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COVID-19 Vaccines and the Case for a New Global Health Diplomacy

By Padmashree Gehl Sampath

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Gehl Sampath P. COVID-19 vaccines and the case for a new global health diplomacy. HPHR. 2021; 29.

COVID-19 Vaccines and the Case for a New Global Health Diplomacy

Introduction

A year into the COVID-19 crisis, the virus has exposed and strengthened the global fault lines in healthcare. On the good side, the pandemic brought together governments, pharmaceutical companies, and academic/ research institutes in an unprecedented manner to actively forge new collaborations and produced impressive results. Several vaccines are already in the market, and a steady pipeline is in place, promising new introductions in the coming months. At the same time, we have newfound evidence that availability does not translate into access for all even in the direst situations. In just a few months, COVID-19 has morphed from a global to a regional pandemic. As a small set of countries prepares to re-open their economies after having administered over seventy percent of all vaccine doses globally (McClellan et al, 2021), other regions of the world are beleaguered by mounting death rates, new virus variants and dwindling vaccine reserves.

 

It was not meant to be this way. Efforts to ensure that treatments to address COVID-19 did not exclude low- and middle-income countries (LMICs) where most of the world’s people reside was a concern from the start of the pandemic for those on the frontlines of access to medicines debates. The COVAX Facility,[1] an ambitious global blueprint on health collaboration, led by the World Health Organization in collaboration with Gavi and the Coalition for Epidemic Preparedness Initiative (CEPI), was created to mitigate such fallouts. The facility aims to provide COVID-19 vaccines to all participating countries, but particularly the 92 low- and middle-income countries (LMICs) that form part of the COVAX-AMC, its advance market mechanism (Gavi, 2021). The initial objective is to cover at least twenty percent of high-risk populations (frontline health workers and the most vulnerable groups) and make further doses available on set criteria.[2]

 

It is now widely acknowledged that early purchase agreements – signed bilaterally by a few countries – are the prime culprits for propagating unequal vaccines’ access on a global scale. These agreements, while accelerating national vaccine programs, most notably, in the United States of America, United Kingdom, Canada and now parts of the European Union, have resulted in widespread scarcity elsewhere. For example, compared with 297 million doses of vaccines already administered in the United States of America,[3] only 15 million vaccines have been administered throughout the African continent,[4] of which only six million reached sub-Saharan Africa as of April 2021 (Dahir, 2021).

 

In a world with finite production capacity, bilateral deals and stockpiling of vaccines in some countries has meant less and less for supply elsewhere. This has endangered self-financed purchases of vaccines in other countries limiting their ability to respond effectively. Equally importantly, it has also put at risk supply expansion by the COVAX Facility. As of May 2021, the Facility has supplied 59 million doses of vaccines to roughly 122 countries over a half of which are LMICs that are COVAX-AMC eligible according to WHO (2021a),[5] and reserved another 1.8 billion doses for the year to meet its target of supplying 2 billion doses by the end of 2021.[6] In recent weeks, however, supply shortages from firms such as SII and AstraZeneca (WHO, 2021b),[7] have been forecasted to impact the expansion of supplies through the COVAX Facility.[8]

 

Ironically, the supply shortages caused by one or even a few firms are unlikely to be the main bottlenecks to equitable global access to vaccines. Infinitely more worrying is the insidious blend of domestic politics and industry support in rich countries that has now culminated into a much more potent version of vaccine nationalism. In this new version, while continuing to reserve products for rich countries at the expense of LMICs (Fisher et al, 2021), some countries are, in effect, trying to change the rules of what many assumed was a somewhat settled multilateral game.

 

[1] The acronym stands for the COVID-19 Vaccines Global Access (COVAX) Facility.

[2] 182 countries are in the COVAX Facility since 15 December 2020. 90 are fully self-financed, and 92 are LMICs that form part of the COVAX-AMC, of which 58 Gavi-eligible countries form part of the core COVAX-AMC, and 34 countries that are transitioning out of, or have already transitioned out of Gavi. See https://www.gavi.org/sites/default/files/covid/pr/COVAX_CA_COIP_List_COVAX_PR_15-12.pdf

[3] https://usafacts.org/visualizations/covid-vaccine-tracker-states/

[4] https://africacdc.org/covid-19-vaccination/

[5] https://www.gavi.org/covax-facility, data updated 12 May 2021.

[6] https://launchandscalefaster.org/covid-19/vaccineprocurement, data updated 23 April 2021; Gavi (2021).

[7] Also see: https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-requirements-causing-delays-covax-deliveries-gavi-2021-03-02/

[8] The Facility currently has a contract with SII for the supply of 200 million doses before the end of 2021, with an option of another 330 million (CEPI et al, 2021).

Situating Vaccine Nationalism in the Global Access to Medicines Debate

Vaccine nationalism – or more broadly, medicines nationalism – is not new. Countries have historically viewed health care as an issue of national sovereignty and security, for promoting and protecting their pharmaceutical industry, and for securing health care for their people. With widespread globalization, and the establishment of multilateral regime, richer governments with strong pharmaceutical industries have sought to protect their incumbent advantages by granting intellectual property rights and other regulatory exclusivities to established firms. This has had significant impacts on medicines introduction, availability, and access in other parts of the world, not only because drugs are not easily available or necessarily more expensive, but also because pharmaceutical patents increase the barriers to entry for new firms in a highly concentrated global market. This debate, where trade and intellectual property protection concerns compete with the humanitarian objective of promoting of access to medicines, shapes global health diplomacy. Operating within this wider landscape, the current COVID-19 vaccine nationalism exacerbates prior access divides in four specific ways.

There is a return of nationalistic health-industrial policy programs

The crisis essentially marks a definite return of health-based industrial policy approaches in the interest of national security. The largest such national program, the US government’s Operation Warp Speed (hereafter, OWS) was created to offer a much-needed public-private push for vaccines development for the United States of America. As is now widely known, the OWS chose to fund 8 candidates from 4 new technology platforms based on criteria that set out to yield a safe and effective vaccine against Covid-19 (Slaoui & Hepburn, 2020). In that process, OWS chose six companies that included American biotechnology firms Moderna and Novavax as frontrunners. The UK government similarly formed a vaccines taskforce in April 2020 to locate investments into COVID-19 vaccines and invested 400 million USD in vaccine trials with the University of Oxford, which culminated in a vaccine development project with AstraZeneca (Dellanna, 2020). On a smaller scale, the EU invested 80 million Euros to support a German company CureVac for its vaccine development. China’s CanSio’s adenovirus vaccine Ad5 and Sinovac’s CoronaVac, and Russia’s Gam-Covid-Vac (Sputnik V) are similar outcomes of national R&D investments. The Indian government has partially funded the ZyCoV-D, the plasmid DNA vaccine designed and developed by Zydus (India).

 

There is no doubt that public funding has been instrumental in ensuring quick vaccine introductions. A program like the OWS, in particular, has brought into sharp relief how a targeted industrial policy program can be used to accomplish a relevant mission: in this case, the speedy discovery of COVID-19 vaccines. But national interventions and funding have also helped countries leverage soft power to secure advance purchase agreements, and often to unfairly position domestic candidates in a global vaccines race. The US, for instance, secured early purchase agreements with reserved buying options for up to 1.9 billion doses already by September 2020 riding strongly on the billions of investments it made into R&D through the OWS.[1]

 

By the end of 2020, vaccine discovery had transformed into a covert national race, leading to emergency approvals that piqued legitimate concerns regarding the choice of projects, their safety and efficacy (Kaplan, 2020). China fast-tracked CanSino’s adenovirus vaccine Ad5 in June 2020 and granted approval to Sinovac’s CoronaVac in August 2020 after limited Phase I and Phase II trials (Corum et al, 2020). Gam-Covid-Vac (Sputnik V) was approved for emergency use by the Russian government in August 2020: much before it demonstrated a 91.6% efficacy (Logunov et al, 2021). The Indian government similarly accelerated the emergency approval of Bharat Biotech’s Covaxin in January 2021, when phase III trials were still underway, and efficacy was unproven.

 

[1] The US government had secured agreements for the purchase of 100 million (plus option of 500 million) vaccine doses from Moderna, Pfizer/ BioNTech and GSK/ Sanofi Pasteur respectively, 100 million from Novavax, and 100 million (plus option of 200 million) from Johnson and Johnson by September 2020.

With significant impacts on sequencing innovation

There are undeniable links between innovation choices, production capacity and access. Public funding of R&D, in many instances, has focused largely on new vaccine technologies such as DNA or mRNA platforms on grounds that these are highly flexible for antigen manipulation and can lead to speedy outcomes once the sequence has been identified (Thanh le et al, 2020). Vaccines based on viral vectors have also been preferred for their strong immunological responses (Thanh le et al, 2020). But conventional vaccine platforms, such as those used to treat smallpox, have been less preferred (van Riel and de Witt, 2020, pp. 810).

 

This bias toward new technology platforms is shaping the innovation environment for COVID 19 vaccines in ways that have large consequences for global access over the next few years. Today, the six vaccine companies that received an estimated USD 12 billion public investments from OWS (MSF, 2020) are among the fourteen vaccine producers that have emergency approvals (except for Novavax, which is still in the trial phase). The only other additions to that are the vaccines from China,[1] Russia (Gamalaya Institute) and India (Bharat Biotech).[2] The COVID-19 vaccine tracker of the London School of Hygiene and Tropical Medicine shows that of the 21 vaccines in Phase II/III clinical trials today, 14 use new technology platforms as opposed to 7 that are traditional in nature.[3]

 

Vaccines using new technology platforms are not just more expensive; they also tend to require high thermostability making it dependent on new storage and transport infrastructure for administration in several LMICs. Second, new vaccines rely on several components, ranging from viral matter to stabilizers, adjuvants, delivery devices and methods, all of which are heavily protected by intellectual property thickets (Rutschman, 2020; Shores et al, 2021). Compulsory licensing, the classic “go to” legal mechanism in the access to medicines debate, is insufficient to break the legal monopoly that surrounds COVID technologies not only because of the technological intensity of the process, and entire supply chains for production may have to be created, starting from machines, to antigens and adjuvants (recombinant viruses, modified nucleosides, lipids, etc), to bioreactor bags, and more. Moderna and BioNTech have both in-licensed core patents to create their vaccines but are estimated to have over a hundred patents covering their technologies (Shores et al, 2021). It is also likely that beyond patents, trade secrets and manufacturing processes covering technical specifications are required for the true transfer of know-how related to production.

 

[1] Anhui Zhifei Longcom Biopharma, CanSino Biologicals, Sinovac, Beijing Institute of Biological products and Wuhan Institute of Biological Products. See https://www.unicef.org/supply/covid-19-vaccine-market-dashboard

[2] Same as above.

[3] https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/

Leaving few options for LMICs to enhance supplies

Stark divides in production capacity exist in the vaccines market. The WHO lists over 80 vaccine companies worldwide, but most companies produce generic or older vaccines operating on a low cost, high volume model. Pooled procurement through Gavi has, in the past, paved the way for the entry of many new producers from LMICs bringing down the prices. Thanks to these efforts

the global vaccines market expanded to 3.5 billion doses in 2018 (WHO, 2019). At the same time, in many vaccine categories like DTP, Measles Rubella, Meningitis A, or Japanese Encephalitis, economies of scale seem to be the key driving factor undergirding the expansion of capacity of LMIC firms. India accounts for a large share, producing 3 billion doses per annum, and the key new players that have emerged are SII (India), Biologicals (Indonesia), and Chengdu Institute (China), all of which supply to Gavi.[1] Other firms like Bharat Biotech (India), Shantha Biotech (India), Panacea Biotech (India), Aspen (South Africa), and Incepta (Bangladesh) have varying levels of capacity.

 

Currently, nine companies from developing countries account for 80% of all vaccine sales in volume,[2] but four global companies that conduct new vaccine R&D and produce branded products captured over 2/3rds of the market by value, estimated at USD 36 billion in 2018 (Pearman, 2020). Manufacturers from developing countries that have managed to break into vaccines R&D successfully remain painfully few and far between. These include Bharat Biotech’s new rotavirus vaccine (Rotavac) and SII’s new rotavirus vaccine (Rotasil) and pneumococcal vaccine (Pneumosil).

 

Indian companies entered the COVID-19 landscape in 2020 promising large scale, cheap and fast production of vaccines for supply to other LMICs. SII has been producing around 80 million COVID-19 vaccines a month but has not been able to scale up to the promised 100 million per month capacity yet. Additionally, a devastating second wave of COVID-19 that is ravaging the country, and low domestic vaccination rates imply that the country’s supply potential in the foreseeable future might mostly be utilized internally. Outside of large-scale supplies from India, the licensing landscape is sparse (Table 1).

 

[1] Data available with the WHO’s MI4A database.

[2] Same as above.

Table 1: The Current Licensing LandscapeSource: Compiled by author. Note: Sputnik V licenses have all been concluded recently (March-April 2020), and production is expected to commence later in the year.

In particular, the three companies with highly efficacious vaccines – Pfizer/BioNTech, Moderna and Johnson and Johnson – have not concluded licenses for production dedicated to the developing world. Johnson and Johnson’s license to Aspen Pharmaceuticals in South Africa, is currently expected to produce around 350 million doses of the vaccine annually, of which half are reserved for exports back to rich countries as part of early purchase agreements. Only the other half are expected to supply to Africa to cater to the African Union purchase agreement with the company for 400 million doses. Novavax, which is still in clinical trials, has agreements with eight production plants worldwide including SII (India), Takeda (Japan), SK Bioscience (South Korea), but has recently announced delays in introduction with forecasts that it will not reach peak production until end of 2022 (Thomas, 2021).

 

A major barrier for expansion of production in other parts of the world is not finance, but the technology and know-how for these vaccines. Assured market access to national, regional and export markets – if producers are successful – also remains extremely important (Abbott et al, 2021). To address these production disparities, we not only need the full use of all flexibilities available in Agreement on Trade Related Aspects of Intellectual Property Rights (the TRIPS Agreement) to help new firms access proprietary knowledge but we also need to support the emergence of a dynamic capabilities in countries through technology transfer and know-how sharing to produce them more vehemently than ever before.

Continued purchase agreements are transforming the pandemic into a regional crisis

In September 2020, projections on what can be produced and made available by the end of 2021 ranged between 5.9 and 9 billion vaccine doses (Oxfam, 2020; Agarwal et al, 2020). That production capacity was cornered by a few, fast-moving countries in early purchase agreements, ensuring that 51% of all capacity would be diverted to supplying their populations (Oxfam, 2020).

 

Since then, the handful of companies that have discovered vaccines have been expanding capacity. Current forecasts of manufacturing capacity for 2021 range between 9.5 and 13 billion doses (Taylor et al, 2021). While this could be sufficient to vaccinate most people globally (calculated as two doses per person),[1] two problems persist: rich countries have continued to negotiate purchases of vaccine doses, and it is unclear whether these self-projections by large companies will materialise.

 

New estimates show that confirmed purchases have reached 8.6 billion doses, and rich countries with 16% of the global population will continue to account for 53% of total vaccine procurements even if the expanded capacity materialises, whereas low-income countries account for only 770 million doses.[2] Additional vaccine negotiations for 6.6. billion doses (as options) are underway. If those are successful, the purchase agreement with the COVAX Facility will be at just over 300 million doses, with the EU and USA following shortly thereafter with 288.5 million doses and 251 million doses respectively.[3] In effect, COVAX’s goals of vaccinating up to 20% of LMICs would be met, but this situation leaves questions of how the rest of the 80% in the developing world will fare.

 

[1] https://launchandscalefaster.org/covid-19/vaccinemanufacturing, data updated 23 April 2021.

[2] McClellan et al (2021); https://launchandscalefaster.org/covid-19/vaccineprocurement

[3] https://launchandscalefaster.org/covid-19/vaccineprocurement, data updated 23 April 2021.

The need for a new global health diplomacy

Recent discussions on vaccine access allude to the fact that rich countries with excess vaccine supplies will eventually spare additional doses – through the COVAX Facility, or directly in bilateral ways – with the world’s poor. This idea disturbingly conflates equitable access with eventual access. A COVID-19 vaccine is a global public good. Continuing to allocate scarce vaccines on a ‘first-come-first-serve’ manner does not maximise its health impact from a global welfare perspective. If at all, such an approach monetizes morbidity and mortality in favour of those who can pay for it.

 

Equitable access to COVID-19 vaccines implies early and equal access. In other words, putting aside priority health care workers, two individuals with similar health situations should be able to access the vaccine at around the same time globally. By undermining this simple but important global objective, the new vaccine nationalism endangers our common future. It also fails to answer why it is acceptable for countries like Canada, UK, New Zealand, Chile and the European Union to hold 10.4, 8.18, 6.57, 5.07 and 4.6 doses per inhabitant respectively.[1] Instead of offering accountability, it seeks to justify the slow and satiated vaccine campaigns unfolding in richer countries when lives are being lost and people struggle in desperation to survive in the developing world.

 

The future of the global economy hinges on two simple truths. There will not be enough vaccines, at reasonable prices, without expanding production capacity. And there cannot be a full return to normalcy without the threat of more dangerous mutations of the virus if we do not embark on vaccinating everyone. A third truth comes closely behind: regardless of optimistic expansion projections, we risk putting the world’s future in the hands of a few large companies if we do not use the current opportunity to diversify the global supply pool for production and future innovation.

 

Addressing this requires a new approach to global health diplomacy along three axes. First, the separation of R&D, innovation, and access especially for pandemics. Granted, we need big pharma to continuously invest in vaccines innovation given the threat of new variants and new diseases. So, a solution to the current ‘winner-takes-all’ dynamic could be to benchmark patent rents from new innovations in a way that companies can recover R&D investments with some premium for a limited time, but to balance that with technology transfer and supply expansion. Second, we need to actively focus on creating supply capacity across all regions to enable the availability of life saving supplies to one and all. Third, the global community should prioritise parallel approaches for innovation, production, and access simultaneously. The COVAX Facility, initiatives that promote voluntary licensing by firms by national governments, the transfer of technology and know-how to a wider pool of manufacturers (e.g., through a COVID 19 Technology Access Pool) should co-exist with those that facilitate investments into production capacity, and broker other forms of technology partnerships to enable the emergence of new firms, new knowledge, and new products. Such an outcome can only boost global health.

 

[1] Same as above.

References

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About the Authors

Padmashree Gehl Sampath

Padmashree Gehl Sampath is Senior Advisor Global Access in Action Program, and Fellow, Berkman Klein Center for Internet and Society, Harvard University, and Adjunct Professor, Department of Social Sciences, University of Aalborg, Denmark. Her work focuses on policy forecasting and analysis, policy design and implementation of relevance to global and national governance in select sectors, especially pharmaceuticals and health.