Persons living in conflict settings, areas of state failure, and those affected by humanitarian emergencies are some of the most vulnerable in the world. Not easily reached with existing governmental and institutional efforts, they are at particular risk when it comes to accessing health interventions, especially during a health emergency like COVID-19. Recognizing this issue early on in the COVID-19 pandemic, a “Humanitarian Buffer” vaccine delivery mechanism was created as part of COVAX, the international partnership launched to help distribute COVID-19 vaccines globally. COVAX and the Buffer have been able to develop and introduce new structures and innovations for serving those in humanitarian settings and as such offer lessons for the future. At the same time, the Buffer has faced numerous structural, legal, and operational challenges, including some faced by COVAX more broadly as well as others specific to setting up an international vehicle for delivering novel vaccines to those in humanitarian settings. As a result, the Buffer has only been able to deliver a relatively limited number of vaccines to these populations.
With much of the world now shifting from an acute pandemic response to supporting longer-term resilience and looking to draw lessons from the past two years, it is an opportune time to review and assess the effort to support global vaccine equity. Still, little independent assessment and policy analysis has been directed so far toward examining humanitarian vaccine access during COVID-19 and the Buffer experience, and thus far, this issue has not featured prominently in global discussions on reforming pandemic response. This runs the risk of leaving those facing humanitarian crises further behind and could pose even more serious challenges if a future pandemic is more virulent. To help shine a light on this issue and inform ongoing policy discussions, this brief summarizes the experience of the COVAX Humanitarian Buffer, reviewing its history, its operational approach, its progress to date, and the challenges it has faced.
Those living in conflict settings, areas of state failure, and affected by humanitarian emergencies are some of the most vulnerable people in the world. They are often not easily reached with existing governmental and institutional efforts and therefore at particular risk when it comes to accessing health interventions, especially during a health emergency like COVID-19. At the start of the COVID-19 pandemic, it was estimated that as many as 167 million people worldwide were living in such conditions, raising concerns about their ability to access COVID-19 vaccines once they became available. With this in mind, as the World Health Organization (WHO), the Gavi Alliance (Gavi), donors, governments, and other partners developed COVAX (the international facility to support global COVID-19 vaccine access), they included a mechanism designed to provide humanitarian access to vaccines. This mechanism, which was formally created in December 2020 and which began operations in May 2021, is known as the COVAX Humanitarian Buffer (the “Buffer”).
Despite what appeared to be a significant need worldwide and support from variety of key actors at its launch, however, the impact of the Buffer has been quite limited so far. While an idea early on, the Buffer itself did not begin operating until almost a year after COVAX was formed. An early goal for the Buffer was that it be able to deliver and administer 100 million doses of COVID-19 vaccines by the end of 2022. However, COVAX has received a total of eight applications for Buffer doses and approved six. Just two of these – 1.6 million doses provided to Iran for vaccination of Afghan refugees and 840,000 doses provided via UNICEF for vaccination of refugees in Uganda – were finalized and doses distributed for use in country. Moreover, no mRNA vaccines – some of the most effective and popular vaccines globally – have been available via the Buffer because their manufacturers have not agreed to blanket indemnity waivers.
With much of the world now shifting from an acute pandemic response to supporting longer-term resilience and looking to draw lessons from the past two years, it is an opportune time to review and assess the effort to support global vaccine equity. The process has begun already, with a number of efforts already published and surely more to come. For its part, COVAX has begun examining lessons from the last two years to determine how vaccine access may be promoted in future epidemics and pandemics, and Gavi released a preliminary report summarizing the lessons learned in spearheading the Buffer. Still, little independent assessment and policy analysis has been directed so far toward examining humanitarian vaccine access during COVID-19 and the Buffer experience, and (at least so far) this issue has not featured prominently in global discussions on reforming pandemic response.
To help shine a light on this issue and inform ongoing policy discussions, this brief draws on published literature, news articles, key informant interviews and other sources to summarize the experience of the COVAX Humanitarian Buffer, reviewing its history, its operational approach, its progress to date, and the challenges it has faced.
Background and Overview
The Buffer was designed to be a safety net of last resort, intended to fill in gaps where standard national COVID-19 vaccine procurement and distribution processes could not or would not reach vulnerable populations that were facing humanitarian emergencies. While governments would be responsible for vaccinating most people within their territories, there were going to be some populations that government vaccination programs would not or could not reach, including refugees, persons living in conflict zones, and those facing disasters or other emergencies. Through the Buffer, COVAX would designate and set aside a portion of its COVID-19 vaccine doses to help reach these populations. Governments, humanitarian agencies, non-governmental organizations, and others would be able to apply for these designated Buffer doses, after identifying that there were high-priority populations without access via other means. Applications would be reviewed and, if they met certain criteria, would be approved and a shipment of doses from the Buffer’s earmarked supply would be provided to the applicants (whether a government, agency, or non-governmental organization) who would oversee administration of the vaccines in the identified population in need.
The COVAX facility overall began to take shape over the early months of 2020, soon after the COVID-19 pandemic emerged. Even early on during discussions about creating COVAX, there was an idea that a specific mechanism to direct vaccines for humanitarian purposes would be important. COVAX itself launched in June 2020, and conversations about the Buffer proceeded throughout the summer and fall of 2020, and more detail about how the mechanism would work began to take shape. In December 2020, the Gavi Board officially approved the Humanitarian Buffer, and subsequently more details about its operations were discussed throughout early 2021. In May 2021, applications to the Buffer were opened, and the Buffer has been in continuous operation since then, revising and updating its practices and procedures over time.
The Buffer concept evolved as pandemic and policy conditions themselves changed. For example, upon its initial approval by the Gavi Board, the COVAX Buffer was to include two components: 1) a Contingency Provision to set aside and direct doses for outbreak response in low- and middle-income countries with limited vaccine access but significant public health needs and, 2) a Humanitarian Buffer to set aside and direct doses to vulnerable populations in emergencies, conflicts, and other humanitarian situations. However, the Contingency Provision was repeatedly put on hold and actually never implemented as it became clearer over time that the epidemiology of COVID-19, the characteristics of the vaccines, and the magnitude of vaccine inequity argued against reserving a pool of COVAX vaccines for outbreak response purposes. The argument in favor of a Buffer component, in contrast, grew stronger over time as it became clearer that governments often overlooked the issue of vaccine access for vulnerable populations facing humanitarian emergencies in their COVID-19 response plans.
For more information about key milestones in the development, launch, and operation of the Buffer, see Box 1.
Governance and Administration
Broadly, governance of the Buffer mirrors the governance of COVAX. Gavi is the organization with primary responsibility for developing policy and administering the Buffer, with Gavi Secretariat staff providing much of the day-to-day operational oversight and the Gavi Board reviewing and approving Buffer policies. Even so, given the cross- sectoral nature of Buffer operations – which overlap with global humanitarian efforts, multiple UN agencies, national governments, and other entities – there have been many other organizations involved in the design, operationalization, and oversight of the Buffer. These include WHO, UNICEF, the UN-based humanitarian agencies such as the Office for the Coordination of Humanitarian Affairs (OCHA), the UN High Committee United Nations High Commissioner for Refugees (UNHCR) and the International Organization for Migration (IOM). Also involved have been governments, private donors, non-governmental organizations such as Medicines sans Frontières (MSF), and independent outside experts. Many of these organizations have also been involved in review and approval of Buffer applications (see below for more information).
Doses and Funding
As initially outlined by the Gavi Secretariat and approved by the Gavi Board, 5% of COVAX Advance Market Commitment (AMC) funding (drawn from donor contributions to support vaccine access for 92 low- and middle-income country participants of the COVAX facility) was to be reserved for purchase of vaccine doses for use via the Buffer. With COVAX initially expecting to be able to procure up to 2 billion doses in 2021 alone, this could have translated into 100 million doses earmarked for Buffer use. However, global supply constraints driven by a number of factors (e.g., hoarding of vaccine supplies by higher income countries, India’s months-long ban on vaccine exports, longer than expected timelines for regulatory approval for some vaccines) meant COVAX was able to procure far fewer doses in 2021 than initially hoped. This restricted supply environment translated into similarly restricted supply for the Buffer, especially in the first few months after the Buffer was launched.
In addition to fewer doses than expected, funding for delivery and administration of Buffer doses was also limited. As COVAX rolled out, it was initially unable to fund the bulk of delivery and administration costs for COVAX participants, costs which instead fall on governments or other entities receiving COVAX doses. This has applied to Buffer doses as well, meaning Buffer recipients were primarily responsible for administration costs once doses were shipped out. While “exceptional delivery support” financing totaling $150 million was made available for COVAX-wide use in early 2021, it was estimated that $983 million more was needed to support delivery operations in COVAX AMC countries in 2021 alone. The Gavi Board decided to reserve 5% of the $150 million – or $7.5 million – for delivery support funding for Buffer applicants specifically. An additional amount of delivery and administration funding was made available for Buffer doses via UNICEF through its Humanitarian Appeal for Children (HAC), but even so there remained a significant gap in the estimated need and the actual level of funding available for in-country operations via the Buffer through early 2022.
Eligibility, Application, Approval, and Shipment PROCESS
The processes for eligibility, application, and approval for Buffer doses were developed by Gavi, with significant input from other partners, including the WHO and other UN agencies, and external experts. All COVAX facility participant country governments are considered eligible to apply for Buffer doses, including the 92 COVAX AMC countries as well as “self-financing” countries, although non-participating governments are not eligible. In addition to national governments, humanitarian agencies are also eligible to apply for Buffer doses. This includes UN humanitarian agencies, the International Committee of the Red Cross (ICRC), national Red Cross and Red Crescent societies, as well as non-governmental/civil society-based humanitarian organizations. In their submission, applicants are required to demonstrate why the target populations for which they are applying for doses were not included in national vaccination plans and what other attempts have been made to provide vaccines for them. They are also required to indicate whether they are able to import COVID-19 vaccines to the country or territory of concern or, alternatively, if they are working with a consignee who is able to do so.
Buffer applications are reviewed and, if found to meet the established criteria, approved by an Interagency Standing Committee (IASC) Emergency Directors Group (EDG), which is comprised principally of experts from UN humanitarian agencies. Delegating the review and approval process to this group is designed to “ensure that humanitarian experts are involved in decision-making…and judgements on the feasibility of delivery to populations of concern are made by those with experience.” If an application is approved, an expert “decision group” that reports to the IASC EDG (with input and support from Gavi Secretariat staff) makes a decision about dose allocations taking into consideration such factors as the number and type of Buffer doses available, the preference of the applicant, and specific circumstances in country. This decision group is comprised of members from the following agencies and organizations: WHO, UNICEF, OCHA, IOM, UNHCR, ICRC, IFRC, MSF and ICVA (the International Council of Voluntary Agencies, a global network of non-governmental humanitarian organizations). The process from receipt of a complete application to allocation decision is meant to take no longer than a few weeks.
The actual shipment of Buffer doses to a destination country or territory requires a few more steps and takes additional time. These steps include reviewing and signing legal agreements between relevant parties (such as Gavi, the UNICEF Supply Division, and in some cases the vaccine manufacturer), ensuring regulatory approval of the vaccine is in place, obtaining import authorization from the relevant government, checking cold-chain preparedness, submitting a purchase order, and packing, labelling and, finally, shipment. Where vaccines are deployed “in territories subject to relevant bilateral or UN sanctions, additional time will be needed to obtain the necessary licenses and undertake preparedness checks” and the “global supply of injection devices and shipping containers may also impact final shipment timelines.” Much of this Buffer review and approval process mirrors that used for any doses coming from COVAX in general, though in the case of Buffer doses there may be even additional complications and challenges given that multiple actors beyond governments could be involved, and there may be even greater logistical challenges due to restricted access to some populations and geographic areas due to instability, conflict, and/or emergency situations.
Vaccine Products, Liability, and Indemnification
The Buffer, and COVAX overall, have had to find ways address liability risk inherent in the use of newly developed vaccine products, just as national governments have. These risks exist to both manufacturers and the entities administering the product, as each can be exposed to legal action from persons claiming injury/adverse events from vaccination. In general, there are several approaches to addressing liability risk, including: liability insurance (such as insurance policies that cover financial costs borne from legal action), indemnification (such as when a government or other procuring entity grants a manufacturer protection against legal action within procurement contracts), and vaccine injury compensation schemes (such as government-provided financial compensation for individuals found to have been injured by a vaccine). However, the rapid development and deployment timeline for COVID-19 vaccines meant that, at least initially, they were administered under emergency use authorizations rather than full regulatory approval, so traditional vaccine liability insurance was not available. This led pharmaceutical companies to require that entities procuring COVID-19 vaccines indemnify them from any liability associated with use of their products. In practice, this meant that each government negotiated legal agreements with each manufacturer to cover the vaccines they sought to procure. Many governments (particularly in higher income countries) were willing and able to undergo this process and granted indemnification to gain access to vaccines. In addition, many governments had prior vaccine injury compensation schemes and adapted them for COVID-19 vaccines, or implemented new schemes for that purpose.
Lower-income country recipients of vaccines through COVAX (including through the Buffer) faced the same liability issues, but many were not in a position to address them fully or in a timely fashion. Recognizing this, Gavi and COVAX tried to overcome these legal obstacles in several ways. For one, Gavi and others developed model language and provided legal assistance to COVAX AMC countries for their contract negotiations with vaccine manufacturers, including on the topic of indemnification. Second, a vaccine injury compensation scheme for COVAX was created known as the No Fault Compensation Program, which launched in February 2021 and applied to the 92 COVAX AMC countries (the group of low- and middle-income countries that were the primary focus for COVAX vaccine distribution). Even with this in place, however, risk remained for COVAX recipients because civil legal claims could be filed that the NFC program could not address.
For Buffer doses specifically, liability issues proved even more complex and difficult. For example, NFC program protections applied only to the 92 COVAX AMC countries and given that an estimated one-third of people facing humanitarian conditions were residing in non-COVAX AMC countries, a significant portion of the potential target population for the Buffer would not have this protection in place. Further, given that the presence and authority of governments in many of the areas facing humanitarian conditions is weak, contested, or non-existent, there may be an absence of relevant governmental authorities willing and able to shoulder the liability burden or negotiate contracts with manufacturers for doses provided to persons in humanitarian emergencies. In theory, non-governmental organizations or humanitarian agencies could assume these roles in procuring Buffer doses, but in practice such organizations have said they are not in a position to take on the legal burdens and liability risks. Gavi recognized this would be an issue as the Buffer was being designed and sought to address it by asking vaccine manufacturers to waive their indemnification requirements for vaccines used via the Buffer for humanitarian purposes. However, talks between Gavi and manufacturers were slow, and at the time the Buffer mechanism was formally launched in May 2021, no manufacturer had granted such a blanket waiver, though a number of companies did so months later (see more below).
Status of Applications, Shipments, and Waiver Agreements
From the time applications opened in May 2021 through October 2022, eight formal applications for Buffer doses had been received by COVAX. Six applications had been approved after review (one of these approved applications was subsequently withdrawn). Therefore, to date there have been two instances of an application leading to a shipment of Buffer doses. The first shipment, 1.6 million doses sent to Iran to support vaccination of Afghan refugees, was completed in November 2021. The second shipment, 840,000 doses sent to Uganda to support vaccination of refugees in several regions of the country, was completed in March 2022.
While no blanket waivers had been granted by vaccine manufacturers at the launch of the Buffer in May 2021, by the end of that year, four companies had announced such waivers: Johnson & Johnson (J&J), Sinovac, Sinopharm, and Clover (Clover’s COVID-19 vaccine is not yet authorized and therefore has not been available for Buffer use). By September 2022, another two manufacturers had granted blanket waivers for the Buffer, covering three COVID-19 vaccines: Serum Institutes’ Covishield & Covovax, and Novavax. Neither Pfizer nor Moderna, which produce some of the most effective and popular vaccines worldwide, have granted a blanket waiver for use of their mRNA vaccines via the Buffer.
Key Issues and Challenges
Despite high expectations upon launch and early estimates of a large potential humanitarian need for COVID-19 vaccines, the number of applications actually submitted and approved was relatively small, with only about 2.5 million doses having been shipped to two countries. This compares to the potential to have provided up to 70 million doses (5% of the 1.4 billion doses procured by COVAX in 2021) via the Buffer, and a goal of distributing and administering 100 million Buffer doses by the end of 2022.
Many barriers and challenges contributed to this relatively limited impact to date. Some of these were specific to the Buffer itself, while others were reflective of broader challenges faced by COVAX and, indeed, by the overall global response to the pandemic. Based on the existing literature (including Gavi’s own assessment of the Buffer and an external evaluation of the Access to COVID Tools Accelerator (ACT-A) of which COVAX is the vaccine arm) and information from interviews with subject matter experts, key barriers and challenges included the following:
- Limited vaccine availability. Throughout 2021, the global supply of COVID-19 vaccines fell far short of global demand. Much of the early supply of vaccines with WHO emergency use authorization (the only vaccines available for use by COVAX and the Buffer) had been monopolized through advance purchases by governments, particularly those in high income countries. This left COVAX with limited and delayed access to COVID-19 vaccine doses, which translated into limited supply for the Buffer as it launched and throughout the rest of 2021 and into 2022.
- Limited funding. In parallel with a restricted supply of vaccines was a limited amount of funding for COVAX overall, and for the Buffer specifically. The lack of available funding early on was a major reason why COVAX could not complete purchase agreements with pharmaceutical manufacturers in a timely fashion, which led to delayed access. It also restricted the amount of operational and delivery support that COVAX and/or the Buffer could offer, even with significant need for this type of assistance in many areas with populations facing humanitarian emergencies. Some humanitarian organizations report the lack of operational support presented a barrier for potential applicants, which may have reduced demand for Buffer doses and/or the narrowed the scope of applications submitted.
- Lack of priority placed on vaccinating populations facing humanitarian emergencies. The target populations for the Buffer were often not prioritized (and sometimes ignored) by governments when drawing up national COVID-19 vaccination plans. Despite WHO, humanitarian agencies, and others emphasizing the need for governments to include high-risk migrants, refugees, and other people facing humanitarian emergencies in such plans as the Buffer was launched, a majority of the national vaccination plans submitted to COVAX in early 2021 did not explicitly include these populations among priority vaccination groups. The relative lack of priority by many national governments led to a belated focus on vaccinating these groups, translating into lower initial demand for Buffer doses.
- Added complexity from pandemic conditions. Delivering and administering vaccines requires a functioning transportation/logistics capability, cold and supply chains, a sufficient number of prepared personnel, adequate safety and security, among other conditions. Ensuring all of these pieces were in place during a pandemic was challenging enough, but ensuring they were in place in areas facing humanitarian emergencies was even more difficult, and it added another layer of complexity to delivering and administering Buffer doses where they were most needed.
- Extended delays and restricted choice of vaccines due to liability and indemnification issues that were only partially solved. Vaccine manufacturers’ requirement they be indemnified against liability for potential damages from their products proved to be one of the most critical sticking points for implementation of the Buffer. While legal assistance for countries negotiating contracts and a global No Fault Compensation program helped reduce liability risk in COVAX AMC countries, these did not eliminate the issue, particularly for Buffer doses outside of these countries. Shouldering the risk of liability was a non-starter for the humanitarian agencies and non-governmental groups that were positioned to be a core set of partners in administering the vaccines in the populations being targeted by the Buffer. A blanket liability waiver was viewed as the best option to address this issue for the Buffer, but the extended negotiations with pharmaceutical companies and their initial reluctance to sign on to the waivers led to major delays. Moreover, only a subset of manufacturers eventually agreed to such blanket waivers, and agreements were reached piecemeal over a period of months, which limited which vaccines available for Buffer use at any given time.
- No access to effective and popular mRNA-based vaccines. Moreover, Pfizer and Moderna have not provided a blanket liability waiver for use of their COVID-19 vaccine products via the Buffer, unlike a number of other vaccine manufacturers. So there has been no option for Buffer applicants to request these vaccines, despite their proven effectiveness and global popularity. While mRNA vaccines have presented additional challenges compared to other vaccines due to logistical and cold chain requirements, the inability to request these specific vaccines represented a limitation of the Buffer.
- Weak or absent regulatory and/or government oversight in many areas. An overarching structural challenge facing the Buffer was a lack of regulatory and other decision-making authority in many areas facing humanitarian emergencies. COVID-19 vaccine authorization, approval, procurement, and distribution processes have primarily relied on governments that are willing and able to take on these tasks. However, many humanitarian situations occur in areas with weak or no government presence. For example, there may be cross-border issues, disputed territorial sovereignty concerns, and large numbers of refugees and/or people in conflict situations that result in a decision-making vacuum. If there is no entity in a position to take on an important role such as overseeing the import of vaccines for such areas, the system breaks down. Given the limited authority of international humanitarian agencies and non-governmental organizations to take on many of these very same responsibilities, people in these areas can be left behind. The Buffer mechanism was not able or intended to solve these structural, political, and governance issues.
- Complex application, review and approval process. As an entirely new mechanism launched in the context of the ongoing evolution of COVAX itself and the changing supply and epidemiological circumstances of the pandemic, there was a balance struck between a speedy approval and delivery process for Buffer doses and the due diligence required to ensure those doses were being used according to the principles of the Buffer – in an effective and efficient manner, and in keeping with the rules, legal obligations, and other constraints of the various stakeholders. The cross-agency and multi-sectoral nature of providing COVID-19 vaccines for use in humanitarian contexts meant that Buffer applications had multiple stages of review and points at which approvals had to be obtained (even more so than regular COVAX channels), and each stage and review added further complexity and time to a process that already had a steep learning curve for all involved. At a minimum, Gavi, COVAX, WHO, other UN agencies, national governments, and (often) non-governmental organizations had to be involved. Some external groups have criticized the process as being drawn out, bureaucratic, and a significant challenge to navigate to completion.
- Shifting pandemic risk perceptions and waning demand over time. While the global COVID-19 vaccine context of very limited supply and very high demand was present through much of 2021, it changed as the pandemic entered its third year in early 2022. Supply finally began to catch up with and overtake demand as production grew, additional vaccines were authorized, and perceptions about the risk from the pandemic shifted for many. Given the time that elapsed from Buffer concept to operationalization, and post-launch delays generated by the many complications discussed above, demand for Buffer doses (and COVID-19 vaccines overall) eventually dropped off.
Implications for the Future
With much of the world now shifting from an acute pandemic response to supporting longer-term resilience and looking to draw lessons from the past two years, it is an opportune time to review and assess the effort to support global vaccine equity. COVAX and ACT-A, for example, have entered into a transition process that aims to integrate these tools and partnerships into routine country and global immunization and health systems efforts and ensuring systems are better prepared for future health emergencies. A new Pandemic Fund, supported by donors such as the U.S., has been launched at the World Bank and is meant to stimulate investments in global, regional, and country-level pandemic preparedness capacities. In addition, member states of the WHO are in the process of negotiating changes to the global governance framework for pandemics, including making revisions to the International Health Regulations and potentially crafting a new and more expansive pandemic treaty instrument. So far, however, little attention has been directed in these processes to how best to ensure humanitarian access to pandemic vaccines going forward, or in taking a systematic approach to building on the Buffer experience to improve future pandemic response efforts. This runs the risk of leaving those facing humanitarian crises further behind and could pose even more serious challenges if a future pandemic is more virulent. Among the areas that could be examined in this regard include:
- Ensuring ongoing visibility for the issue of humanitarian access to pandemic vaccines in the context of discussions around new global health security and pandemic preparedness and response mechanisms, including those related to the Pandemic Fund, the pandemic treaty, IHR reforms, as well as humanitarian sector reform efforts.
- Extending and building up cross-agency and cross-sectoral partnerships forged by the Buffer. Many of these relationships and processes were built from scratch when designing and implementing the Buffer, so institutionalizing them to the extent possible could mean not having to reinvent the wheel during the next pandemic.
- Addressing in advance liability and indemnification issues for pandemic vaccines administered under emergency authorizations for humanitarian needs. Global sharing of newly developed pandemic vaccines will likely always raise issues of liability. Policy tools put in place by COVAX during COVID-19, such as the No Fault Compensation program and legal assistance for governments in designing indemnification agreements provide partial solutions but do not fully address the added complications of delivering pandemic vaccines for humanitarian populations, which could require a specially tailored approach. Requesting manufacturers grant blanket waivers during a pandemic was one approach used by the Buffer, but given the extended time needed to reach the agreements for COVID-19 vaccines, it could help to pre-position or vet these kinds of agreements and negotiations in advance as much as possible.
- Assuring that adequate funding is available in advance of a health emergency that allows international agencies to purchase countermeasures and help defray operational costs of delivering and administering vaccines during a pandemic, rather than having to request such funding from donors during a crisis response. For humanitarian contexts, this could include assured delivery and operational support for non-governmental organizations that might have the best or only access to key target populations in need.
This work was supported in part by The Hilton Foundation. KFF maintains full editorial control over all of its policy analysis, polling, and journalism activities.