Bayer to also Manufacture CureVac Covid Shot

02.02.2021 - Vaccines and treatments for Covid-19 continue to dominate global pharma market headlines. As the pandemic drags on, new issues continuously arise, some of them discouraging, such as the emergence of more and more virus mutants or production glitches that threaten to curb supply.

Encouragingly, though, the intervals between announcements of new collaborations among players of all sizes are growing shorter and the structure of the deals is becoming more heterogeneous. When the coronavirus first surfaced, Big Pharma names with experience in vaccines lined up to try their hand at a new product, only to be upstaged by small biotechs with recombinant know-how and more flexibility.

Potential Covid vaccine producers of all sizes initially allied themselves with CDMOs to speed up development and production. Now, heeding desperate calls for help from Brussels, Berlin, London and Washington, big European drugmakers with little or no experience in vaccines, such as Sanofi, Novartis and Bayer, are wading into the fray.

Just three weeks ago, Bayer said it planned to collaborate with compatriot CureVac on speeding the biotech’s deployment of its Covid-19 candidate CVnCOV.  As this week started, the Leverkusen pharma major announced it had agreed to also help manufacture CVnCOV y in addition to the previously announced support in other areas.

It will be the first time in its nearly 160-year history that Bayer has produced vaccines. But unveiling the expanded cooperation plan on Feb. 1 at a press conference with CureVac CEO Franz-Werner Haas, Germany’s health minister Jens Spahn and the prime minister of the state of North Rhine-Westphalia, Armin Laschet, Bayer’s pharma chief Stefan Oelrich, touted the top-seeded conventional drugmaker’s “strong expertise in the development of biotech products.”

Earlier, Bayer had said it would lend CureVac – in which the German state owns a 23% stake – its  expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance as well as support in selected countries.  While the biotech would be the marketing authorization holder for the vaccine it developed, the multinational added that it might seek authorization itself in non-EU markets.

Bayer now plans to make 160 million doses of the CureVac shot by next year, with the first commercial product expected to emerge at the end of this year. The Tübingen biotech began Phase 3 clinical trials in December 2020 and has said it hopes to submit an application for marketing by mid-2021, pending completion of the ongoing trial.

CureVac’s candidate is based on mRNA technology but it uses a different approach from that of Pfizer-BioNtech and Moderna. Oelrich said Bayer’s work on the vaccine will be concentrated at Bayer’s Wuppertal, Germany, campus, which has a biologics focus. Here, it plans to repurpose existing plants to make the new mRNA vaccine drug substance.

“Since the announcement of our alliance with CureVac earlier this year, we have diligently assessed our ability to further contribute with end-to-end manufacturing,” Oelrich said, adding that Bayer has discovered it does indeed have the necessary skills and capabilities to make the vaccine.

CureVac is simultaneously widening its global output program on its own as clinical studies continue. Also on Feb. 1, the company announced that, together with Rentschler Biopharma, one of its several CDMO partners, it has begun preparing Rentschler’s facilities at Laupheim, Germany, to produce 100 million doses annually as part of a cooperation agreed last November.

Rentschler CEO Frank Mathias said his company is currently looking to hire up to 80 highly qualified new team members, such as lab technicians and bioprocess engineers, to support the Covid project.

Author: Dede Williams, Freelance Journalist