Inactivated COVID-19 Vaccine Candidate Expands Clinical Studies

France-based Valneva SE announced today that it had commenced recruitment of adolescents in the United Kingdom for its pivotal Phase 3 Clinical Trial (Cov-Compare") for its inactivated COVID-19 vaccine candidate VLA2001.

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.

This COVID-19 vaccine candidate 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 SARS-CoV-2 betacoronavirus variants. 

Topline results from the pivotal Cov-Compare trial are expected early in the fourth quarter of 2021 and are intended to form the basis for potential regulatory approval in adults. The Company has also started to provide boosters to volunteers in its Phase 1/2 VLA2001-201 trial.

This planned expansion of VLA2001 clinical trials will support future approval in other age groups, in addition to adults.

A further expansion of the clinical study to include volunteers younger than 12 years old is also envisaged, subject to data from the adolescent group.

Valneva has also commenced booster vaccinations as a continuation of the Phase 1/2 VLA2001-201 trial. The booster shot will be provided to each volunteer six months after the initial vaccination.

Thomas Lingelbach, CEO of Valneva, commented in a press release, "Our teams at Valneva remain fully committed to carry out VLA2001's development plan and bring our inactivated vaccine to all patient groups who could benefit."

"We continue to receive messages on a daily basis from people across the world who are waiting for an inactivated vaccine, so we continue to believe that our differentiated vaccine candidate could contribute to the ongoing fight against the COVID-19 pandemic."

"We're confident that many countries, and regulators, will want to have the opportunity to consider our inactivated COVID-19 vaccine." 

Valneva is conducting several clinical trials of VLA2001.

In addition to Cov-Compare and VLA2001-201, VLA2001 is being evaluated in elderly volunteers in study VLA2001-304 in New Zealand and a small, policy-led trial sponsored by University Hospital Southampton NHS Foundation Trust, which is not part of Valneva's regulatory package.

Valneva continues discussions with the European Commission regarding a potential VLA2001 supply contract. The Company is also actively pursuing opportunities to make VLA2001 available to other customers, subject to positive Cov-Compare data and regulatory approval.

Valneva is a specialty vaccine company located in Saint-Herblain, France, focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical need.