On 12 October 2023, the European Commission withdrew the marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva (SARS-CoV-2 virus, strain Wuhan hCoV-19/Italy/INMI1- isl/2020, inactivated) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Valneva Austria GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
COVID-19 Vaccine (inactivated, adjuvanted) Valneva was granted marketing authorisation in the EU on 24 June 2022 for active immunisation against coronavirus disease 2019 (COVID-19). The marketing authorisation was initially valid for a 5-year period.
The European Public Assessment Report (EPAR) for COVID-19 Vaccine (inactivated, adjuvanted) Valneva is updated to indicate that the marketing authorisation is no longer valid.
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COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age.
The use of this vaccine should be in accordance with official recommendations.