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

Hum Vaccin Immunother. 2018 May 4;14(5):1103-1106. doi: 10.1080/21645515.2017.1391434. Epub 2017 Dec 1.

Abstract

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.

Keywords: Group A meningococcal conjugate vaccine; Meningitis; PATH; SIIPL; WHO; vaccine development.

MeSH terms

  • Africa South of the Sahara / epidemiology
  • Disease Outbreaks / prevention & control*
  • Drug Development / economics
  • Drug Development / methods
  • Drug Development / organization & administration
  • Europe
  • Humans
  • India
  • International Cooperation*
  • 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*
  • Polysaccharides, Bacterial / immunology
  • Tetanus Toxoid / immunology
  • United States
  • Vaccines, Conjugate / economics
  • Vaccines, Conjugate / immunology
  • Vaccines, Conjugate / therapeutic use
  • World Health Organization

Substances

  • MenAfriVac
  • Meningococcal Vaccines
  • Polysaccharides, Bacterial
  • Tetanus Toxoid
  • Vaccines, Conjugate
  • meningococcal group A polysaccharide