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23
July
2020
23rd July 2020
 

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

Saint-Herblain (France), July 20th, 2020 – Valneva SE, a specialty vaccine company focused on prevention against diseases with major unmet needs, today confirmed its participation in the UK government COVID-19 vaccine response program.


Valneva has reached agreement in principle with the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine candidate, to be manufactured at its facilities in Livingston, Scotland. The UK government is expected to contribute to UK clinical studies costs and is negotiating funding to expand Valneva’s Scottish facility. As part of its broader COVID-19 response, Valneva plans to further invest in its manufacturing facility in Livingston, Scotland and also in Solna, Sweden.


Thomas Lingelbach, CEO of Valneva, commented, “We are delighted to have been selected to participate in this important program with the UK government. This recognizes the strong track record and capabilities that we have built in the last fifteen years both in the UK and beyond. Our Livingston facility has been FDA approved for over a decade and we have a strong team both there and in Solna. We also envisage manufacturing vaccines to support the need for prevention of COVID-19 beyond the UK.”


On 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.


About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease


SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported in late-2019, the virus has infected over 14 million people and has caused over 600,000 reported deaths (as of July 18, 2020). It has been declared a pandemic by the World Health Organization (WHO). Currently, there is no vaccine available for COVID-19.

 
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23
July
2020
23rd July 2020
 

Valneva Announces Positive Initial Results for Phase 2 Study of Lyme Disease Vaccine Candidate




  • Compared to Phase 1, the higher doses used in this trial elicited higher antibody responses across all serotypes

  • Encouraging immunogenicity profile confirmed, including older adults (50-65 years)

  • VLA15 generally safe across all dose and age groups tested

    • No related Serious Adverse Events (SAEs) associated with VLA15




Saint-Herblain (France), July 22, 2020 – Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, today announced positive initial results for its first Phase 2 study (VLA15-201) of Lyme disease vaccine candidate VLA15.


VLA15 was immunogenic across all dose groups tested. Compared to Phase 1, the higher doses used in this trial elicited higher antibody responses across all serotypes. Seroconversion rates (SCR) in the highest dose ranged from 81.5% (ST1) to 95.8% (ST2). In the age group comparable to the age group investigated in Phase 1 (18-49 years), SCRs ranged from 85.6% to 97%. The immunological response in older adults, one of the main target groups for a Lyme vaccine, is particularly encouraging.


Results did not indicate that prior exposure to Lyme (sero-positivity) has an impact on immunogenicity or safety.


As part of further Phase 2 data to be released in a few months, an analysis of the functionality of the antibodies generated with VLA15 will be conducted. In close collaboration with regulatory authorities, Valneva has developed a Serum Bactericidal Antibody assay (“SBA”) for that purpose.


VLA15 was generally safe across all dose and age groups tested. No related Serious Adverse Events (SAEs) were observed with VLA15 in this study in any treatment group. Reactogenicity decreased with subsequent vaccinations.


Overall, the tolerability profile including rates of fever appeared to be comparable to other lipidated recombinant vaccines or lipid-containing formulations.


 
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