2020 Annual Business Report

COVID-19 – VLA2001

VLA2001 is the only inactivated COVID-19 vaccine candidate in clinical development in Europe today.

COVID-19 – VLA2001

The strength of an integrated business model

  • VLA2001 is a vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.  VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. The Phase 1/2 clinical trial is fully enrolled and is expected to report initial results in April 2021.
  • VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. Valneva has commenced production in parallel to the ongoing clinical trial in order to optimize the timeline for potential deliveries of the vaccine.
  • Assuming positive results from the ongoing Phase 1/2 trial and subject to regulatory approval Valneva plans to progress expeditiously into Phase 3 clinical development. Valneva is currently discussing Phase 3 design with the UK Medicines and Healthcare Products Agency (MHRA).
  • Although vaccines against SARS-CoV-2 have already been approved, given the potential advantages often associated with inactivated whole virus vaccines, Valneva believes its vaccine can be incorporated into the current and future portfolio of SARS-CoV-2 vaccines to address the global need for billions of doses of vaccines to prevent further spread of the virus.
  • In September 2020, Valneva announced a collaboration with the UK Government, which has the option to purchase up to 190 million doses through 2025 [1]. Following an initial order for 60 million doses to be delivered in 2021, the UK Government exercised an option in February 2021 to order 40 million doses for supply in 2022 [2]. This brings the total volume of the Valneva vaccine ordered by 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 total value of the 190 million doses, if all options are exercised, is up to €1.4 billion. Valneva also announced in January 2021, it is in advanced discussions with the European Commission to supply up to 60 million doses of its COVID-19 vaccine [3].

[1] Valneva Confirms Participation in UK Government COVID-19 Vaccine Response Program

[2] Valneva Announces UK Government Exercise of Option for 40 Million Doses of its Inactivated, Adjuvanted COVID-19 Vaccine

[3] Valneva in Advanced Discussions with European Commission to Supply up to 60 Million Doses of Inactivated, Adjuvanted COVID-19 Vaccine Candidate