Status: 04/25/2022 2:12 p.m
Approval of Valneva’s corona vaccine has been delayed. The European Medicines Agency is asking for more information from the Franco-Austrian biotech company.
The Franco-Austrian biotech company Valneva is not making progress as planned with its vaccine candidate against Covid-19. The European Medicines Agency (EMA) has requested more information about the vaccine, the company said today. So far, the group hoped to get approval for its so-called inactivated vaccine in April.
“We are disappointed that the EMA has so far not considered our submissions to be sufficient,” said Valneva boss Thomas Lingelbach. “We remain fully committed to working with regulators towards product approval.”
list of questions
EMA’s Committee for Medicinal Products for Human Use (CHMP) has sent another list of questions to the company, Valneva said. Among other things, the authority expects additional data and further justification of the application for conditional market approval of the vaccine candidate.
Such a conditional market approval is an approval subject to conditions. This can be granted when the benefit of immediate availability of a vaccine, for example, outweighs the risk of less extensive data than would normally be the case.
Valneva now wants to respond to the inquiries in the coming days. If regulators accept the new information, Valneva expects market approval later this quarter.
Stock under strong pressure
The news was bad for investors. The Valneva shares came under pressure on the main stock exchange Euronext in Paris and collapsed by more than twelve percent. That was the biggest loss since early January.
Earlier this month, the UK Medicines Agency (MHRA) approved Valneva’s vaccine for adults between the ages of 18 and 50. The UK is the first European country to give the vaccine the green light.
An inactivated vaccine contains dead viruses or parts thereof. Most influenza vaccines, many vaccines against childhood diseases or vaccines against rabies are dead vaccines. Sinovac from China produces such vaccines against corona.