European Recommendation On Valneva's COVID-19 Shot Pushed Into April

  • Valneva SE VALN now expects a positive recommendation from the European Medicines Agency (EMA) for its VLA2001 COVID-19 candidate vaccine in April.
  • Earlier, the Company expected the European recommendation by the end of March.
  • As announced in February, Valneva received a list of questions as part of the CHMP's initial assessment, to which it responded within two working days. 
  • Valneva has now received a small set of additional questions and is confident it will respond to these in the coming days. 
  • Related: Valneva Secures £20M From Scottish Enterprise For Vaccine Development.
  • "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.
  • Valneva signed an agreement with the European Commission (EC) in November 2021 to supply up to 60 million doses of VLA2001 over two years, including 24.3 million doses in 20221 and an option for delivery of the remaining doses in 2023. 
  • Valneva also signed an agreement with the Kingdom of Bahrain in December 2021 to supply 1 million doses of VLA20012. 
  • The Company has commenced manufacturing for the EC and Bahraini supply contracts and expects to deliver its first doses to Bahrain in March 2022.
  • Price Action: VALN shares are up 3.35% at $33.61 on the last check Friday.
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