EMA Has More Questions About Valneva’s Inactive COVID-19 Vaccine

Valneva said the European Medicines Agency (EMA) has asked for more data on the company’s COVID-19 vaccine candidate, VLA2001, which the agency is reviewing for a possible marketing authorization.

Valneva CEO Thomas Lingelbach expressed disappointment that the EMA did not consider the company’s submissions “sufficient to date,” but said the company will work with the agency to move the vaccine toward product approval.

The vaccine, which uses an inactivated coronavirus rather than messenger-DNA technology, has already gained a conditional authorization in the UK for the inoculation of individuals aged 18 to 50 years old.

In November 2021, Valneva inked a purchase agreement with the European Commission to supply up to 60 million doses of VLA2001 over a two-period, provided the vaccine gains EU authorization.