Valneva has begun a rolling submission for initial approval of its Covid-19 vaccine candidate, VLA2001, with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate and is the only vaccine candidate of this type currently in clinical trials in Europe.
VLA2001 is currently being studied in the UK in a Phase III trial, “Cov-Compare” (VLA2001-301), for which topline results are currently expected early in the fourth quarter 2021. Subject to positive Cov-Compare data and MHRA review, Valneva believes that initial approval could be granted before the end of 2021.
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, Chief Medical Officer of Valneva, said: “We are pleased to begin the regulatory review process for our Covid-19 vaccine with the MHRA. 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 (NIHR), Public Health England (PHE), and other partners for their unstinting support and hard work.”
Valneva recently initiated a further Phase III 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 is evaluating different Covid-19 vaccines, including VLA2001, as potential boosters.