Valneva SE announced additional data from remaining clinical studies and an update on regulatory submissions for its inactivated COVID-19 vaccine, VLA2001. As previously announced, Valneva will not invest in further development of the vaccine, in the absence of a new partnership1. It is, however, completing remaining clinical studies and submissions as agreed with regulators.

On February 23, 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the use of VLA2001 in adults 18 to 50 years of age as a booster dose to be given at least seven months following primary vaccination (the second dose) with VLA2001 (homologous booster dose) or with an adenoviral vector COVID-19 vaccine (heterologous booster dose). Valneva also provided an update on its pivotal Phase 3 Study COV-Compare (VLA2001-301). In this study, neutralizing antibodies on Day 208 (six months after the second dose of the primary vaccination with VLA2001) were non-inferior compared to the active comparator AZD1222, an adenoviral vector vaccine.

The fold decline of neutralizing antibodies over six months after a second vaccination with VLA2001 was similar to the active comparator, and less pronounced than for other licensed COVID-19 vaccines2,3. The T-cell response against the spike protein elicited upon vaccination with VLA2001 was in the same range as for the active comparator. Moreover, T-cell reactivity against the nucleocapsid and membrane protein was induced upon vaccination with VLA2001. Additionally, results from VLA2001-304, a Phase 3 study in older adults, 56 years of age and above, showed that VLA2001 was well tolerated by these participants when administered as a two-dose or three-dose immunization, thus confirming the previously reported favorable safety profile of VLA20014.

In this age group, a two-dose vaccination with VLA2001 was inferior in terms of geometric mean titers and seroconversion rates compared to younger adults aged 30 years and above. After two doses, immunogenicity in older adults was at a level which could be correlated with 60-70% vaccine efficacy against ancestral SARS-CoV-25. A third dose of VLA2001 further increased immunogenicity in participants aged 56 years and above to the titers associated with vaccine efficacy of >90% against ancestral SARS-CoV-26,7. Finally, VLA2001's shelf life was recently extended to 21 months compared to 18 months previously.

The Company will continue to submit data to further extend it.