The German government has granted pandemic preparedness contracts for the manufacturing and supply of mRNA vaccines to several bio/pharmaceutical companies and CDMOs.

Separate contracts have been granted to: (1) BioNTech, a Mainz, Germany biopharmaceutical company; (2) GlaxoSmithKline and CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger mRNA therapeutics and vaccines; (3) two CMDOs, CordenPharma and Wacker.

The German government awarded these contracts to secure vaccine production and supplies going forward following vaccine shortages initially experienced during the COVID-19 pandemic.

Contracts with biopharma companies
Under the preparedness agreement with BioNTech, the company will reserve and maintain manufacturing capabilities to produce at least 80 million mRNA-based vaccine doses per year. The contract has an initial term of five years (as reported on April 8, 2022).

Separately, under a contract with GSK and CureVac, following a setup period of a maximum of two years, the contract grants the German federal government access to CureVac’s manufacturing capacity until 2029 to enable availability of 80 million mRNA-based vaccine doses during the remainder of the current pandemic or in future infectious disease outbreaks.

In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on CureVac’s mRNA technology. This collaboration was later extended to the development of second-generation COVID-19 vaccine candidates and modified mRNA vaccine technologies

The German federal government will pay CureVac and GSK an annual standby fee after successful completion of the setup period, which requires the companies to maintain manufacturing capacity at constant readiness.

Contracts with CDMOs
Wacker and CordenPharma have also been granted a joint contract and say they are expected to manufacture 80 million vaccine doses per year if the COVID-19 pandemic continues or if a new pandemic occurs. Additionally, the German government has the option to increase the amount to 100 million doses per year. The two companies will receive an annual stand-by fee for keeping production capacity available. The stand-by phase starts in 2024, once the companies have created the necessary capacity, and ends in 2029.

Wacker has operated a biomanufacturing site in Halle, Germany, since 2014, and is expanding capacity for pandemic preparedness with a goal to expand production to a total of four production lines. Wacker says it intends to hire over 200 new employees as part of expansion. At the end of March 2022, Wacker announced that it would increase its biomanufacturing investments in the future, including plans to invest over EUR 80 million ($87 million) annually in the coming years (as reported on April 11, 2022).

At the Halle site, Wacker will produce plasmid DNA (pDNA), which is a starting material for the manufacture of mRNA and will also conduct formulation using lipid nanoparticles (LNP) of the mRNA active. The company says other Wacker sites will assist to establish the required technological expertise for the production of pDNA and mRNA in Halle.

CordenPharma will produce not only standard lipids, but also custom lipids for LNP formulation. In addition, CordenPharma says it will handle the aseptic filling and packaging of the mRNA vaccine produced and formulated in Halle. When needed, Wacker and CordenPharma say they will jointly supply the German government with 80 million or 100 million vaccine doses per year.

Wacker and CordenPharma will keep production capacity available from 2024, the start of the stand-by phase. Should the need arise, the German government will contact the developer of the specific mRNA vaccine that is required. Wacker and CordenPharma will then jointly produce this mRNA vaccine. Most of the production steps will take place in Germany and every production step will occur within the European Union.

Source: BioNTech, CureVac, CordenPharma, and Wacker