VLA2001 SARS-CoV-2 Vaccine Description
VLA2001 is a Vero-cell based, highly purified inactivated vaccine candidate against the novel coronavirus SARS-CoV-2. VLA2001 leverages Valneva’s well-established platform for IXIARO, its vaccine approved for active immunization for the prevention of Japanese encephalitis.
Valneva has designed a process that largely uses this platform in regards to upstream- and downstream process steps as plug-and-play with moderate adjustments. The process includes inactivation with BPL to preserve the native structure of the S protein.
The Company announced on April 22, 2020, it is collaborating with Dynavax to evaluate the adjuvant CpG 1018, which is a component of the U.S. FDA-approved HEPLISAV-B vaccine. The combination with CpG 1018 adjuvant is expected to induce a strong immune response and has the potential to generate high titers of neutralizing antibodies.
In July 2020, Valneva reached an agreement in principle with the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine, to be manufactured at its facilities in Livingston, Scotland.
The VLA2001 vaccine candidate is expected to enter clinical studies by the end of 2020 and to potentially reach regulatory approval in the second half of 2021, said the company.
Valneva announced it has ramped up its Biosafety Level 3 laboratory capabilities at its sites in Nantes, Vienna, and Livingston, NJ. Assuming that preclinical activities are successful and the requisite financing is in place, Valneva plans to commence clinical studies by the end of 2020 with the objective to achieve first regulatory approval in the second half of 2021, subject to the appropriate regulatory authority requirements.
Valneva SE is a vaccine company specializing in the prevention of diseases generating significant or unmet medical needs. Their vision is to contribute to a world where no one dies or suffers from preventable diseases through vaccination.
VLA2001 SARS-CoV-2 Vaccine Indication
VLA2001 is indicated to prevent SARS-Cov-2 infection which causes COVID-19 disease
VLA2001 SARS-CoV-2 Vaccine News
August 5, 2020 - A manufacturing facility in Livingston, West Lothian, United Kingdom, will be at the heart of efforts to produce a new coronavirus vaccine - VLA2001 - thanks to a multi-million-pound joint investment as part of an agreement in principle by the UK government to secure early access to 60 million doses of Valneva’s promising vaccine candidate.
July 20, 2020 - Valneva has reached an agreement in principle with the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine candidate. The UK government is expected to contribute to UK clinical studies costs and is negotiating funding to expand Valneva’s Scottish facility.
June 18, 2020 - Valneva SE and Bavarian Nordic A/S announced that they have signed a binding term sheet to establish a partnership for the marketing and distribution of their commercial products. Under the agreed terms, Valneva will commercialize Bavarian Nordic’s marketed vaccines leveraging its commercial infrastructure in Canada, UK, France, and Austria.
April 22, 2020 - Valneva announced that it is developing VLA2001, an inactivated whole virus vaccine candidate against the novel coronavirus SARS-CoV-2. VLA2001 leverages Valneva’s well-established platform for IXIARO®, its vaccine approved for active immunization for the prevention of Japanese encephalitis. The Company is also collaborating with Dynavax to evaluate the potential use of its CpG 1018 adjuvant as part of the VLA2001 vaccine. This vaccine is expected to enter clinical studies by the end of 2020 and to potentially reach regulatory approval in the second half of 2021.
VLA2001 SARS-CoV-2 Vaccine Clinical Trials
The VLA2001 vaccine candidate is expected to enter clinical trial studies by the end of 2020.