Valneva Commences Manufacturing of its Inactivated, Adjuvanted COVID-19 Vaccine, Completes Phase 1/2 Study Recruitment
- Vaccine production initiated to optimize timeline for potential deliveries
Phase 1/2 clinical study now fully enrolled; initial data read out expected in April 2021
Saint-Herblain (France), January 28, 2021 – Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it has commenced production of its inactivated, adjuvanted COVID-19 vaccine candidate in parallel to the ongoing clinical studies, in order to optimize the timeline for potential deliveries of the vaccine. The Phase 1/2 clinical study is now fully enrolled and is expected to report initial results in April 2021.
VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe. A total of 150 healthy adults aged 18 to 55 years have been recruited for the Phase 1/2 study which commenced mid December 20201.
Thomas Lingelbach, Chief Executive Officer of Valneva, said, “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 enrollment 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 announced a major COVID-19 vaccine partnership with the UK government for the supply of up to 190 million doses of its COVID-19 vaccine VLA20012. Under this partnership agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. Valneva also announced in January 20213 it is in advanced discussions with the European Commission for the supply of up to 60 million doses of VLA2001.
About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease
SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused over 2 million reported deaths globally. It has been declared a pandemic by the World Health Organization (WHO).