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Valneva COVID-19 vaccine

Valneva COVID-19 vaccine is a COVID-19 vaccine developed by French biotechnology company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies.[6][7][8]

Vaccine description

VLA2001,[1] VLA2101, COVID-19 Vaccine (inactivated, adjuvanted) Valneva[2]

In April 2022, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) approved the vaccine, being the first in the world to do so.[3] It was approved for medical use in the European Union in June 2022.[2]

Technology[edit]

It is a whole inactivated virus vaccine,[7] grown in culture using the Vero cell line and inactivated with BPL. It also contains two adjuvants: alum and CpG 1018.[9] It uses the same manufacturing technology as Valneva's Ixiaro vaccine for Japanese encephalitis.[1]

History[edit]

Clinical trials[edit]

Valneva COVID-19 vaccine completed phase I/II trial with 153 participants in the United Kingdom.[10][11] The trials were supported by the UK National Institute for Health Research and four British universities.[12]


In April 2021, Valneva COVID-19 vaccine commenced phase III trials with approximately 4,000 participants.[13] In August 2021, New Zealand was chosen for trialing on 300 adult volunteers, due to low case numbers and slow vaccine rollout.[14] Positive results for the phase III trials were reported in October 2021.[15]

Clinical trial number for "Dose Finding Study to Evaluate The Safety, Tolerability and Immunogenicity of an Inactiviated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate Against Covid-19 in Healthy Subjects" at ClinicalTrials.gov

NCT04671017

Clinical trial number for "Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine (COV-COMPARE)" at ClinicalTrials.gov

NCT04864561

Clinical trial number for "Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years " at ClinicalTrials.gov

NCT04956224

from the European Medicines Agency

COVID-19 Vaccine (inactivated, adjuvanted) Valneva Safety Updates