Valneva Update on European Inactivated, Whole-Virus COVID-19 Vaccine Program

 ValnevaSE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today provides an update on its European inactivated whole-virus COVID-19 vaccine candidate VLA2001.

Following receipt of the European Commission (EC)’s notice of intent to terminate the Advance Purchase Agreement (APA)¹, 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 Europe”.

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, 2022² 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.

https://www.biospace.com/article/releases/valneva-provides-update-on-european-inactivated-whole-virus-covid-19-vaccine-program-vla2001/