COVID-19 – VLA2001

COVID-19 est la maladie infectieuse causée par le nouveau coronavirus (SARS-CoV-2) identifié fin 2019. COVID-19 touche de nombreux pays dans le monde et l’Organisation Mondiale de la Santé (OMS) a déclaré cette maladie comme étant une pandémie.

“The partnership with the UK government validates our inactivated vaccine approach and recognizes the strong track record and capabilities we have built in the last fifteen years both in the UK and beyond.”
Thomas Lingelbach, CEO de Valneva

About the vaccine candidate VLA2001

  • Vero-cell based
  • Highly-purified
  • Inactivated
  • Adjuvanted
  • Whole virus candidate
  • Based on the manufacturing platform of Valneva’s commercial Japanese encephalitis (JE) vaccine

 

Agreement with the UK government

In September 2020, Valneva announced a vaccine partnership with the UK government for its inactivated COVID-19 vaccine, VLA2001. Under the agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. UK Government then has options over 40 million doses in 2022 and a further 30 million to 90 million doses, in aggregate, across 2023 to 2025. UK government is also investing up-front in the scale up and development of the vaccine. The agreement follows the initial intent to participate in the UK Government’s COVID-19 vaccine response announced in July.

 

avril
2020
Initiation of Valneva’s COVID-19 vaccine program
septembre
2020
Major COVID-19 vaccine partnership with UK government
End of
2020
VLA2001 expected to enter clinical studies
2021
Potential regulatory approval in the second half of the year

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 will be the production hub for Valneva’s COVID-19 vaccine candidate. The UK government funding will allow Valneva to expand the site’s capacity for drug
substance production, accelerate clinical development
and increase the number of jobs at the Livingston facility.

 

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.
  • Valneva is the only commercial stage vaccine company in Europe and the United States that has an inactivated approach for a COVID-19 vaccine.
  • The inactivated vaccine is a proven approach that has been used for decades.[1]
  • An inactivated SARS-CoV-2 vaccine would be suitable for wide deployment including at risk groups (e.g. the elderly or immunocompromised populations).
  • Processes and infrastructures for the inactivated approach are well established.
  • Valneva’s vaccine candidate is based on the same manufacturing platform the Company already uses to produce its FDA/EMA approved JE vaccine.
  • VLA2001 combined with the Dynavax’s FDA-approved adjuvant CpG 1018 is expected 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 ne devrait nécessiter qu’une chaîne du froid standard (2 à 8 degrés centigrades).

[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 will be tested in clinical trials to confirm safety and effectiveness against this disease. 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?

This vaccine is expected to enter clinical studies by the end of 2020 and potentially reach a first regulatory approval in the second half of 2021.

For whom will this vaccine be available?

Valneva has reached agreement in principle with the UK government to provide up to 190 million doses of its SARS-CoV-2 vaccine across 2021 to 2025. As part of its broader COVID-19 response, Valneva is building capacity to deliver up to 200 million doses per year.

Valneva Stands with Science

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