Development of a Thermo-tolerant, Multidose, Egg-produced, Vector-based Coronavirus Vaccine

Aims to alleviate logistical and supply chain challenges by developing a thermostable coronavirus vaccine.

Industry Need

Many mRNA coronavirus vaccines require continuous sterile refrigeration or ultracold storage during transport to keep the vaccines in their active form and ensure efficacy.
Ultracold storage requirements also make sharing vaccines between public health departments and even neighboring states more complex, leading to potential vaccine wastage.
Existing mRNA vaccines are limited by their specialized manufacturing requirements (unlike egg-produced vaccines, which can be more easily mass-produced).
Currently, there are no publicly described plans or initiatives to make coronavirus vaccines thermo-tolerant outside refrigeration or at elevated temperatures.

Solution

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.

Outcomes and Impacts

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.

Updates, Related Publications, and Deliverables

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Project Lead

PATH Center for Vaccines Innovation & Access