EU watchdog asks Valneva for more data on COVID shot, shares slump

Valneva said the EMA's Committee for Medicinal Products for Human Use had another list of questions for the company, including requests for additional data and for further justification of a conditional marketing authorisation for the vaccine candidate. "We are disappointed that the EMA has not considered our submissions sufficient to date.

Valneva's shares tumbled on Monday after the French company said The European Medicines Agency (EMA) has asked for more data on its COVID-19 vaccine. Valneva said the EMA's Committee for Medicinal Products for Human Use had another list of questions for the company, including requests for additional data and for further justification of a conditional marketing authorization for the vaccine candidate.

"We are disappointed that the EMA has not considered our submissions sufficient to date. We remain fully committed and dedicated to working jointly with the regulators towards a product approval," Valneva CEO Thomas Lingelbach said. The company's shares slumped 12.4%.

Valneva's whole-virus inactivated COVID-19 vaccine - which was cleared for use in Britain earlier this month - relies on technology that has been used for decades, for instance in some shots against polio, influenza, and hepatitis. The approach involves growing the virus in a lab, then rendering it completely inactive so it cannot infect cells or replicate in the body, but can still trigger an immune response.

The shot is seen by some as having the potential to win over people wary of some vaccines which use newer mRNA technology. Another advantage is that the vaccine can be stored at similar temperatures to those in a domestic fridge.

Valneva said it would respond to EMA's requests in the coming days. If the regulator accepts its response, then the company expects a conditional marketing authorization this quarter.