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VLA 2001 begins rolling submission process with UK MHRA in COVID-19.

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Published:24th Aug 2021
Valneva SE commenced rolling submission, for initial approval of its COVID-19 vaccine candidate, VLA 2001, with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK).

VLA 2001 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 pivotal 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.

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.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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