Witness Testimony

Dr. Luz Maria Gutschi, a Doctor of Pharmacy and pharmacotherapeutic specialist with experience in regulatory review and intensive care practice, testified regarding the regulatory and manufacturing assessment of mRNA COVID-19 vaccines. She explained that although mRNA products meet regulatory definitions of gene therapy due to their nucleic acid mechanism of action, they were evaluated under vaccine regulatory pathways rather than gene therapy frameworks. She stated that this classification excluded them from certain long-term studies and testing requirements typically applied to genetic therapies.
Dr. Gutschi described concerns identified in European Medicines Agency (EMA) review documents, including manufacturing scale-up changes between clinical trial batches and commercial production, high levels of truncated and fragmented mRNA, variability in batch integrity, and outstanding obligations related to spike protein characterization. She testified that quality control standards used for large-scale commercial batches differed from those used in clinical trials and expressed concern that additional clinical verification was not required after manufacturing changes. She further discussed lipid nanoparticle stability, potential contamination with residual DNA, endotoxin, and other impurities, and variability in mRNA concentration within production vats.
She also testified that biodistribution studies were limited in duration and that pharmacokinetic, long-term metabolism, drug interaction, and genotoxicity assessments were not conducted under vaccine guidelines. Dr. Gutschi characterized the regulatory review process as insufficiently rigorous given the novelty and complexity of the platform. She concluded that regulatory agencies lowered critical quality thresholds to permit approval and stated that, in her professional opinion, the manufacturing and quality control standards did not meet what she would consider acceptable pharmaceutical practice.