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PARIS, March 11 (Reuters) – Valneva (VLS.PA) now expects a positive recommendation from the European Medicines Agency (EMA) in April for its VLA2001 COVID-19 candidate vaccine, the French vaccine maker said on Friday, compared to an earlier target for the end of March.
“Following such conditional approval, the company would expect to start delivering planned doses of VLA2001 to European countries in the second quarter of 2022,” said Valneva.
It cited a “a small set of additional questions” from the EMA as reason for the delay, adding it was set to respond within days.
In early February, the EMA flagged it was unsure whether Valneva’s vaccine candidate could win approval by Easter, or mid-April. read more
Still, Valneva said in mid-February it was hoping for a recommendation by the end of March. read more
If approved, the shot would be the first inactivated whole-virus vaccine against COVID in Europe. The technology has been used for decades, for instance in some shots against polio, influenza as well as the hepatitis A.
The shot, known as VLA2001, last week won emergency use authorisation in Bahrain, which had purchased 1 million doses, but Europe poses a far greater opportunity for Valneva. read more
The biotech firm last November signed an agreement with the European Commission to supply 24.3 million doses in 2022. Further EU purchase options could boost total deliveries this year and next to up to 60 million doses.
The shares gained 4.6% at 1545 GMT with analysts at Guggenheim Securities saying in a note that the shot’s excellent tolerability and safety profile should win over regulators.
“We continue to believe that VLA2001 can be part of the longer-term COVID vaccines toolbox as part of the global booster market,” the analysts wrote.
Reporting by Benoit Van Overstraeten
Editing by Sudip Kar-Gupta, Mark Potter and Louise Heavens
Our Standards: The Thomson Reuters Trust Principles.
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