Protecting human rights in the COVAX roll-out
The COVID-19 pandemic is the biggest economic and social crisis of a lifetime. Human rights are key in shaping our collective pandemic response, both for the public health emergency and the broader impact on people’s lives and livelihoods.
This information will be periodically updated as new information is published.
Overview of COVAX
COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is convened by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance and the World Health Organization (WHO) – working in partnership with UNICEF as key delivery partner, vaccine manufacturers, the World Bank, civil society, the private sector and others. COVAX’s foundational goal is to enable equitable access in an unprecedented time frame.
COVAX is the only global initiative through which donor-funded COVID-19 vaccines are distributed to 92 lower-income countries and economies at the same time as 98 higher-income countries and economies receive self-financed vaccines. As of 8 April 2021, COVAX has delivered more than 38 million safe and effective COVID-19 vaccine doses to 100 countries – including nearly 33 million donor-funded vaccine doses to 69 lower-income countries, as funded through the Gavi COVAX Advance Market Commitment (AMC). UNICEF’s COVID-19 Vaccine Market Dashboard is available here.
Overview of dialogue with public health and human rights organisations
COVAX leadership believe that initiatives that are shaped by and respect human rights will result in better outcomes for all, protecting the right to life and health for everyone, and preserving human dignity everywhere. Over the past 13 months, COVAX leadership have been in regular dialogue – both in writing and via conference calls – with public health, civil society and human rights organisations regarding the challenges and issues inherent to providing equitable global access to COVID-19 vaccines. Some of these organisations have identified concerns, while others have shared with COVAX leadership concrete recommendations around transparency, availability and affordability, governance, vaccine injury compensation and other areas. A number of organisations that specialise in delivering health services in fragile and conflict settings with high numbers of zero-dose children now have Memoranda of Understanding (MOUs) with Gavi, with the aim of leveraging each other’s strengths to work towards equitable access to immunisation.
Given the urgency of the task to end the acute phase of the COVID-19 pandemic, COVAX’s priorities remain volume, price and speed of delivery of safe, effective and stringently regulated COVID-19 vaccines in the context of a rapidly evolving pandemic. Access to life-saving immunisation is a fundamental human right, and the Gavi COVAX AMC was set up to provide safe, effective vaccines to high-risk people in lower-income economies who would have been most likely to miss out on COVID-19 vaccines. COVAX anticipates being able to provide participating countries and economies with enough doses by the end of 2021 to protect high-risk individuals, including health care and other frontline workers, and vulnerable groups – approximately 20% of each participating population (unless a participant has requested a lower percentage of doses). COVAX is also exploring means for economies to achieve higher coverage, through additional donor financing and doses if available, as well as through the support of multilateral development banks. In order to enable COVAX to deliver on its equitable access mission, political will of both economies and manufacturers, together with funding, is needed. The support from human rights-focused and other civil society organisations in achieving this ambition is much appreciated.
COVAX leadership are grateful to civil society-led public health and human rights organisations, not only for sharing their expertise, feedback, guidance and time, but also for their candor, commitment and collaboration – which have increased COVAX’s attention on human rights standards and principles, and helped inform its operations. COVAX agrees with the need for further alignment with the Sustainable Development Goals (SDGs), particularly SDGs 3 and 9. Please see below for COVAX’s views and the latest developments in areas relating to human rights standards and principles.
- To maintain the transparency of COVAX plans and operations – as well as to communicate vital and timely information to a spectrum of COVAX stakeholders – documents relating to COVAX’s operations and allocation decisions are made available to the public via the Gavi website, except in such cases where the disclosure of such documents would infringe upon confidentiality obligations. For further information, please refer to the responses below, as well as:
- The COVAX governance system was built to ensure high-quality due diligence at every step of the process. Please refer to this explainer and COVAX: Structure and Principles for more information about the roles of the technical, advisory and governance bodies such as the Independent Product Group (IPG), Market-Sensitive Decisions Committee (MSDC), and Research and Development and Manufacturing Investment Committee (RDMIC).
- In 2020, CEPI issued two Calls for Expressions of Interest to assess the available manufacturing capacity globally for drug substance and drug product (report available here). The information gathered was used to connect developers in need of additional capacity to those with suitable capacity. This is being closely monitored as part of project management. As outlined in this equitable access paper, CEPI supports the scale-up of manufacture for its portfolio of candidates to maximise capacity and mitigate risks to technology transfer. The current market for manufacturing capacity is highly dynamic, which limits the operational value of reporting.
- In accordance with regulatory obligations, manufacturers are typically required to publish clinical results if public funding has been received for research and development. Meanwhile, CEPI funding agreements contain requirements for awardees to publish and share data and materials to ensure that all can benefit from the work funded by CEPI. For more information, please reference CEPI’s Clinical Trials Policy and Equitable Access Policy.
AVAILABILITY AND AFFORDABILITY
- Equitable access is the core principle of the COVAX Facility and the Gavi COVAX Advance Market Commitment (AMC); as such, it is embedded in every aspect of COVAX’s operations – from upstream research and development (R&D) and manufacturing investments, through fair allocation and, finally, delivery. COVAX doses are being delivered to all countries on the same time frame, regardless of economic status (reference UNICEF’s COVID-19 Vaccine Market Dashboard). These principles are articulated in a spectrum of foundational COVAX documents and CEPI’s equitable access documents.
- Since the October 2020 dialogue with civil society and subsequent appointment of ten civil society representatives to all key COVAX working groups, COVAX has benefited not only from their technical expertise, but also from understanding better the concerns of and challenges faced by the constituencies they represent. The role of civil society in enabling equitable access to safe and effective COVID-19 vaccines through their participation in key COVAX working groups is a testament to the priority that COVAX places on maintaining the transparency of its operations. Since August 2020, public dialogue webinars have taken place every few months to share regular updates on COVAX’s progress. Information given during these sessions is extremely detailed; senior staff answer questions, and slide decks containing the information are circulated afterwards.
- In support of the principle of life-saving immunisation as a fundamental human right, COVAX guidance is that governments prioritise COVID-19 immunisation for all high-risk individuals and populations, according to the WHO Strategic Advisory Group of Experts (SAGE) on Immunization recommendations, independent of their residency and legal status, including internally displaced populations, refugees, migrants and detainees.
- COVAX’s foundational goal is to enable equitable access in an unprecedented time frame. In the current context, this means working with vaccine manufacturers around the world to attain ambitious goals of delivering at least two billion doses of vaccine to COVAX’s participating economies in 2021. The WHO COVID-19 Technology Access Pool (C-TAP) is an innovative and vital initiative, and there is potential for COVAX to align and cooperate with C-TAP in the medium to longer term; however, this is not an immediate priority, given the international pressure upon COVAX to deliver these vaccines. Further, the scope of C-TAP is much broader and involves a number of issues that are outside COVAX’s remit. Additionally, the time frames of C-TAP (i.e. medium to longer term) and COVAX (i.e. addressing a current pandemic emergency) are different.
- In line with C-TAP proposals, CEPI funding agreements contain requirements for awardees to publish and share data and materials to ensure that all can benefit from the work funded by CEPI, as outlined in this February 2021 summary of CEPI’s COVID-19 vaccine development agreements. CEPI does not seek to own the Intellectual Property (IP) developed from its partnerships but, rather, requires its awardees to manage their IP in such a way that equitable access can be realised (i.e. doses are made available to the COVAX Facility for fair allocation and procurement). CEPI believes this is the most effective way of delivering accessible vaccines as quickly as possible, without stifling innovation or delaying the urgent vaccine development process. Furthermore, CEPI collaborates with partners in the selection of additional manufacturers to increase manufacturing capacity and enable equitable access. Developers agree to technology transfer to trusted partners, and/or standing up manufacturing capacity in two or more countries, if applicable.
- COVAX shares the ambition of building capacity for manufacturing vaccines in lower-income countries, expanding diversity in vaccine manufacturing and ensuring healthy markets for vaccines. COVAX encourages technology transfer to economies that have the capacity to produce vaccines, facilitating introductions and pairing where this is helpful, and where resources permit providing financial support to enable such processes.
- Technology transfer works best when it is based on close partnerships in which both parties – the innovator company and the recipient – are committed to overcoming the many challenges involved in replicating the complex manufacturing processes in partnership. COVAX is committed to expanding diversity of manufacturing and has been supportive of two technology transfer deals involving Serum Institute of India (SII), as well as further scale-out agreements between other manufacturers to increase available volumes. Agreements such as these recognise that the role of expertise and capital-intensive start-up costs alongside intellectual property are effective in shaping markets, as demonstrated by the success of the Vaccine Alliance model over the past two decades: through technology transfer, Gavi has been able to dramatically reduce the price of vaccines.
- With 190 participating countries and economies, COVAX has a collective purchasing power to negotiate highly competitive, sustainable prices from manufacturers that are in turn passed on to participating countries and economies, while being sensitive to their income levels. COVAX is also working with manufacturers committed to minimal profit pricing – which form the core of the COVAX vaccine portfolio.
- Ninety-two lower-income countries and economies are eligible for free, donor-funded COVID-19 vaccine doses through the Gavi COVAX Advance Market Commitment (AMC) – enabling them to protect high-risk populations without having to spend constrained domestic resources or take on additional financing.
- COVAX distributes vaccines equitably according to a Fair Allocation Mechanism. COVAX allocations are published on a regular basis, starting with the first round of allocations published on 2 March 2021. COVAX is also developing a mechanism through which Gavi COVAX AMC-eligible countries that choose to complement the essential foundation built by donor-funded doses should be able to access vaccines at COVAX-negotiated prices through a cost-sharing approach.
- A “humanitarian buffer” could also be made available as a backstop mechanism to serve as a provider of last resort for if/when national, government-led planning and roll-out fail to reach certain high-risk populations in humanitarian settings. For example, populations living outside government-controlled areas could be served through the humanitarian buffer. This would be implemented once all other options have been explored; and applicants would be asked to demonstrate a gap in coverage among relevant populations within the scope of this buffer.
- COVAX is coordinating and collaborating with CEPI to support CEPI’s Equitable Access Policy, and to enable participating countries and economies to benefit from the access terms in CEPI’s agreements, including public health licenses and other safeguards. This partnership enables COVAX to leverage CEPI’s progress in facilitating equitable access to COVID-19 vaccines, and to ensure CEPI’s investments in equitable access translate into equitable procurement and, ultimately, delivery of COVID-19 vaccine doses.
- Lower-income economy government and civil society representatives form an important part of the COVAX Facility’s governance and decision-making processes through their participation in the Gavi Board and committees, such as Programme and Policy Committee (PPC), Market-Sensitive Decisions Committee (MSDC) and Audit and Finance Committee (AFC). Civil society organisations (CSOs) are represented in all key COVAX working groups. Further, the Gavi COVAX AMC Engagement Group is a key component of COVAX Facility governance. Co-chaired by ministers from the Governments of Canada, Ethiopia and Indonesia, the Gavi COVAX AMC Engagement Group is composed of participants from the governments of lower-income countries, as well as donors and other stakeholders.
- COVAX’s bespoke governance system was designed with equity and transparency at its core and leverages the governance of its component organisations. Each of COVAX’s three convening organisations already have requirements for senior staff to regularly disclose conflicts of interest through their governance processes. In addition, all staff engaged in COVAX working groups are bound by a Conflict of Interest policy, as indicated in COVAX: Structure and Principles, along with the names of staff members in the groups.
- COVAX is committed to further increasing the transparency of how its Conflict of Interest principles are implemented and managed. This includes expanding the number of staff and partners to which the Conflict of Interest policy applies; following up to ensure declarations are made; and acting on information provided – ranging from recusing individuals from decisions to removing people from roles if their interests present a perceived, potential or actual conflict.
- Each of COVAX’s three convening organisations have established whistleblower policies and procedures in place (and these are published on their websites), with oversight from their relevant governing bodies as appropriate. Recognising the importance of accountable governance systems, COVAX will ensure transparency on how the existing whistleblower policies and reporting facilities of the COVAX convening organisations, with newly agreed lines of communication among them, will enable appropriate accountability and integrity. Relevant matters will be reported to the COVAX Coordination Meeting (CCM) as appropriate.
VACCINE INJURY COMPENSATION PROGRAMME
- On 22 February 2021, COVAX launched the COVAX No-Fault Compensation Programme for AMC-Eligible Economies, which is the first and only vaccine injury compensation programme operating on an international scale. The programme will offer eligible individuals in the Gavi COVAX Advance Market Commitment (AMC)-eligible economies a fast, fair, robust and transparent process to receive compensation for certain rare but serious adverse events associated with a COVID-19 vaccine, or the administration of a COVID-19 vaccine, procured or distributed through COVAX until 30 June 2022. The programme is fully operational through its web portal: www.covaxclaims.com.
- CEPI’s 2019 Equitable Access Policy is primarily for CEPI activities. CEPI contracts enable end-to-end access and for COVID-19 vaccines include first right of refusal to supply volumes for COVAX, as well as enabling scale-out to increase available volume. COVAX contracts complement the investments made by CEPI by establishing advance purchase agreements (APAs) of the vaccines to enable this equitable access for COVAX participants.
- CEPI is fully committed to transparency and has published a summary of the equitable access provisions for CEPI partnership agreements in the COVID-19 portfolio. CEPI’s Board and Investors receive summaries of the access provisions of these agreements, and they can access the full agreements on request. Contracts with developers and manufacturers contain commercially sensitive and proprietary information protected under confidentiality obligations. Consequently, Gavi and CEPI are not in a position to disclose these contracts without infringing confidential obligations.
HUMAN RIGHTS DUE DILIGENCE
Human rights due diligence:
- The foundational principles of corporate responsibility to respect human rights are reflected in CEPI’s Third Party Code, as the Ten Principles of the UN Global Compact are built into the Code. This applies for all partners of CEPI and is in scope for audit of partners. For each individual project, due diligence is undertaken to evaluate the risks related to access including the ability to develop a successful vaccine, including manufacturing and supply capacity (e.g. the need for additional capacity and technology transfer to meet volume commitments), vaccine nationalism and intellectual property risks. Steps are agreed to eliminate or mitigate the risk to meet the requirements of CEPI and COVAX as a whole as part of formation of the agreements and monitored throughout implementation.
- There are many uncertainties affecting the supply of COVID-19 vaccines, not least around manufacturing capacity, regulation, funding availability, final contract terms and the readiness of countries themselves to begin their national COVID-19 vaccination programmes. Similarly, allocation timelines are dependent on a variety of factors, including: national regulatory requirements; availability of supply; and fulfilment of other criteria, such as validated national deployment and vaccination plans (NDVPs) from Gavi COVAX AMC participants, indemnification and liability agreements, and export and import authorisations.
- COVAX cannot overcome these challenges alone; rather, all stakeholders must work together to build on the efforts of the market shaping work that has been at the core of the Vaccine Alliance operating model for the past two decades, and to ensure that vaccine manufacturers honour their commitments to keep COVID-19 vaccines affordable.
- Despite the breadth of expertise and extent of resources invested in COVAX to date, there will always be room for improvement and areas in which additional expertise and resources are required. To this end, COVAX leadership welcome specific guidance on best practices in conducting effective human rights due diligence, in order to study this specific area further and also to assess how best to incorporate relevant considerations in the work of each convening organisation going forward.
- In this compressed timespan, COVAX is working with manufacturers to reach ambitious goals. Negotiations between governments and manufacturers around intellectual property (IP) may take more time, and are not in the purview of the work of COVAX. When it comes to patents, it is essential to note that IP, in the case of vaccine manufacturing, represents only a part of the relevant expertise required to establish new capacity. The more challenging aspect involves know-how and high start-up costs, as vaccine production requires thousands of manufacturing steps. The key constraint in 2021 will not be IP but rather supply constraints, especially in the still evolving context of new variants. Addressing these issues will require utilising all available expertise and resources – including that of industry. Efforts are already under way in this regard, with recent discussions with global pharmaceutical and public health sector organisations to address COVID-19 vaccine supply chain and manufacturing bottlenecks (upstream, downstream, fill-and-finish) to enable large vaccine manufacturing scale-up to meet the cumulative supply target of up to 14 billion doses by the end of 2021. For more information, please refer to the discussion document “Towards Vaccinating The World”, whose co-authors include CEPI personnel.
Modelling vaccine access studies:
- Under the guidance of the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on COVID-19 Vaccines’ COVID-19 Vaccine Impact Modelling Subgroup, which provides high-quality modelling guidance to inform policy recommendations related to COVID-19 vaccine prioritisation, WHO has commissioned modeling vaccine access studies mainly around five main topics that are of critical interest to SAGE:
1. vaccination strategies to maximise in-person schooling;
2. vaccination strategies to keep health system use below maximum capacity;
3. importation into settings with no cases and outbreak response vaccination;
4. extent to which vaccination can allow non-pharmaceutical interventions to be lifted; and
5. strategies to maximise impact of available supply of vaccines.
Results from eight selected modeling groups from both high-income countries (HICs) and low- and middle-income countries (LMICs) are expected by mid-2021.
- At this moment, low- and lower middle-income economies, as well as upper middle-income economies that are World Bank International Development Association (IDA)-eligible, are receiving COVID-19 vaccine doses that are fully subsidised by the Gavi COVAX AMC. Therefore, the current pricing structures will not affect them. At present, COVAX is not requiring mandatory co-financing from these Gavi COVAX AMC-eligible economies.
Moving forward together
The COVID-19 pandemic is the biggest economic and social crisis of a lifetime. Human rights are key in shaping our collective pandemic response, both for the public health emergency and the broader impact on people’s lives and livelihoods. COVAX was established to support the Access to COVID-19 Tools (ACT) Accelerator goal of accelerating equitable access to COVID-19 tests, treatments and vaccines. A crucial goal of COVAX is to draw attention to those who are left furthest behind and, most importantly, effect a strategy to include them. In reaching the most vulnerable, whether through furthering the scope of our global coverage or through partnering with civil society and humanitarian actors to reach high-risk individuals in humanitarian settings, COVAX is laying the foundation now to emerge from this crisis with more equitable and sustainable health systems. The gains made through COVAX, for example, in reaching conflict-affected populations in humanitarian settings, will be leveraged to also strengthen routine immunisation in marginalised communities.
To successfully deliver safe and effective COVID-19 vaccines to billions of people across the globe – for which both scale and speed are needed – COVAX must find the right balance between innovation and the reality of the current inter-governmental, legal and trade frameworks. That does not mean “business as usual” – but it does mean upholding human rights standards and principles. Both through the formal channels of the COVAX Facility governance structure and through the personal commitment of the global health professionals who comprise COVAX leadership and staff, there is an unflagging commitment to improving COVAX’s adherence to human rights principles and standards. COVAX’s dialogue with public health and human rights organisations will continue, as will our work to address the concerns and gaps identified.