Inactivated, Adjuvanted COVID-19 Vaccine Candidate Commences Rolling Submission Review

France-based Valneva SE announced the rolling submission with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to Approve VLA2001, a COVID-19 vaccine candidate.

VLA2001 is currently being studied in the UK in a pivotal Phase 3 trial, “Cov-Compare,” for which topline results are currently expected early in the fourth quarter of 2021. Subject to positive Cov-Compare study data and MHRA review, Valneva believes that initial approval for its vaccine could be granted before the end of 2021.

VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate and is the only vaccine candidate of this type currently in clinical trials in Europe, says the company.

In September 2020, Valneva announced a collaboration with the UK Government, which has the option to purchase up to 190 million doses through 2025. So far, the UK Government has ordered 100 million doses for supply in 2021 and 2022.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, stated in a related press release, “Valneva believes that everyone should have access to technology best suited to protect them against this virus."

"We are working hard to make our vaccine candidate available as soon as possible.  We are grateful to the National Institute for Health Research, Public Health England, and other partners for their unstinting support and hard work.”

Furthermore, Valneva recently initiated a further Phase 3 clinical trial, VLA2001-304, to generate data in the elderly and as part of the Company’s strategy to evaluate variant-based vaccines. Data from VLA2001-304 will complement Cov-Compare and other clinical trials.

In parallel, the UK Government is funding a clinical trial, “COV-Boost,” which evaluates different COVID-19 vaccines, including VLA2001, as potential boosters.

VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1.

Valneva is a specialty vaccine company located in Saint-Herblain, France, focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical need.