PARIS (Agefi-Dow Jones)–The biotechnology company Valneva announced on Monday that it has received new questions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) as part of the regulatory review of the inactivated vaccine candidate against Covid-19, VLA2001.
This list of questions “includes requests for submission of new data and additional justifications for conditional marketing authorization,” Valneva said in a statement.
“Valneva will answer these questions in the coming days,” the company said.
“If the CHMP accepts the material sent by Valneva, the company could obtain conditional marketing authorization during this quarter,” Valneva added.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted Valneva conditional marketing authorization for VLA2001 in the UK and Northern Ireland in mid-April.
-Alice Doré, Agefi-Dow Jones; +33 (0)1 41 27 47 90; [email protected] ed: VLV
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April 25, 2022 01:18 ET (05:18 GMT)