COVID-19 Vaccines: Allocation

Featured Journal Content

Editor’s Note:
We have not encountered any update on country pledges to the COVAX facility as of yesterday, 18 September.

COVAX: A Moment of Truth in the Pandemic
18 Sep 2020
By Richard Hatchett (CEO, CEPI), Seth Berkley (CEO, Gavi, the Vaccine Alliance), Soumya Swaminathan (Chief Scientist, WHO)
This article originally appeared on Project Syndicate on 16 Sep 2020.

As the most ambitious pandemic-response initiative ever conceived, the COVID-19 Vaccine Global Access Facility is the best chance the world has to bring the pandemic to an end. But to succeed, COVAX requires broad international buy-in, based on the recognition that no one is safe until everyone is.

Now almost in its tenth month, the COVID-19 pandemic is still wreaking havoc on economies and lives around the world. But while the end of the crisis seems as far away as ever, the fact is that we are approaching a potential turning point. World leaders now have an opportunity to seal the deal on a global framework that puts international cooperation above vaccine nationalism in stopping the pandemic.

The moment of truth will be at midnight on September 18. That is the deadline for countries to join the COVID-19 Vaccine Global Access Facility (COVAX), an initiative launched by Gavi, the Vaccine Alliance, the World Health Organization, and the Coalition for Epidemic Preparedness Innovations. COVAX represents the best chance we have to provide people in all countries with rapid, fair, and equitable access to COVID-19 vaccines as soon as they become available. The initiative has already achieved an extraordinary scale, with more than 170 countries (representing 70% of the global population) already signaling their intent to join. At a time when most countries are undergoing unprecedented crises, governments are eager for solutions that will benefit everyone.

Nothing like COVAX has ever been attempted, and the short timeframe in which it has been assembled makes it all the more remarkable. If successful, this will be the first time that the international community has come together to ensure equitable and simultaneous access to new lifesaving pandemic interventions for rich and poor alike.

As we head into the fall, and COVID-19 continues to spread, the global death toll is approaching one million, with monthly economic losses estimated at $500 billion. Under these conditions, ensuring fair, universal access to vaccines is not only the right thing to do. It is also necessary if we are to bring the crisis to an end. Until everyone is protected, everyone will remain at risk of the disease, its adverse economic effects, or both.

As the only truly global approach available, COVAX’s importance cannot be overstated. Although there are more than 200 COVID-19 vaccines in development, and at least 35 clinical trials underway, the vast majority are likely to fail. Historically, candidate vaccines at the preclinical stage have less than a 10% chance of succeeding. And of those that do advance to the clinical trials stage, only around 20% will ultimately be approved. Given these odds, even wealthy governments that are currently negotiating bilateral deals with individual vaccine manufacturers cannot guarantee access to a vaccine on their own.

By contrast, COVAX is specifically designed to maximize the chances of success by investing in the development and manufacture of a large number of vaccine candidates at the same time. With the world’s largest and most diverse vaccine portfolio – which currently comprises nine candidates already in development and a further nine or more under evaluation – COVAX will act as a global insurance policy. Under this framework, member countries that have bilateral deals will still have vaccine access options in the event that those gambles fail, and the majority of countries that have no other options will be extended a critical lifeline.

COVAX’s initial aim is to have two billion vaccine doses available by the end of 2021, as that should be enough to protect high-risk/vulnerable populations and frontline health-care workers. But to hit that target, we first need the legally binding commitments of as many countries as possible.

After the sign-up deadline of September 18, the priority will be to complete the development and testing process to ensure that all forthcoming vaccines are both effective and safe. COVAX will need to put in place agreements with drug manufacturers, so that it can begin delivering vaccines at scale as soon as they are approved. And donor funds will be needed to subsidize the purchase of vaccines for low- and lower-middle-income countries.

But even with financial solutions in place, the process of distributing vaccines will pose significant challenges. The delivery of COVID-19 vaccines will be the single largest vaccine deployment the world has ever seen, and it will have to be executed at a time when misinformation (the “infodemic”) is threatening to undermine public confidence in vaccine safety.

Though the pandemic is far from over, we at least have a global solution in sight. COVAX represents the best hope that we have for bringing a prompt end to the crisis. When people look back and marvel at how quickly the scientific community and development practitioners responded to the COVID-19 threat, they will be able to point to the speed with which governments put aside national interests in the name of international cooperation and solidarity. Whatever specific moment future historians choose as the pandemic’s turning point, there will be little doubt that the creation and widespread adoption of the COVAX framework played an indispensable role in ending it.

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The Lancet
Sep 19, 2020 Volume 396 Number 10254 p799-866, e30-e40
https://www.thelancet.com/journals/lancet/issue/current
Comment
Legal agreements: barriers and enablers to global equitable COVID-19 vaccine access
Alexandra L Phelan, Mark Eccleston-Turner, Michelle Rourke, Allan Maleche, Chenguang Wang

Law can serve as both an enabler and a barrier to global health, equity, and justice.1 The impact of legal determinants of health on the COVID-19 pandemic is evident where law is being used as a mechanism to enable or prevent global equitable access to COVID-19 vaccines. Barriers to equitable access are partly driven by vaccine nationalism2 with governments seeking to use law to secure priority access to future vaccines through Advance Purchase Agreements (APAs) with vaccine manufacturers. These bilateral legal agreements can be in a nation’s interest, but given the uncertain success of individual COVID-19 vaccine candidates and the global spread of SARS-CoV-2, APAs are a gamble and erode collaboration between countries. Importantly, such bilateral legal agreements are likely to contribute to inequities and potentially extend the pandemic’s time frame. By contrast, multilateral legal agreements could be the path back to global health security and justice by re-establishing norms of international solidarity, committing to global equitable vaccine access initiatives, and laying a foundation for a post-pandemic era built on multilateralism and cooperation.

In the lead-up to the World Health Assembly (WHA) in May, 2020, current and former politicians and civil society leaders from around the world, including the President of Ghana, Nana Akufo-Addo, the Prime Minister of Pakistan, Imran Khan, and the President of South Africa and Chair of the African Union, Cyril Ramaphosa, called for a “bold international agreement” that guarantees global equitable access to vaccines as global public goods.3 At the WHA, China’s President Xi Jinping stated that any Chinese vaccine developed will be a “global public good”, and contribute to “ensuring accessibility and affordability in developing countries”.4 The only resolution adopted during the truncated WHA recognised immunisation, rather than vaccines themselves, as a global public good.5 However, since then, the global legal landscape has shifted from a rhetoric of global public goods to a reality largely based on nationalism. According to WHO, there are more than 170 COVID-19 candidate vaccines in development.6 Although only eight of those vaccine candidates are now in phase 3 trials,7 some wealthy nations have secured more than 2 billion doses of potential future COVID-19 vaccines using APAs.8

APAs are legally binding contracts whereby one party, such as a government, commits to purchasing from a vaccine manufacturer a specific number or percentage of doses of a potential vaccine at a negotiated price if it is developed, licensed, and proceeds to manufacture. These bilateral agreements often secure priority access to vaccine and manufacturing capacity. Governments of countries that disagree with the ethics and effectiveness of APAs or that do not have the financial resources to purchase vaccines at comparable prices or engage in commercial negotiations are at risk of not having access to vaccines when they first become available and of having access delays while manufacturing capacity is fulfilled first by wealthy countries’ orders. This was the case during the 2009 influenza A H1N1 pandemic when many APAs held by high-income countries (HICs) were used to secure their priority access to vaccine, making procurement in other countries more difficult.9 APAs were used so extensively in 2009 that more than 56% of pandemic influenza vaccine manufacturers surveyed by WHO were unable to commit to guaranteeing 10% of real-time vaccine production for purchase by UN agencies due to pre-existing commitments under APAs with HICs.10 Governments that enter into APAs for candidate vaccines that do not demonstrate evidence of safety and efficacy also risk not getting immediate or sufficient access to successful vaccine candidates.

APAs are not always legal tools for vaccine nationalism but can be used by global health organisations to secure vaccines for low-income and middle-income countries (LMICs) as part of an Advanced Market Commitment (AMC). Global health organisations, most notably Gavi, The Vaccine Alliance, have used donor-funded AMCs to enter into APAs with vaccine manufacturers to supply a guaranteed number of vaccine doses to countries with limited profit-based markets; AMCs were used in this way for childhood pneumococcal vaccines and Ebola vaccines.11 In June, 2020, Gavi established the COVID-19 Vaccine Global Access (COVAX) AMC to use funds from donors and HIC governments to purchase a guaranteed volume supply of COVID-19 vaccines to be distributed to LMICs participating in the COVAX Facility.12

Launched in April, 2020, and co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and WHO, the COVAX Facility is a platform for all participating governments to access a diversified portfolio of COVID-19 vaccines when they become available, distributing risk across multiple vaccine candidates. The COVAX Facility aims to have enough doses of COVID-19 vaccines for at least 20% of participating countries’ populations, with a goal of 2 billion doses by the end of 2021. Civil society has criticised COVAX for negotiating prices that include profit rather than vaccines at cost as a global public good, the lack of transparency of contracts entered into with vaccine manufacturers, limits on civil society participation, failure to address potential impacts of intellectual property rights on pandemic vaccines, and governance questions, including the role of WHO and limited experience procuring vaccines for middle-income countries and HICs.13 The latter point led the EU to decline using the COVAX Facility for purchasing vaccines, stating that bilateral APAs enable it to access vaccines faster and at a lower cost. On Aug 24, 2020, the WHO Director-General noted that although 172 countries are in discussions about joining the COVAX Facility, more support, particularly from wealthy countries, is “urgently needed” to “secure enough doses to rollout the vaccines” and address equitable vaccine access.14 Despite not participating in the COVAX Facility for purchasing its own COVID-19 vaccines, on Aug 31, 2020, the EU made a €400 million commitment to participation in parallel to existing APAs.15

Allocation questions for COVID-19 vaccines have focused on equitable distribution within countries, including prioritising vulnerable populations and health-care and essential workers. However, justice also demands consideration of the equitable vaccine distribution between countries. Under the Pandemic Influenza Preparedness (PIP) Framework—the only international legal instrument for the global equitable distribution of vaccines—WHO intends to distribute pandemic influenza vaccines that are secured under contracts with manufactures to countries on the basis of public health risk and needs.16 However, in a pandemic with a restricted supply of available vaccine, public health need alone is unlikely to guide decisions, especially in the early stages of vaccine distribution when supply will be limited and the need will be equally high across many countries. Furthermore, unlike pandemic influenza, there is not an international legal instrument, agreed to by all WHO member states, for COVID-19. Nor is there yet public international agreement on how distribution of COVAX Facility (or alternative platforms) vaccines should occur. WHO has developed a proposal for a Global Framework to Ensure Equitable and Fair Allocation of COVID-19 Products, highlighting how a global access mechanism would distribute risk and maximise equitable allocation between countries; however, the legal process and form for adoption of such a framework has not been publicly proposed.17

Despite the lack of a specific international agreement for COVID-19 vaccines, 171 countries already have legally binding obligations under the International Covenant on Economic, Social, and Cultural Rights (1966) to take steps, individually and through international assistance, to realise the right to health and the right to enjoy the benefits of scientific research and its applications, without discrimination. Respecting, protecting, and fulfilling these rights in the context of COVID-19 would mean ensuring that COVID-19 vaccines are available, accessible, acceptable, and of good quality, in all countries.18

Multilateral commitment is needed to help pre-empt an additional legal risk arising from vaccine nationalism that could render multilateral and some bilateral APAs ineffective, such as the use of government export controls. During the 2009 influenza A H1N1 pandemic, governments in HICs with vaccine manufacturers restricted export of vaccines until domestic needs had been met.19 As a result, even where governments or international institutions have entered into APAs, vaccine nationalism in the country of manufacture could embargo or requisition vaccines, delaying global distribution.

Any international governance platform for COVID-19 vaccines, including the COVAX Facility or a new mechanism, will only succeed if there is global momentum and commitment to global equitable COVID-19 vaccine access, particularly from HICs. Yet many HICs are currently driving the proliferation of bilateral APAs, entrenching nationalism, and directing future vaccine distribution. In November, 2020, countries will meet for the second part of the pandemic segmented WHA. This meeting might be the last chance all countries have to adopt an international instrument and agree on a mechanism for COVID-19 vaccines before they become available. Any international COVID-19 vaccine allocation framework, even as a non-binding resolution, must establish governance principles, including accountability, transparency, and participation, and define decision makers, increase country commitments to financing and acceptable conduct, and set principles and a mechanism for equitable distribution within and, importantly, between countries. Such an agreement is necessary to protect human rights and ensure transparency, accountability, participation, and equity.3 Finally, at the G20 in late November, 2020, HICs have a crucial opportunity to choose the world we will face if successful COVID-19 vaccines are developed: one where law is not a barrier but a tool for achieving global health equity with justice.

ALP is a consultant for WHO and has previously consulted to Gavi, The Vaccine Alliance. ME-T has previously consulted for WHO on equitable access to pandemic influenza vaccines. ALP, ME-T, and MR are supported by the Arts and Humanities Research Council of the UK, grant: AH/V006924/1. AM and CW declare no competing interests.

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WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination, 14 September 2020
World Health Organization
14 September 2020 :: 13 pages
PDF: WHO-2019-nCoV-SAGE_Framework-Allocation_and_prioritization-2020.1-eng.pdf
Executive Summary
This Values Framework offers guidance globally on the allocation of COVID-19 vaccines between countries, and to offer guidance nationally on the prioritization of groups for vaccination within countries while supply is limited. The Framework is intended to be helpful to policy makers and expert advisors at the global, regional and national level as they make allocation and prioritization decisions about COVID-19 vaccines. This document has been endorsed by the Strategic Advisory Group of Experts on Immunization (SAGE).

The Framework articulates the overall goal of COVID-19 vaccine deployment, provides six core principles that should guide distribution and twelve objectives that further specify the six principles (Table 1). To provide recommendations for allocating vaccines between countries and prioritizing groups for vaccination within each country, the Values Framework needs to be complemented with information about specific characteristics of available vaccine or vaccines, the benefit-risk assessment for different population groups, the amount and pace of vaccine supply, and the current state of the epidemiology, clinical management, and economic and social impact of the pandemic. Hence, the final vaccination strategy will be defined by the characteristics of vaccine products as they become available.

SAGE is currently engaged in the process of applying the Values Framework to emerging evidence on specific vaccines, and the evolving epidemiology and economic impact of the pandemic. The first stage of this process was the identification of populations and sub-populations which would be appropriate target groups for prioritization under the various values-based objectives in the Framework (Table 2), before data on Phase 3 vaccine performance are not yet available. Specific priority group recommendations for specific vaccines will be made as vaccine products become authorized for use; initial vaccine specific policy recommendations are expected in the final quarter of 2020 or early 2021, depending on timing of and findings from phase 3 vaccine trials.

The Framework also complements the principles on equitable access and fair allocation of COVID-19 health products developed for the ACT Accelerator COVAX facility.

Framework Goals and Principles at a Glance
Overarching goal
COVID-19 vaccines must be a global public good. The overarching goal is for COVID-19 vaccines to contribute significantly to the equitable protection and promotion of human well-being among all people of the world.

Principles
Human Well-Being
Protect and promote human well-being including health, social and economic security, human rights and civil liberties, and child development.
Equal Respect
Recognize and treat all human beings as having equal moral status and their interests as deserving of equal moral consideration.
Global Equity
Ensure equity in vaccine access and benefit globally among people living in all countries, particularly those living in low-and middle-income countries.
National Equity
Ensure equity in vaccine access and benefit within countries for groups experiencing greater burdens from the COVID-19 pandemic.
Reciprocity
Honor obligations of reciprocity to those individuals and groups within countries who bear significant additional risks and burdens of COVID-19 response for the benefit of society.
Legitimacy
Make global decisions about vaccine allocation and national decisions about vaccine prioritization through transparent processes that are based on shared values, best available scientific evidence, and appropriate representation and input by affected parties.

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Statement on COVID-19 Immunization and Equitable Access to Vaccines
World Federation of Public Health Associations [WFPHA] – Taskforce on Immunization
Friday, 18 September 2020

Immunization is one of the most successful public health measures of modern times. In fact, according to a World Health Organization (WHO) report on the prevention of infectious diseases, it is second only to clean water (WHO 2008). Annually immunization prevents an estimated 2.5 million deaths globally and reduces disease-specific treatment costs (WHO 2018).

For all the devastation caused by COVID-19, an important lesson is that the balance needs to shift from treating disease to preventing it. Immunization has an important role to play in prevention not only for infants but throughout life as a key component of healthy ageing. It saves, prolongs and improves the quality of lives, at the same time that it saves time and other resources, leading to sustainable healthcare systems (UK Chief Medical Officers’ Guidelines 2011). Further, immunization has positive long-term impact, contributing to make communities healthier and promote social and economic development.

GAVI, WHO and UNICEF have warned that 80 million children under the age of one are at risk of disease due to disruptions to vital immunisation programmes because of COVID-19 (2). Specific to COVID-19, almost everyone is at risk and may require vaccination if given the opportunity. Hence, it is likely that demand will surpass supply. The concern of the WFPHA Immunisation Taskforce is the tendency for the rich to acquire and pay for the limited supply of available efficacious vaccines to the detriment of the at-risk populations in low income settings.

Not surprisingly, the race to produce a safe and efficacious vaccine for COVID-19 has been on-going and there are indications that success may not be too far away. An important lesson that experience has taught us from previous immunization programs is that, even when effective vaccines are available, vulnerable persons in low income settings usually do not have access to these vaccines for some time, if at all. There is a myriad of reasons for this state of affairs. These include (among others) high cost of vaccination programs for countries, health systems, families and individual, individual’s poor geographical access to vaccination centres, and inadequate supply of available vaccines due to competition. To worsen matters, GAVI (The Vaccine Alliance) indicated (prior to COVID-19) its intention to wean itself off such funding support.

Therefore, the WFPHA Immunisation Taskforce recommends:
1. The international community should widen the process of coming together to support research and development of effective COVID-19 vaccines from multiple centres.
2. The international community should establish a COVID-19 vaccination fund to support needy but resource-constrained countries.
3. Supporting the World Health Organization in its efforts to coordinate the response to COVID-19 and in the development of an appropriate vaccine.
4. National authorities should financially support the WHO and invest in strengthening national health systems with a particular focus on sustainable immunization programs.
5. GAVI should continue to work for equitable distribution of any effective vaccine against COVID-19 and postpone any plans of withdrawing funding support to developing countries.

References
GAVI (2020) COVID-19: massive impact on lower-income countries threatens more disease outbreaks https://www.gavi.org/news/media-room/covid-19-massive-impact-lower-income-countries-threatens-more-disease-outbreaks

WHO (2008) Vaccination greatly reduces disease, disability, death and inequity worldwide. Available at: https://www.who.int/bulletin/volumes/86/2/07-040089/en/. Last accessed: June 2019.

WHO (2018) Vaccines: the powerful innovations bringing WHO’s mission to life every day. Available at: https://www.who.int/news-room/commentaries/detail/vaccines-the-powerful-innovations-bringing-who-s-mission-to-life-every-day. Last accessed: May 2019.

UK Chief Medical Officers’ Guidelines (2011) Physical activity benefits for adults and older adults. Available at: https://www.health-ni.gov.uk/sites/default/files/publications/dhssps/physical-activity-info.pdf. Last accessed: June 2019

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IVAC [to 19 Sep 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar Recording: Avoiding Barriers to Access for a COVID-19 Vaccine
The International Vaccine Access Center (IVAC) hosted a webinar on September 16th,
Description: Even before the COVID-19 pandemic, countries worked to overcome a myriad of challenges when introducing new safe and effective vaccines. While policy makers and health advocates addressed barriers, from understanding disease burden and cost effectiveness to establishing cold chain systems, preventable diseases spread, sicken populations, and cost lives. Learning from the past failures of vaccine introductions will be crucial for ensuring equitable access to a COVID-19 vaccine. Leaders and scientists in the international vaccine field discussed the barriers to vaccine access we must overcome to avoid and the role the international community will play in promoting equity in delivering a COVID-19 vaccine.
The webinar featured a presentation by Jerome Kim, MD, Director General, IVI.
Watch: https://youtu.be/5U6SYVqhquY
Slides: https://www.jhsph.edu/ivac/wp-content/uploads/2020/09/Presentation_Barriers-to-Vaccine-Access.pdf