COVID-19 has caused millions of deaths globally and has been declared a pandemic by the World Health Organization (WHO). To help fight the pandemic, Valneva has developed VLA2001, currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.

About the vaccine candidate VLA2001


  • Inactivated
  • Adjuvanted with Alum and CpG 1018
  • Highly-purified
  • Whole virus candidate
  • Vero-cell based
  • Using the manufacturing platform of Valneva’s commercial Japanese encephalitis (JE) vaccine

 

Rolling submission with the MHRA in the UK commenced


In August 2021, Valneva commenced rolling submission, for initial approval of VLA2001 with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK).

Pivotal Phase 3 trial Cov-Compare 


Over 4,000 volunteers have been recruited in the United Kingdom (Press release) for the Phase 3 immunogenicity trial “Cov-Compare”, which compares VLA2001 against AstraZeneca’s conditionally approved vaccine, Vaxzevria (Press release). Valneva has also commenced recruitment of adolescents in the “ Cov Compare” study. Positive topline data in adults have been reported in October 2021 (Press release).

Valneva completed recruitment of Elderly Participants in Further Phase 3 Trial


In Parallel to the Phase 3 trial conducted in the UK, Valneva has initiated a Phase 3 trial in New Zealand, VLA2001-304, to generate data in the elderly and to potentially enable variant-bridging through immune-comparability (Press Release). In September 2021, Valneva completed recruitment of the initial cohort of 300 elderly participants aged 56 years and older with the objective to generate further safety and immunogenicity data for this age group. The cohort size has been increased to 300, from 150, in consultation with the European Medicines Agency (“EMA”). Topline data from this cohort will read out in early 2022, and it is expected that the data will support additional regulatory submissions.

Valneva participates in the world’s first COVID-19 vaccine booster trial in the UK


Valneva is participating in a UK government-funded clinical trial looking at different COVID-19 ‘booster’ vaccines. The Cov-Boost trial, led by University Hospital Southampton NHS Foundation Trust, will look at seven different COVID-19 vaccines, including VLA2001, as potential boosters.

Designed and manufactured in-house in Europe


VLA2001 was developed by Valneva’s R&D teams in France & Austria. It is the only inactivated, adjuvanted whole virus COVID-19 vaccine in clinical trials in Europe.

Valneva’s UK-based manufacturing facilities


Valneva’s facility in Livingston, Scotland has been producing FDA/EMA/MHRA approved commercial-grade travel vaccines for more than a decade. It has been expanding its capacity and will be the production hub for Valneva’s COVID-19 vaccine candidate.

 

Valneva’s fill and finish capacities in Sweden


Initially dedicated to the production of the Company’s cholera vaccine, Valneva’s facility in Solna has been expanding its capacity in order to provide full fill and finish operations for the VLA2001 vaccine.

 

 

FAQ about VLA2001

What is VLA2001 and how is it different from other approaches?
  • VLA2001 is a Vero-cell based, highly-purified inactivated whole virus vaccine candidate.
  • VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.
  • The inactivated vaccine is a traditional and proven approach that has been used for decades. [1]
  • An inactivated SARS-CoV-2 vaccine is expected to be suitable for wide deployment.
  • Valneva’s vaccine candidate is based on the same manufacturing platform the Company already uses to produce its FDA/EMA/MHRA approved JE vaccine.
  • VLA2001 combined with alum and Dynavax’s adjuvant CpG 1018 has induced a strong immune response and generated high titers of neutralizing antibodies in a Phase 1/2 trial (Press release).
  • Valneva’s inactivated SARS-CoV-2 vaccine is expected to have a two-dose regimen.
  • VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees centigrade).

[1] Inactivated Viral Vaccines. Vaccine Analysis: Strategies, Principles, and Control. 2014 Nov 28 : 45–80. Published online 2014 Nov 28. doi: 10.1007/978-3-662-45024-6_2 PMCID: PMC7189890

Will VLA2001 be safe and effective against SARS-CoV-2?

Valneva is working as quickly as possible to develop a safe and effective vaccine against COVID-19, VLA2001 is being tested in clinical trials to confirm safety and effectiveness against this disease. Valneva reported positive Phase 1/2 data in April 2021 (Press release) and positive topline Phase 3 results in October 2021 (Press release) for its COVID-19 vaccine candidate. In addition, Valneva has a very solid database on the safety of this inactivated virus approach from its JE vaccine, which has been FDA/EMA/MHRA approved for over a decade.

When could Valneva deliver an approved COVID-19 vaccine?

VLA2001 is currently being studied in the UK in a pivotal Phase 3 trial, “Cov-Compare” (VLA2001-301), for which topline results have been reported in October 2021 (Press release).

How can I participate in Valneva’s clinical COVID-19 studies?

Learn more about Valneva’s COVID-19 vaccine trial here: https://www.ukcovid19study.com/

Medical Requests COVID-19 Vaccine Candidate

T: +43 1 20620 1444
covid19@valneva.com

 

Valneva Stands with Science


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