Unitaid statement on the MPP agreements for local production of generic versions of the oral COVID-19 antiviral nirmatrelvir
Geneva – Unitaid welcomes the agreements signed by the Medicines Patent Pool (MPP) with generic manufacturers to produce Pfizer’s oral COVID-19 treatment nirmatrelvir, co-administered with ritonavir, accelerating access to this promising outpatient medicine in low- and middle-income countries (LMICs).
Nirmatrelvir is an oral antiviral co-administered with ritonavir for non-hospitalized mild-to-moderate COVID-19 patients at highest risk of developing severe forms of the disease. According to a study conducted by Pfizer, the new medicine can notably avert progression to severe illness and reduce the risk of hospitalization and death when administered in early stages of the infection. The oral outpatient antiviral is currently under assessment by the World Health Organization.
With COVID-19 vaccine coverage still limited in low resource settings, oral outpatient treatments can play a critical role in the management of COVID-19, with a potential to save lives and ease the pressure on healthcare systems. But challenges in equitable access remain and global efforts are needed to support production of generic versions of medicines and ensure systems are in place for these products to be promptly prequalified and adopted.
This is a significant step for the work the Access to COVID-19 Tools (ACT) Accelerator’s therapeutics pillar partners are leading, working closely with the MPP, originator and generic companies, to rapidly introduce new treatments in LMICs, alongside adequate testing, and ensure rapid and affordable access to those products.
These sub-licenses follow the voluntary licensing agreement MPP and Pfizer signed in November 2021 and will enable 36 qualified sub-licensees, across thirteen countries in Asia, the Caribbean, the Middle East and Eastern Europe, including Ukraine, to supply 95 LMICs, comprising more than half of the world’s population.
Unitaid pays tribute to the MPP for these agreements, in line with WHO’s COVID-19 Technology Access Pool (C-TAP) principles for licensing, that will help expand access to affordable oral outpatient COVID-19 treatments in LMICs.
Unitaid hopes other manufacturers, notably on the African continent, will be able to sign such agreements in the near future to ensure a manufacturing base as geographically wide as possible is established.
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Unitaid commits US$ 56 million to boost access to medical oxygen globally, calls on other donors to close US$ 1 billion gap
- New investments will boost access to medical oxygen globally and save lives during the COVID-19 pandemic and beyond
- In low- and middle-income countries, these grants will increase liquid oxygen supplies, lower costs, strengthen infrastructure, expand technical capacity, and ensure the safe use of medical oxygen
- Oxygen remains a critical component of the global COVID-19 response – 75% of patients hospitalized for COVID-19 can be treated with oxygen alone — without any other advanced care
- Oxygen is a high-return lifesaving treatment, a hallmark of functional health systems. Investments now will save lives for years to come. But access to oxygen still does not meet needs for COVID-19 and/or other serious illnesses
- Unitaid calls on donors to close the ~US$ 1 billion gap in the oxygen response, building on the ~US$ 700 million investments by the Access to COVID-19 Tools Accelerator Oxygen Emergency Taskforce partners since the beginning of 2021
Geneva – Unitaid announces today US$ 56 million of investments to increase and enhance access to medical oxygen, a life-saving essential treatment for severe COVID-19 and other severe illnesses.
The four Unitaid-funded projects, designed to rapidly address global inequities in access to medical oxygen, will be implemented by ALIMA (The Alliance for International Medical Action), the Clinton Health Access Initiative (CHAI), Partners in Health (PIH) and the WHO Health Emergencies Programme. The projects will not only ensure medical oxygen is available for COVID-19 patients but will also lay the groundwork to improve access to oxygen for the long-term. These investments will support reliable, equitable access to oxygen and will pay dividends now and going forward, as a critical foundation for future pandemics.
Oxygen is a high-return, lifesaving treatment for COVID-19 and a hallmark of functional health systems. Investments now will continue to save lives beyond the pandemic. It is an essential medicine for the treatment of many conditions affecting newborns, children, and adults – including pneumonia, the world’s biggest infectious killer. But, even before the health crisis, access to safe and affordable oxygen in low- and middle-income countries (LMICs) was low. The pandemic has exacerbated this situation, leading to many preventable deaths. Challenges for accessing oxygen in LMICs are multiple and can range from complex logistics with oxygen supply not always reaching the destination on time, to the need for good infrastructure and upkeep for most oxygen systems, or to a lack of market competition in countries resulting in high prices and fragmented access.
These investments directly support the work of the Access to COVID-19 Tools Accelerator (ACT-A) Oxygen Emergency Taskforce (Oxygen Taskforce) by ensuring countries have access to adequate, affordable oxygen solutions such as bulk liquid oxygen, oxygen generation systems and other important oxygen equipment. They also complement the significant oxygen investments of the U.S. Agency for International Development (USAID), the Global Fund and the World Bank’s COVID-19 emergency health response. They will expand on the unprecedented efforts of Oxygen Taskforce partners that have included technical support and emergency procurement for medical oxygen for nearly 100 countries, as well as successfully achieving ~15% price reductions for bulk liquid oxygen versus current pricing and between 10-50% reductions in filled cylinder pricing.
The Oxygen Taskforce, launched one year ago and led by Unitaid, is working to maximize the impact of these investments and to dramatically increase liquid oxygen supply, repair broken equipment and expand the number of functioning oxygen generation systems available in LMICs.
While some countries are seeing a downturn in COVID-19 cases and less disease severity, other countries continue to face oxygen surges and need is still outstripping supply. Current reports from Hong Kong indicate that hospitals are running out of oxygen during the worst COVID-19 outbreak yet, and some Asia Pacific countries have surging COVID-19 oxygen needs.
Unitaid’s investment represents an important commitment towards closing the funding gap of ~US$ 1 billion identified in the ACT-A Strategic Plan and Budget for 2022 , and builds on the US$50 million USAID has committed in new funding for oxygen as pledged at President Biden’s Global COVID-19 Summit in September 2021. Unitaid is calling on donors, including governments, foundations, and private sector partners to join in the effort to help meet this significant need for medical oxygen globally and save lives.
“With limited COVID-19 vaccine coverage in low resource settings, many countries continue to face high rates of hospitalization and equitable access to medical oxygen remains critical,” Unitaid Executive Director, Dr Philippe Duneton, said. “This additional investment fills an immediate access gap for safe and affordable oxygen, but the job is not finished. More funding is vital to scale-up supply and prepare countries for future case surges. Just this month, 20 countries have surging COVID-19 oxygen needs. Beyond COVID-19, ~7 million children with hypoxic pneumonia will need oxygen. Oxygen is an essential medicine. Investing now will save lives.”
EDITOR’S NOTES
Background
Medical oxygen shortages around the world have been a tragic feature of the pandemic, impacting the poorest countries disproportionately. These access difficulties were entrenched in many parts of the world before COVID-19, and have been exacerbated by the pandemic, putting strain on fragile health systems and resulting in preventable deaths. Even before COVID-19, pneumonia was the world’s biggest infectious killer of adults and children, claiming the lives of 2.5 million people in 2019. The pandemic has exacerbated this problem, particularly in ‘double-burden’ countries which are contending with high levels of pneumonia and COVID-19. As well as meeting the immediate needs of the pandemic, the Oxygen Taskforce would look to leverage gains in this area to help with long-term pneumonia control.
About the Access to COVID-19 Tools Accelerator (ACT-A) Oxygen Emergency Taskforce (Oxygen Taskforce)
The Oxygen Taskforce was launched in February 2021 to bring together key partners already working to address critical oxygen gaps, as part of a coordinated COVID-19 response. The Oxygen Taskforce is led by Unitaid, under the Therapeutics Pillar of the Access to COVID-19 Tools Accelerator. Partner organizations include Unitaid, WHO (and the Biomedical Consortium it coordinates), UNICEF, The Global Fund, the World Bank, UNOPS, the Every Breath Counts coalition, CHAI, PATH, Save the Children, The Bill and Melinda Gates Foundation, Access to Medicine Foundation, the Pan American Health Organization (PAHO), and the Africa Centre for Disease Control and Prevention.
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Canada commits an additional $20 million CAD contribution to Unitaid to further enhance global access to COVID-19 treatments
Geneva – Unitaid welcomes the contribution of C$20 million from Canada to its work under the Access to COVID-19 Tools (ACT) Accelerator’s Therapeutics pillar to increase and enhance access to effective medicines and lifesaving medical oxygen in low- and middle-income countries.
Canada’s significant funding will contribute to build on the groundwork the ACT-Accelerator therapeutics pillar partners have laid to address research & development gaps, and rapidly introduce new effective treatment options alongside adequate testing in low- and middle-income countries (LMICs).
Harjit S. Sajjan, Minister of International Development and Minister responsible for the Pacific Economic Development Agency of Canada said: “Since the beginning of the pandemic, Canada has worked in close partnership with the ACT-Accelerator because we know that our health depends on the health of everyone. We have more to do to end this health crisis and Canada is committed to ensuring equitable access to lifesaving tools everywhere.”
Securing rapid, equitable access to emerging products is key in the global response to the pandemic, and new oral outpatient treatments are potential gamechangers in the management of COVID-19. But we need to expand global efforts to support production of generic versions of medicines and ensure that systems are in place for these products to be promptly prequalified and adopted.
This new contribution will also finance further oxygen procurement and delivery, and support the repair, maintenance and scale up of local medical oxygen production in LMICs, helping to meet the essential medical oxygen needs of 6 to 8 million severe and critical COVID-19 patients by September 2022.
“With vaccine coverage remaining limited in LMICs and many countries still facing high rates of hospitalization, there is a continued need for effective access to oxygen and medicines. Unitaid hails Canada’s strong support to ensure reliable and equitable access to those lifesaving products,” Unitaid Executive Director Dr Philippe Duneton said.
The funding comes in addition to last year’s contribution, bringing Canada’s direct support to Unitaid for equitable access to COVID-19 treatments up to C$35 million.
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Sarah Mascheroni
Communications officer
Email: mascheronisa@who.int
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Unitaid statement on WHO guidelines for COVID-19 antiviral molnupiravir
Geneva – Unitaid today welcomes the conditional recommendation from the World Health Organization (WHO) on the use of molnupiravir to treat adult patients with mild to moderate COVID-19 at highest risk of developing severe forms of the disease.
Oral outpatient treatments are potential gamechangers in the management of COVID-19. They are critical in the global response to the pandemic, with a potential to save lives and ease the pressure on healthcare systems, and an important step toward realizing the promise of test-and-treat strategies in decentralized settings.
Molnupiravir is the first oral antiviral for non-hospitalized mild-to-moderate COVID-19 patients to be recommended by WHO, bringing an additional treatment option to the COVID-19 clinical care package.
When administered in early stages of the infection for a full five-day course, the antiviral medicine – developed by MSD in collaboration with Ridgeback Biotherapeutics – can avert progression to severe illness and reduce the risk of hospital admission and time to resolve symptoms. The WHO recommendation flags the need to address this medicine’s contraindications to ensure appropriate use.
The newly recommended treatment is a significant step for the groundwork Unitaid and partners have laid to rapidly introduce new treatments and adequate testing in low- and middle-income countries. This global effort is being carried out through the Access to COVID-19 Tools (ACT) Accelerator’s therapeutics pillar, with partners including the Global Fund, UNICEF, Unitaid and WHO.
Working closely with the Medicines Patent Pool, originator and generic companies, the ACT-Accelerator therapeutics pillar has secured agreements to ensure rapid and affordable access to molnupiravir, preparing for a robust generic supply base for more than 100 low- and middle-income countries.
But strong, continuous support is needed to address the remaining gaps in access to new therapeutics in low- and middle-income countries. That means supporting production of generic versions of medicines, and ensuring that systems are in place for these products to be promptly prequalified and adopted.
Additional promising oral outpatient therapeutics for COVID-19 are in the pipeline. A second oral antiviral, nirmatrelvir/ritonavir, and other compounds including fluvoxamine, are under assessment by WHO.
Media contact:
Sarah Mascheroni
Communications officer
Email: mascheronisa@who.int
Mobile: +41 79 728 73 11
The ACT-A Oxygen Emergency Taskforce…one year on
One year after the launch of the Access to COVID-19 Tools Accelerator (ACT-A) Oxygen Emergency Taskforce, what has been achieved? Has this unprecedented effort by more than 20 United Nations and global health agencies to work together to support low- and middle-income countries (LMICs) to mitigate pandemic-related medical oxygen shortages delivered on its promise? And what remains to be done in 2022?
Against the backdrop of widespread oxygen shortages across Latin America, Asia, Africa, and the Middle East, the ACT-A Oxygen Emergency Taskforce was launched on 25 February 2021. Unitaid and the Wellcome Trust were announced as Co- chairs with membership drawn from the World Health Organization (WHO) and its Biomedical Consortium,[1] UNICEF, UNOPS, The Global Fund to Fight AIDS, Tuberculosis, and Malaria (The Global Fund), the World Bank, USAID, the Clinton Health Access Initiative (CHAI), PATH, Save the Children, the Bill & Melinda Gates Foundation (BMGF), the Access to Medicine Foundation, and the Every Breath Counts (EBC) Coalition.
Later in the year, the Pan American Health Organization (PAHO) and the Africa Centres for Disease Control and Prevention (Africa CDC) joined the Taskforce. As of January 2022, Unitaid is the sole chair.
The first phase (February – October 2021)
The initial focus of the Taskforce was to pursue five key objectives:
- Assess acute and longer-term oxygen needs in LMICs
- Support and review LMIC funding requests to ACT-A Taskforce members
- Procure oxygen and related products and services
- Increase LMIC access to liquid oxygen, oxygen plant repairs, and critical parts (e.g., zeolite, compressors, etc.)
- Strengthen advocacy and communication efforts to highlight the importance of oxygen and accelerate financing available via the ACT-A
During this period, Taskforce members mobilized ~$US700 million in grant financing to help LMICs avert oxygen shortages and ensured that access to oxygen was front and center of the overall ACT-A response.[2]
Between February and October 2021, The Global Fund, supported by several government and private sector donors, provided ~$US475 million in grants to help more than 66 low- and lower-middle income countries purchase oxygen supplies, including Pressure Swing Adsorption (PSA) plants, concentrators, liquid oxygen, ventilators, cylinders, pulse oximeters, and more.
WHO and UNICEF provided direct technical and operational support, procuring $US132 million and delivering $US89 million worth of oxygen supplies to more than 120 countries, including oxygen plants, concentrators, cylinders, advanced respiratory equipment, patient monitors, pulse oximeters, and oxygen delivery consumables, supported by several governments and private sector donors.[3]
Unitaid, the Wellcome Trust, and the BMGF, provided ~$US30 million to the WHO Health Emergencies Programme (WHE) and to NGOs including PATH and CHAI to increase the oxygen support they provide to specific LMIC governments – for procurement as well as maintenance and training.
Over 2021, Unitaid invested an additional $US17 million to NGOs ALIMA, PATH, Partners in Health, The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), and CHAI, as well as the WHE, for catalytic interventions including rapidly establishing COVID-19 treatment facilities in West Africa, distributing pulse oximeters, and improving the oxygen market by putting up collateral for emergency oxygen access and equipment stockpiling.
And in September 2021 at the Global COVID-19 Summit, the US Government announced $US50 million to increase access to medical oxygen in partner countries and called for a coalition of governments, foundations, NGOs, and companies to mobilize significant additional funding for oxygen access to “Save Lives Now.”
The second phase (October 2021 – present)
On 28 October 2021, the ACT-A released a new Strategic Plan and Budget seeking an additional $US1.4 billion to enable the ACT-A Oxygen Emergency Taskforce to continue to finance and provide oxygen supplies to LMICs in need during 2022.
The new strategy set an immediate goal of supporting the delivery of 110 to 140 million cubic meters of oxygen to LMICs by the end of 2021 and a longer-term goal of meeting the medical oxygen needs of 6 to 8 million severe and critical patients by September 2022.
The majority of the oxygen funding needed is for procurement and delivery and to support the repair, maintenance, and scale up of local medical oxygen production via The Global Fund, UNICEF, Unitaid, and WHO.
To implement the new strategy the Taskforce announced three new objectives:
- Prioritize allocation of additional resources towards highest impact with a special focus on identifying priority countries and short- and long-term oxygen sources
- Coordinate action on quick wins with a special focus on monitoring PSA plant repairs and coordinating financing for technical support
- Address supply gaps and bottlenecks for services and related equipment with a special focus on unlocking liquid oxygen supply agreements, expanding service offerings on PSA plants, and resolving bottlenecks in the supply of components and spare parts
In December 2021, the US Government announced a further $US75 million for additional support for USAID’s Rapid Response efforts, which includes investment to help strengthen oxygen market systems to improve reliable oxygen production and delivery.
A detailed list of oxygen milestones by Taskforce members to date is outlined below.
What’s next?
As a result of the critical work of the Taskforce in 2021, many LMICs entered 2022 with a far greater capacity to meet the oxygen needs of COVID-19 patients. Despite causing less severe disease, the sheer scale of global transmission of the Omicron variant has driven hospital admissions to record highs in many countries, increasing the need for medical oxygen.
More support is needed to bridge LMIC oxygen gaps during 2022. Oxygen therapy remains the first line of treatment for those with severe and critical COVID-19 in low-resource settings and the ACT-A Oxygen Emergency Taskforce has demonstrated that it can work effectively with LMIC governments and their local partners to increase access to medical oxygen in hospitals, ensure safe oxygen therapy to patients, and support staff to operate and maintain the equipment.
Most of the G20 nations have not yet contributed to ACT-A efforts and to oxygen support. Outreach and coordinated efforts through the ACT-A mechanism continue to mobilize countries and private sector donors with the financial and/or industrial capacity to support LMICs in their national COVID-19 responses, including increased access to oxygen.
Investments made via the Taskforce will not only help countries reduce COVID-19-related deaths but will strengthen health systems for the long term so they can continue delivering oxygen to save lives well beyond the pandemic. This will help countries make progress on many of their Sustainable Development Goal targets, including reducing deaths among newborns, children, women in childbirth, and adults with both communicable and non-communicable diseases.
Investing in medical oxygen will also help countries improve national pandemic preparedness and response, as the risk of respiratory outbreaks where oxygen is a cornerstone of critical care remains high.
[1] Members of the WHO Biomedical Consortium include ALIMA, BMGF, International Medical Corps (IMC), Médecins Sans Frontières (MSF), UN Development Programme (UNDP), UN High Commissioner for Refugees (UNHCR), UNICEF, UNOPS, USAID, and the World Food Programme (WFP).
[2] The World Bank also provided significant loan financing as part of their $US157 billion COVID-19 Crisis Response, which some LMICs have used to improve medical oxygen access. The value of these investments is not included.
[3] This is in addition to the $US96 million of oxygen support that WHO and UNICEF provided to 145 countries in 2020.
Media contact:
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FIND and Unitaid, through the ACT-Accelerator, seek organizations to advocate and raise awareness on COVID-19 testing and treatment solutions
FIND and Unitaid today launched a request for proposals (RFP) to select services of organizations, with a proven record of advocacy and awareness-raising in healthcare in low- and middle-income countries, to implement projects to achieve the below specific objectives:
- Increase access and uptake to COVID-19 testing and therapeutics, as they get recommended, through development and implementation of robust and evidence-based advocacy strategies supported by advocacy, literacy and communication materials and initiatives adapted to specific population groups, regional and country contexts
- Disseminate and amplify these materials and initiatives through appropriate communication channels to increase prioritization of COVID-19 testing and linkage to treatment in the national pandemic response as well as generate demand for testing and therapeutics within relevant target groups
The Access to COVID-19 Tools (ACT) Accelerator is a groundbreaking global collaboration to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines. FIND co-leads the Diagnostics Pillar and Unitaid co-leads the Therapeutics Pillar. This RFP has been launched under the Advocacy, Communications and Community Engagement (ACCE) task force of the Diagnostic Pillar’s Country Support Working Group.
With this RFP, we are aiming to create an enabling environment for increased access to and scaled-up use of COVID-19 testing and linkage to treatment in target regions (Africa, Asia, Latin America, Middle East).
We are especially seeking country-level organizations including, but not limited to, health sector implementers, marketing agencies, advocacy organizations, not-for-profits, community-led and civil society organizations (CCSO), and faith-based organizations.
The total budget envelope for this RFP is anticipated to be US$ ~2 million. This amount will be distributed among selected partners with an average award of no less than US$50,000 to a maximum of US$100,000
Proposals along with appendices/supporting documents must be received by FIND at [advocacy_RFP@finddx.org] no later than 2 February 2022 at 17h00 CET.
Two applicant webinars are being organized to provide an overview of the RFP and answer queries.
- Webinar of 19 January 2022 in English with interpretation in French
RECORDING | Powerpoint presentation in English - Webinar of 20 January 2022 in English with interpretation in Spanish and Portuguese
RECORDING | Powerpoint presentation in English - FAQ
English | French | Spanish | Portuguese
Request for proposals for developing and deploying advocacy strategies to promote COVID-19 diagnostic testing and linkage to care and treatment in low- and middle-income countries (LMICs) – submission deadline 2 February 2022 at 17h00 CET
- Request for proposal [.pdf]
English | French | Spanish | Portuguese - Appendix A – Financial proposal template [.xlsx]
English | French | Spanish | Portuguese - Appendix B – Self-check form [.xlsx]
English | French | Spanish | Portuguese
Note: Applications and supporting materials can be submitted in English, French, Spanish and Portuguese. If you have any questions on the application or exclusion criteria, please write to advocacy_rfp@finddx.org
Find out more: https://www.finddx.org/calls-for-partners
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Former French Minister Marisol Touraine reelected chair of the Unitaid Executive Board; Unitaid on track to deliver its new strategy for 2022-26
Geneva – At its virtual 39th meeting, the Unitaid Executive Board reelected Marisol Touraine as Board Chair for a further two-year term. Ms Touraine will continue in the position until June 2024.
Marisol Touraine is former French Minister of Social Affairs, Health and Women’s Rights and has served as chair of the Unitaid Executive Board since June 2019.
“I am grateful to the Executive Board for this vote of confidence,” said Ms Touraine. “I remain fully committed to support and ensure Unitaid delivers successfully on its mandate of making equitable access to innovative health solutions a reality for all.”
During her tenure as chair, Ms Touraine helped to strengthen Unitaid’s governance and create greater transparency and inclusivity. The Executive Board’s strategic leadership has brought clear guidance to the Secretariat and delivered informed decisions during the COVID-19 pandemic. With sustained mobilization from the Board, Unitaid has gained visibility and recognition, triggering interest and contributions from new donors.
Amid the COVID-19 pandemic, Unitaid has managed to adapt and evolve, demonstrating the relevance of its model and how its unique expertise and leadership is essential and complements the work of other key global health players in delivering effective solutions.
“I applaud the reelection of Marisol Touraine as chair of the Unitaid Executive Board. This is the result of her invaluable leadership and strategic guidance,” Unitaid Executive Director Dr Philippe Duneton said. “The renewal of her mandate is timely as Unitaid enters the last phase of developing its new strategic plan for the next five years. Marisol’s contribution and engagement alongside our Board members are key in the success of this endeavour.”
During this two-day session, the board also agreed on a strategic framework for Unitaid’s new strategy for 2022-26, keeping the Secretariat on track to approve its ambitious and transformative strategic plan next year.
This collaborative work the Secretariat is steering builds on Unitaid’s current strengths and reinforces its position in a fast-evolving global health landscape. It was developed based on lessons learnt from the COVID-19 global health crisis and defines where and how Unitaid can bring the greatest impact.
The new strategy is a step forward in Unitaid’s ambition to bring innovative, integrated, end-to-end solutions to those who need them most. Fully financing its implementation will be key and continued support from the Executive Board for resource mobilization efforts remain crucial.
“We had very constructive and vivid discussions around Unitaid’s future during this board. I am pleased we have been able to bring together the richness of different perspectives and provide clear directions for the next steps of the development of our new strategy,” said Marisol Touraine.
“In addition to taking on a lead role in the global COVID-19 response, in 2021 we moved forward in developing our next strategy in collaboration with the Board and aggressively ramped up efforts to mobilize resources in an increasingly competitive environment,” Dr Duneton added. “I believe we are well prepared as an organization to meet the challenges ahead.”
Media contact
For more information and media requests:
Hervé Verhoosel
Mobile: +44 77 29 618 634
Email: verhooselh@unitaid.who.int