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
  • Whole virus candidate
  • Using the manufacturing platform of Valneva’s commercial Japanese encephalitis (JE) vaccine

 

Mode of Action

 

Conditional Marketing Authorization from the UK MHRA and Emergency Use Authorization from Bahraini NHRA and the United Arab Emirates granted


In April 2022, VLA2001 was granted Conditional Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom for primary immunization in adults 18 to 50 years of age. This follows the emergency use authorization that was granted by the Bahraini NHRA in March 2022.
On May 16, 2022, the United Arab Emirates (UAE) granted emergency use authorization for VLA2001.

 

Review process by EMA’s Committee for Human Medicinal Products initiated


The European Medicines Agency (“EMA”) has accepted the filing of a marketing authorization application (MAA) for VLA2001. Acceptance of the MAA means VLA2001 is advancing from the rolling review process and beginning the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP). If the CHMP accepts Valneva’s conditional marketing authorization application, the Company confirms it would expect to receive a positive CHMP opinion in June 2022.

 

Purchase Agreement with EC


The Company signed a supply agreement with the European Commission (EC) in November 2021 (Press release).

 

Positive Phase 3 results


Positive Phase 3 results of a randomized, observer-blind controlled immunogenicity trial Cov-Compare comparing the vaccine candidate VLA2001 to an active comparator vaccine (Press Release)

~3000 participants aged 30 and over
~1000 participants aged 18-29 years

  • Superior neutralizing antibody titer levels compared to the active comparator vaccine
  • Neutralizing antibody seroconversion rate above 95% (Non-inferiority compared to active comparator vaccine)
  • Generally well tolerated (significantly better tolerability profile than AZD1222)
  • Complete absence of severe COVID-19 cases despite circulating variants
  • VLA2001 induced broad T-cell responses against S, M, and N proteins

 

VLA2001 booster, adolescent and elderly trials

Valneva reported initial results confirming that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination 7-8 months before (Press release). Valneva expects to report further homologous booster data and first heterologous booster data from its Phase 3 Cov-Compare study.

Valneva initiated a heterologous booster trial of VLA2001 to provide booster data following primary vaccination with an mRNA vaccine or natural COVID-19 infection. These data, if positive, could support potential use of VLA2001 as heterologous booster, subject to applicable regulatory recommendations and approvals.

Valneva announced the recruitment of adolescents as an expansion of the Cov-Compare trial (Press release) and is preparing for trials in children (5-12 years of age). Valneva has also completed recruitment of 306 volunteers aged 56 years and older in New Zealand (Press release) into its VLA2001-304 trial. 

Cross-neutralization against Variants of Concern

Valneva has been evaluating sera from boosted participants for cross-neutralization against Variants of Concern, including Omicron. Laboratory studies demonstrated that serum antibodies induced by three doses of Valneva’s inactivated COVID-19 vaccine candidate, VLA2001, neutralize the initial SARS-CoV-2 virus as well as the Omicron and Delta variants (Press release).

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

How does Valneva’s COVID-19 vaccine candidate (VLA2001) work?

As a specialty vaccine company, Valneva has leveraged its scientific expertise and manufacturing capabilities to develop a new vaccine against COVID-19, based on a traditional, tried and tested vaccine technology: inactivation of the whole virus.

VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations. The vaccine is produced using Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine.

How is Valneva’s COVID-19 vaccine candidate different to other existing Covid-19 vaccines?

VLA2001 is currently the only inactivated, adjuvanted, whole virus vaccine candidate against COVID-19 in clinical development in Europe. The vaccine is based on well-established technology which, in contrast to novel COVID-19 vaccines such as mRNA vaccines, has a long history of use – notably in seasonal flu and polio vaccines.

In an inactivated vaccine, the virus is killed but the whole virus envelope is preserved, so compared to those COVID-19 vaccines that target only the spike protein, Valneva’s inactivated vaccine candidate has the potential to provide an added benefit by boosting T-cell responses against additional SARS-CoV-2 proteins.

Positive Phase 3 results for VLA2001 demonstrated that our COVID-19 vaccine candidate induced broad T-cell responses against multiple viral proteins (S, N and M proteins) while showing a significantly better tolerability profile compared to an EMA-approved COVID-19 vaccine.

In addition, first homologous booster data showed that a third dose of VLA2001 significantly boosted immunity in participants who had received two doses of VLA2001 as primary vaccination; and in January 2022, laboratory studies confirmed VLA2001’s ability to neutralize the Omicron and Delta variants and its potential for broad-spectrum protection.

Have clinical trials found Valneva’s COVID-19 vaccine candidate to be safe and effective?

In October 2021, Valneva reported positive results from Cov-Compare, the pivotal Phase 3 comparative immunogenicity trial of VLA2001, where the vaccine demonstrated superiority in terms of neutralizing antibody titer levels against the active comparator vaccine, AstraZeneca’s AZD1222, as well as non-inferiority in terms of seroconversion rates and a significantly better tolerability profile. These data form the basis of Valneva’s ongoing regulatory submissions for VLA2001.

Additionally, in December 2021, Valneva announced first positive booster data which confirmed that VLA2001 significantly boosted immunity in participants who had received VLA2001 as a primary vaccination. And, in January 2022, results from an initial laboratory study confirmed VLA2001’s ability to address the Delta and Omicron variants of concern and VLA2001’s potential for broad-spectrum protection.

More broadly, as a platform, inactivated vaccines are a well-established technology used over the last seventy years to vaccinate billions – including for seasonal flu and polio. Valneva has successfully developed and manufactured another inactivated vaccine – its licensed Japanese encephalitis vaccine – and the Company has leveraged the manufacturing platform for that vaccine to produce VLA2001.

How does Valneva’s vaccine compare to existing COVID-19 vaccines?

Different developers have used different technologies to create COVID-19 vaccines. Given that protective thresholds against COVID-19 – that is, the amount of neutralizing antibodies required to protect against infection – are not yet known, and as a result, comparisons of neutralizing antibody data are difficult because differences in the amount of neutralizing antibodies produced by one vaccine versus another do not necessarily indicate that one vaccine protects more than another.

Valneva announced positive primary vaccination and first homologous booster data for VLA2001 – and, as the only inactivated, adjuvanted, whole virus COVID-19 vaccine candidate in clinical development in Europe, the Company believes that it could add value to the COVID-19 vaccine portfolio if approved.

In October 2021, Valneva announced positive results from the pivotal Phase 3 Cov-Compare trial of VLA2001, which found that VLA2001 had a significantly better tolerability profile and induced higher levels of antibody titers (the test that detects the presence and measures the amount of antibodies within a person’s blood) than AstraZeneca’s AZD1222. Additionally, in January 2022, results from an initial laboratory study confirmed VLA2001’s ability to address the Delta and Omicron variants of concern and its potential for broad-spectrum protection.

Why is Valneva developing a COVID-19 vaccine?

As a specialty vaccine company, Valneva is using its expertise and capabilities to develop the only inactivated, adjuvanted, whole virus COVID-19 vaccine candidate in Europe. Inactivated vaccines are a well-established technology used over the last seventy years to vaccinate billions worldwide. Indeed, Valneva receives messages every day from people across the world who are keen to receive VLA2001, and the Company believes that if approved its vaccine could help close the vaccination gap by increasing coverage, particularly with those who are hesitant about novel technologies.

Will it be suitable for use as a booster vaccine?

While Valneva is focused on completing regulatory submissions for initial approval for use in primary vaccination, the Company is also working hard in parallel to assess the role VLA2001 could play as a booster.

The duration of protection induced by current vaccines suggest that repeated doses will be needed to maintain higher levels of antibodies. In December 2021, Valneva announced first positive homologous booster data, confirming that VLA2001 significantly boosted immunity in participants who received a VLA2001 booster dose seven to eight months after primary vaccination with VLA2001.

In January 2022, Valneva also announced the start of booster vaccinations in adult participants from its Phase 3 pivotal trial, Cov-Compare. This booster extension is intended to provide both homologous and first heterologous booster data to complement previous positive homologous booster results.

Is Valneva’s COVID-19 vaccine effective against Omicron and other variants?

In January 2022, Valneva announced results from a laboratory study demonstrating that serum antibodies induced by three doses of VLA2001 neutralize the Omicron variant. 100% of tested serum samples presented neutralizing antibodies against the Delta variant and ancestral virus (Wuhan), and 87% against the Omicron variant. This suggests that VLA2001 may offer broad-spectrum protection against the SARS-CoV-2 virus, although further studies will be necessary to determine protection against specific variants.

Where is Valneva’s COVID-19 vaccine being manufactured?

Since January 2021, Valneva has been manufacturing VLA2001 at in its site in Livingston, Scotland, and the Company’s site in Solna, Sweden, provides full fill and finish operations for the vaccine. Additionally, in November 2021, Valneva announced a collaboration with IDT Biologika to produce VLA2001’s drug substance at its facilities in Dessau-Roßlau, Germany, in addition to Valneva’s manufacturing site in Livingston, Scotland.

     

 

Additional information about COVID-19

 

Medical Requests COVID-19 Vaccine Candidate

T: +43 1 20620 1444
covid19@valneva.com