dose is significantly more expensive than public-sector procurement. Given such factors, central procurement could arguably be advantageous as parallel negotiations between various levels of government and multiple private sector and civil society actors, could drive up prices amid already fierce international competition and supply constraints. South Africa offers an example of a highly inequitable setting where COVID-19 vaccine procurement is centralised, despite the country having a dual public sector and private sector health systems. The South African government has indicated that the while country’s private sector could co-fund centralised vaccine procurement and also participate in vaccination drives as service providers, only the national / federal government could source, distribute and oversee the country’s COVID-19 vaccine rollout. While such a strategy may hold the advantage of resource-pooling and facilitating economy of scale negotiations, the country’s civil society, at least one provincial government, the private health sector, and some actors in the corporate sector have voiced their preference to independently and directly procure their own COVID-19 vaccines. The central government’s stance on vaccine procurement has led to accusations of monopolisation, nationalisation, and threats of court action. In situations where vaccine procurement is centralised, individuals who are willing to be vaccinated may find themselves faced with no other option but to accept the vaccines that their central government procures (subject to regulator approval), regardless of personal preference or their financial ability to directly purchase a COVID-19 vaccine of their choice, and/or their regional government’s procurement preferences.

How protectionism and nationalism can dictate vaccine access and impact on autonomy at the grassroots level

Uneven distribution of vaccine manufacturing and financing capabilities yields unequal access to COVID-19 vaccines. Severe supply chain constraints, even in affluent settings, such as the European Union (EU), where multiple COVID-19 candidate vaccines are being deployed, is well documented. In such settings, individuals eligible for vaccination may face the possibility of not being vaccinated with a candidate vaccine of their choice because of supply constraints. In such instances, the individual faces the option of being vaccinated with an available vaccine they lack confidence in, or refusing vaccination and remaining at risk of COVID-19 infection until their preferred candidate vaccine becomes available. Such a situation is playing out in some EU countries and India. On the other hand, some authorities may only have procured a candidate vaccine that is mistrusted in their setting. In such instances, eligible but sceptical individuals face the option of acquiescing to vaccination with a product they mistrust, or declining vaccination and remaining indefinitely at risk of infection. Such a scenario is playing out in settings such as Russia.

Some settings are demonstrating that self-interest trumps global health and the ethics principle of solidarity. The US, EU, and India count amongst the world’s largest producers of COVID-19 vaccines. Severe COVID-19 vaccine supply constraints has resulted in the EU and India imposing COVID-19 vaccine export restrictions, for self-serving reasons. Similarly, the US federal government has used the country’s Defense Production Act (DPA) to spur domestic COVID-19 vaccine production. The DPA gives the US President powers to allocate “materials, services, and facilities” and award contracts that take priority over any other contract to “promote the national defence.” In the context of the COVID-19 pandemic, the DPA is being used to ‘defend’ the country against the COVID-19 pandemic. The DPA can also be used to prevent companies from exporting certain goods, to ensure their availability within the US. As a result, the US President has to approve the export of COVID-19 vaccines and vaccine-related raw materials. By 1 March 2021, the US had not exported any COVID-19 vaccines produced in the country. While the US has since lifted its ban on vaccine exports to enable key allies to gain access to US-made COVID-19 vaccines that are not being locally deployed, by 20 April 2021, the US had still not lifted its export ban of raw materials necessary to produce COVID-19 vaccines. Such prohibitions have a paralysing impact on vaccine production. For example,  the BioNTech/Pfizer vaccine contains 280 ingredients sourced from 19 countries. As a consequence of such export bans, COVAX suppliers, including those in India, could experience major production constraints that could have global implications. In all such instances, protectionism, self-interest, and vaccine nationalism could frustrate the realisation of the right to health and will dictate vaccine availability and choice at the individual level.

Conclusion

Financial self-interest, fiscal considerations, geopolitics, sovereignty, governance, protectionism, and nationalism are currently dictating COVID-19 vaccine procurement at the macro level. Such structural factors indirectly vitiate autonomy at the grassroots level and run counter to the ideal that individuals should have access to the highest attainable standard of health.

Acknowledgements

This manuscript is part of an Epidemic Ethics/WHO initiative which has been supported by FCDO/Wellcome Grant 214711/Z/18/Z. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.