An Analysis of COVAX’s Equity Mandate with Reference to Liability and Indemnity
KATHERINE GINSBACH*, SAM HALABI**, JOHN MONAHAN***, RICHARD WILDER****[1] ∙ April 15, 2024 ∙ ARTICLE
I. Background on COVAX
COVAX was developed to implement the vaccination goals of WHO’s Access to COVID-19 Tools Accelerator (“ACT-Accelerator”), a global collaboration established in April 2020 to accelerate development and production of, and equitable access to, COVID-19 tests, treatments, and vaccines. The ACT-Accelerator consisted of four pillars designed to address the COVID-19 pandemic: (1) diagnostics, (2) treatments, (3) vaccines, and (4) the health systems and response connector.[2]
To help address challenges that developing countries would face in accessing and administering COVID-19 vaccines, leading global health entities launched COVAX—a partnership to accelerate the development and manufacture of COVID-19 vaccines and to promote fair and equitable access for every country in the world—as the ACT-Accelerator’s vaccine pillar.
The lead conveners of COVAX were the Coalition for Epidemic Preparedness (“CEPI”), a public-private partnership that aims to accelerate the development of vaccines against emerging infectious diseases; Gavi, the Vaccine Alliance, a global health partnership created to improve access to vaccines in developing countries; the WHO, the Specialized U.N. Agency, with the mandate to act as the directing and coordinating authority on international health work; and the United Nations Children’s Fund (“UNICEF”), the U.N. agency responsible for providing humanitarian and developmental aid to children worldwide, acting as the delivery partner.[3]
More specifically:
· Gavi’s role was to lead global procurement and delivery at scale for COVAX;[4]
· CEPI led on the COVAX vaccine research and development portfolio, leveraging investments it had made in research and development across a variety of promising vaccine candidates;[5]
· WHO’s multiple roles within COVAX included providing normative guidance on matters such as vaccine policy, regulation, safety, research and development, allocation, and country readiness and delivery; providing global coordination on vaccine safety monitoring; and developing target product profiles for COVID-19 vaccines;[6] and
· UNICEF deployed its experience as the largest single vaccine buyer in the world to lead COVAX on organizing the international transport of COVID-19 vaccines.[7]
The procurement mechanism resulting from this partnership—the COVAX Facility—was chiefly designed and managed by Gavi based on a core mission: pooled procurement and equitable distribution of COVID-19 vaccines.[8] Wealthy countries would gain self-financed access to COVID-19 vaccines, while low- and middle-income counties could obtain subsidized and facilitated access for priority populations through COVAX.
The COVAX Facility offered two main categories of benefits: a Committed Purchase Arrangement or an Optional Purchase Arrangement. In the Committed Purchase Arrangement, participants will commit to purchase allocations of approved vaccines from the program.[9] With the Optional Purchase Arrangement, a participant will be able to decide whether to purchase any approved vaccine allocated to them, while retaining the ability to receive its full share of doses of other approved vaccines.[10] Ninety-two countries qualified for AMCs, including all economies with a gross national income per capita of less than $4,000, plus other World Bank International Development Association (IDA)-eligible economies.[11] Such countries were initially eligible to receive donor-funded vaccines to cover up to 20% of their populations. Key donor sources for this funding included bilateral and multilateral development partners, private industry, and individual philanthropists.[12] Wealthier countries would not qualify for AMC funding and would have to finance their own vaccines.[13] For those self-financing countries, depending on their level of financial commitment, COVAX offered guaranteed doses to cover 10-50% of their populations.[14]
As the pandemic wore on, various factors began to threaten the COVAX Facility’s viability. In particular, wealthy nations began entering into bilateral purchase agreements with COVID-19 vaccine manufacturers, which limited the supply available for countries not party to such agreements.[15] As a result of such vaccine “hoarding,” COVAX’s goal of an equitable global vaccine rollout began to lose momentum.[16]
II. Planning and Distribution
Over time, contradictory goals and limited infrastructure in recipient countries hindered vaccine distribution planning through COVAX and delayed delivery of vaccines to those in greatest need. COVAX allocated doses in two phases based on two different, and competing, values: equitable access versus addressing greatest need.[17] The first phase, which allocated a fixed number of vaccines per capita to each country (up to 20% of their total population), represented COVAX’s commitment to ensuring that poorer nations received an equitable number of vaccines.[18] This allocation scheme, intended to be sufficient to vaccinate the most vulnerable groups in every country, was criticized for not considering the specific needs and characteristics of recipient nations or prioritizing vaccines for countries with the greatest need.[19] The second phase, by contrast, allocated vaccines based on need, with countries experiencing worse COVID-19 outbreaks receiving larger vaccine allocations.
Further constraints that impacted multiple countries, and were foreseeable, included logistical and resource constraints, specifically: limitations on availability of warehousing and cold-chain equipment to store vaccines, along with shortages in personnel to administer vaccines, impeded roll-out in recipient nations.[20] In December 2021 alone, developing countries rejected 100 million doses of vaccines from COVAX, mostly due to their short shelf life; among doses distributed to AMC-eligible countries, more than 15 million were destroyed due to their expiration before they could be administered.[21]
Logistical planning and distribution plans are only half of the solution when it comes to vaccine delivery. An important part of distribution is the need to address the risk of liability that arises from the use of novel vaccines.[22]
III. The Role of Liability and Indemnity
As with other vaccines, drugs and medical products, vaccines that are approved for general use may, in rare cases, cause serious adverse events in some individuals.[23] Governments that received COVID-19 vaccines through the COVAX Facility, were required to indemnify manufacturers against any financial losses they may incur from the deployment and use of the vaccines.[24] For the governments of AMC Eligible Economies, this kind of financial exposure could present too much risk for already-stretched health budgets. The Program for Advance Market Commitment Eligible Economies recognizes that individuals who get inoculated put themselves at a very small risk of injury following vaccination, for the wider benefit of the community, and acknowledges that in the very rare cases where a vaccine causes permanent impairment or death, affected individuals deserve compensation.[25] This is an important piece of the Program’s commitment to vaccine equity as it reduces the financial exposure for AMC Eligible Economies by minimizing the number of instances in which these economies may be required to indemnify manufacturers, and ensures that affected eligible individuals have access to fair compensation. The Program also reduces the risk of litigation for manufactures.
The Program is an essential part of the COVID-19 vaccine deployment strategy because, for some countries, offering indemnity or complete immunity from lawsuits to pharmaceutical companies is constitutionally or financially impossible.[26] Some governments will refuse to make such offers because of basic fairness principles, arguing that manufacturers should pay for the injuries their products cause.[27] Such policies result in certain low- and middle-income countries either refusing to offer manufacturers protection against liability and forgoing COVID-19 vaccines, or extending liability protections and risking a large number of people injured to whom the government is unable to offer compensation.[28]
By creating a comprehensive system for no-fault vaccine-injury compensation, the Program promotes equity. It allows countries that are unable to provide indemnity or immunity to manufacturers to access COVID-19 vaccines, ensuring that people who have serious adverse events will be compensated.[29]
All vaccines made available or procured through the COVAX Facility had received either (i) a WHO Emergency Use (“EUL”) recommendation or prequalification (if applicable), following authorization from a functional or stringent national regulatory authority of reference for vaccines,[30] or, under exceptional circumstances, (ii) a standard or a conditional marketing authorization, or emergency use authorization, from a stringent regulatory authority of reference for vaccines.[31] These COVID-19 vaccines received regulatory approval or emergency use authorization as they were generally deemed to be safe, and it was considered that the benefit of vaccination outweighed the risks.[32]
The importance of addressing the potential liability of vaccine manufacturers and administrators cannot be overemphasized. Unlike most medications, which are developed to treat existing diseases or conditions, prophylactic vaccines like the COVID-19 vaccine are pre-emptive: they are used on otherwise healthy people to prevent infection, or to prevent the worst effects of infection (for example, hospitalization or death). In the former situation, patients give informed consent to treatment after balancing their personal risk of side effects against the desirability of mitigating or eliminating an existing illness. While results are not guaranteed, patients have at least some expectation that they will benefit personally from the medication and can weigh that potential benefit against the potential risks about which they are informed.
In contrast, vaccines are societally desirable as much to prevent infection in other people as to protect the individual. In particular, young and healthy people might be unwilling to accept the risk of side effects; such hesitancy would reduce vaccine uptake and allow a communicable infection like SARS-Cov-2 to continue to spread, with the greatest adverse effects on others: older persons, immunocompromised patients, or individuals with complex medical circumstances. To encourage particularly the young and healthy to be vaccinated, developed nations have deemed it necessary, or at least highly desirable, to provide some mechanism for monetary compensation to address the risks of adverse vaccine events even in the absence of any fault by the manufacturer.[33] Similarly, to encourage development and production of vaccines, it is necessary to find a mechanism to protect manufacturers from liability for the inevitable side effects that some recipients will experience without any fault on the manufacturer’s part.
Traditionally, vaccine liability risk management has been handled at a national[34] (not international) level through two main mechanisms: statutory protections and contracts.[35] Roughly twenty-five WHO member states, including the United States, have passed legislation that limits manufacturer liability and creates no-fault compensation funds for vaccine-related injuries,[36] while most others require individuals injured by vaccination to seek redress in domestic civil courts.[37] In addition to directly legislating on the issue, some nations and supra-national organizations, like the European Union, may address liability for certain vaccines directly in their purchasing agreements with manufacturers. European Union purchasing agreements, for example, commit the Union to indemnifying manufacturers for a certain share of liability (depending on the price paid for the product).[38] Such indemnification funding comes from the Emergency Support Instrument, a European Commission financing instrument created in 2020 in the early stage of the COVID-19 crisis to provide support and strategic coordination at the European level during disasters, which operated until January 2022.[39]
IV. COVAX’s Risk Management Mechanism including No-Fault Compensation Program for AMC-Eligible Economies
COVAX recognized that the financial exposure arising from the above-mentioned indemnification requirements could present too much risk for the already-stretched health budgets of the AMC Eligible Economies. COVAX also recognized that while the benefits of immunization against COVID-19 (not only for vaccinated individuals, but also for society at large) greatly outweigh the limited risk of serious adverse events, solidarity requires that those who in rare cases suffer a serious injury as a result of vaccination deserve compensation.
To reduce the risk of litigation against manufacturers, thereby reducing financial exposure for resource-constrained AMC Eligible Economies to which the indemnification requirements give rise, COVAX established the COVAX No-Fault Compensation Program for AMC Eligible Economies (the “Program”).[40] The Program is the world’s first international vaccine injury compensation mechanism.[41] It is independently administered by an experienced claims administrator and provides compensation directly to individuals for permanent impairment or death associated with COVID-19 vaccines distributed through the COVAX Facility to the 92 AMC Eligible Economies or the administration of such vaccines.[42]
The multi-national nature of COVAX necessitated an international approach to addressing vaccine liability. Two key factors animated the push to create an international compensation system. Firstly, as noted above, COVAX wished to reduce the financial exposure to which the indemnification requirements described in section III above give rise for the resource constrained AMC Eligible Economies, i.e. by reducing the number of instances in which these economies may be required to indemnify manufacturers.[43] This prevented limitations and delays in the rollout of COVID-19 vaccines through the COVAX Facility in a time when health systems and budgets were under significant strain. Secondly, COVAX wished to offer to eligible individuals in the AMC Eligible Economies a fast, fair, robust, and transparent process to receive compensation for certain rare but serious adverse events associated with COVAX-distributed vaccines or their administration. This method allows for individuals to avoid seeking recourse through a court system, a process which is often expensive, complex and lengthy and has a higher burden of proof and, therefore, a more uncertain outcome.[44] Unlike claims brought under the court system, where an applicant would have to prove that the vaccine or its administration was actually the cause of the injury in question, the Program assesses an injury using the most probable cause standard (based on the balance of probabilities), as defined in the Program’s Protocol.[45] Under the Program, a claimant does not need to demonstrate that the vaccine actually caused the injury.[46]
The Program is funded by donations to an innovative financing instrument called the Gavi COVAX AMC and complemented by a robust insurance layer, providing up to USD $150 million insurance coverage for compensation payments.[47] The Program is administered by an independent claims administrator[48] and provides a centralized online portal (covaxclaims.com) for the submission of applications for compensation. To be eligible for compensation, a person must have suffered permanent impairment or death after being vaccinated with a COVID-19 vaccine that was earmarked for delivery through the COVAX Facility to an AMC Eligible Economy, or to a Humanitarian Agency for use in an AMC Eligible Economy, up to and inclusive of 30 June 2023.[49] Applicants have a long reporting period for submitting applications for compensation under the Program. Applications are administered in accordance with the terms of the Program’s Protocol and other relevant Program documents, which are publicly available in English, French and Spanish on the Program’s web portal. Applicants whose claims are approved for compensation are eligible to receive a formula-based[50] lump-sum payment.
V. Lessons for Future
In the face of an emerging pathogen with pandemic potential, innovative pharmaceutical companies, researchers, governments, funders, manufacturers, distributors, and other stakeholders across the world will again turn their focus to develop and deliver novel vaccines to avert or control a newly emerging pandemic threat. The importance of addressing the potential liability arising from such novel vaccines before such new threats emerge cannot be overemphasized. Anticipating the needs of pandemic preparedness and response will need to include expedited development and approval of vaccines; attention to unique logistical hurdles including the availability of warehousing and cold-chain equipment to store vaccines; and the need to include well-designed no-fault compensation systems that provide administrative, non-judicial process for individuals to seek compensation for serious vaccine-related injuries as an essential element to achieving rapid vaccine uptake.
*Senior Associate with the Center for Transformational Health Law at the O’Neill Institute for National and Global Health Law, Georgetown University. JD, MS in Global Health from University of Notre Dame, BA College of the Holy Cross (MA)
**Director, Center for Transformation Health Law, O’Neill Institute for National and Global Health Law. JD Harvard, MPhil Oxford, BS Kansas State University
***Advisor to the President, Global Health at Georgetown University; Professor, Department of Medicine. JD, BA Georgetown University
****Senior Scholar at the O’Neill Institute
[1] The authors would like to sincerely thank the International Senior Lawyers Project (ISLP) for their research and useful comments on this manuscript.
[2] What Is the Act Accelerator, WHO, https://www.who.int/initiatives/act-accelerator/about (last visited July 14, 2023). Since October 2022, the ACT-Accelerator has implemented a transition plan designed to support developing nations that now treat COVID-19 as an endemic disease, rather than an acute emergency, see ACT-Accelerator Transition Plan, WHO, Oct. 28, 2022, https://www.who.int/publications/m/item/act-accelerator-transition-plan-(1-oct-2022-to-31-mar-2023).
[3] COVAX, Gavi, the Vaccine All., https://www.gavi.org/covax-facility (last visited July 5, 2023).
[4] The U.S. Government & Gavi, the Vaccine Alliance, KFF (Mar. 7, 2023), https://www.kff.org/global-health-policy/fact-sheet/the-u-s-government-gavi-the-vaccine-alliance/#:~:text=Gavi's%20role%20in%20COVAX%20is,%2D%20and%20middle%2Dincome%20countries.&text=As%20of%20January%202023%2C%20COVAX,vaccine%20doses%20to%20146%20countries.
[5] COVAX: The Vaccines Pillar of the Access to COVID-19 Tools Accelerator Structures and Principles, Coalition for Epidemic Preparedness Innovations (Nov. 2022), https://www.who.int/publications/m/item/covax-the-vaccines-pillar-of-the-access-to-covid-19-tools-(act)-accelerator#:~:text=Its%20goal%20is%20to%20help,vulnerable%20in%20all%20participating%20economies.
[6] Id.
[7] COVAX: Ensuring Global Equitable Access to COVID-19 Vaccines, UNICEF (Sept. 5, 2020), https://www.unicef.org/supply/covax-ensuring-global-equitable-access-covid-19-vaccines#:~:text=UNICEF%20has%20been%20organizing%20the,high%2Drisk%20and%20vulnerable%20groups.
[8] Sam F. Halabi, Solving the Pandemic Vaccine Product Liability Problem, 12 U.C. Irvine L. Rev. 111, 138-40 (2021).
[9] COVAX Facility Explainer- Participation Arrangements for Self-Financing Economies, WHO, https://www.who.int/docs/default-source/coronaviruse/covax-facility-explainer.pdf (last visited Mar. 22, 2024).
[10] Id.
[11] 92 Low- and middle-income economies eligible to get access to COVID-19 vaccines through Gavi COVAX AMC, Gavi, the Vaccine All. (July 31, 2020), https://www.gavi.org/news/media-room/92-low-middle-income-economies-eligible-access-covid-19-vaccines-gavi-covax-amc.
[12] See Halabi, supra note 8, at 138-40.
[13] David Bishai, et al., COVAX and equitable access to COVID-19 vaccines, 100 Bull. of the WHO 315 (2022), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9047429/.
[14] Id. at 315.
[15] David McAdams, et al., Incentivizing wealthy nations to participate in the COVID-19 Vaccine Global Access Facility (COVAX): a game theory perspective, Brit. Med. J, Glob. Health, Oct. 21, 2020, at 1 (citing Gavin Yamey, et al., Ensuring global access to COVID-19 vaccines, 395 Lancet 1405-06 (2020)), https://gh.bmj.com/content/bmjgh/5/11/e003627.full.pdf.
[16] Id.
[17] See Halabi, supra note 8, at 144.
[18] COVAX: Policy and Allocation of Vaccines: Update, Status, and Next Steps, UNICEF (Nov. 2020), https://www.unicef.org/supply/media/5821/file/Policy-Allocation-framework-logistics-meeting-Nov2020.pdf.
[19] See Siddhanth Sharma, et al., WHO’s Allocation Framework for COVAX: is it fair?, 48 J. of Med. Ethics 434-38 (Apr. 2021), https://jme.bmj.com/content/48/7/434.
[20] Mathumalar Loganathan Fahrni, et al., Management of COVID-19 vaccines cold chain logistics: a scoping review. J. of Pharm. Pol’y and Prac. (Mar. 2, 2022), https://joppp.biomedcentral.com/articles/10.1186/s40545-022-00411-5; Stephen Hall, et al., None are safe until all are safe: COVID-19 vaccine rollout in low- and -middle income countries, McKinsey & Company (Apr. 23, 2021), https://www.mckinsey.com/industries/healthcare/our-insights/none-are-safe-until-all-are-safe-covid-19-vaccine-rollout-in-low-and-middle-income-countries.
[21] Francesco Guarascio, Poorer Nations Reject Over 100 Mln COVID-19 Vaccine Doses as Many Near Expiry, Reuters (Jan. 14, 2022), https://www.reuters.com/business/healthcare-pharmaceuticals/more-than-100-million-covid-19-vaccines-rejected-by-poorer-nations-dec-unicef-2022-01-13/.
[22] See Halabi, supra note 8, at 144.
[23] Selected Adverse Events Reported after COVID-19 Vaccination. U.S. Centers for Disease Control and Prevention (Sept. 12, 2023), https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html#:~:text=Anaphylaxis%20after%20COVID%2D19%20vaccination%20is%20rare.&text=Anaphylaxis%2C%20a%20severe%20type%20of,and%20allergic%20reactions%2C%20including%20anaphylaxis.
[24] COVAX No-Fault Compensation Program, WHO (July 7, 2022), https://www.who.int/initiatives/act-accelerator/covax/no-fault-compensation/covax-no-fault-compensation-program-explained.
[25] Id.
[26] Sam F. Halabi, Andrew Heinrich, & Saad B. Omer, No-Fault Compensation for Vaccine Injury—The Other Side of Equitable Access to COVID-19 Vaccines, 125 New Eng. J. Med. 383 (2020), https://www.nejm.org/doi/full/10.1056/NEJMp2030600.
[27] Id.
[28] Id.
[29] Id.
[30] Questions and Answers (Q&A) on regulatory matters related to the introduction and pharmacovigilance of vaccines against COVID-19, Pan American Health Org. (Jan. 19, 2021), https://covid-19pharmacovigilance.paho.org/img/recursos/607860b26a42d2c7e0689db9c.pdf.
[31] WHO Lists two additional COVID-19 vaccines for emergency use and COVAX roll-out, WHO (Feb. 15, 2021), https://www.who.int/news/item/15-02-2021-who-lists-two-additional-covid-19-vaccines-for-emergency-use-and-covax-roll-out#:~:text=WHO's%20Emergency%20Use%20Listing%20(EUL,and%20administer%20COVID%2D19%20vaccines.
[32] COVAX No-Fault Compensation Program: Explained, WHO (July 7, 2022), https://www.who.int/initiatives/act-accelerator/covax/no-fault-compensation/covax-no-fault-compensation-program-explained; WHO Target Product Profiles for COVID-19 Vaccines Revised Version, WHO (Apr. 2022), https://cdn.who.int/media/docs/default-source/blue-print/tpp-6apr-2022-final.pdf?sfvrsn=4f8cede5_4&download=true.
[33] Briefing Note: Additional Information on Indemnification for COVAX AMC Participants, COVAX (Nov. 2020), https://www.who.int/docs/default-source/coronaviruse/act-accelerator/briefing-note-indemnification-and-compensation-covax-amc-countries.pdf.
[34] Id. In principle, vaccine manufacturers should accept normal full product liability for vaccines with full or standard marketing authorization.
[35] See Halabi, supra note 8, at 148.
[36] MacKenzie Sigalos, You Can’t Sue Pfizer or Moderna If You Have Severe Covid Vaccine Side Effects. The Government Likely Won’t Compensate You For Damages Either, CNBC (Dec. 17, 2020), https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html; National Vaccine Injury Compensation Program, Health Res. & Serv. Admin., https://www.hrsa.gov/vaccine-compensation (last reviewed Apr. 2023). In the United States, funding under the Vaccine Injury Compensation Program comes from an excise tax on vaccine sales paid by manufacturers rather than from general revenues. See 42 U.S.C. § 300; See also About the National Vaccine Injury Compensation Program, Health Res. & Serv. Admin. (last reviewed Apr. 2024), https://www.hrsa.gov/vaccine-compensation/about/index.html. In contrast, in the United Kingdom, the Vaccine Damage Payment Scheme is funded out of general tax revenues. Vaccine Damage Payments Act 1979, c. 17 (UK). See also Clare Looker & Heath Kelly, No-fault Compensation Following Adverse Events Attributed to Vaccination: A Review of International Programmes, 89 Bull. of the WHO 379 (2011), https://iris.who.int/bitstream/handle/10665/270902/PMC3089384.
[37] Of the 151 WHO-member states responding to a survey, 126 did not indicate that they utilized a no-fault compensation system. See Randy Mungwira, et al., Global landscape analysis of no-fault compensation programmes for vaccine injuries: A review and survey of implementing countries, PLOS One (May 2020), https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0233334&type=printable.
[38] Sam F. Halabi, Solving the Pandemic Vaccine Product Liability Problem, 12 U.C. Irvine L. Rev. 111, 148 (2021).
[39] Special Report: EU COVID-19 Vaccine Procurement, Eur. Ct. of Auditors (2022), https://op.europa.eu/webpub/eca/special-reports/covid19-vaccines-19-2022/en/.
[40] See COVAX No-Fault Compensation Program: Explained, supra note 32.
[41] Id.
[42] Id.
[43] Id.
[44] Sam Halabi, Katherine Ginsbach, Katie Gottschalk, John Monahan & Judith Murungi, No-Fault Vaccine Injury Compensation Systems Adopted Pursuant to the COVID-19 Public Health Emergency Response, 37 Emory Int’l L. Rev. 55 (2022), https://scholarlycommons.law.emory.edu/eilr/vol37/iss1/2.
[45] Program Protocol, ESIS, https://covaxclaims.com/program-protocol/ (last visited Mar. 18, 2024).
[46] Id.
[47] No-Fault Compensation Programme for COVID-19 vaccines is a world first, WHO (Feb. 22, 2021), https://www.who.int/news/item/22-02-2021-no-fault-compensation-programme-for-covid-19-vaccines-is-a-world-first; Chubb and Marsh Collaborate to Secure Insurance Coverage for the COVAX No-Fault Compensation Program for 92 Low- and Middle- Income Countries, Chubb (Apr. 29, 2021), https://news.chubb.com/2021-04-29-Chubb-and-Marsh-Collaborate-to-Secure-Insurance-Coverage-for-the-COVAX-No-Fault-Compensation-Program-for-92-Low-and-Middle-Income-Countries.
[48] See COVAX No-Fault Compensation Program: Explained, supra note 32.
[49] See Program Protocol, supra note 45.
[50] The COVAX No Fault Compensation Programme: Explained, Gavi, the Vaccine All. (July 20, 2021), https://www.gavi.org/vaccineswork/covax-no-fault-compensation-programme-explained (“GDP per capita of the AMC-eligible economy in which the claimant resides x 12 x a harm factor ranging from 1.5 to 0.1 dependent on the nature of the injury and level of impairment, as evaluated based upon the most recently published edition of the American Medical Association’s (AMA) Guides to the Evaluation of Permanent Impairment.”).