Witness Testimony

Deanna McLeod described her background in evidence-based medicine and guideline development, including work analyzing clinical trials and preparing guidance for oncology clinicians. She testified that “safe and effective” claims for COVID-19 vaccines were not supported by the level of evidence normally required for high-risk biologics, and she contrasted standard development timelines and precautionary testing with the compressed pathway used for COVID-19 vaccines.
She argued that regulatory changes enabled expedited authorization through measures such as rolling reviews, adaptive trial approaches, and authorization conditions that lowered the burden of proof from demonstrating safety and efficacy to providing evidence that could support a benefits-over-risks conclusion. She described perceived conflicts of interest driving regulatory reform, criticized limited and incomplete preclinical testing (including gaps she identified in reproductive, genetic, and cancer-related toxicity assessment), and highlighted trial design issues such as short follow-up, minimal active safety monitoring, and rapid placebo crossover that, in her view, reduced the ability to detect longer-term harms.
McLeod further discussed post-market safety monitoring, contrasting active versus passive surveillance and asserting that reliance on passive reporting substantially under-detects adverse events. She referenced findings she characterized as safety signals from multiple reporting systems and argued that risk-management approaches based on observational data cannot establish safety. She concluded by warning against proposed expansions of expedited regulatory pathways to broader drug and device categories, and she shared a personal account of her sister’s death following vaccination as part of her testimony about the human impact of these policy decisions.