The deals are aimed at ensuring long-term vaccine manufacturing capacity either for the current coronavirus pandemic or a future infectious disease outbreak: mitigating risks associated with potential supply bottlenecks in pandemic situations.
The companies all champion the ability of the mRNA technology to easily adapt to new coronavirus variants or other threats.
mRNA's potential for rapid response
The German government will pay CureVac and GSK an annual standby fee to reserve domestic mRNA vaccine manufacturing capacity until 2029, thus strengthening the country’s pandemic preparedness. Following a setup period of up to two years, the five-year contract will enable production of up to 80 million mRNA vaccine doses at short notice in case of a public health emergency.
Tübingen-headquartered CureVac is focusing on the development of new products based on second-generation mRNA tech with GSK, having dropped its first-generation COVID-19 vaccine candidate last year.
Last month, the second-generation mRNA COVID-19 vaccine candidate, CV2CoV, entered into Phase 1 clinical trials. This vaccine uses CureVac’s modified mRNA backbone, which ‘has the potential to be applied broadly in future vaccines against COVID-19 variants and other pathogens’, according to the company.
“Over the last two years, our social and economic lives as well as global healthcare systems and medical supply infrastructures were severely challenged by the COVID-19 pandemic,” said Dr. Franz-Werner Haas, CEO of CureVac. “This underscored the importance of having access to innovative technology platforms, such as mRNA technology, as well as corresponding robust manufacturing capacities to rapidly develop and deliver life-saving vaccines – particularly as a protective measure in case of future infectious disease emergencies. Considering the unpredictable and variant-driven course of the COVID-19 pandemic, we are fully committed to safeguarding public health today and into the future.”
“We welcome this announcement of the German federal government, which aims to strengthen the country’s preparedness against future pandemics,” said Roger Connor, President of Vaccines and Global Health, GSK. “Our mRNA development program in collaboration with CureVac could play a key role for pandemic preparedness thanks to adaptability of the mRNA technology and its potential for a rapid response, in combination with our significant vaccine manufacturing expertise.”
Addressing new variants
On Friday, a similar contract with BioNTech was announced: under which the German company will reserve and maintain manufacturing capabilities to product at least 80 million mRNA-based vaccine doses a year. The contract has an initial term of five years.
“There is growing evidence that viral pandemics will continue to pose a public health challenge for years. This contract with the German government will ensure significant supply of vaccine doses to address potential public health threats by 2027,” said Sean Marett, chief business and chief commercial officer at BioNTech.
“We are proud to be in a position to be a long-term partner for Germany and remain steadfast in our commitment to continued investments in research and development aimed at bringing new vaccine candidates against infectious diseases to people and adapting our COVID-19 vaccine to address potential new and emerging variants.”
Wacker and CordenPharma
Having presented a joint bid to the German government, Wacker and CordenPharma have also become part of the pandemic plan.
The two companies are able to cover the entire manufacturing chain for mRNA vaccines between them, with most steps in Germany and if not, within the EU.
They are together expected to produce 80 million doses a year if required, with the government having the option to increase this to 100 million doses a 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 biotech site on Weinberg Campus (a technology park) in Halle, Germany, since 2014. The capacity expansion for pandemic preparedness is part of a broader expansion project at the site.
The aim is to expand production to four lines; with the company hiring more than 200 new employees as part of its growth.
Wacker will produce plasmid DNA in Halle, as well as the mRNA based on pDNA. Formulation of Lipid NanoParticles (LNP) of the mRNA active will also take place there, while other sites will help establish the technological expertise.
CordenPharma, for its part, will produce not only standard lipids, but also custom lipids for LNP formulation. In addition, CordenPharma will handle the aseptic filling and packaging of the mRNA vaccine produced and formulated in Halle.