Valneva, a specialty vaccine company based in France, and IDT Biologika, headquartered in Germany, agreed to collaborate on the production of Valneva’s inactivated COVID-19 vaccine candidate VLA2001. This follows last week’s announcement that Valneva signed an Advance Purchase Agreement with the European Commission to supply up to 60 million doses of VLA2001, over two years.
IDT Biologika will produce VLA2001’s drug substance at its Biosafety Level 3 facilities in Dessau-Roßlau, Germany, in addition to Valneva’s manufacturing site in Livingston, Scotland.
“IDT is a well-established partner within Valneva’s manufacturing network,” said Thomas Lingelbach, CEO of Valneva. “As such we are extremely pleased to extend this partnership to supply VLA2001. This collaboration will help ensure our inactivated vaccine is available for rapid deployment as we continue to believe that our differentiated vaccine candidate can make an important contribution to the global fight against the COVID-19 pandemic.”
“This assignment shows the importance of the role played by IDT in the fight against COVID-19,” added Jürgen Betzing, CEO of IDT Biologika. “The expansion of our production capacity combined with our expertise were key factors in the choice of IDT.”
Reviewing the company’s manufacturing strategy
Valneva officials say they have continued to review the company’s manufacturing strategy following discussions with the UK Government in the summer and again after the termination of the UK contract in September 2021. Valneva plans to operate a combination of external and internal production of VLA2001 and will further review its manufacturing plans based on demand.
The company’s sites in Scotland and Solna, Sweden will continue to form part of its core manufacturing strategy.
Valneva reported positive Phase III results for VLA2001 in October 2021. Delivery of the vaccine in Europe is currently expected to begin in April 2022, subject to approval by the European Medicines Agency (EMA), which is expected to start a rolling review of VLA2001 shortly, according to Valneva.
The company reports that VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate against COVID-19 in clinical trials in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants.
VLA2001, which may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines, is produced on Valneva’s Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®.
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 and shown a shift of the immune response towards Th1, according to Valneva.
CpG 1018 adjuvant, supplied by Dynavax Technologies is a component of the FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein.
VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).