The specialty vaccine company Valneva SE has issued positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate VLA2001.
Officials noted subject to regulatory approval, the company plans to initiate a Phase 3 clinical trial by the end of April 2021, adding via study VLA2001-201 three dose levels of VLA2001, based on a schedule of two doses with vaccinations three weeks apart, were evaluated in 153 healthy adults aged 18 to 55 years.
VLA2001 was generally safe and well-tolerated across all dose groups tested, per the research, with no safety concerns identified by an independent Data Safety Monitoring Board.
“We are extremely pleased with these results, which take us a step closer to providing an inactivated vaccine to help the global fight against COVID-19,” Valneva Chief Executive Officer Thomas Lingelbach said. “The world needs multiple vaccines as well as booster options. Given the potential advantages often associated with inactivated whole virus vaccines, we believe that VLA2001 has an important role to play.”
The data indicated no statistically significant differences between dose groups and no differences between first and second vaccinations in terms of reactogenicity, and the majority of Adverse Events (AEs) were mild or moderate. Only two subjects reported severe solicited AEs.
Health and Social Care Secretary Matt Hancock said the U.K. government has funded the clinical trials and expressed enthusiasm regarding Valneva’s vaccine producing a strong immune response.
“This vaccine will be made onshore in Livingston in Scotland, giving another boost to British life science, and if approved, will play an important role in protecting our communities,” he said. “I look forward to seeing the results of the upcoming phase three trial.”