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
- Adjuvanted with Alum and CpG 1018
- Whole virus candidate
- Vero-cell based
- Using the manufacturing platform of Valneva’s commercial Japanese encephalitis (JE) vaccine
Valneva Signs Purchase Agreement with European Commission for up to 60 Million Doses of VLA2001
Valneva signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA2001, over two years (Press release).
Positive Topline Results for VLA2001 from Pivotal Phase 3 trial
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).
VLA2001 elderly, adolescent and booster trials
As part of the product development strategy, Valneva has initiated additional clinical trials to support future approval in further age groups, in addition to adults.
Valneva has completed recruitment of 306 volunteers aged 56 years and older in New Zealand (Press release) into its VLA2001-304 trial and expects topline data in early 2022. Valneva has also announced the start of recruitment of adolescents as an expansion of the Cov-Compare trial (Press release).
The Company is preparing for trials in children (5-12 years of age) and a Valneva sponsored booster trial to evaluate VLA2001’s booster performance for people in need of a booster.
Designed and manufactured 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 candidate 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.
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
- 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. 
- 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).
 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
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).
Topline results of Valneva’s Phase 3 trial released in October 2021 showed that VLA2001 induced high levels of neutralization antibody titers as well as broad T-cell responses, and was well tolerated (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.
Valneva commenced rolling submission for initial approval with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and is preparing to commence rolling submission for conditional approval with the European Medicines Agency. Valneva believes that initial approval for VLA2001 in the UK could be granted later this year.
Learn more about Valneva’s COVID-19 vaccine trial here: https://www.ukcovid19study.com/
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Related Press Releases
- Valneva Announces European Commission Approval of Advance Purchase Agreement for up to 60 Million Doses of Inactivated COVID-19 Vaccine VLA2001
- Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001
- Valneva Continues Expansion of Clinical Trials of its Inactivated COVID-19 Vaccine Candidate VLA2001
- Valneva Completes Recruitment of Elderly Participants in Phase 3 Trial of its Inactivated COVID-19 Vaccine
- Valneva Commences Rolling Submission to MHRA for its Inactivated, Adjuvanted COVID-19 Vaccine
- Valneva Initiates Further Phase 3 Clinical Trial for its COVID-19 Vaccine Candidate
- Valneva Continues Ongoing Discussions with the European Commission for Inactivated COVID-19 Vaccine Candidate
- Valneva Completes Phase 3 Trial Recruitment for its Inactivated COVID-19 Vaccine Candidate
- Valneva to Participate in the World’s First COVID-19 Vaccine Booster Trial in the UK
- Valneva Initiates Phase 3 Clinical Trial for its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001
- Valneva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001
- Valneva in Advanced Discussions with European Commission to Supply up to 60 Million Doses of Inactivated, Adjuvanted COVID-19 Vaccine Candidate
- Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine Candidate
- Valneva and Dynavax Announce Collaboration to Advance Vaccine Development for COVID-19