French COVID-19 Vaccine Highlights Its Effectiveness

Valneva SE today announced additional data from clinical studies and an update on regulatory submissions for its inactivated COVID-19 vaccine, VLA2001.

On February 23, 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency 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 published an update on March 2, 2023, its pivotal Phase 3 Study COV-Compare.

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 other licensed COVID-19 vaccines.

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 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 VLA2001.

In this age group, a two-dose vaccination with VLA2001 was inferior regarding 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 that could be correlated with 60-70% vaccine efficacy against ancestral SARS-CoV-2 coronavirus.

A third dose of VLA2001 further increased immunogenicity in participants aged 56 years and above to the titers associated with a vaccine efficacy of >90% against ancestral SARS-CoV-2.

Finally, VLA2001’s shelf life was extended to 21 months compared to 18 months.

VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®.

As previously announced, Valneva will not invest in further development of the vaccine in the absence of a new partnership[1]. It is, however, completing remaining clinical studies and submissions as agreed with regulators.