COVID-19 – VLA2001

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

 

Valneva initiated a Phase 3 clinical trial for its COVID-19 vaccine candidate

The Phase 3 trial “Cov-Compare” was initiated in April 2021 and will compare VLA2001 against AstraZeneca’s conditionally approved vaccine, Vaxzevria, in an immunogenicity trial including approximately 4,000 participants (Press release).

Valneva reported positive Phase 1/2 trial data for VLA2001 at the beginning of April 2021 (Press release). VLA2001 was well tolerated with no safety concerns identified. In the high dose group, IgG seroconversion rate was 100%, and neutralizing antibody titers were at or above levels generally seen in convalescent sera. Based on the data assessed, the Company has decided to advance the high dose into the Phase 3 clinical trial.

Agreement with the UK & discussions with the EC and other countries

In September 2020, Valneva announced a collaboration with the UK government, which has the option to purchase up to 190 million doses through 2025. So far, the UK Government has ordered 100 million doses to be delivered in 2021 and 2022 and retains options over a further 90 million doses for supply between 2023 and 2025. The UK government is also investing up-front in the scale up and development of the vaccine candidate.

In January 2021, Valneva announced it is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of VLA2001. In April 2021, Valneva announced it is now focusing on bilateral discussions, on a country by country basis, to supply VLA2001 and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC).

September
2020
Major COVID-19 vaccine partnership with UK government
December
2020
Initiation of VLA2001 Phase 1/2 clinical trial
April
2021
Initiation of VLA2001 Phase 3 clinical trial
2021
Potential regulatory submissions for initial approval

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

The facility in Livingston 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

Valneva’s facility in Solna, dedicated to the production of the Company’s cholera vaccine, 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 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 been demonstrated in preclinical studies and as confirmed by recently obtained initial Phase 1/2 clinical data to induce a strong immune response and has the potential to generate high titers of neutralizing antibodies.
  • 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 and VLA2001 is being tested in clinical trials to confirm safety and effectiveness against this disease. Valneva reported positive Phase 1/2 data for its COVID-19 vaccine candidate in April 2021 (Press release). 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?

The Company is currently conducting a pivotal Phase 3 trial with more than 4,000 participants with the aim of making regulatory submissions for initial approval in the autumn of 2021.

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/

Valneva Stands with Science

Additional information about COVID-19

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