Developmental strategy for a new Group A meningococcal conjugate vaccine (MenAfriVacR)

Until recently, periodic Group A meningococcal meningitis outbreaks were a major public health problem in the sub-Saharan Africa. In 2001, the Meningitis Vaccine Project (MVP), a partnership between the World Health Organization (WHO) and PATH, a Seattle-based NGO, and the Serum Institute of India P...

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Bibliographic Details
Published in:Human vaccines & immunotherapeutics 2018-05, Vol.14 (5), p.1103-1106
Main Authors: Kulkarni, Prasad S., Jadhav, Suresh S., LaForce, F. Marc
Format: Article
Language:English
Subjects:
Africa South of the Sahara - epidemiology
Disease Outbreaks - prevention & control
Drug Development - economics
Drug Development - methods
Drug Development - organization & administration
Europe
Group A meningococcal conjugate vaccine
Humans
India
International Cooperation
Meningitis
Meningitis, Meningococcal - epidemiology
Meningitis, Meningococcal - immunology
Meningitis, Meningococcal - microbiology
Meningitis, Meningococcal - prevention & control
Meningococcal Vaccines - economics
Meningococcal Vaccines - immunology
Meningococcal Vaccines - therapeutic use
Neisseria meningitidis, Serogroup A - immunology
PATH
Polysaccharides, Bacterial - immunology
SIIPL
Tetanus Toxoid - immunology
United States
vaccine development
Vaccines, Conjugate - economics
Vaccines, Conjugate - immunology
Vaccines, Conjugate - therapeutic use
WHO
World Health Organization
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Summary:Until recently, periodic Group A meningococcal meningitis outbreaks were a major public health problem in the sub-Saharan Africa. In 2001, the Meningitis Vaccine Project (MVP), a partnership between the World Health Organization (WHO) and PATH, a Seattle-based NGO, and the Serum Institute of India Pvt Ltd (SIIPL) initiated discussions aimed at establishing a collaboration to develop a Group A meningococcal conjugate vaccine for this unmet medical need. Over the next 8 years the partnership made countless strategic decisions about product characteristics, raw materials, potential target populations, geographic prioritization and affordability of the vaccine to name a few. These decisions evolved into detailed plans for preclinical development, extensive field trials in Africa and India and a focused regulatory strategy specific for the Men A conjugate vaccine. Important characteristics of the process included, flexibility, transparency andeffective partnerships that included public agencies as well as private companies in Africa, Europe, the United States and India.
ISSN:2164-5515
2164-554X
DOI:10.1080/21645515.2017.1391434