A Senate investigation claims Biden-era FDA officials sidelined internal warnings about COVID-19 vaccine adverse events while major media outlets focused on defending vaccine safety studies later challenged over methodology and conclusions.
By yourNEWS Media Newsroom
A congressional investigation led by Ron Johnson alleges officials inside the Food and Drug Administration suppressed internal COVID-19 vaccine safety findings and discouraged publication of adverse-event analyses that identified statistically significant injury signals during the pandemic.
According to a report by Just the News, the Senate Permanent Subcommittee on Investigations reviewed internal Department of Health and Human Services records indicating senior FDA officials marginalized alternative vaccine safety analyses while major media organizations devoted extensive attention to defending disputed FDA-backed vaccine safety studies.
Johnson previewed the findings before an April 29 hearing alongside an interim staff report based on documents provided by HHS.
The investigation centers heavily on FDA senior medical officer Ana Szarfman, who reportedly developed an updated methodology for vaccine safety surveillance that identified approximately 25 statistically significant adverse-event signals the FDA’s default monitoring system failed to detect as early as March 2021.
Szarfman developed the methodology with the creator of the FDA’s existing data-mining algorithm, according to the Senate report.
The findings allegedly revealed a growing number of adverse events — including deaths — following COVID-19 vaccination.
According to the investigation, Szarfman repeatedly presented the findings to senior agency officials after “unmasking” adverse-event signals inside the FDA’s surveillance systems.
Internal communications reviewed by investigators reportedly show one senior official urging colleagues to avoid email communications while discussing how to respond to Szarfman’s concerns.
Officials inside the FDA’s Center for Biologics Evaluation and Research allegedly instructed Szarfman to “hold off on creating and sending data mining reports and analyses.”
Then-CBER Director Peter Marks reportedly warned then-Center for Drug Evaluation and Research Director Patrizia Cavazzoni that Szarfman’s work could “create erroneous conflicts that feed in to anti-vaccination rhetoric.”
The Senate findings emerged alongside controversy surrounding two separate FDA-sponsored COVID vaccine safety studies that were ultimately withdrawn from peer-reviewed publication during the Trump administration.
According to HHS, the studies were halted because FDA officials and pharmaceutical consultants involved in the projects allegedly “drew broad conclusions that were not supported by the underlying data.”
One proposed study submitted to Drug Safety analyzed Medicare beneficiaries age 65 and older. Another proposed study submitted to Vaccine examined commercial health plan enrollees ages six months through 64 years.
The second study included every author involved in the 65-and-up study in addition to 15 others, including former FDA Office of Biostatistics and Pharmacovigilance officials.
The controversy drew major media attention after STAT News reported in November on internal disputes involving former CBER Director Vinay Prasad and acting CDER Director Tracy Beth Hoeg over what critics described as weak methodology in FDA-backed research.
Meanwhile, The New York Times reported Tuesday that FDA staff were directed in October to withdraw the studies from journals that had accepted them for publication.
The reports fueled criticism from former FDA officials and outside researchers who argued mainstream media organizations ignored Johnson’s Senate investigation while aggressively defending disputed vaccine safety research.
Former FDA regulatory review officer Jessica Adams publicly criticized the imbalance in media coverage.
“No such energy for Dr. Sztarfman’s studies,” Adams wrote on X while criticizing New York Times reporting on the withdrawn studies.
“Which is worse: FDA declining to publish two studies over methodological concerns and overstated conclusions, or senior officials directing their own data-mining expert to ‘cease and desist’ an alternative safety data-mining approach because it could ‘create erroneous conflicts that could be used to feed into anti-vaccination rhetoric’?” Adams added.
The controversy also intensified scrutiny surrounding the statistical methodology used in the disputed vaccine studies.
Both papers relied on a “self-controlled case series” design, a methodology described in a 2016 British Medical Journal analysis as a model where patients effectively serve as their own control groups.
Critics argue the methodology becomes problematic in vaccine safety research because people often delay vaccination when ill, artificially lowering observed adverse-event rates immediately following vaccination.
Former New York Times pharmaceutical industry reporter Alex Berenson criticized the methodology as producing a built-in bias favoring vaccine safety conclusions.
“Thus the days immediately following vaccination are likely to see a DROP in serious side effects,” Berenson wrote, arguing the design would require extremely severe vaccine injuries to overcome the statistical bias.
“The people talking to Christina Jewett certainly know that inherent flaw makes the study basically useless. Does she?” Berenson wrote.
The New York Times article by reporter Christina Jewett did not mention Johnson’s Senate investigation despite her FDA reporting role, critics noted.
Jewett’s report also did not discuss questions surrounding authorship disclosures involving former FDA Office of Biostatistics and Pharmacovigilance Director Steven Anderson.
According to Anderson’s LinkedIn profile, he left the FDA in December 2024 before launching a pharmaceutical consultancy in March 2025.
However, the 65-and-up study preprint continued listing Anderson as affiliated with the FDA, while a trade association biography described him as having directed the office “until” January 2025.
Former Senate pharmaceutical investigator Paul Thacker accused major media outlets of ignoring potential conflicts of interest and political dynamics surrounding the studies.
“Shouldn’t the NY Times do a journalism and report the blatant politics, instead of pretending this is ‘science’?” Thacker wrote on X.
Meanwhile, Jay Bhattacharya has separately criticized what he describes as weak evidentiary standards in federal COVID vaccine research.
Bhattacharya previously halted publication of a CDC study in the agency’s Morbidity and Mortality Weekly Report journal that concluded updated COVID vaccines protected healthy adults against severe illness.
Critics have long questioned the reliability of MMWR publications, arguing the journal frequently published research supporting Biden-era COVID policies despite methodological weaknesses.
Just the News previously reported on criticism directed at Bhattacharya and acting CDC leadership after they challenged COVID vaccine research standards inside HHS.
The outlet also reported on earlier disputes involving CDC pandemic research and questions surrounding pediatric COVID vaccine studies.
Jeffrey Morris, who reviewed the disputed studies at Jewett’s request, later stated publicly that important methodological limitations and concerns were omitted from the Times coverage.
Morris wrote on X that the papers likely could have been published if unsupported conclusions claiming vaccine “benefits outweighed the risk” had been removed.
He also argued that large-scale studies involving millions of patient records remain valuable tools for evaluating potential vaccine harms.
The Senate investigation remains ongoing as lawmakers continue examining FDA internal communications, COVID vaccine surveillance systems, and allegations that agency officials suppressed or minimized adverse-event findings during the pandemic.
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