Valneva reports positive phase III results for inactivated, adjuvanted COVID-19 vaccine candidate VLA 2001.

The pivotal Phase III, Cov-Compare trial recruited a total of 4,012 participants aged 18 years and older across 26 trial sites in the United Kingdom. The trial met its co-primary endpoints: VLA 2001 demonstrated superiority against AZD 1222 (ChAdOx1-S), in terms of geometric mean titer for neutralization antibodies (GMT ratio=1.39, p<0.0001), (vla2001 gmt 803.5 (95% ci: 748.48, 862.59)), (azd1222(chadox1-s) gmt 576.6 (95% ci 543.6, 611.7)), as well as non-inferiority in terms of seroconversion rates (scr above 95% in both treatment groups) at two weeks after the second vaccination (i.e. day 43) in adults aged 30 years and older.></0.0001),>

T-cell responses analyzed in a sub-set of participants showed that VLA 2001 induced broad antigen-specific IFN-gamma producing T-cells reactive against the S- (74.3%), N- (45.9%) and M- (20.3%) protein.

VLA 2001 was generally well tolerated. The tolerability profile of VLA 2001 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 (ChAdOx1-S), p<0.0001) and systemic reactions (70.2% vla2001 vs. 91.1% azd1222 (chadox1-s), p><0.0001). no unsolicited treatment-related serious adverse events (sae) have been reported. 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.></0.0001).></0.0001)>

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).

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. A final assay validation required by the MHRA to verify the integrity of the VLA2001-301 data remains ongoing and is a prerequisite for final submission of the clinical study report.

As part of the product development strategy, Valneva has completed recruitment of 306 volunteers aged 56 years and older in New Zealand into its VLA2001-304 trial and expects topline data in early 2022. Valneva has also announced the start of recruitment of adolescents as an expansion of the Cov-Compare trial.

The Company is preparing for trials in children (5-12 years of age) and a Valneva sponsored booster trial to evaluate VLA2001’s booster performance for people in need of a booster.