Marks the latest big pharma partnership for CureVac around its Covid vaccine candidate, CVnCoV
CureVac N.V. and Novartis AG have signed an initial agreement for the manufacturing of CureVac’s Covid-19 vaccine candidate, CVnCoV. Preparations for the start of production, technology transfers and test runs have already begun. Once the companies reach a final agreement, Novartis plans to manufacture the mRNA and bulk drug product of CVnCoV for up to 50 million doses by the end of 2021, and up to an additional 200 million doses in 2022. Delivery from the manufacturing site in Kundl, Austria, is expected to start this summer.
CureVac started building an integrated European vaccine manufacturing network with various contract development and manufacturing organization (CDMO) partners in the fall of 2020. So far, CureVac is working with Bayer, GlaxoSmithKline and Fareva, among others.
The vaccine has been in Phase IIb/III clinical trials since December. And as of last month, CureVac has started a rolling review with the European Medicines Agency (EMA).
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.