Valneva has launched rolling submission for initial approval of its COVID-19 vaccine candidate VLA2001 with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate and is the only vaccine candidate of this type currently in clinical trials in Europe.
The COVID-19 vaccine candidate is currently being studied in the UK in a Phase III trial, Cov-Compare, with results expected early in the fourth quarter of 2021.
Depending on if this trial yields positive data as well as the 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. Currently, the UK government has ordered 100 million doses for supply in 2021 and 2022.
Valneva CMO Juan Carlos Jaramillo 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.”
A further Phase III trial, VLA2001-304, is set to generate data in the elderly and in variant-based vaccines.
Meanwhile, a UK government-funded clinical trial – COV-Boost – is evaluating different COVID-19 vaccines, including VLA2001, as potential boosters.