Nyon, 29th September 2020 – The Developing Countries Vaccine Manufacturers’ Network (DCVMN), with the support of a grant awarded by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), has established an international consortium of laboratories, to advance the in-house validation of a serological potency test for whole-cell pertussis-containing childhood vaccines.
Pertussis, commonly known as whooping cough, is a severe disease caused by the Bordetella pertussis bacterium. A cornerstone of routine childhood immunization programs around the world, pertussis-containing vaccines save hundreds of thousands of lives annually.
The project, budgeted at 750 thousand USD, aims to support the in-house validation of a serological assay (Pertussis Serological Potency Test – PSPT) to replace the Kendrick Test currently used for Pertussis potency testing. The PSPT benefits from increased reliability and reproducibility, ultimately reducing the cost of a single vaccine dose while sparing countless laboratory animals from the distress implied in the current test.
The DCVMN-led international consortium of twelve laboratories launched today, includes vaccine manufacturers and national control laboratories, joining forces for the 18-month study. The Senior Scientific Adviser and PSPT Steering Committee Chairperson, Dr. Christina von Hunolstein, at the Istituto Superiori di Sanità, noted that “strong scientific evidence will be crucial to adopt state-of-the-art testing and shaping future requirements for testing pertussis-containing vaccines. This requires a concerted effort among vaccine manufacturers and expert control laboratories.” Data and scientific evidence derived from the study will allow an open dialogue on the broader use of the in vitro testing.