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Valneva VLA2001

Vaccine type: Whole Virion Inactivated adjuvanted SARS-CoV-2 vaccine using a Vero Cell manufacturing platform
Commercial name: VLA2001

Developed by: Valneva SE
Location: Saint-Herblain, France

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. CpG 1018 adjuvant is supplied by Dynavax Technologies Corporation.

  • April 6, 2021: Valneva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001
  • November 23, 2021: Valneva signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its COVID-19 vaccine candidate.
  • December 2, 2021: the EMA’s human medicines committee (CHMP) has started a rolling review of VLA2001.
  • October 18, 2021: Valneva announced Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001.
  • December 8, 2021: Valneva signs advance purchase agreement with Bahrain for 1 million doses
Clinical Trials Summary
Participants Covid+ Total Adverse Events # of Solicited Severe Adverse Events Reported # of Vax Related Serious Adverse Events Observed AE's
Phase1/2 153 2 106 2 0 pain, tenderness, erythema, induration/swelling, nausea/vomiting, headache, fatigue, myalgia, neutropenia, eosinophilia, thrombocytopenia, chilblains, haematuria, rise in red blood cell/erythrocyte sedimentation rate
Phase3 4,012 ? ? 0
Published Clinical Trial Results
Registered Clinical Trials
NCT04671017 Dose Finding Study to Evaluate Safety, Tolerability and Immunogenicity of an Inactiviated Adjuvanted Sars-Cov-2 Virus Vaccine Candidate Against Covid-19 in Healthy Adults. 
NCT04864561 Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine (COV-COMPARE). 
NCT04956224 Immunogenicity of VLA2101 Compared to VLA2001. 

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