The partners said preparations for the start of production, technology transfers and test runs are already underway.
Following final agreement, Novartis plans to manufacture the mRNA and bulk drug product of the Germany company’s CVnCoV vaccine candidate for up to 50 million doses by the end of 2021 and up to a further 200 million doses in 2022.
Delivery from Novartis’ manufacturing site in Kundl, Austria, is expected to start in summer 2021.
Dr Florian von der Mülbe, chief production officer, CureVac, said the deal with Novartis would significantly increase its manufacturing capacity
Novartis’ Kundl site has decades of experience in pharmaceutical production of proteins and, in more recent years, nucleic acids. “We are currently expanding our site with additional capacities for the production of mRNA in order to best serve the increasing demand,” said Steffen Lang, global head of Novartis technical operation.
CureVac started building an integrated European vaccine manufacturing network with several CDMO partners. So far, it is working with Bayer, Fareva, Wacker and Rentschler, among others.
The Germany company’s work on its mRNA-based COVID-19 vaccine candidates began in January 2020. The vaccine candidate chosen first for clinical development, CVnCoV, is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs).
Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively.
Phase 1 interim data reported in November 2020 showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. The quality of immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection.
In December 2020 CureVac initiated a pivotal Phase 2b/3, the HERALD study, with a 12μg dose of CVnCoV.
EU approval pending
Last month, it initiated a rolling submission with the European Medicines Agency (EMA) for that vaccine.
CureVac also announced then that it would be working with GlaxoSmithKline on the development of next-generation multi-valent mRNA vaccines against COVID-19.