This hub includes curated resources related to vaccine patch technology, product development, and regulatory navigation. All links and resources are provided for informational purposes only.
Resources
Regulatory navigation
Understand the regulatory pathways governing patch-based RNA vaccines.
Development & Approval Process (CBER)
FDA
Overview of how the Center for Biologics Evaluation and Research (CBER) regulates vaccines as biological products.
Combination Products
FDA
Overview of how combination products are regulated, as well examples and common questions about this product category.
Chemistry, Manufacturing, and Controls (CMC) and Good Manufacturing Practice (GMP) Guidances
FDA
A list of resources for ensuring CMC and GMP compliance in regulatory pathways.
Role of the Advisory Committee on Immunization Practices in CDC’s Vaccine Recommendations
CDC Advisory Committee on Immunization Practices
Understand how the CDC makes recommendations for use of vaccines to control disease.
Patch and RNA technologies
Explore resources for different patch and RNA vaccine technologies.
Microarray patch resources
PATH
A list of resources from PATH’s Center of Excellence for Microarray Patch Technology.
mRNA Candidate Database
Public Citizen
A public database of mRNA vaccines in development or commercialized.
Self-Amplifying RNA Vaccine Candidates: Alternative Platforms for mRNA Vaccine Development
Pathogens, Jan 2023
A journal publication summarizing current knowledge about self-amplifying RNA vaccines.
Vaccine Microarray Patches
UNICEF
A resource page describing the use of microarray patches in global immunization efforts.
Product development
Learn more about different aspects of product development.
Prepared by Design: How human-centered design can improve public health emergency preparedness and response
BARDA DRIVe
A resource exploring how human-centered design can improve emergency preparedness and response.
Vaccine Innovation Prioritisation Strategy (VIPS)
GAVI, the Vaccine Alliance
A framework to evaluate, prioritize, and accelerate vaccine innovation that includes technical notes on patch-based vaccine product development challenges.