To address these problems, PATH focused on developing a thermostable COVID-19 vaccine formulation in product formats—both liquid and dry–that are thermotolerant (i.e., do not require ultra-cold storage or continuous extended refrigeration). Using stabilizing ingredients with verified safety profiles that are common in other established vaccines, will allow the heat-stable formulation to be mass-produced on standard vaccine manufacturing lines.
The project will demonstrate that a thermo-tolerant, multidose coronavirus vaccine can significantly reduce storage and transportation costs and improve vaccine availability and access for communities across the United States and the world.
The findings of this project support storage of a multidose coronavirus vaccine candidate out of the cold chain, simplifying transport and distribution logistics, potentially reducing the overall cost and enabling more equitable access to vaccines.
Key outcomes includes the development of two vaccine product formats (liquid and dry) using thermostable formulations from a New Castle Disease Virus (NDC) vector-based COVID-19 vaccine candidate, NDV-HXP-S—developed by Icahn School of Medicine at Mount Sinai and University of Texas at Austin and manufactured by Instituto Butantan. This vaccine candidate has already demonstrated efficacy in preclinical studies and acceptable safety and potent immunogenicity in clinical studies.
By transitioning from specialized mRNA synthesis to the Newcastle Disease virus (NDV) platform, this initiative eliminates the "ultracold tax," reducing logistics-related operating expenses (OpEx) by an estimated 30–50% through the use of standard refrigerated or ambient supply chains. The shift to thermostable liquid and lyophilized formats targets a 90% reduction in vaccine wastage caused by cold-chain breaches, while enabling mass production on existing global manufacturing lines. Furthermore, the development of Sublingual Fast-Dissolving Tablets provides a high-margin delivery alternative that removes the need for vials and needles, significantly lowering the total cost per administered dose in low-resource markets.
Identification of two or more thermostable multidose liquid formulation of NDV-HXP-S coronavirus vaccine antigen, with a preservative Identification of two or more thermostable multidose lyophilized formulation of NDV-HXP-S coronavirus vaccine, without preservatives Identification of one or more lead thermostable multidose NDV-HXP-S formulations (lyophilized and/or liquid), based on stability testing and preservative and/or endotoxin targets Identification of one lead formulation of sublingual fast-dissolving tablets (SL FDTs) containing NDV-HXP-S, based primarily on antigen content but also appearance and pH
Bzami, A., Zhu, C., Estrada, M., White, J. A., & Lal, M. (2024). Development of multidose thermotolerant formulations of a vector-based Covid-19 vaccine candidate, NDV-HXP-S in different product formats: Stability and preservative efficacy study. Vaccine: X, 20, 100535. https://doi.org/10.1016/j.jvacx.2024.100535
Lal, M., Presenter, ARP-13 Development of thermotolerant multidose formulations for a vector-based SARS-CoV-2 vaccine candidate, NDV-HXP-S, NIIMBL National Meeting, Washington, D.C., July 26, 2022.
Lal, M., Presenter, ARP-13 Development of thermotolerant multidose formulations for a vector-based SARS-CoV-2 vaccine candidate, NDV-HXP-S, NIIMBL National Meeting, Washington, D.C., July 28, 2022.
Bzami, A., Lal, M., Presenter, Development of thermotolerant multidose formulations for a vector-based SARS-CoV-2 vaccine candidate, NDV-HXP-S, NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals, Washington, D.C., July 26-28, 2022.
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PATH Center for Vaccines Innovation & Access
