CureVac N.V., a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), announced that its mRNA-based COVID-19 vaccine candidate, CVnCoV, remained stable and within defined specifications for at least three months when stored at a standard refrigerator temperature of +5°C (+41°F) and up to 24 hours as ready-to-use vaccine when stored at room temperature.
“Transport and storage of vaccines requiring ultra-low temperature setups to keep them stable, has been the topic of intense discussions and concerns in terms of feasibility, added costs and wastage,” said Dr. Florian von der Mülbe, Chief Production Officer of CureVac. “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 both to enable decentralized storage and to significantly facilitate large-scale vaccination efforts during the current pandemic.”
Storage of sample material, as well as analytical testing of CVnCoV was performed under standard conditions defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 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) .
CVnCoV 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.
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. The Phase 1 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). 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. CureVac plans to initiate a pivotal Phase 2b/3 clinical study by the end of 2020. Clinical trial material is provided by the company’s substantial production capacities for mRNA vaccines at its headquarters in Tübingen. The company is currently expanding those manufacturing capacities to allow for broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.
CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. It is headquartered in Tübingen, Germany, and employs more than 500 people at its sites in Tübingen, Frankfurt, and Boston, USA.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) develops guidelines and defines standards for drug development including methodologies to ensure efficacy, safety and quality of active drug substance and dosage forms over time and to establish shelf life or expiration period and to support label claims.