The French pharmaceutical company Valneva announced positive topline results from the Phase 3 trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
According to the company, the Phase 3 Cov-Compare trial showed the vaccine was superior to the AstraZeneca AZD1222 vaccine, in terms of geometric mean titer for neutralization antibodies as well as non-inferiority in terms of seroconversion rates at two weeks after the second vaccination (Day 43) 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.
According to the company, VLA2001 was generally well tolerated and its tolerability profile was significantly more favorable compared to the active comparator vaccine. Participants 30 years and older reported significantly fewer solicited adverse events up to seven days after vaccination, both with regards to injection site reactions (73.2% VLA2001 vs. 91.1% AZD1222) and systemic reactions (70.2% VLA2001 vs. 91.1% AZD1222), Valneva reported. No unsolicited treatment-related serious adverse events (SAE) have been reported, the company added. Less than 1% reported an adverse event of special interest in both treatment groups. 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).
“These results confirm the advantages often associated with inactivated whole virus vaccines,” said Thomas Lingelbach, Chief Executive Officer of Valneva. “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.”
Valneva commenced rolling submission for initial approval with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and is preparing to commence rolling submission for conditional approval with the European Medicines Agency.