Stability of live plague vaccine production: Analysis of potency using Shewhart charts
Biological Products. Prevention, Diagnosis, Treatment·
- DOI
- 10.30895/2221-996x-2026-753
- PMID
- —
- PMCID
- —
- OpenAlex
- W7203603149
- Study type
- Journal article
- Publisher
- SCEEMP
- Article type
- journal-article
- Integrity
- current
Why this research matters now
The findings indicate that statistical process-control methods were used to evaluate consistency of live plague vaccine potency during production. The supplied evidence does not establish clinical effectiveness, safety outcomes, population protection, or a current public-health threat.
Structured evidence summary
Research question
The study evaluated whether potency measurements and Shewhart control charts could be used to assess the stability of live plague vaccine production.
Study design
This was a retrospective analysis of potency quality-control data, using individual-value and moving-range Shewhart charts together with Pearson correlation analysis.
Population and setting
The analysis covered 121 live plague vaccine batches manufactured in the Russian Federation between 2012 and 2025. It used manufacturer summary protocols and results from a Testing Center.
Main findings
For 2012–2018, the control charts showed patterns classified as process instability, including observations or trends beyond control limits. For 2019–2025, after reported manufacturing-process optimization, fewer special-cause signals and longer periods within control limits were observed. Manufacturer and Testing Center potency results had a reported Pearson correlation of 0.7.
Public-health relevance
The findings indicate that statistical process-control methods were used to evaluate consistency of live plague vaccine potency during production. The supplied evidence does not establish clinical effectiveness, safety outcomes, population protection, or a current public-health threat.
Important limitations
The supplied material does not state study limitations. This summary relies on a single supplied article abstract and associated metadata; the original paper is required for decision-grade assessment of the methods, control-chart assumptions, process changes, data completeness, and interpretation of the correlation.
GIDS interpretation
The article is discoverable in a plague and vaccination context and concerns vaccine manufacturing quality control in the Russian Federation. These classifications and article findings do not confirm or characterize a live surveillance signal.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 5 auditable classifier relationships to diseases, places, topics, and study design.