Next-generation potency tests for whole cell pertussis vaccines

The adoption of the intracerebral mouse potency test (MPT), commonly known as the Kendrick assay, as the standard batch release test for whole cell pertussis (wP) vaccines in the 1950s had an immeasurable impact on infant morbidity and mortality. Prior to that time, the benefit of wP vaccines in preventing whooping cough remained questionable. The establishment of a definitive link between the effective dose 50 (ED₅₀) in the MPT and vaccine efficacy in pediatric populations enabled regulators to ensure batch to batch consistency in wP potency prior to release. Even today the MPT remains the gold standard for batch release testing of wP-based combination vaccines used routinely in low- and middle-income countries. In the age of immunomics, however, it is hard to justify the continued reliance on a highly variable and arduous lethal challenge mouse model like MPT. In this review, we showcase efforts to replace the MPT with high-resolution serology tests and non-animal potency and stability indicating assays.

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