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 and the advanced discussions with the EC validate our inactivated vaccine approach and recognize the strong track record and capabilities we have built in the last fifteen years.”
Thomas Lingelbach, CEO de Valneva

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 Phase 1/2 clinical study in December 2020

The VLA2001-201 study is a randomized, double blind trial evaluating the safety and immunogenicity for three dose levels in approximately 150 healthy adults. The primary endpoint read-out will be two weeks after completion of the two-dose primary immunization (day 0, 21). Subject to analysis of this data, additional trials are expected to commence immediately thereafter. The Company currently plans to include more than 4,000 participants in additional trials, which it believes could support an initial regulatory approval as soon as the fourth quarter of 2021.

Agreement with the UK & discussions with the EC

In September 2020, Valneva announced a 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 an additional 130 million doses, across 2022 to 2025. UK government is also investing up-front in the scale up and development of the vaccine.

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.

Major COVID-19 vaccine partnership with UK government

Initiation of VLA2001 Phase 1/2 clinical trial

Initial data of VLA2001 Phase 1/2 clinical trial expected

Potential regulatory approval in Q4 2021

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 facilitya déclaré cette maladie comme pandémie.

Valneva’s fill and finish capacities in Sweden

Valneva’s facility in Solna, dedicated to the production of the Company’s cholera vaccine, is 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 the first inactivated COVID-19 vaccine in clinical development in Europe.
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 particularly vulnerable 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/MHRA approved JE vaccine.
VLA2001 combined with Alum and 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 entered a Phase 1/2 clinical study in December 2020. The Company currently plans to include more than 4,000 participants in additional trials. Due to the extensive history and success of inactivated virus vaccines, Valneva believes that VLA2001 has a high likelihood of a first regulatory approval in the fourth quarter of 2021, subject to the appropriate regulatory authority requirements.

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

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

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. Valneva is also in advanced discussions with the EC for the supply of up to 60 million doses of VLA2001. As part of its broader COVID-19 response, Valneva is building capacity to deliver up to 200 million doses per year.