Drip, drip, drip. Three years after the COVID-19 pandemic, more details are being revealed concerning the failure of federal public health officials to come clean about lingering safety issues with the COVID-19 vaccine.
Senate investigators have conclusively proved, for example, that Biden administration officials downplayed the risk of vaccine-induced myocarditis (heart inflammation) and failed to warn the public. Widespread and dangerous loss of trust in public health authorities is thus hardly unsurprising.
Consider the latest. Sen. Ron Johnson, R-Wis., the indefatigable chairman of the Senate’s Permanent Subcommittee on Investigations, recently notified Robert F. Kennedy Jr., secretary of the U.S. Department of Health and Human Services, that records show that Biden officials failed to notify the public about “significant safety signals for ischemic stroke” (a blockage of blood to the brain) among patients aged 65 and older who had received the Pfizer Corporation’s COVID-19 bivalent booster.
Safety Concerns. After reviewing about 2,000 pages of records, Senate investigators revealed that officials from the Food and Drug Administration and the Centers for Disease Control and Prevention were aware of safety concerns regarding the booster but did not share this information with the public.
In the fall of 2022, as Johnson’s letter to Kennedy makes clear, CDC officials had become aware of a “statistically significant safety signal” for ischemic stroke for persons aged 65 and older. Between November 2022 and March 2023, seven separate analyses of the incoming data detected the stroke signal (an early warning) for the older population.
As Johnson told Kennedy: “HHS records show that as early as October 2022, federal health officials identified a potential connection between the Pfizer-BioNTech COVID-19 bivalent booster and ischemic stroke for individuals over the age of 65. However, after identifying the safety signal, federal health officials did not issue any formal warnings, such as a Health Alert Network(“HAN”) message, about their findings, nor did they pause or modify their recommendations for the affected population.”
Citing CDC communications, Johnson reports that between August 2022 and February 2023, there were 226 stroke cases. In 2023 and 2024, more stroke cases continued to surface. CDC officials, knowing the weaknesses of the Vaccine Adverse Events Reporting System (VAERS), clearly understood that the cases obviously required more detailed analyses, and thus, in February 2023, HHS hired Lukos LLC, a private firm, to undertake “The Stroke Project” and do a deeper dive into the data.
As Johnson observes, “Taken together the records … reflect an extended period in which federal health officials continued to evaluate a statistically significant ischemic stroke safety signal while leaving booster recommendations for adults aged 65 years and older wholly unchanged. From the initial detection of the safety signal in late 2022, through the contractor-led case review, VAERS data mining analyses, and follow-up VSD (Vaccine Safety Datalink) studies references in MMWR (Morbidity and Mortality Weekly Report) publications through at least September 2024, health officials continued to say the vaccine was safe while simultaneously searching for evidence to support that assertion.”
Federal officials developed a “communications plan” addressing vaccine-related strokes, including a section on “Tough Questions and Answers” for President Joe Biden and his White House team. Curiously, the final edits to the draft changed the original language to say that the safety signal for stroke was “moderately elevated” to “slightly elevated.” The obvious point was to downplay the risks. As Johnson notes, “It is unclear who provided this edit.”
Flawed Process. In fact, as House investigators reported in 2024, Team Biden rushed the process; a lesson in how not to move ahead with a universal vaccine booster program. On Aug. 18, 2021, Biden announced that the government would offer booster shots to “all” Americans, even before the FDA’s final evaluation and the Advisory Committee on Immunization Practices’ recommendations to the CDC.
In fact, as House investigators also noted, two senior FDA officials—Marion Gruber and Philip Krause—resigned because they felt that a booster program should be limited to the most vulnerable and that there was insufficient data at the time to recommend boosters for the entire population. That is why the House Select Subcommittee on the Coronavirus Pandemic concluded: “The Biden administration arbitrarily and without scientific support announced COVID-19 vaccine boosters would be available to all Americans.”
Failing to reveal the full story—the potential costs as well as the true benefits of the COVID-19 vaccines—has done enormous damage to trust in federal public health agencies. Today, less than half of all Americans have confidence in the CDC and the FDA to execute their core tasks without special-interest group or political influence.
Johnson has asked Kennedy to deliver all remaining department communications concerning decisions to inform the public about the risks of ischemic stroke; all records relating to the Lukos LLC “Stroke Project” report; and all remaining CDC and FDA records, especially those relating to deep-dive data analyses of vaccine safety signals for stroke.
Kennedy has made commonsense changes in COVID-19 vaccine policy, aligning U.S. practice with the broad international consensus on COVID-19 booster shots among our European friends and allies. In sharp contrast to the previous administration, Kennedy is committed to “radical transparency” in his dealings with Congress. So, there is little doubt he will deliver on this most recent congressional request.
Nonetheless, the crucial restoration in federal public health is going to take time and effort; this is a necessary task well before the onset of the next pandemic.