Development of Scalable, Thermostable, Spray Dried Vaccine Formulations Applicable for Coronavirus Vaccines

To prepare for the next coronavirus outbreak, vaccines need to be developed that can be produced quickly, stockpiled effectively, and distributed efficiently. A clear limitation of the current vaccines is the difficulty of worldwide distribution, requiring a cold or ultra-cold chain. This work’s overall goal is to develop dry formulations of two vaccines, a Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein and a VLP vaccine antigen, and demonstrate their stability to a vaccine vial monitors category type 14 (VVM14) stability level. This will be achieved using a scalable spray drying process that avoids the known limitations of lyophilization. The planned work will require 12 months and will be performed through three main tasks.

The objectives of the proposed work are:

• The generation or acquisition of up to 1,000 dose equivalents of the vaccine antigens and the components required to generate the dried formulations.
• The preparation of initial vaccine candidate dry powders and their biochemical, biophysical, and bioactivity characterization.
• The iterative development of stabilized versions of the vaccine candidates, culminating in the creation of a lead RBD protein subunit and a VLP that are fully characterized at a range of temperatures and have demonstrated a VVM14 stability level.