In that context, the Tübingen, Germany headquartered biopharma company, CureVac, announced today that its mRNA-based candidate vaccine, CVnCoV, is suitable for standard refrigeration and the current cold chain distribution channel.
In addition, it reported 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.
Dr Florian von der Mülbe, chief production officer, CureVac, said: “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.”
Storage of sample material, as well as analytical testing of its mRNA vaccine was performed under standard conditions defined by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The German group said stability of the liquid drug product of CVnCoV was tested at the anticipated storage concentration and stored at +5°C (+41°F) as well as below -60°C (-76°F) .
The vaccine candidate fulfilled all set release specifications at both temperatures after three months; the stability study is ongoing with the goal to further evaluate the potential for a longer commercial product shelf-life, said the developer.
Clinical trial work
CureVac began development of its mRNA-based COVID-19 vaccine candidate in January this year. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus.
The Phase 1 clinical study of CVnCoV began in June 2020 at centers in Germany and Belgium in collaboration with the Coalition for Epidemic Preparedness Innovation (CEPI).
At the end of September 2020, CVnCoV entered a Phase 2a clinical trial in Peru and Panama, extending clinical studies into older adults and regions with high-incidence of COVID-19 infections.
It is planning to initiate a pivotal Phase 2b/3 clinical study by the end of 2020.
German government support
CureVac was one of three companies that received financial backing from the German government in September to accelerate their Covid-19 vaccine development, as well as upscale domestic manufacturing capabilities.
The German authorities announced then a €750m (US$890m) fund to support the vaccine programs of CureVac and two other domestic developers, BioNTech and IDT Biologika.
German minister for health, Jens Spahn, speaking at a press conference about the funding initiative, said it was not “about being first. Rather, we want an effective and safe vaccine."