Stopping epidemics when and where they occur
2023; Elsevier BV; Volume: 401; Issue: 10374 Linguagem: Inglês
10.1016/s0140-6736(23)00015-6
ISSN1474-547X
AutoresEls Torreele, Michel D. Kazatchkine, Joanne Liu, Mark Dybul, Mauricio Cárdenas, Sudhvir Singh, Helena Legido Quigley, Christine McNab, Ellen Johnson Sirleaf, Mariana Mazzucato, Helen Clark,
Tópico(s)Vaccine Coverage and Hesitancy
ResumoThroughout the COVID-19 pandemic, vaccines and other health tools have reached lower-income countries out-of-step with need and demand.1Batista C Hotez P Amor JB et al.The silent and dangerous inequity around access to COVID-19 testing: a call to action.EClinicalMedicine. 2022; 43101230Summary Full Text Full Text PDF PubMed Scopus (22) Google Scholar, 2Our World in DataCoronavirus (COVID-19) vaccinations.https://ourworldindata.org/covid-vaccinationsDate: 2023Date accessed: January 4, 2023Google Scholar, 3Iacobucci G COVID-19: "grotesque inequity" that only a quarter of paxlovid courses go to poorer countries.BMJ. 2022; 379o2795Google Scholar Yet lessons from this pandemic to address such inequities are not catalysing the fundamental changes required.4Clark H Johnson Sirleaf E Transforming or tinkering? Inaction lays the groundwork for another pandemic.https://theindependentpanel.org/wp-content/uploads/2022/05/Transforming-or-tinkering_Report_Final.pdfDate: 2022Date accessed: December 26, 2022Google Scholar Similarly, despite the well known risk of Ebola virus disease outbreaks, it took months before candidate vaccines were made available for testing during an outbreak in Uganda in late 2022.5Nickerson J Houston A A viable vaccine for Ebola's latest strain is shamefully collecting a decade of dust in Canada. The Globe and Mail, Nov 15, 2022https://www.theglobeandmail.com/opinion/article-a-viable-vaccine-for-ebolas-latest-strain-is-shamefully-collecting-a/Date accessed: December 20, 2022Google Scholar And although there have been cases of mpox (formerly known as monkeypox) in Nigeria, the Democratic Republic of the Congo, and Central African Republic for many years, it was only when the virus spread globally during 2022 that high-income countries focused on the disease, with people in wealthy countries getting access to mpox vaccines and therapies.6Gleeson D Monkeypox—the next global vaccine equity failure?. The Conversation, Aug 30, 2022https://theconversation.com/monkeypox-the-next-global-vaccine-equity-failure-189045Date accessed: December 20, 2022Google Scholar Governments and the global community must urgently tackle difficult questions about why, how, where, and when diagnostics, treatments, and vaccines are produced, and about who is in control of their availability and distribution. Epidemics present unique and complex scientific, health, socioeconomic, and international cooperation challenges that require a fit-for-purpose response.7Olliaro P Torreele E Global challenges in preparedness and response to epidemic infectious diseases.Mol Ther. 2022; 30: 1801-1809Summary Full Text Full Text PDF PubMed Scopus (7) Google Scholar Current market forces cannot provide the tools to stop disease outbreaks. We propose a new framework that is designed in the public interest and rooted in equity from start to finish to create a sustainable ecosystem for medical countermeasures to outbreaks, based on the sharing of knowledge and technology and governed and financed through a global commons approach (panel).PanelVisions, values, aims, and six essential building blocks of a new framework for a global commons approach to stop epidemicsVision and values of the new framework for effective health innovation•Health technologies for PPR should be considered common goods, not private commodities•A new business model is needed to deliver common goods for PPR•Collective intelligence and technology sharing are the most effective ways to deliver innovation for public health•A true end-to-end approach to medical innovation is rooted in equity at every step•Appropriate health technologies are those that ensure the right outcome for health•Structuring partnerships with the private sector towards shared public health goalsAims of the new equitable global commons approach•Timely development of appropriate health technologies for epidemic preparedness and response that are fit-for-purpose in all countries in need and in various health settings•Timely and equitable availability, with access to technologies when and where they are needed•Equipping and supporting countries to use these technologies to address their health needs•Mechanisms to facilitate innovation to adapt to the evolving needs and demands of pandemic controlSix essential building blocks for an effective PPR innovation ecosystem•Regional research and development hubs built around ready-to-adapt technology platforms for "last-mile innovation"•Pre-negotiated financing and governance for research, development, and manufacturing, including ownership rules over technologies and commitments for availability and access following a common good approach•Ready-to-use clinical trial networks, conducting public-health-focused trials•Ready-to-activate regional and subregional manufacturing capacity linked to the selected technology platforms•Continuous assessment of health needs to inform and guide the priority research and development agenda•Coordinated allocation and supply management that ensures equity at regional and subregional levelsPPR=pandemic prevention, preparedness, and response. Vision and values of the new framework for effective health innovation •Health technologies for PPR should be considered common goods, not private commodities•A new business model is needed to deliver common goods for PPR•Collective intelligence and technology sharing are the most effective ways to deliver innovation for public health•A true end-to-end approach to medical innovation is rooted in equity at every step•Appropriate health technologies are those that ensure the right outcome for health•Structuring partnerships with the private sector towards shared public health goals Aims of the new equitable global commons approach •Timely development of appropriate health technologies for epidemic preparedness and response that are fit-for-purpose in all countries in need and in various health settings•Timely and equitable availability, with access to technologies when and where they are needed•Equipping and supporting countries to use these technologies to address their health needs•Mechanisms to facilitate innovation to adapt to the evolving needs and demands of pandemic control Six essential building blocks for an effective PPR innovation ecosystem •Regional research and development hubs built around ready-to-adapt technology platforms for "last-mile innovation"•Pre-negotiated financing and governance for research, development, and manufacturing, including ownership rules over technologies and commitments for availability and access following a common good approach•Ready-to-use clinical trial networks, conducting public-health-focused trials•Ready-to-activate regional and subregional manufacturing capacity linked to the selected technology platforms•Continuous assessment of health needs to inform and guide the priority research and development agenda•Coordinated allocation and supply management that ensures equity at regional and subregional levels PPR=pandemic prevention, preparedness, and response. This conversation and some actions are already under way. Hard lessons from the Access to COVID-19 Tools Accelerator (ACT-A), which despite efforts failed to reach targets, are spurring discussions.8Open ConsultantsExternal Evaluation of the Access to COVID-19 Tools Accelerator (Act-A).https://www.who.int/publications/m/item/external-evaluation-of-the-access-to-covid-19-tools-accelerator-(act-a)Date: 2022Date accessed: December 21, 2022Google Scholar WHO's mRNA vaccine technology transfer hub in South Africa and other related initiatives in Africa, Asia, and Latin America, offer promise.9Maxmen A The radical plan for vaccine equity.Nature. 2022; 607: 226-233Crossref PubMed Scopus (9) Google Scholar, 10Medicines Patent PoolCOVID-19 mRNA Technology Transfer Hub Programme: parallel initiatives.https://medicinespatentpool.org/covid-19/mrna-technology-transfer-hub-programme/parallel-initiativesDate: 2022Date accessed: December 21, 2022Google Scholar Public–private partnerships are building vaccine manufacturing capacity in some lower-income countries. But these efforts, without innovative approaches linked to governance and finance, will not produce the equitable start-to-finish or "end-to-end platform" that encompasses every stage from research and development to manufacturing, distribution, and access, recommended by the Independent Panel for Pandemic Preparedness and Response in its May, 2021 report and demanded now on many continents.11Independent Panel for Pandemic Preparedness and ResponseCOVID-19: make it the last pandemic.https://theindependentpanel.org/mainreport/Date: May, 2021Date accessed: January 4, 2023Google Scholar, 12Ramchandani R Kazatchkine M Liu J et al.Vaccines, therapeutics, and diagnostics for COVID-19: redesigning systems to improve pandemic response.BMJ. 2021; 375e067488PubMed Google Scholar The most promising opportunity lies with research and development efforts that allow scientists to rapidly create new medical countermeasures on the basis of existing technologies, as was done successfully for COVID-19 vaccines, treatments, and testing.13Chavda VP Yao Q Vora LK et al.Fast-track development of vaccines for SARS-CoV-2: the shots that saved the world.Front Immunol. 2022; 13961198Crossref PubMed Scopus (16) Google Scholar, 14Guy RK DiPaola RS Romanelli F Dutch RE Rapid repurposing of drugs for COVID-19.Science. 2020; 368: 829-830Crossref PubMed Scopus (198) Google Scholar, 15Pecetta S Finco O Seubert A Quantum leap of monoclonal antibody (mAb) discovery and development in the COVID-19 era.Semin Immunol. 2020; 50101427Crossref Scopus (25) Google Scholar, 16Xu M Wang D Wang H et al.COVID-19 diagnostic testing: technology perspective.Clin Transl Med. 2020; 10: e158Crossref PubMed Google Scholar Enabling scientists in every region to build on existing knowledge and promptly adapt technologies to respond to epidemics when and where they occur could be transformational. Given the limitations of current market-based incentives and of donor-to-recipient aid models, we have considered how to deliver appropriate health technologies and equitable access where and when they are needed.12Ramchandani R Kazatchkine M Liu J et al.Vaccines, therapeutics, and diagnostics for COVID-19: redesigning systems to improve pandemic response.BMJ. 2021; 375e067488PubMed Google Scholar As part of a new framework for a global commons approach to stop epidemics, we propose six essential building blocks to create an equitable end-to-end ecosystem for medical countermeasures (panel). The first and central building block is the establishment of regional research and development hubs built around existing technologies for the development of diagnostics, vaccines, and therapies, such as mRNA vaccines, viral vectors, or monoclonal antibodies. When scientists everywhere, working in the public interest, have the expertise and capacity to work with these technologies without intellectual property restraints, they can promptly develop new tools to address local disease outbreaks.9Maxmen A The radical plan for vaccine equity.Nature. 2022; 607: 226-233Crossref PubMed Scopus (9) Google Scholar These hubs would be based on collective intelligence and technology sharing, foster equity in research and development capability, and reduce reliance on goodwill for voluntary licensing.17Mazzucato M Torreele E How to develop a COVID-19 vaccine for all. Project Syndicate.https://www.project-syndicate.org/commentary/universal-free-covid19-vaccine-by-mariana-mazzucato-and-els-torreele-2020-04Date: April, 2020Date accessed: December 22, 2022Google Scholar, 18Silverman E The pandemic exposed global gaps in access to medicines. Can a contentious approach to close them gain traction?. STAT, Jan 5, 2023https://www.statnews.com/pharmalot/2023/01/05/drug-pricing-cancer-voluntary-licensing-hepatitis/Date accessed: January 8, 2023Google Scholar, 19Médecins Sans FrontièresVoluntary licenses and access to medicines.https://msfaccess.org/voluntary-licenses-access-medicinesDate: 2020Date accessed: December 22, 2022Google Scholar The WHO-supported mRNA vaccine technology transfer hub is a first step but needs to be taken further with more hubs and additional types of vaccine technologies. The second building block is a pre-negotiated governance and financing framework, to be agreed through a mandated mechanism decided by the international community, that would promote a common good approach to the development and distribution of health tools. Common goods are shared resources that people manage or govern collectively in the public interest by negotiating specific rules, such as user and access rights and obligations. Governance and financing should be established in advance to include the legal, policy, and institutional frameworks to organise ownership arrangements for the common good,20Mazzucato M A collective response to our global challenges: a common good and "market-shaping" approach. UCL Institute for Innovation and Public Purpose, Working Paper (IIPP WP 2023–02).https://www.ucl.ac.uk/bartlett/public-purpose/publications/2023/jan/collective-response-our-global-challenges-common-good-and-market-shapingDate: 2023Date accessed: January 9, 2023Google Scholar, 21WHOCouncil on the Economics of Health for All. Governing health innovation for the common good—the WHO Council on the Economics of Health for All—Council brief no. 1.https://www.who.int/publications/m/item/governing-health-innovation-for-the-common-goodDate: 2021Date accessed: December 22, 2022Google Scholar including agreements on intellectual property of existing technologies, technology sharing, and knowledge transfers. These issues will be challenging, but there is both a moral imperative and national self-interest to work through them, given the global devastation pandemics such as COVID-19 can cause. The third building block is ready-to-use clinical trial networks linked to the research and development hubs that undertake trials focused on products that will protect people and stop disease outbreaks. Health authorities, rather than companies developing products for marketing, should steer and shape which type of products are developed for outbreak control and which public health questions trials seek to answer, including on efficacy, safety, and comparative effectiveness. Several such public-health-oriented trial networks already exist.22Tikkinen KAO Malekzadeh R Schlegel M et al.COVID-19 clinical trials: learning from exceptions in the research chaos.Nat Med. 2020; 26: 1671-1672Crossref PubMed Scopus (36) Google Scholar The fourth building block is ready-to-activate decentralised regional and subregional manufacturing capacity linked to the selected technology platforms. Such manufacturing facilities need to engage in routine production and be able to switch to manufacture a different product or scale up rapidly in an outbreak emergency. Manufacturing capacity in China, Europe, India, Russia, and the USA made all the difference to access to COVID-19 vaccines in those regions. The same should also happen in Africa, Latin America, and more broadly across Asia through sharing of technology and know-how to build greater manufacturing autonomy and resilience, not only manufacture under licence. Medical countermeasures must be manufactured locally so they can be distributed rapidly to the communities that need them. Here too, initiatives to build local manufacturing capacity have begun.23Clinton Health Access InitiativeA database of local vaccine manufacturing commitments and tech-transfers.https://www.clintonhealthaccess.org/database/a-database-of-local-vaccine-manufacturing-commitments-and-tech-transfers/Date: 2022Date accessed: December 14, 2022Google Scholar However, true expansion of manufacturing capacity for public health must go beyond private companies' building sites to produce proprietary vaccines. The fifth building block is continuous assessment of health needs and emerging threats to inform and guide a priority research and development agenda, including products that are tailored to local contexts, such as for heat stability or ease of production. This approach includes ongoing assessments as threats evolve, such as characterising different viral strains and diversifying technologies to tackle epidemics more effectively, for instance by developing vaccines that block transmission. The sixth building block is an inclusive, transparent, and accountable system for coordinated governance of allocation of supply and supply management to ensure equity in access to medical countermeasures, delivering products to regions and localities where there are priority needs. These six building blocks are inter-related and together form an equitable end-to-end ecosystem for outbreak and pandemic tools. There are various scenarios to operationalise the six building blocks and we assume that different regions and countries may choose to organise ownership and control of the research and design of new outbreak tools according to local contexts. We highlight here three possible scenarios for end-to-end health innovation for an effective pandemic prevention, preparedness, and response ecosystem. The three scenarios are not mutually exclusive and can be combined depending on regional needs and preferences. The first scenario involves pre-negotiated public–private partnerships. Both ACT-A and the Coalition for Epidemic Preparedness Innovation (CEPI) are examples of public–private partnerships and offer one clear option. However, these models have fallen short in sharing technologies and building the autonomy, capacity, and resilience demanded by many in the Global South.24Storeng KT Stein F de Bengy Puyvallée A COVAX and the many meanings of sharing.BMJ Glob Health. 2021; 6e007763Crossref PubMed Scopus (11) Google Scholar To attain their public health objectives, these partnerships should build common good principles into their design, including clear conditions on pricing, equitable access, intellectual property, and profit sharing that private partners must meet to receive public funds or other benefits.25Mazzucato M Rethinking the social contract between the state and business: a new approach to industrial strategy with conditionalities. UCL Institute for Innovation and Public Purpose, Working Paper (IIPP WP 2022–18).https://www.ucl.ac.uk/bartlett/public-purpose/wp2022-18Date: 2022Date accessed: December 22, 2022Google Scholar Although the implementation had its challenges, the original intentions of the licensing of the University of Oxford ChAdOx1 nCoV-19 vaccine to AstraZeneca and then to the Serum Institute of India is such an example.26Fortner R AstraZeneca's COVID-19 (mis)adventure and the future of vaccine equity.BMJ. 2022; 379o2592Google Scholar A second scenario involves the creation of a dedicated public research and development infrastructure with pooled financing for epidemic response. This could be a structure within the UN system or it could be set up as global or regional networks of research centres, such as the Consultative Group on International Agricultural Research27Alston JM Pardey PG Rao X Payoffs to a half century of CGIAR research.AJAE. 2022; 104: 502-529Google Scholar or CERN, the European Organization for Nuclear Research.28Naim K Pia MG Kohls A et al.Pushing the boundaries of open science at CERN: submission to the UNESCO Open Science Consultation. UNESCO, 2020https://en.unesco.org/sites/default/files/cern-unesco_consultation_jul_15.pdfDate accessed: December 22, 2022Google Scholar Health technologies could then be developed outside the commercial realm and produced at cost for delivery to public health systems. A third scenario involves regional hubs with shared technology platforms. This scenario is perhaps the most transformative and would consist of public or public and private networks with a core feature of sharing technologies and manufacturing know-how regionally and nationally in the public interest. In this scenario, national and regional hubs would have access to key technologies for diagnostics, treatments, and vaccines that can be adapted to respond to multiple pathogens, with equity built in from the research phase and approached through a common good lens. The WHO mRNA vaccine technology transfer hub in South Africa and its network of producers in 15 countries could serve as a pilot for a broader network of epidemic preparedness and response research and development hubs that encompass a diversity of technologies.9Maxmen A The radical plan for vaccine equity.Nature. 2022; 607: 226-233Crossref PubMed Scopus (9) Google Scholar The openly shared development of the COVID-19 vaccine Corbevax is another example.29Salam E Texas scientists' new COVID-19 vaccine is cheaper, easier to make and patent-free. The Guardian, Jan 15, 2022https://www.theguardian.com/us-news/2022/jan/15/corbevax-covid-vaccine-texas-scientistsDate accessed: January 9, 2023Google Scholar Where elements of these technologies are under private sector control through patents and trade secrets, the international community could, for example, collectively buy them out as part of the public interest, as suggested by the economist and Nobel laureate Michael Kremer and recently proposed in the context of COVID-19 vaccines.30Kremer M Patent buyouts: a mechanism for encouraging innovation.Q J Econ. 1998; 113: 1137-1167Crossref Scopus (249) Google Scholar, 31Love J Buying know-how to scale vaccine manufacturing. Medium.https://jamie-love.medium.com/buying-know-how-to-scale-vaccine-manufacturing-586bdb304a36Date: March 20, 2021Date accessed: December 22, 2022Google Scholar Moving forward, conditions should be attached to public investments in research and development so that its results and outcomes are made global commons from the start. Both ideas have also been proposed as elements for a pandemic accord.32Perehudoff K 't Hoen E Mara K et al.A pandemic treaty for equitable global access to medical countermeasures: seven recommendations for sharing intellectual property, know-how and technology.BMJ Glob Health. 2022; 7e009709Crossref Scopus (15) Google Scholar The status quo is no longer an option. A new pandemic accord must lay the basis for an end-to-end system grounded in equity, regional resilience, and a common good approach. A political declaration from the upcoming UN General Assembly high-level meeting for pandemic prevention, preparedness, and response to be held before the end of September, 2023 should do the same. It is past time for governments and all stakeholders to define a clear path forward and create a truly equitable ecosystem for pandemic countermeasures.33Liu J Clark H Kazatchkine M Leaders can choose to prevent pandemics.Nature. 2022; 610: S37Crossref PubMed Scopus (3) Google Scholar In this evermore interconnected world, the duty of governments and the international system to control outbreaks and avert costly pandemics requires solutions that protect everyone. ET has received funding from the Open Society Foundations, which had no role in the content and writing of this Comment. MK is an independent Board Member of Exevir Bio, a biotechnology company designing therapeutic monoclonal antibodies to SARS-CoV-2. MD reports consulting fees from Greenlight BioSciences (a biotechnology company developing RNA platforms for biocontrols in agriculture and for human, plant and animal health) and Platform Life Sciences (a company that has developed a clinical trials network in a low-income and middle-income country setting), is a Board Member of Clinton Health Access Initiative, the Elton John AIDS Foundation, the Friends of the Fight, USA, and IAVI, is the Chief Executive Officer and the Director of Enochian Biosciences (a biotechnology company developing advanced allogenic cell and gene therapies), and holds options or stock in Greenlight BioSciences, Platform Life Sciences, and Enochian Biosciences; none of these roles relate to the content of this Comment. HC and EJS were Co-chairs of the Independent Panel for Pandemic Preparedness and Response (IPPPR). MC, MD, MK, and JL were all members of the IPPPR. CM, SS, and HLQ are former Secretariat members of the IPPPR. MM declares no competing interests. Lessons learned from COVID-19 to stop future pandemicsThe pharmaceutical industry delivered billions of safe and effective COVID-19 vaccines at speed but, as highlighted by Els Torreele and colleagues,1 these vaccines did not reach lower-income countries quickly enough. Science delivered, but the equity challenge did not. To acknowledge this, we supported calls for greater sharing of vaccines.2 Full-Text PDF
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