==== 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	 	 \\
URL:	https://www.valneva.com/	 	 \\
 	 	
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.	 
 	
	 
== News == 
  * April 6, 2021: Valneva [[https://valneva.com/press-release/valneva-reports-positive-phase-1-2-data-for-its-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/|Reports]] Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001
  * November 23, 2021: Valneva [[https://valneva.com/press-release/valneva-signs-purchase-agreement-with-european-commission-for-its-inactivated-covid-19-vaccine-vla2001/|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 [[https://valneva.com/press-release/valneva-reports-positive-phase-3-results-for-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/|announced]] Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001.
  * December 8, 2021: Valneva [[https://valneva.com/press-release/valneva-signs-advance-purchase-agreement-with-bahrain-for-inactivated-covid-19-vaccine-vla2001/|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 == 
[[https://www.medrxiv.org/content/10.1101/2021.08.13.21262021v2|NCT04671017: Immunogenicity and safety of inactivated whole virion Coronavirus vaccine with CpG (VLA2001) in healthy adults aged 18 to 55: a randomised phase 1 /2 clinical trial]]

{{https://www.medrxiv.org/content/medrxiv/early/2021/08/20/2021.08.13.21262021/T3.medium.gif}}


== 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.