ContractPharmaNovember 24, 2021
Tag: Valneva , Vaccine , VLA2001
Valneva SE, a specialty Vaccine company, has signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA2001, over two years. The EC approved the APA earlier this month.
Under the agreement following final review of the volumes by each of the EU Member States, Valneva expects to deliver 24.3 million doses during the second and third quarters of 2022, subject to approval of VLA2001 by the EMA . The EC has the option to increase this initial firm purchase order up to a total of 60 million doses, the remainder of which would be delivered in 2023.
Valneva reported positive Phase 3 results for VLA2001 in October 2021, demonstrating superiority in terms of neutralizing Antibody titer levels against the active comparator vaccine, AstraZeneca’s AZD1222, as well as non-inferiority in terms of seroconversion rates and a significantly better tolerability profile.
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in Clinical Trials in Europe. It’s intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting.
VLA2001 is produced on Valneva’s established Vero- Cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S- Protein density, in combination with two adjuvants, alum and CpG 1018.
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