from Your News:
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.
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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.
