Regulators embrace modelling to accelerate vaccine development

May 2026

A new manuscript published in ‘Vaccine’ highlights the outcomes of discussions on incorporating new modelling tools in vaccine  Development, Testing, and Lifecycle Management.

In silico modelling offers the potential to accelerate and optimise  vaccine manufacturing. Inno4Vac, an Innovative Medicines Initiative 2–funded project, aims to modernise vaccine manufacturing through open source, data-driven models. In addition to developing these cutting-edge digital tools, the consortium is engaging regulators to ensure their acceptance of these new methods in the vaccine production pipeline. The consortium therefore organised a second regulatory workshop on utilising in silico models to expedite vaccine development, testing, and lifecycle management in Brussels in May 2025, which convened experts from regulatory agencies, vaccine manufacturers, academia, and global health organisations. The workshop focused on how these tools can support Chemistry, Manufacturing and Control (CMC) submissions, particularly for stability assessment, shelf-life prediction, and process optimisation. An expert meeting report on the event was recently published in Vaccine: Second regulatory workshop on utilising in silico models to expedite vaccine development, testing, and lifecycle management .

A key outcome was strong regulatory recognition that model-informed approaches, when scientifically justified and supported by experimental data, can complement traditional methods. This is especially relevant for vaccine stability, where advanced kinetic and statistical models combined with accelerated studies can enable earlier shelf-life estimates. Such approaches are critical for improving pandemic preparedness and supporting rapid response goals such as CEPI’s 100 Day Mission.

Participants highlighted a shift away from simple linear regression toward Bayesian and hierarchical models that better account for variability across batches and manufacturing conditions. While current regulatory frameworks do not yet fully reflect these advances, regulators expressed openness to innovation and emphasised the importance of early dialogue, transparency, and validation.

The workshop also demonstrated the value of digital twins and process simulations for upstream and downstream manufacturing steps, including bioreactors, purification, and filtration. These tools can reduce experimental burden, support scale up, and improve process robustness with low regulatory risk when appropriately applied.

Finally, the report underscored the importance of open modelling platforms, such as CADET-Hub, in enabling collaboration, reproducibility, and wider access to advanced modelling capabilities.

Overall, the Inno4Vac findings signal a clear shift toward evidence-based digital innovation in regulatory science, with in silico modelling poised to play a central role in faster, more resilient vaccine development.

EVI would also like to thank all external experts who participated in the EVI-led workshop and contributed their valuable insights and perspectives to the discussions.

Full article: https://doi.org/10.1016/j.vaccine.2026.128733

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007799 (Inno4Vac). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA (www.imi.europa.eu). This communication reflects the author´s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein