Saturday, September 18, 2021

Vaccine manufacturing greenhorn Bayer to make 160M doses of CureVac’s COVID-19 shot

In its nearly 160-year history, Bayer has never produced vaccines for humans. But the COVID-19 pandemic is changing that.

As part of a recently penned collaboration, Bayer will help manufacture German compatriot CureVac’s mRNA-based coronavirus vaccine, CVnCOV, in addition to aiding in R&D, regulatory affairs, supply chain management and potential marketing operations, Stefan Oelrich, Bayer’s pharma chief, said in a press briefing Monday.

To that end, Bayer plans to make 160 million doses of the CureVac shot in 2022, with the first commercial product expected to be made available at the end of this year. The vaccine entered phase 3 testing in December.

The work will be done at Bayer’s Wuppertal site in Germany, Oelrich said. The company recently inked a deal to sell a plant at the site to Chinese CDMO WuXi Biologics for €150 million, with COVID-19 vaccine production also featured as part of WuXi’s plan for use of the facility.

The plant being sold to WuXi is designed to make cell-culture-derived proteins, including vaccines, a Bayer spokesperson told Fierce Pharma. “We will now modify other facilities better suited to mRNA vaccine drug substance production,” the spokesperson said.

RELATED: mRNA latecomer CureVac recruits Bayer to speed COVID-19 vaccine to market

Before the CureVac pact, Bayer had never made vaccines for humans, but it figures its knowledge in the development of other biologics must mean something.

“Since the announcement of our alliance between Bayer and CureVac earlier this year, we have diligently assessed our ability to further contribute with end-to-end manufacturing,” Oelrich said in a prepared statement. “I am glad to report today that we have the necessary skills and capabilities at Bayer to manufacture CureVac’s mRNA-based vaccine.”

CureVac previously said it would supply “hundreds of millions” doses of its COVID-19 shot once it’s approved. The 160 million doses from Bayer will add to CureVac’s output.

RELATED: WuXi Bio lays out €150M to take over Bayer plant in Germany, boosting pandemic supply network

Meanwhile, CureVac is busy building out its global manufacturing network. Monday, the company and contract manufacturer Rentschler Biopharma said they have started setting up manufacturing at the latter’s site in Laupheim, Germany, to produce 100 million doses each year. Through a deal the two signed in November, the CDMO will contribute to manufacturing of active pharmaceutical ingredients, downstream processing and formulation for the vaccine.

Several Big Pharma companies have signed on to help young biotechs manufacture their COVID-19 vaccines. Fellow German mRNA player BioNTech has Pfizer as a partner on FDA-authorized Comirnaty, and Sanofi just offered to make 100 million doses of that shot. Novartis also recently said it’s in discussions with several companies to potentially support manufacturing of their COVID-19 vaccines, and soon after said it too had signed on to turn out BioNTech vaccines.

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