Under the terms of the initial agreement, Wacker will ramp up Good Manufacturing Practice (GMP) production of the messenger ribonucleic acid (mRNA) drug substance for CVnCoV at its biotech site in Amsterdam in the first half of 2021.
Preparations for the start of production, technology transfers and test runs are already underway.
The Tübingen, Germany headquartered CureVac said the plan is to produce more than 100 million doses of the CVnCoV per year at Wacker’s Amsterdam site. There is also further potential for expansion at the site in order to meet rising demand in the future, it added.
Wacker’s Amsterdam site has been producing vaccines for clinical development and commercial supply for 20 years - from conventional live and killed vaccines to protein-based, polysaccharide and glycoconjugate vaccines. In recent months, the CDMO has invested in the site to extend production to include mRNA-based vaccines.
CureVac is building an integrated European vaccine manufacturing network with several CDMO partners.
With this strategy, the company is expecting to significantly increase its existing manufacturing capacities for CVnCoV to up to 300 million doses in 2021 and up to 600 million doses in 2022, while managing potential supply chain risks.
"Geographic proximity is an important factor for facilitating alignment and technology transfers,” said Florian von der Mülbe, CureVac’s chief production officer, in a release.
An additional large-scale production facility supported by the European Investment Bank (EIB) at CureVac´s headquarters in Tübingen is currently in development. The EIB financing of €75m (US$89m) will be provided in three €25m tranches upon completion of pre-defined milestones.
CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus.
Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. Phase 1 interim data reported in November 2020 showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation.
The quality of immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection, said the developer.
And the company said the data support its decision to advance a 12μg dose in its upcoming pivotal Phase 2b/3 study, which CureVac plans to initiate before the end of 2020.
No storage headaches, significant EU Commission deal
The German group reported, earlier this month, that CVnCoV is suitable for standard refrigeration and the current cold chain distribution channel. It also said that its vaccine remains stable for at least three months at +5°C (+41°F) and up to 24 hours as a ready-to-use vaccine when stored at room temperature.
“We are very encouraged by the emerging stability profile of our COVID-19 vaccine candidate compatible with standard fridge-temperature storage as well as a required room temperature application. This compatibility has the potential to enable both decentralized storage and to significantly facilitate large-scale vaccination efforts during the current pandemic,” said von der Mülbe.
This month also saw the EU Commission reach an agreement with CureVac for up to 405 million doses of its vaccine, representing the biggest COVID-19 vaccine deal the Commission has inked so far.
The deal with CureVac is for 225 million doses with the option for an additional purchase of 180 million doses.