Senate investigation materials show changes to federal communications while studies into potential stroke risks continued.
By yourNEWS Media Newsroom
Federal health officials continued promoting COVID-19 booster shots for older Americans after internal monitoring systems identified a statistical signal linked to ischemic stroke, according to documents released by Sen. Ron Johnson.
In a letter sent Monday, Johnson told Health and Human Services Secretary Robert F. Kennedy Jr. that surveillance systems detected “statistically significant safety signals for ischemic stroke” in individuals who received the Pfizer bivalent booster as early as November 2022.
The disclosure was accompanied by nearly 2,000 pages of federal records released in multiple batches, including internal communications and data analyses related to vaccine safety monitoring.
According to Johnson, the White House subsequently modified draft federal messaging intended to increase booster uptake. He said edits were made to a communications plan developed by the Centers for Disease Control and Prevention and the Food and Drug Administration in January 2023.
The changes altered language describing the stroke signal, shifting from “moderately elevated” to “slightly elevated,” according to Johnson’s account in the letter.
At the same time, federal agencies publicly maintained their vaccination guidance.
“Biden health officials posted on FDA’s website that ‘no change is recommended in COVID-19 vaccination practice,’” Johnson wrote, while noting that internal efforts to study the signal continued through at least September 2025, including a project specifically focused on stroke risk.
The released materials indicate that officials acknowledged limitations in their ability to detect safety signals through available data systems, according to the Senate investigation.
Johnson requested additional information from HHS, stating that “the full extent of HHS’s awareness of the ischemic stroke safety signal remains incomplete and key records are still missing.”
Additional documents cited in the investigation describe federal officials addressing safety concerns related to combined COVID-19 and influenza vaccinations in 2023, as well as continued evaluations of booster-related risks using different analytical methods.
The records also reference prior agency actions involving further investigation into the stroke signal and subsequent assessments that relied on revised methodologies, as described in reporting that outlined earlier findings and documented additional analysis, along with reporting that described changes in evaluation methods.
The investigation materials focus on the timeline of internal findings, public communications, and ongoing studies related to vaccine safety monitoring.
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