The Committee for Medicinal Products for Human Use (CHMP) has provided an initial assessment of Valneva’s inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Following the company’s response, the European Medicines Agency (EMA) will provide a timetable for approval.
Valneva expects to receive a positive CHMP recommendation for the conditional approval of VLA2001 – for primary immunisation in adults 18 to 55 years of age – at the end of the first quarter of 2022. In the wake of conditional approval, the company anticipates the delivery of the first shipments to European countries early in the second quarter of the year.
CEO of Valneva, Thomas Lingelbach, remarked: “We are pleased with the initial CHMP assessment and look forward to providing our responses as soon as possible. VLA2001 is the only inactivated COVID-19 vaccine in clinical development in Europe and this brings us closer to our objective of providing a differentiated vaccine option to the population and physicians who need it.”
“Adults aged 18 to 55 represent the vast majority of unvaccinated people in Europe and we continue to receive messages every day from many who are looking for a more traditional and established vaccine approach,” Lingelbach added.
The vaccine is intended for the active immunisation of at-risk populations, to prevent symptomatic infection with COVID-19. It 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 combination has demonstrated high antibody levels across numerous preclinical experiments. It is expected to conform with standard cold chain requirements – two to eight degrees celsius – thereby creating greater ease of distribution.