Specialty vaccine company, Valneva, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation for its single-shot Phase 3 chikungunya vaccine candidate VLA1553.
This new designation from the EMA complements the Fast Track designation received by the U.S. Food and Drug Administration (FDA) in December 2018.
The PRIME designation is awarded by the EMA 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.”
On September 8, 2020, Valneva announced the initiation of a pivotal Phase 3 clinical trial for VLA1553, becoming the first company worldwide to advance a chikungunya vaccine candidate into Phase 3.
VLA1553 is a live-attenuated, single dose vaccine candidate for protection against chikungunya disease and currently tested in clinical Phase 3. VLA1553 has been designed by deleting a part of the chikungunya virus genome. As a live-attenuated vaccine, VLA1553 is particularly well suited to target long-lasting protection.
- Thailand chikungunya cases top 10,000 in 2020
- Philippines: Official says COVID-19 responsible for mental health crisis
- Ebola: FDA approves Inmazeb, 1st treatment for the virus
- First patients dosed with the first oral COVID-19 tablet vaccine in clinical trials
- Candida: NDA submitted to the FDA for antifungal drug representing a new class in over 20 years
- French Guiana: Oropouche virus outbreak reported, 1st cases in the country
- Q fever in Western New South Wales, Australia
- Hepatitis E outbreak in Burkina Faso