Sen. Ron Johnson, R-Wis., stated on Thursday that congressional investigators have uncovered evidence the FDA knew as early as 2021 its COVID-19 vaccine safety monitoring system was “completely inadequate.”
Johnson detailed findings from newly released federal documents he said point to a breakdown in transparency and oversight. The documents were obtained after years of limited access under the previous administration.
“Because of Health and Human Services Secretary Robert F. Kennedy Jr.’s dedication to radical transparency, we got about 11 million pages of documents that we weren’t getting from HHS under the Biden administration,” Johnson said.
According to Johnson, those records reveal internal warnings that were never fully disclosed to the public.
“We have now uncovered the fact that FDA officials knew in March of 2021 that their analytical system for the VAERS [Vaccine Adverse Event Reporting System] was completely inadequate and would mask significant safety signals,” he said.
Johnson emphasized that these officials had access to a more effective system capable of identifying those risks.
“They had a different system that would produce this information unmasked,” he said. “They presented that to top FDA officials.”
Instead of acting on those findings, Johnson alleged, officials chose not to highlight the data.
“And they covered it up,” he said, describing the decision-making at the agency.
Johnson pointed to what he called “49 cases of extreme masking, resulting in 25 safety signals” based on the internal analyses.
Those signals, he said, included serious conditions: “Sudden cardiac death, Bell’s palsy, pulmonary infarction — very serious side effects.”
He argued that the use of the flawed system allowed regulators to publicly maintain that no major issues had been detected.
“FDA officials hid behind their analytics that they knew would hide these safety signals to continue claiming, to this day, ‘We didn’t see any safety signals with the COVID injection,’” Johnson said.
Johnson also cited broader trends: “I saw deaths per year go from a couple hundred to over 20,000 the year the vaccine came out in 2021.”
Johnson indicated that his investigation is ongoing as more documents are reviewed.
