Many developers are using platforms from modalities, such as, mRNA, protein subunits and viral vectors, to design multiple possible vaccines for use in preventing severe disease. However, each developer’s platform is unique with its own set of benefits and risks. The amount of experience a developer has and their ability to adapt a platform for different immunogens with minimal changes will impact the amount of prior knowledge that can be leveraged during development.
The draft FDA Guidance for Industry, Platform Technology Designation Program for Drug Development, introduces the concept of designation of a platform that has been validated and licensed for use. That proposes a minimum threshold for defining a platform. As that platform is used for development of more vaccines for protection from other variants of the same disease and for protection from other diseases, confidence in its use may increase, which could lead to acceleration of the development process.
Platforms could evolve over time as experience is gained through three categories ranging from Potential Platform to Designated Platform, to Established Platform. High level descriptions of each are outlined in Figure 1.
Figure 1: Platform Categorization
One primary benefit of categorization of platforms is that it allows for development of principles for differentiated investment in vaccine candidates to help meet CEPI’s aspiration to be able to respond to the next Disease X with a new vaccine in just 100 days in a way that honors CEPI’s commitment to equitable access. Additional benefits are outlined in Figure 2.
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