Valneva provides regulatory update on COVID-19 vaccine candidate
pharmafile | March 11, 2022 | News story | Medical Communications |
Valneva has announced an update on the regulatory review of its inactivated COVID-19 vaccine candidate VLA2001, by the CHMP.
The company anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001, for primary immunisation in adults aged 18 to 55 years of age in April 2022. Following this approval, the company would expect to begin delivering planned doses of VLA2001 to European countries in the second quarter of 2022.
Valneva signed an agreement with the EC in November 2021, to supply up to 60 million doses of VLA2001 over two years, including 24.3 million doses in 2022, and an option for the delivery of the remaining doses in 2023. The company also signed an agreement with the Kingdom of Bahrain in December 2021, to supply one million doses of VLA2001. It has commenced manufacturing for the EC and Bahraini supply contracts, and expects to deliver its first doses to Bahrain in March 2022.
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. The vaccine is intended for the active immunisation of vulnerable populations to prevent carriage and symptomatic infection with COVID-19, and to minimise the risk of new variants.
The vaccine candidate consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density. The combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations.
The manufacturing process of VLA2001, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein.