Bayer said that it has reached an agreement to further the development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate CVnCoV. The companies indicated that they plan to combine their strengths for CureVac to be in a position to supply “hundreds of millions” of CVnCoV doses around the world, once approvals are granted, with Bayer pharmaceutical head Stefan Oelrich saying “we are highly committed to making our capabilities and networks available to help end this pandemic.”
No financial details of the deal were released, but Bayer said it would assist in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information and supply-chain performance as well as support in selected countries. CureVac will be the marketing authorization holder for the mRNA vaccine candidate, while Bayer will support CureVac with country operations in the EU and other select markets. Meanwhile, Bayer will have options to become the marketing authorization holder in other markets outside of Europe.
“Building on the positive data we have seen so far with CVnCoV, we now also have another strong partner on our side,” remarked Franz-Werner Haas, chief executive at CureVac, adding that Bayer’s “expertise and infrastructure will help us make our vaccine candidate CVnCoV even more rapidly available to as many people as possible.”
Large-scale trial launched last month
Until now, CureVac has said it would have the capacity to produce up to 300 million doses of CVnCoV in 2021, and another 600 million in 2022, fewer than the 1.3 billion doses Pfizer and BioNTech are projecting to be able to produce of their coronavirus vaccine BNT162b2 next year. CureVac signed a deal with the EU in November to supply up to 405 million doses of its two-course inoculation. However, it has given up plans to supply its vaccine to the US, citing market saturation, despite reports earlier this year that the Trump administration was trying to secure exclusive access to the German company’s work on CVnCoV.
Meanwhile, CureVac initiated a phase 2/3 trial last month to test CVnCoV at a dose of 12 mcg in more than 35,000 adult participants in Europe and Latin America. The move followed the release of positive early-stage results showing CVnCoV had induced strong binding and neutralising antibody responses, as well as a “first indication” that T-cells had been activated in a cohort of health volunteers. CureVac also recently announced plans to ramp up its European manufacturing network, working with Wacker and Fareva, amongst others.