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Valneva initiates Phase 1/2 study of its vaccine candidate

Covid-19 Valneva laboratories

Valneva SE has announced the initiation of a Phase 1/2 clinical study for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

VLA2001 leverages the manufacturing platform of Valneva’s licensed Japanese encephalitis vaccine, IXIARO and is the first publicly announced inactivated vaccine against COVID-19 to commence clinical development in Europe.

“Our teams have been working extremely hard to develop our differentiated vaccine candidate and I would like to thank them, as well as the UK government, for their dedication and support. While conducting our first clinical trials, we are already ramping-up our manufacturing capacities and commencing production at full-scale so that we can make the vaccine widely available across the world assuming the vaccine is safe and effective,” says Thomas Lingelbach, Chief Executive Officer of Valneva.

About the VLA2001-201 study

The VLA2001-201 study is a randomized, double blind trial evaluating the safety and immunogenicity for three dose levels in approximately 150 healthy adults. The study will be conducted in study sites across the United Kingdom and is supported by the National Institute for Health Research (NIHR).

The primary endpoint read-out will be two weeks after completion of the two-dose primary immunization (day 0, 21). Subject to analysis of this data, including the selection of the optimal dose currently expected in the early second quarter of 2021, additional trials are expected to commence immediately thereafter.

The company currently plans to include more than 4,000 participants in additional trials, which it believes could support an initial regulatory approval as soon as the fourth quarter of 2021, it states.

Read more: Valneva Sweden prepares for production of COVID-19 vaccines

COVID-19 vaccine partnership with the UK government

In September 2020, Valneva announced a major COVID-19 vaccine partnership with the U.K. government. Under the agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021 and UK government has options over provision of a further 130 million doses from 2022-2025. UK government is also investing up-front in the scale up and development of the vaccine, with the investment being recouped against the vaccine supply.

Image caption: Growth media for virus producton is eximanined in the Valneva laboratories in Vienna Austria, on Thursday, 06. August 2020. Photo: Akos Stiller