On April 29, 2026, a hearing before the US Senate Standing Subcommittee, chaired by Senator Ron Johnson, caused an earthquake in the world of pharmacovigilance. Among the witnesses was Dr. David Wiseman, Ph.D., Ph.D. in Science and Experimental Pharmacology from the University of Manchester, former head of research at Johnson & Johnson and expert in the regulation of medical products. His testimony, entitled Unmasked, is based on internal FDA documents recently made public by a FOIA request (equivalent to a CADA request for access to administrative documents) made by Senator Johnson to the US Department of Health (HHS). The result is a damning finding : the American health authorities were informed of critical failures in their system for monitoring the adverse effects of Covid-19 vaccines — and chose to do nothing.
Concrete evidence of deliberate inaction
For Dr. Wiseman, the stakes of this hearing go beyond the simple technical question. “I think this is the first time that we have really concrete evidence that within federal government officials, there was knowledge of the potential safety issues related to Covid-19 vaccines, and that they failed to act.”
This evidence comes from internal email exchanges made public following a subpoena from Senator Johnson and Secretary Kennedy’s decision to open 11 million pages of classified documents. At the heart of the case: two scientists, Dr. Dumouchel (Oracle), inventor of the statistical method used by the FDA to detect safety signals, and Dr. Anna Scharfman, a doctor and statistician within the FDA itself, who had collaborated with him on the design of this system more than twenty-five years ago.
“Masking”: when the numbers hide the truth
The central problem highlighted by Dr. Wiseman is called masking — masking. To explain this, he uses a clear analogy : imagine that we want to measure the toxicity of hemlock by comparing it to everything else, but that “ everything else “ includes arsenic. Mechanically, hemlock seems as dangerous as the average — or even less. This is exactly what happened with the data on myocarditis related to the Pfizer and Moderna vaccines: Moderna’s figures, which were themselves very high, were integrated into the comparison baseline, thus neutralizing the warning signal.
Even before the launch of the vaccines in December 2020, Dr. Scharfman had alerted her colleagues at the FDA to this flaw and recommended a corrected system developed by Dumouchel. She repeated her warnings throughout 2021. The institution’s response? An order to stop his analyses. Dr. Scharfman continued. “I am amazed that the system detects anything,” she wrote in one of the emails produced before the Senate.
A national alerting system out of service
The consequences of this inaction are quantified. In a preprint published in September 2024, Dr. Wiseman estimates that “about 700 lost signals” are the number of vaccine/adverse reaction associations that should have been detected — myocarditis, neurological disorders, bleeding disorders, and many others. However, the VAERS system was officially “described by the CDC on numerous occasions as the nation’s early warning system for vaccine safety”. His conclusion is clear: “The FDA’s early warning system, in my opinion, was disabled.”
The priority: not to fuel mistrust of vaccines
Why not correct the situation? The internal documents speak for themselves. According to Dr. Wiseman, internal FDA memos make it clear that “their primary concern was vaccine hesitancy.” Changing the analysis system in the midst of the vaccine rollout risked bringing out new signals – and therefore fuelling doubt. This logic of communication has taken precedence over the logic of health security.
Dr. Wiseman quotes a maxim from his former boss at Johnson & Johnson: “If you don’t process data, it will process you.” A warning that resonates far beyond American borders.
And Europe?
Asked about the implications for the Old Continent, Dr Wiseman is blunt: the same questions must be asked of the European agencies. The European Medicines Agency (EMA), the UK MHRA and national agencies use similar methods — the PRR system in particular — which can also suffer from masking. He calls on MEPs to demand answers: were their systems also biased during the massive rollout of Covid-19 vaccines?
Dr. Wiseman’s testimony may mark the beginning of a longer procedure. He submitted 248 questions to the FDA and is still waiting for answers. The Senate, for its part, now has evidence. The story is not over.
Interview conducted by Xavier Azalbert on May 9, 2026