FAILURE TO DISCLOSE
Safety Signals, Scientific Transparency, and the Erosion of Informed Consent in the COVID-19 Vaccine Rollout
On April 26, 2026, Senator Ron Johnson released an explosive and damning report from the U.S. Senate Permanent Subcommittee on Investigations titled Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals.
The report centers on Dr. Ana Szarfman, who at the time was a senior medical officer and safety data mining developer at the Food and Drug Administration (FDA), and how her warnings about safety signals for adverse events associated with the COVID-19 vaccines during the nationwide rollout were initially ignored; she was later asked to stop her data analysis altogether.
According to the FDA website, data mining refers to “the use of complex data analytics to discover patterns of associations or unexpected occurrences (‘signals’) in large databases. When such signals are identified, they can then be evaluated for potential intervention as appropriate, such as further assessment (‘signal refinement’), labeling revisions, and hypothesis testing studies. Much of the data mining work at FDA involves detecting safety signals among adverse events reported to the Agency.”
Dr. Szarfman, a known expert in data mining, was using a newer methodology for evaluating COVID-19 vaccines; one that reduced masking. Masking is a “known data limitation with FDA’s current data mining method that can inhibit the detection of safety signals for adverse events,” according to the report.
The newer data mining methodology that Dr. Szarfman was using, in conjunction with Dr. William DuMouchel, then Chief Statistician at Oracle, was significantly more effective at uncovering safety risks associated with the COVID-19 vaccines. It identified approximately 25 statistically significant safety signals not previously detected by the FDA’s existing methodology; including risks such as sudden cardiac death, acute myocardial infarction, embolism/thrombosis, dementia, Bell’s palsy, and pulmonary infarction.
As highlighted in Chairman Johnson’s report on myocarditis and COVID-19 vaccines, on May 24, 2021, draft notes from a meeting involving federal health officials included the question: “Is the Vaccine Adverse Event Reporting System (VAERS) signaling for myopericarditis?” The answer stated: “For the age groups 16–17 years and 18–24 years, yes.” Despite this clear acknowledgment of a myopericarditis signal, federal health officials did not immediately warn the public about potential cardiac risks associated with the vaccines.
Dr. Szarfman repeatedly brought attention to her and Dr. DuMouchel’s findings to senior FDA officials in 2021. However, rather than pause distribution of the vaccines or issue public communications with updated safety information, records indicate that officials were concerned about “creating erroneous conflicts that feed into anti-vaccination rhetoric,” as cautioned by Dr. Peter Marks, a strong supporter of the vaccines. Instead, senior FDA officials instructed Dr. Szarfman to “hold off” on generating and distributing their analyses.
Throughout 2021 and into 2022, Dr. Szarfman continued to raise concerns to senior FDA officials, advocating for the use of the newer methodology to better identify what she described as an “increased mortality signal” associated with the COVID-19 vaccines. She eventually co-authored a paper published in Drug Safety in June 2022, which discussed their data mining techniques and noted that masking is “roughly eight times more likely to occur with COVID-19 vaccines than with other vaccines.”
No substantive action was taken. Notably, Dr. Szarfman and Dr. DuMouchel’s data mining research had been relied upon by the FDA for over two decades; until the COVID-19 vaccines.
In September 2021, Dr. Szarfman was instructed to “cease and desist” conducting data mining on COVID-19 vaccines. This was followed by restrictions on the distribution of FDA COVID-19 vaccine data mining reports, ultimately leading to their complete discontinuation. Various explanations were offered, but one CDC official stated, “I think that because of the FOIAs (Freedom of Information Act requests), we may have asked FDA to stop sending these weekly data mining outputs.” Indeed, several FOIA requests had been submitted to the CDC and FDA; including requests from Children’s Health Defense, Senator Ron Johnson, and the Informed Consent Action Network in the weeks leading up to the FDA’s decision.
Why is this important?
The report centers on the claim that the FDA, and to some extent the CDC, did not act on or disclose emerging safety signals during the early rollout of COVID-19 vaccines. During the first month of availability, from December 2020 through January 2021, approximately 13 million Americans received at least one dose of either the Pfizer or Moderna vaccine. By May of 2023, approximately 270.3 million Americans had received at least one dose of the vaccine. Very few got true informed consent.
There are significant implications for informed consent. The report raises concerns that:
Known limitations in surveillance systems were not adequately conveyed or addressed
Emerging safety signals were not sufficiently developed or communicated
Intentional withholding of risk information may have undermined the ethical standard of informed consent
In clinical ethics, informed consent requires both:
Disclosure of known risks, benefits, and alternatives
Disclosure of uncertainty and limitations of knowledge
This report suggests that uncertainty itself may not have been adequately disclosed; this is ethically significant.
There also appears to have been a lack of scientific and procedural transparency:
A more sensitive safety signal detection method was available but not adopted; the rationale remains unclear
A senior FDA scientist was ordered to “cease and desist” work consistent with her established role for decades
Emerging safety signals were not publicly disclosed
There was a misalignment between internal uncertainty and external messaging; “safe and effective” remained the public mantra
Additionally, there appears to have been a prioritization of population-level outcomes over individual autonomy:
The report indicates that rapid vaccine uptake across the population was emphasized over individualized informed consent.
This report does not, on its own, establish definitive causation or misconduct, as it is an interim majority staff report. However, it provides a foundation for examining potential ethical and procedural failures during the COVID-19 vaccine rollout, as well as areas for future improvement.
To maintain ethical medical practice, institutions should:
Disclose uncertainty explicitly
Clearly communicate limitations in available evidence
Preserve independent clinical judgment alongside institutional guidance
Prioritize transparency and individual autonomy over the general population
As a reminder to newer readers, MMFA took the lead during the 2025 Montana legislative session in efforts to ban mRNA vaccine platforms for both human and animal use. House Bills 371 and 418 were sponsored by Representative Greg Kmetz of Miles City. We recognize his leadership and willingness to critically evaluate the issue in the interest of public safety. The effort was supported by local physicians, citizens, ranchers, and physicians of the Independent Medical Alliance (formerly FLCCC). Despite this collaboration, the bills were not passed. However, we are not deterred and will continue our work toward restoring integrity to healthcare in Montana.