Asphalion is proud to have been the regulatory partner in the Horizon Europe RBDCOV project, which aimed to develop and bring to market a recombinant protein-based COVID-19 vaccine for vulnerable populations, including children and immunocompromised individuals.
Throughout the project, Asphalion provided end-to-end regulatory support:
- Strategic regulatory planning from early development through to the marketing authorisation application (MAA)
- Scientific Advice submissions to European regulatory agencies
- Dossier preparation for clinical trials and the full eCTD submission for regulatory review
- Guidance on innovative regulatory pathways and emergency use procedures
In April 2022, the European Medicines Agency (EMA) initiated a rolling review of the vaccine, now known as Bimervax®, a major milestone in the RBDCOV project.
In May 2022, a Phase III clinical trial targeting immunocompromised patients was approved in Spain and Turkey. The trial was a key part of RBDCOV’s broader goal of demonstrating safety and efficacy in populations with limited access to vaccination.
The project was officially concluded in July 2025 during its final meeting held in Barcelona. On this occasion, Asphalion presented the results of Work Package 6 (WP6), which focused on regulatory strategies for the final development phases and post-marketing activities.
We are proud of our contribution to a project that played a critical role in the EU’s pandemic response and set a benchmark for future public-private partnerships in vaccine development.
Want to learn more about the project? https://rbdcov.eu/
Need help for your HORIZON Europe projects? Contact us! [email protected]
