CureVac – whose vaccine candidate CVnCoV headed into Phase 3 trials in December – will benefit from Bayer’s expertise and established infrastructure as it takes the vaccine forward through clinical trials, authorization and mass production and supply.
The collaboration and services agreement will see Bayer support fellow German company and mRNA specialist CureVac in further development, supply and key territory operations of the vaccine candidate. This includes areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance.
CureVac will be the Marketing Authorization Holder for the product, while Bayer will support CureVac with country operations within the European Union and selected additional markets. Bayer holds further options to become Marketing Authorization Holder in other markets outside of Europe.
By combining their strengths, the companies say they will be able to supply hundreds of millions of CVnCoV doses around the world once approvals are granted.
Stefan Oelrich, Member of the Board of Management, Bayer AG and President of the Bayer’s Pharmaceuticals Division, said: “The need for vaccines against COVID-19 is enormous. We are therefore pleased to be able to provide significant support to CureVac, a leader in mRNA technology, in advancing the further development and supply of its COVID-19 vaccine candidate.
“We are highly committed to making our capabilities and networks available to help end this pandemic.”
Dr. Franz-Werner Haas, Chief Executive Officer of CureVac, added: “Building on the positive data we have seen so far with CVnCoV, we now also have another strong partner on our side to get the vaccine to the people who need it following the receipt of the requisite regulatory approvals.”
Production and supply
CureVac began development of CVnCoV in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus.
Phase 1 interim data reported in November 2020 showed that the vaccine candidate was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. Curevac notes the quality of immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection.
CVnCoV is stable for at least three months at +5°C (+41°F), according to information presented in November, which differes it from fellow mRNA vaccines from Pfizer and Moderna (Pfizer's requires ultra-low temperatures while Moderna's short-term storage at standard refrigerator temperatures last for up to 30 days).
CureVac has been expanding its partner network for the development, production and distribution of its vaccine candidate: ramping up its European network with Wacker and Fareva (announced in November) among others.
It has an agreement to provide the EU with up to 405 million doses, which represents the largest agreement to date that the EU has inked.