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.
Categories
Vaccines
Process control
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.
Outputs/Deliverables
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
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