Valneva begins manufacturing its inactivated, adjuvanted COVID-19 vaccine
The company announced that the Phase I/II trial for VLA2001 is now fully enrolled and that it has begun manufacturing the vaccine candidate on an industrial scale.
Valneva SE has commenced production of its inactivated, adjuvanted COVID-19 vaccine candidate in parallel to the ongoing clinical studies. According to the enterprise, the move should optimise the timeline for deliveries of the vaccine.
VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe. The Phase I/II trial evaluating three dose levels of VLA2001 for safety, tolerability and immunogenicity, which commenced in mid-December 2020, is now fully enrolled with a total of 150 healthy adults aged 18 to 55 years. Initial reports are expected in April 2021.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented: “We are extremely pleased to have achieved these two important milestones in such a short period of time. Our team in Scotland have done an amazing job to get manufacturing started so quickly. I would like to thank the UK Vaccines Taskforce and National Institute for Health Research who have played vital roles in the rapid recruitment and enrolment of the volunteers for the clinical study. We believe that our vaccine, assuming successful development, can make a major contribution in the UK and beyond.”
In September 2020, Valneva agreed to supply the UK Government with up to 190 million doses of its COVID-19 vaccine VLA2001. Under this agreement, if vaccine development is successful, the company will provide the UK government with 60 million doses in the second half of 2021. It is also in advanced discussions with the European Commission for the supply of up to 60 million doses.
The vaccine candidate, 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. It is produced on Valneva’s Vero-cell platform and the process has already been upscaled to final industrial scale. According to the enterprise, it expects VLA2001 to conform with standard cold chain requirements (two to eight degrees Celsius).