COVID-19 – VLA2001

COVID-19 is affecting many countries 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.

“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 reported positive Phase 1/2 data for its COVID-19 vaccine candidate

Valneva reported positive Phase 1/2 trial data for VLA2001 at the beginning of April 2021 (Press release (English)). 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, expected to start by the end of April 2021, subject to regulatory approval.

Agreement with the UK & discussions with the EC

In September 2020, Valneva announced a collaboration with the UK government, which has the option to purchase up to 190 million doses through 2025 . Following an initial order for 60 million doses to be delivered in 2021, the UK Government exercised an option in January 2021 to order 40 million for supply in 2022 . This brings the total volume of the Valneva vaccine ordered by the UK Government to 100 million doses and the UK Government 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.

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

Phase 3 clinical trial initiation, subject to regulatory approval

Potential regulatory approval in Q4 2021

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 FDA-approved adjuvant CpG 1018 has been demonstrated in preclinical studies 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 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 (English)). 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 currently plans to include more than 4,000 participants in additional trials and anticipates making a regulatory licensure submission 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/

For whom will this vaccine be available?

Valneva has entered into an agreement 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 scaling up its manufacturing capacity.