Witness Testimony

Dr. Joseph Fraiman, an emergency physician and clinical scientist specializing in harm–benefit analysis, testified regarding his published reanalysis of the Pfizer and Moderna mRNA vaccine clinical trial data. He explained that while the original trials demonstrated reductions in symptomatic infection and some reduction in COVID-19 hospitalization, the hospitalization benefit was small in absolute terms and based on approximately two months of blinded data before unblinding occurred.
He described his team’s analysis of serious adverse events (SAEs) and “adverse events of special interest” (AESIs), using definitions consistent with regulatory documentation and the Brighton Collaboration framework. He testified that when serious adverse events were summed by total event count rather than only by participant count, the vaccine groups demonstrated an increased rate of serious adverse events compared to placebo. He emphasized that these findings suggest a narrow margin between measured harms and measured COVID-19 hospitalization reduction in the early trial period.
Dr. Fraiman further testified that observational data during the Omicron period were increasingly unreliable due to incidental COVID hospitalizations and declining vaccine efficacy against infection. He stated that waning efficacy, high rates of prior infection, and variant changes complicate harm–benefit calculations over time. He concluded that current uncertainty regarding long-term risk–benefit balance could only be resolved through properly designed, double-blind randomized controlled trials measuring all-cause hospitalization or mortality rather than disease-specific endpoints.
When questioned about regulatory approval, he stated that emergency authorization was granted during a period of high uncertainty and public fear, and that in hindsight he would have preferred more complete data, particularly for individuals under age 65.