Washington D.C. – A recent interim majority staff report, titled “Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals,” released by Senator Ron Johnson (R-Wis.), chairman of the Senate Permanent Subcommittee on Investigations, alleges that federal health officials were aware of a superior data-mining method that could have detected numerous COVID-19 vaccine adverse event signals but chose not to implement it. The report, accompanied by approximately 600 pages of internal FDA and HHS communications, claims this decision led to the suppression of critical safety information.
According to the report, FDA senior medical officer Dr. Ana Szarfman, in collaboration with Dr. William DuMouchel (the inventor of the FDA's original data-mining algorithm), developed and utilized an advanced method known as Regression-Adjusted Gamma Poisson Shrinker (RGPS). This tool reportedly identified over 20 statistically significant safety signals that the FDA's standard Multi-item Gamma Poisson Shrinker (MGPS) method failed to detect. These signals included serious conditions such as sudden cardiac death, pulmonary infarction, Bell’s palsy, acute myocardial infarction, embolism, thrombosis, and increased mortality.
The core issue highlighted is "masking," where the high volume of adverse event reports across multiple COVID-19 vaccines could statistically obscure signals for individual products when using the older MGPS method. Dr. Szarfman reportedly presented RGPS to FDA leadership in March 2021, emphasizing its ability to "unmask" these hidden signals. However, internal communications cited in the report suggest that senior FDA officials, including Dr. Peter Marks, then-Director of the Center for Biologics Evaluation and Research (CBER), expressed concerns that Dr. Szarfman's findings could "create erroneous conflicts that feed into anti-vaccination rhetoric."
The report further alleges that by September 2021, Dr. Szarfman was instructed to "cease and desist" her data analyses. Despite internal acknowledgments from other FDA staff, even in 2024 emails, that RGPS produced "significantly higher" and "way more sensitive" scores for serious events, the agency reportedly continued to use the older, less sensitive method. Senator Johnson stated, "The FDA knew that COVID injections were causing severe adverse events, including sudden cardiac death, pulmonary infarction, and Bell’s palsy. Americans had the Right to Know, and those affected deserve justice."
While the FDA's own clinical review for the Pfizer-BioNTech vaccine (BNT162b2) acknowledged Bell's Palsy as a "potential, but unconfirmed, infrequent adverse reaction" and myocarditis/pericarditis as a "rare but serious adverse reaction" identified through post-authorization surveillance, Senator Johnson's report argues that a more robust detection system was available and deliberately overlooked. This alleged failure to adopt advanced analytical methods and the subsequent silencing of internal warnings raise significant questions about the transparency and efficacy of vaccine safety monitoring during the pandemic, potentially impacting public trust and informed consent.
