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Development of a novel safety assessment method for quality control of mRNA vaccines based on lung biomarker gene
Kou Hiraga1, Haruka Momose1, Wakako Kuribayashi1
1Center for Next-Generation Biologics Research, National Institute of Infectious Diseases, Japan Institute for Health Security, 4-7-1 Gakuen, Musashi-Murayama, Tokyo 208-0011, Japan.
Abstract:
In this study, we tested whether our previously developed biomarker analysis could evaluate the bioactivity of SARS-Cov-2 mRNA vaccines, including their toxicity profiles. We also identified novel biomarkers that could be used to evaluate mRNA vaccine quality by analyzing global gene expression. We administered saline (SA), an influenza hemagglutinin (HA) vaccine, a toxic reference influenza vaccine (RE), and different amounts of an mRNA vaccine (Spikevax or COMIRNATY) to mice, either intraperitoneally or intramuscularly. Sixteen hours post-administration, we analyzed mouse body weight (BW), white blood cell (WBC) count, plasma cytokine levels, and biomarker gene expression in the lungs. Moreover, we performed a comprehensive gene expression analysis using DNA microarrays. BW and WBC count in the mRNA vaccine and RE groups significantly decreased compared with those in the HA group. BW and WBC count between the mRNA vaccine and RE groups did not significantly differ. In contrast, analysis of the expression levels of 15 biomarker genes revealed that 14 of the 15 biomarkers in the Spikevax group and all biomarkers in the COMIRNATY group were significantly upregulated compared with those in the HA group. The expression levels of some biomarkers (Psme1, Trafd1, Lgals9, Mx2) were significantly higher in the mRNA groups than those in the RE group. Furthermore, the mRNA vaccine groups exhibited significantly higher production of inflammatory cytokines than did the HA and RE groups. Global gene expression analysis revealed the gene signature following mRNA vaccination and confirmed that most of our biomarkers were present in the set of genes that were upregulated in the mRNA vaccine groups. In addition, we identified novel genes with significantly increased mRNA expression levels. Our results suggest that this biomarker-based evaluation system is highly sensitive to mRNA vaccine bioactivity and is useful for assessing vaccine safety in the quality control of mRNA vaccines.
