France-based Valneva has started booster vaccinations with its inactivated COVID-19 vaccine candidate VLA2001, following on from the Phase I/II VLA2001-201 trial.
At the same time, Valneva has also announced it will start recruiting adolescents aged 12- to 17-years-old into its Phase III vaccine trial, with results expected early in the fourth quarter of 2021.
Initially, a cohort of adolescents will be enrolled in an open label, non-randomised format, while remaining participants will be randomised to receive two doses of the vaccine candidate or a placebo 28 days apart.
Following this, participants will receive a booster dose seven months after enrolling into the study – in total, Valneva is hoping to enrol approximately 660 participants for this trial.
In a statement, Valneva added that it is continuing discussions with the European Commission for a potential VLA2001 supply contract.
Earlier this month, the UK government terminated its supply agreement with Valneva for VLA2001, after alleging that the company breached its obligations under the agreement, something which Valneva ‘strenuously’ denies.
“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,” said Thomas Lingelbach, chief executive officer of Valneva.
“We’re confident that many countries, and regulators, will want to have the opportunity to consider our inactivated COVID-19 vaccine,” he added.