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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Project Lead

PATH Center for Vaccines Innovation & Access

PATH Center for Vaccines Innovation & Access