Witness Testimony

Hélène Banoun, a pharmacist-biologist and former Inserm researcher, testified regarding the scientific and regulatory classification of mRNA COVID-19 vaccines. She explained the immunological principles underlying conventional vaccines and contrasted them with mRNA platforms, which involve injection of synthetic genetic material directing host cells to produce spike protein. She argued that, based on definitions from the FDA and European Medicines Agency (EMA), mRNA vaccines meet the criteria for gene therapy medicinal products because their effects are mediated by transferred nucleic acid translated within the body.
Banoun presented a historical overview of regulatory decisions between 2007 and 2013 in which nucleic acid-based vaccines were excluded from gene therapy classification for infectious diseases. She contended that this exclusion allowed mRNA vaccines to bypass regulatory requirements typically applied to gene therapy products, including extensive biodistribution, pharmacokinetic, genotoxicity, reproductive toxicity, germline transmission, and long-term carcinogenicity studies. She further stated that preclinical and clinical trial timelines were unusually compressed, with overlapping phases and limited dose-optimization studies, and referenced concerns about product integrity and batch variability.
Her testimony also addressed reported biodistribution of lipid nanoparticles and spike protein throughout the body, potential transplacental and breast milk transfer, and alleged presence of DNA contaminants including SV40 promoter sequences. She concluded that mRNA vaccines represent a novel gene-based technology intended for widespread use in healthy populations and should therefore be subject to the full regulatory controls applied to gene therapy products, including long-term safety monitoring and comprehensive pharmacokinetic evaluation.