Valneva SE, a specialty vaccine company, provides an update on its European inactivated whole-virus COVID-19 vaccine candidate VLA2001.
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Following receipt of the European Commission (EC)’s notice of intent to terminate the Advance Purchase Agreement (APA), Valneva proposed a remediation plan, which is now subject to further discussion within the EC and among the participating member states.
Some member states have confirmed their interest in having an inactivated, adjuvanted whole-virus vaccine solution in their portfolio.
However, the preliminary, unofficial volume indications received from the EC would not be sufficient to ensure the sustainability of Valneva’s COVID-19 vaccine program. This would also impede the future development of the program beyond the current product profile.
If such indications are confirmed, Valneva will not be able to enter into an amendment to the APA that could allow for a reduced order, and the EC is thus likely to terminate the agreement.
As a result, Europeans would not have access to Valneva’s inactivated vaccine VLA2001.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We hope that the EC and its member states will continue to evaluate the potential advantages of an inactivated vaccine.
"There is emerging evidence that hybrid immunity – from a combination of vaccination and natural infection – increases protection against development of severe COVID-19 caused by different variants of concern, and our inactivated vaccine closely mimics natural infection by exposing vaccinees to the entire inactivated SARS-CoV-2 virus.
"Additionally, market research studies in six European countries indicated material interest in an inactivated COVID-19 vaccine for primary or booster vaccination. We continue to receive messages from people looking for a more traditional vaccine technology and we hope to receive a meaningful order size to further support public health in Europeâ€.
In parallel, the regulatory process with the European Medicine Agency (EMA) continues as planned. EMA accepted the filing of Marketing Authorization Application on May 19, 2022 and the Committee for Medicinal Products for Human Use (CHMP) is expected to take a final vote during the week of June 21, 2022.
Valneva also continues to work with agencies outside of the European Union for potential future approvals and additional purchase agreements.
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 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 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines.
VLA2001 is produced on Valneva’s established 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. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation, is a component of the US FDA- and EMA-approved HEPLISAV-B vaccine.
VLA2001’s manufacturing process, 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 to 8 degrees Celsius). ■