Valneva begins COVID-19 vaccine regulatory review process in UK

VLA2001 is currently being studied in the UK in a pivotal Phase 3 trial, Cov-Compare (VLA2001-301), for which topline results are currently expected early in the fourth quarter of 2021.

Subject to positive Cov-Compare data and the review by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Valneva said it believes that initial approval could be given before the end of this year.

VLA2001 is the only vaccine candidate of this type currently in clinical trials in Europe. The shot uses Valneva’s Vero-cell platform, which is used for the company’s licensed Japanese encephalitis vaccine, IXIARO. 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 (from Dynavax Technologies).

Valneva champions a ‘tried and tested’ approach with its inactivated candidate: drawing on established technology that has been in use for decades. It also says inactivated vaccines could prove to help people with weakened immune systems who are at greatest risk such as pregnant women and certain immunocompromised patients.

And another advantage of the vaccine is that it would require only standard cold chain channels for distribution and storage (2 to 8°C).

Manufacturing capacity 

In terms of production capabilities, a spokesperson for Valneva told BioPharma-Reporter today:

"The manufacturing process for VLA2001 is already at final industrial scale and we commenced commercial production in January 2021 to optimize the timeline for potential deliveries of the vaccine. The UK government has ordered 100 million doses for supply in 2021 and 2022, with the option to purchase a further 90 million doses through 2025.  ​

"In addition, as part of our partnership with the UK government, we are boosting capacity at our Livingston site by building a brand new state-of-the-art vaccine manufacturing facility, which is now nearing completion. This expansion is creating over 200 new jobs, including skilled manufacturing roles."​

The spokesperson added that the biotech is continuing to hold "productive"​ discussions with the EU Commission in relation to an EU vaccine supply deal.

Variant focused trial ​

The Saint-Herblain, France headquartered Valneva recently initiated a further Phase 3 clinical trial, VLA2001-304, to generate data in the elderly and as part of its strategy to evaluate variant-based vaccines. In parallel, the UK government is funding a clinical trial, COV-Boost, which is evaluating different COVID-19 vaccines, including VLA2001, as potential boosters.

Beyond its COVID-19 vaccines, the company is advancing other vaccine candidates into and through the clinic: it has candidates against Lyme disease and the chikungunya virus.