Valneva SE achieved positive results from the Phase 3 trial Cov-Compare of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.  The trial recruited a total of 4,012 participants 18 and older across 26 trial sites in the UK. The trial met its co-primary endpoints: VLA2001 demonstrated superiority against AZD1222 (AstraZeneca and the University of Oxford Covid vaccine), in terms of geometric mean titer for neutralization antibodies, (VLA2001 GMT 803.5 (95%), (AZD1222 GMT 576.6 (95%), as well as non-inferiority in terms of seroconversion rates (SCR above 95% in both treatment groups) at two weeks after the second vaccination in adults aged 30 years and older.
 
T-cell responses analyzed in a sub-set of participants showed that VLA2001 induced broad antigen-specific IFN-gamma producing T-cells reactive against the S- (74.3%), N- (45.9%) and M- (20.3%) protein.
 
The tolerability profile of VLA2001 was significantly more favorable compared to the active comparator vaccine. Participants 30 years and older reported significantly fewer adverse events up to seven days after vaccination, both with regards to injection site reactions and systemic reactions. No treatment-related serious adverse events have been reported. Participants in the younger age group vaccinated with VLA2001 showed an overall safety profile comparable to the older age group.
 
The occurrence of COVID-19 cases (exploratory endpoint) was similar between treatment groups. The complete absence of any severe COVID-19 cases may suggest that both vaccines used in the study prevented severe COVID-19 caused by the circulating variant(s) (predominantly Delta).
 
Thomas Lingelbach, Chief Executive Officer of Valneva, said, “These results confirm the advantages often associated with inactivated whole virus vaccines. We are committed to bringing our differentiated vaccine candidate to licensure as quickly as possible and continue to believe that we will be able to make an important contribution to the global fight against the COVID-19 pandemic. We are keen to propose an alternative vaccine solution for people who have not yet been vaccinated.”