(Boursier.com) — Valneva SE, a vaccine company, today provides an update on its European inactivated whole-virus COVID-19 vaccine candidate, VLA2001.
After receiving the European Commission’s Notice of Intent to terminate the supply agreement for its COVID-191 vaccine candidate, Valneva has submitted a remediation plan which is under discussion with the Commission and participating Member States .
Some Member States have confirmed their interest in including an inactivated and adjuvanted whole virus vaccine solution in their portfolio. However, the preliminary and non-final volume indications received from the Commission would not be sufficient to ensure the sustainability of Valneva’s COVID-19 vaccine program. It would also hamper future development of the program beyond the current product profile.
If these indications were confirmed, Valneva would not be able to conclude an amendment to the supply agreement for a reduction in the volumes ordered, and the European Commission would probably terminate the agreement. As a result, Europeans would not have access to Valneva’s inactivated vaccine, VLA2001.
Thomas Lingelbach, Chief Executive Officer of Valneva, said: “We hope that the European Commission and Member States will continue to assess the potential benefits of an inactivated vaccine. New information demonstrates that hybrid immunity – vaccination and natural infection combined – increases protection against the development of a severe form of COVID-19 caused by different variants of concern, and our inactivated vaccine is the closest to a natural infection because it exposes vaccinated people to the whole inactivated SARS virus -CoV-2.In addition, market research conducted in six European countries has shown significant interest from unvaccinated people for an inactivated vaccine against COVID-19.We also continue to receive messages from people looking looking for a more traditional vaccine technology. We hope to receive a large enough order volume to be able to contribute dav antage to public health in Europe”.
In parallel with the discussions with the Commission, the regulatory process with the European Medicines Agency (EMA) is continuing as anticipated. The EMA accepted the submission of the 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 regulatory agencies outside of the European Union to obtain possible additional marketing authorizations and purchasing agreements.
©2022 Boursier.com