Status: 25/04/2022 14:12
Approval of the Valneva corona vaccine has been delayed. The European Medicines Agency is requesting more information from the French-Austrian biotech company.
The Franco-Austrian biotech firm Valneva is not making progress as expected with its Covid-19 vaccine candidate. The European Medicines Agency (EMA) has requested more information on the vaccine, the company said today. So far, the company was hoping to get approval for its so-called inactivated vaccine in April.
“We are disappointed that the EMA has so far not considered our requests sufficient,” said Valneva boss Thomas Lingelbach. “We remain fully committed to working with regulatory authorities for product approval.”
list of questions
EMA’s Committee for Medicinal Products for Human Use (CHMP) sent another list of questions to the company, Valneva said. Among other things, the authority expects further data and further justification of the application for conditional market approval of the vaccine candidate.
Such conditional market approval is a conditional approval. This can be granted when the benefit of the 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 inquiries in the coming days. If regulators accept the new information, Valneva expects market approval by the end of the quarter.
Stocks under great pressure
The news was bad for investors. Valneva shares came under pressure on the main Euronext stock exchange in Paris and plummeted by more than twelve percent. This was the biggest loss since the beginning of January.
Earlier this month, the UK Medicines Agency (MHRA) approved the Valneva vaccine for adults aged 18-50. The UK is the first European country to give the green light to the vaccine.
An inactivated vaccine contains dead viruses or parts of them. Most flu vaccines, many childhood disease vaccines, or rabies vaccines are dead vaccines. Sinovac from China produces such corona vaccines.