Valneva initiates COVID-19 vaccine candidate third phase

The specialty vaccine firm Valneva SE has initiated a Phase 3 trial for its COVID-19 vaccine candidate, VLA2001.

VLA2001-304 seeks to generate data in the elderly and is designed to potentially enable variant-bridging through immune-comparability. Study data is slated to complement ongoing clinical trials while supporting additional regulatory submissions.

“The fight against COVID-19 continues and it’s extremely important that we continue to gather as much data as possible in all age groups across the population,” Valneva Chief Medical Officer Dr. Juan Carlos Jaramillo said. “Everyone should have access to technology best suited to protect them against this virus. We have also been working on Variants of Concern as part of our continued efforts to stay ahead of the virus causing COVID-19, especially since we believe that our inactivated, whole-virus platform will be adaptable across variants. We are extremely pleased to be able to invest in this very important additional clinical trial.”

The trial would be conducted in New Zealand, recruiting approximately 150 participants aged 56 years and older to generate more safety and immunogenicity data following vaccination with VLA2001.

Valneva officials indicated the company plans to make regulatory submissions as a means of gaining initial approval during the fourth quarter of 2021 – subject to successful data.