CureVac Finalizing EU Supply Pact for COVID-19 Vaccine; Expanding Mfg
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics, is finalizing an agreement with the European Commission (EC) to supply its COVID-19 vaccine, CVnCoV, and is expanding its manufacturing capacity for the vaccine.
CureVac is finalizing an advanced purchase agreement for CVnCoV with the EC to provide European Union member states with up to 225 million doses of the vaccine with an option for an additional purchase of 180 million doses. CureVac will receive an upfront payment to support the advanced clinical development of CVnCoV, the ramp-up of its manufacturing network, supply preparations, and market launch (when approved).
CureVac is expanding its manufacturing capacity for the large-scale manufacturing of its COVID-19 vaccine and expects to increase its existing manufacturing capacity to up to 300 million doses in 2021 and up to 600 million doses in 2022. An additional large-scale production facility, supported by the European Investment Bank, at CureVac´s headquarters in Tübingen, Germany is currently in development. Clinical trial material is now provided by the company’s production capacities at its headquarters in Tübingen.
The company says it also expects to announce CDMO and supplier partnerships over the coming weeks (as reported on November 17, 2020). With these agreements, CureVac says its CVnCoV manufacturing network will have capacity across Germany, France, the Netherlands, Belgium, Spain and Austria as well as potentially Sweden, Poland, Italy and Ireland.
CureVac says it plans to initiate a pivotal Phase IIb/III clinical study for the vaccine by the end of 2020. It began development of the mRNA-based COVID-19 vaccine candidate in January 2020. A Phase I clinical study of CVnCoV began in June 2020 at clinical study centers in Germany and Belgium in collaboration with the Coalition for Epidemic Preparedness Innovation (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases. At the end of September 2020, CVnCoV entered a Phase IIa clinical trial in Peru and Panama and extended clinical studies into older adults and regions with high-incidence of COVID-19 infections.