What are the biggest challenges for MVP?
MVP is partnering with several companies that are each responsible for different steps of vaccine development: production of raw materials, conjugation process, and production and distribution. This new model poses challenges in terms of: • Managerial and technical capabilities: The technical and managerial requirements to bring this vaccine to licensure will be a joint responsibility of MVP and the developing-country manufacturer (Serum Institute of India, Ltd. [SIIL]), as opposed to purchasing these services from an established vaccine manufacturer. • Monitoring: MVP will need to closely monitor process development and subsequent transfer of the technology to SIIL. • Clinical trials and licensing: There will be joint responsibility between MVP and SIIL for the conduct of clinical trials in Africa and for working with regulatory authorities to register the vaccine. • Flexibility: Should the epidemiological situation in the meningitis belt change, MVP will need to be flexible enough to
