Inactivated COVID-19 Vaccine Candidate Launches Phase 3 Study

France-based Valneva SE confirmed today it had completed the recruitment of 4,000 volunteers for the pivotal Phase 3 trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

VLA2001 is currently the only inactivated COVID-19 vaccine in clinical trials in Europe.

It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination, including addressing new variants. 

The UK-based Phase 3 trial “Cov-Compare” will be conducted at 26 sites, will compare Valneva’s VLA2001 against AstraZeneca’s conditionally approved vaccine, Vaxzevria.

Cov-Compare’s topline data are expected by September 2021, and submission to the UK’s Medicines and Healthcare products Regulatory Agency for regulatory approval will follow, subject to the topline data.

UK Health and Social Care Secretary, Matt Hancock, said in a press statement issued on June 3, 2021, “The UK government has fully supported this promising COVID-19 vaccine by funding the early-stage clinical trials and helping to recruit patients through the National Institute for Health Research."

"I’m delighted to see our research teams and the dedication of the public across the UK to beat this coronavirus. Our phenomenal vaccine rollout has shown the strength of our union, and this vaccine will be made onshore in Livingston in Scotland, which, if approved, will play an important role in protecting our country in the future.”

Valneva recently announced that it participates in the world’s first COVID-19 vaccine booster trial in the UK. The COV-Boost trial will look at seven different COVID-19 vaccines and provide vital data on how effective a booster of each vaccine protects individuals from the virus. Initial findings for the COV-Boost study are expected in September 2021.

Valneva is a specialty vaccine company focused on developing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needs.