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Accepted Paper:

Accelerated global health R&D: vaccine platforms and vectors of regulatory magnitude  
Ann Kelly (King's College London)

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Short abstract:

This paper tracks the regulatory lives of rVSV, a viral-vector vaccine platform that has played a central role in recent emergency outbreak response, as a prompt to examine the shifting sociotechnical norms attendant to an emerging paradigm of accelerated global health R&D.

Long abstract:

This presentation elaborates the social and political life of rVSV, a vector vaccine that uses the vesicular stomatitis virus, as a backbone technology upon which multiple target vaccines could be built. Viral vectors like rVSV have enabled a shift from bespoke vaccinology to assembly line—a ‘plug and play’ approach capable of achieving economies of scale through decentralized, tech-transfer driven, production. In addition to greasing the R&D pipeline, platform technologies have torqued our notions of equity, from pursuing justice through the widespread allocation of finished products, to engineering access into the production process—a model of just-in-time innovation that, through the material process of manufacture, could be fundamentally more just. Mapping the regulatory life of rVSV, this paper considers the novel epistemic and ethical imaginations the platform can provoke. To some extent, regulatory science always operates ‘in the wild’, its judgments inflected by explicitly ethical and value-laden concerns—a highly liminal and heterodox process of adjudication that gains considerable amplitude in the context of a public health emergency. Under the pressure of outbreak response, regulation becomes less a matter of fixing new medical products in law, than facilitating their movement across multiple sites and settings. Through plug-and-play design, platforms enable that circulation—an iterative open-endedness that incorporates a wide range of actors—humanitarian, industry, national, philanthropic, that render an emergency workable as a global health response. rVSV provides an opportunity to think through those pragmatics and raise new questions about the evidentiary magnitude of regulation as a means of R&D acceleration.

Traditional Open Panel P396
Probing openness in biomedical platforms: global health meets Open Science
  Session 1 Tuesday 16 July, 2024, -