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Genetic research

Development of a Novel Safety Assessment Method for mRNA Vaccines Based on Lung Biomarker Gene Expression

Strategic Insights

— 1 min read

Researchers from the National Institute of Infectious Diseases in Japan have developed a new safety assessment method for mRNA vaccines based on lung biomarker gene expression. The study, published in the journal Vaccine, examined the bioactivity and toxicity profiles of SARS-CoV-2 mRNA vaccines, including Spikevax and COMIRNATY. The researchers found that the 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.

Key Takeaways:

  • The study tested the bioactivity and toxicity profiles of SARS-CoV-2 mRNA vaccines, including Spikevax and COMIRNATY, using a biomarker-based evaluation system.
  • The researchers found that the 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.
  • The study identified novel biomarkers that could be used to evaluate mRNA vaccine quality by analyzing global gene expression.
  • The expression levels of some biomarkers (Psme1, Trafd1, Lgals9, Mx2) were significantly higher in the mRNA groups than those in the RE (Reference) group.
  • The mRNA vaccine groups exhibited significantly higher production of inflammatory cytokines than did the HA (Influenza Hemagglutinin) and RE groups.
  • Global gene expression analysis revealed the gene signature following mRNA vaccination and confirmed that most of the biomarkers were present in the set of genes that were upregulated in the mRNA vaccine groups.
  • The study concluded that the biomarker-based evaluation system is a valuable tool for assessing vaccine safety and quality control of mRNA vaccines.

Statistics:

  • 14 of the 15 biomarkers in the Spikevax group were significantly upregulated compared to those in the HA group.
  • None of the biomarkers in the HA group were upregulated in the RE group.
  • The expression levels of some biomarkers (Psme1, Trafd1, Lgals9, Mx2) were significantly higher in the mRNA groups than those in the RE group (4.2-fold, 3.5-fold, 2.8-fold, and 2.5-fold, respectively).
  • The mRNA vaccine groups exhibited significantly higher production of inflammatory cytokines than did the HA and RE groups (136.2 pg/mL vs. 123.5 pg/mL and 122.5 pg/mL, respectively).

Sources:

  • Development of a novel safety assessment method for quality control of mRNA vaccines based on lung biomarker gene expression. Vaccine, 2025;65:127805.
  • National Institute of Infectious Diseases, Japan Institute for Health Security, 4-7-1 Gakuen, Musashi-Murayama, Tokyo 208-0011, Japan.
  • Elsevier Sci Ltd, 125 London Wall, London, England.

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