Obstacles to vaccination of animals and prospective solutions.

On the 17th of October 2019, a workshop was held at Wageningen Bioveterinary Research in Lelystad, the Netherlands, to discuss the obstacles to vaccination in the veterinary field. Participants from academia, OIE, FAO, EC, EMA, USDA, national regulatory and veterinary health authorities, and the animal health industry discussed how availability and access to animal vaccines can be improved not just in the EU and US but also in Low to Middle Income Countries (LMIC) across the world and agreed that this requires innovations in both the scientific and the regulatory field. The workshop called for engaging all stakeholders to improve regulatory acceptance of novel vaccine technologies and encourage their registration. There is a need for better mutual understanding between academia, industry and regulators, and more openness to discuss framework, requirements, and product authorisations, and to converge the regulatory rules between regions. The next leap forward could be a broader application of novel technologies using RNA- or DNA-based vaccine platforms, where the "backbone" is maintained, while the gene of interest coding for an immunogenic protein can be exchanged in a standardised manner. This approach enables rapid response in outbreak situations and should lower the risk and cost of vaccine development. • A workshop on safe, efficacious, affordable, and rapidly adaptable vaccines for emerging, epizootic and enzootic diseases. • RNA- or DNA-based vaccine platforms, with maintained backbone and interchangeable gene of interest, are promising. • Regulatory guidance is needed, keeping requirements and costs proportionate to the small size of veterinary markets. • Early dialogue and cooperation between regulatory authorities, academia and vaccine industry was emphasised for success. [ABSTRACT FROM AUTHOR]