Roadmap for the development of candidate vaccines for FMD

What are we trying to achieve and why? What is the problem we are trying to solve?

The development of a highly efficacious inactivated vaccine that provide rapid and long-lasting protection and is safe.

What are the scientific and technological challenges (knowledge gaps needing to be addressed)?

• Ensure cross-protection of vaccines, considering antigenic variation.
• Improve efficacy
• Develop high potency vaccines
• Improve capsid stability
• Generate a Th1/CTC without a replicating organism
• Improve adaptation of field strains to cell culture for vaccine production
• Prevent infection after vaccination
• Reduce the need of applying high doses of immunogen produced in the new platforms
• Ensure pig protection
• Further validation of VP4-based antigen integrity assays across serotypes and production systems is required to support wider adoption as a standard QC release test.

What approaches could/should be taken to address the research question?

• Generation of a range of recombinant viruses expressing protective
• Antigens from a range of strains
• Monitoring the immune response following immunisation with the various candidates
• Challenge experiments with the various vaccine candidates

What else needs to be done before we can solve this need?

• Identifying protective antigens for pigs
• Identify antigens or administration routes grating “sterile” immunity
• The availability of suitable adjuvants to stimulate strong and fast CTC and VN-Ab responses
• The availability of a standardised challenge model

Existing knowledge including successes and failures

Current commercial FMD vaccines consist of inactivated (killed virus) formulated with various proprietary adjuvants
formulation. Significant steps have been made to improve the quality of vaccines, but there are significant differences
between different manufacturers, and vaccines distributed for use in either FMD-endemic regions versus FMD-free
countries. Three main adjuvant formulations available worldwide: emergency use (high potency) vaccines; oil emulsion vaccines; aluminium hydroxide-adjuvanted vaccines.

Recent advances include the development of an anti-VP4 ELISA at The Pirbright Institute, which enables assessment of capsid integrity and vaccine quality for batch release. This assay provides a complementary in vitro tool that may reduce reliance on traditional in vivo potency tests and improve standardisation across manufacturers. (Update 2025, GFRA)