How Vaccine Clinical Trials Work

Since August 2021, the Veristat team, in collaboration with HIPRA, has been at the forefront of data management, clinical database programming, biostatistics, and project management, supporting HIPRA's COVID-19 vaccine development programs. As noted in this specialized article, Veristat's focus has been to align the RBDCOV consortium members within the Horizon Europe Programme, a European Commission initiative addressing coronavirus impacts.

Their involvement has spanned clinical studies from phase II to phase III, initially involving healthy volunteers and expanding to those with immunocompromising conditions and adolescents. Notably, HIPRA obtained European Medicines Agency (EMA) authorization for BIMERVAX® on March 30, 2023, less than two years after the phase II trial began. This marked a historic milestone as the first bivalent recombinant protein COVID-19 vaccine developed in Spain and authorized within the EU. Additionally, on August 1, 2023, BIMERVAX® received authorization from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA), becoming the ninth COVID-19 vaccine approved by the UK regulator.

Vaccines have a rich history of safeguarding populations against infectious diseases, leading to improved quality of life and the elimination of severe diseases like smallpox. Discover how with advanced vaccine technologies, researchers can create safer and more effective vaccines.