Valneva SE, a specialty vaccine company, was granted PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA)  for its single-shot Phase III chikungunya vaccine candidate VLA1553. This new designation from the EMA complements the Fast Track designation received by the U.S. FDA in December 2018.

The PRIME designation is awarded to promising medicines that demonstrate the potential to address substantial unmet medical need based on initial clinical data. The EMA considers PRIME designations a priority and provides medicine developers with special support, including enhanced interactions and dialogue, as well as a pathway for accelerated evaluation and review.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “We are very pleased to receive PRIME designation for our chikungunya vaccine candidate. It provides further validation of our clinical data and recognition of the significant unmet medical need for chikungunya. We look forward to working closely with the EMA to expedite the availability of our single-shot vaccine to people living in the European Union.”

In September 2020, Valneva initiated a pivotal Phase III trial for VLA15533, becoming the first company worldwide to advance a chikungunya vaccine candidate into late stage development.