German biopharma company CureVac has signed an initial manufacturing agreement with Novartis for its COVID-19 vaccine candidate CVnCoV.
When the agreement is finalised, Novartis plans to manufacture the mRNA and bulk drug product of CureVac’s CVnCoV for up to 50 million doses by the end of 2021, with further scale-up to 200 million doses in 2022.
Deliveries of the CVnCoV doses from Novartis’ Kundl, Austria manufacturing site are expected to begin in summer 2021.
“We feel it is our responsibility to do everything in our power to help and we are pleased to announce our collaboration with CureVac,” said Steffen Lang, global head of Novartis technical operations and member of the executive committee, Novartis.
“At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids. We are currently expanding our site with additional capacities for the production of mRNA in order to best serve the increasing demand,” he added.
In a phase 1 study of CVnCoV, the investigational mRNA-based vaccine candidate induced strong binding and neutralising antibody responses.
The vaccine also demonstrated early indications of functional T cells, confirming activation of cellular immune response according to CureVac.
Following the positive phase 1 study results, CureVac launched a phase 2b/3 study of CVnCoV in December 2020, evaluating a 12µg dose of the vaccine.
CureVac has already signed a number of strategic partnerships for the further development, production and commercialisation of the mRNA-based vaccine candidate.
This includes a collaboration agreement with German pharma company Bayer, announced in January, to support the further development, supply and key territory operations of CVnCoV.
As part of the agreement, Bayer is contributing its expertise and established infrastructure in clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance.
In February, CureVac then signed a deal with British drugmaker GlaxoSmithKline (GSK) to develop the next generation of mRNA-based COVID-19 vaccines.
The GSK/CureVac deal will focus on developing a novel mRNA-based COVID-19 vaccine candidate, by using multivalent and monovalent approaches.
The next generation vaccine will aim to offer broader protection against newly emerging variants, which have been reported to have the potential to reduce the efficacy of first-generation mRNA jabs.
The UK Vaccines Taskforce is also working with CureVac to assess multiple variants of the SARS-CoV-2 virus that causes COVID-19, and will seek to generate vaccine candidates against selected strains.
In a statement, the UK government said that ‘almost all vaccines’ developed as part of the CureVac partnership will be variants of the German company’s existing vaccine, CVnCoV.