Increasing efficiency in vaccine Production: A primer for change

Aars, Ole Kristian; Clark, Michael; Schwalbe, Nina

doi:10.1016/j.jvacx.2021.100104

Cited by 6 publications

(13 citation statements)

References 28 publications

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“…Aars, Clark, and Schwalbe (2021) mention the African Vaccine Regulatory Forum (AVAREF) for harmonising regulations for clinical trials and the WHO's prequalification system for lot release. Such efforts are especially important for vaccines with potential for high public health impact (Aars, Clark, and Schwalbe 2021).…”

Section: The Key Impacts Of These Interventions On the Global Vaccine...mentioning

confidence: 99%

“…Source: USAID ( 2014) USAID ( 2014) did not emphasise capacities of market actors outside R&D in their publication for shaping the health care markets. However, this point came across various literature on vaccine manufacturing as an important intervention to shape vaccine markets along the need to finance public and private investments (Nguyen and Schwalbe 2019;Aars, Clark, and Schwalbe 2021;Gehl Sampath 2021;Malhame et al 2019). This is more the terrain of industrial policy and strategy by governments to promote and encourage development and growth of a specific industry.…”

Section: Box 1 Case Study On Shaping the Pneumococcal Conjugate Vacci...mentioning

confidence: 99%

“…(Nguyen and Schwalbe 2019) Aars, Clark, and Schwalbe (2021). mention the example of the meningococcal A conjugate vaccine (MenAfriVac).…”

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confidence: 99%

“…(Nguyen and Schwalbe 2019;Aars, Clark, and Schwalbe 2021). Although the vaccine market experienced such efforts, few agreements are in place for the technology transfer of second-generation vaccines.…”

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confidence: 99%

“…Although the vaccine market experienced such efforts, few agreements are in place for the technology transfer of second-generation vaccines. As suchAars, Clark and Schwalbe (2021) argue that more efforts can be put into creating or engaging with a neutral organisation that could consider a role in brokering partnerships and advising on deal structures. In combination with technical assistance and capacity building processes, this could improve the manufacturing position of manufacturers in LICs(Aars, Clark, and Schwalbe 2021).…”

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confidence: 99%

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Lessons Learned from Market Shaping Interventions to Stimulate Vaccine Production in LMIC

Quak¹

2021

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This rapid review synthesises the literature from academic, policy, and knowledge institution sources on the lessons learned on how market shaping tools can be used to stimulate vaccine production in low- and middle-income countries (LMICs) with a focus on Africa. The purpose is to learn from these interventions in the context of shaping the vaccine markets in Africa to become less dependent on imports and to stimulate local production of vaccines. The rapid review concludes that it is the combination of market shaping tools (supply and demand sides) with efforts to mobilise resources and a clear industrial policy and strategy with long-term political commitment that is needed to develop fully integrated vaccine facilities in LMICs at the national and regional levels. These facilities or “vaccine manufacturing networks” in LMICs, particularly in Africa, need to sell below their production cost for many years after entering the market. This is because they compete within well-established global vaccine markets to which the low-income countries have access through pooled procurement mechanisms. This means that governments in low-income countries have arguably good access to affordable but imported vaccines while needing heavy investment and subsidies to develop competitive vaccine manufacturers. The literature on market-shaping is mainly conceptual without mentioning much empirical evidence. It has a bias on firms and presumes firm strategies to shape markets for their own benefit. The literature often underestimates the role that governments play in shaping markets. As such, this rapid review relies on other sources to investigate the interventions by governments to shape markets and how donors could support these governments in their efforts.

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Section: The Key Impacts Of These Interventions On the Global Vaccine...mentioning

confidence: 99%

Section: Box 1 Case Study On Shaping the Pneumococcal Conjugate Vacci...mentioning

confidence: 99%

“…(Nguyen and Schwalbe 2019) Aars, Clark, and Schwalbe (2021). mention the example of the meningococcal A conjugate vaccine (MenAfriVac).…”

mentioning

confidence: 99%

mentioning

confidence: 99%

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confidence: 99%

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Lessons Learned from Market Shaping Interventions to Stimulate Vaccine Production in LMIC

Quak¹

2021

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Vaccine Innovation Meta-Model for Pandemic Contexts

Fialho¹,

Gauss

Soares³

et al. 2023

J Pharm Innov

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Purpose Over the past decade, successive outbreaks and epidemics of infectious diseases have challenged the emergency preparedness and response systems of global public health institutions, a context in which vaccines have become the centerpiece to strengthening global health security. Nevertheless, vaccine research and development (R&D) is a complex, lengthy, risky, uncertain, and expensive process. Alongside strict, time-consuming regulatory compliance, it takes multiple candidates and many years to register a new vaccine. This is certainly not welcome in a global health crisis such as the COVID-19 pandemic. Therefore, this study aims to understand the R&D paradigm shift in pandemic contexts and its impacts on the value chain of vaccine innovation. Methods To that end, this paper carried out a systematic literature review and meta-synthesis of 27 articles and reports (2011–2021) that addressed vaccine R&D in contexts of global health threats, disease outbreaks, epidemics, or pandemics. Results The research findings are synthesized in a meta-model, which describes a fast-track R&D for pandemic contexts, its driving forces, innovations, mechanisms, and impacts in the value chain of vaccine innovation. Conclusions The study demonstrates that, in pandemic contexts, a fast-track R&D process based on close collaboration among regulators, industry, and academia and leveraging enabling technologies can drastically reduce the time required to bring safe, stable, and effective vaccines to market by an average of 11 years compared to the traditional R&D process. Furthermore, pharmacovigilance and rigorous monitoring of real-world evidence became critical to ensuring that quality and safe products were authorized for use during a pandemic.

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The Value of Flexible Vaccine Manufacturing Capacity: Value Drivers, Estimation Methods, and Approaches to Value Recognition in Health Technology Assessment

McElwee,

Newall

2024

PharmacoEconomics

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Expanding flexible vaccine manufacturing capacity (FVMC) for routine vaccines could facilitate more timely access to novel vaccines during future pandemics. Vaccine manufacturing capacity is ‘flexible’ if it is built on a technology platform that allows rapid adaption to new infectious agents. The added value of routine vaccines produced using a flexible platform for pandemic preparedness is not currently recognised in conventional health technology assessment (HTA) methods. We start by examining the current state of play of incentives for FVMC and exploring the relation between flexible and spare capacity. We then establish the key factors for estimating FVMC and draw from established frameworks to identify relevant value drivers. The role of FVMC as a countermeasure against pandemic risks is deemed an additional value attribute that should be recognised. Next, we address the gap in the vaccine-valuation literature between the conceptual understanding of the value of additional FVMC and the availability of accurate and reliable tools for its estimation to facilitate integration into HTA. Three practical approaches for estimating the value of additional FVMC are discussed: stated and revealed preference studies, macroeconomic modelling, and benefit–cost analysis. Lastly, we review how value recognition of additional FVMC can be realised within the HTA process for routine vaccines manufactured on flexible platforms. We argue that, while the value of additional FVMC is uncertain and further research is needed to help to better estimate it, the value of increased pandemic preparedness is likely to be too large to be ignored.

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Increasing efficiency in vaccine Production: A primer for change

Cited by 6 publications

References 28 publications

Lessons Learned from Market Shaping Interventions to Stimulate Vaccine Production in LMIC

Lessons Learned from Market Shaping Interventions to Stimulate Vaccine Production in LMIC

Vaccine Innovation Meta-Model for Pandemic Contexts

The Value of Flexible Vaccine Manufacturing Capacity: Value Drivers, Estimation Methods, and Approaches to Value Recognition in Health Technology Assessment

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