Valneva SE achieved positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Based on this data, the company plans to begin a Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

In study VLA2001-201, three dose levels of VLA2001 (low, medium, high), 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, with no safety concerns identified by an independent Data Safety Monitoring Board. There were no statistically significant differences between dose groups and no differences between first and second vaccinations in terms of reactogenicity.

VLA2001 was highly immunogenic with more than 90% of all study participants developing significant levels of antibodies to the SARS-CoV-2 virus spike protein across all dose groups tested. Seroconversion Rates (SCR) for S-protein binding IgG antibodies were 89.8% in the medium dose and 100% in the high dose group. Two weeks after completion of the two dose schedule, Geometric Mean Fold Rise (GMFR) from baseline were 26 in the medium dose and 86 in the high dose group.

VLA2001 induced a dose dependent response with statistically significant higher Geometric Mean Titres (GMTs) for both IgG and neutralizing antibodies in the high dose group compared to the low and medium dose groups. In the high dose group, the GMT of neutralizing antibody titres measured two weeks after completion of the two-dose schedule was at or above levels for a panel of convalescent sera.

Based on the data assessed, the Company has decided to advance the high dose into the Phase 3 clinical trial. Other trials, including booster trials, involving antigen sparing doses will also be evaluated.

Valneva now believes that the timeline for delivery of 60 million doses of vaccine to the UK Government will extend into 1Q22. Based on the Phase 1/2 data, the Company is also investigating antigen sparing options for booster strategies. Overall capacity and delivery schedule will be dependent on the UK’s vaccine requirements and production related factors.
Valneva plans to submit for approval to the MHRA in the UK this fall. Discussions with other regulatory bodies are ongoing.