European Medicines Agency has issued a positive opinion for the use of VLA2001 among certain adults
Valneva has announced further data emerging from a study of its inactivated COVID-19 vaccine, VLA2001.
Meanwhile, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for the use of VLA2001 in adults of 18 to 50 years of age. This opinion is based on the vaccine being administered as a booster dose, when provided at least seven months after a primary vaccination.
Valneva has also provided an update on its pivotal phase 3 Study COV-Compare. During this study, neutralising antibodies – 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).
Results from VLA2001-304, a phase 3 study in older adults of 56 years of age and above, demonstrated that VLA2001 was well tolerated by these participants, therefore confirming the previously reported favourable safety profile of VLA2001.
VLA2001 is currently manufactured on Valneva’s Vero-cell platform. The vaccine consists of inactivated whole virus particles of SARS-CoV-2 (COVID-19) with high S-protein density, in combination with a further two essential adjuvants – CpG 1018 and alum.
The adjuvant combination has consistently prompted higher antibody levels in preclinical experiments than alum only. It has also demonstrated a clear shift of the immune response.
The vaccine’s manufacturing process, which was upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein.
VLA2001 is expected to conform with standard cold chain requirements while its shelf life has recently been extended to 21 months compared to its previous limit of 18 months.
The company has decided not to invest in any additional development stages of the vaccine, although it is completing any outstanding clinical studies and regulatory submissions.