CureVac N.V. announced its strategic decision to adjust the long-term footprint of the external European manufacturing network for its mRNA product pipeline. The decision was made in response to the reduced short-term peak demand for vaccines following the first wave of the pandemic vaccination efforts and corresponding changes in the demand of its first-generation COVID-19 vaccine candidate, CVnCoV, currently under regulatory review with the European Medicines Agency (EMA). As a result, the existing contracts with WACKER for the manufacturing of the mRNA drug substance of CVnCoV and Celonic for the manufacturing and formulation of the mRNA drug substance of CVnCoV will be terminated. CureVac’s existing agreements with Rentschler Biopharma and Novartis for mRNA production and formulation are unaffected by this adjustment and remain in place. Streamlining of capacity does not limit availability of clinical trial material for CV2CoV, the second-generation COVID-19 vaccine candidate jointly developed with GSK, expected to enter the clinic in the fourth quarter of 2021.
“The continuous increase in mRNA manufacturing capacity together with the progress of large-scale vaccination efforts have strongly changed the demand for our first-generation COVID-19 vaccine, CVnCoV, over the last months,” said Dr. Malte Greune, Chief Operating Officer of CureVac. “The development from a very high, short-term pandemic demand to broader availability of vaccines has led us to re-evaluate our immediate manufacturing capacity requirements in order to align the capacity with actual commercial and clinical capacity needs for CVnCoV. We would like to thank both our manufacturing partners for their dedication and effort in achieving our common goal to combat the pandemic with this key technology.”
CureVac first announced the build-up of its broad external European manufacturing network in November 2020, next to the ongoing expansion of large in-house clinical and commercial manufacturing capacities. Since then, several manufacturing agreements were made with highly experienced Contract Development and Manufacturing Organization partners for each of the key manufacturing steps for CVnCoV. The agreements with WACKER and Celonic were cancelled within the agreed contractual termination provisions. The parties agreed not to disclose financial details of the cancellation.