Concerns Emerge Over COVID-19 Vaccine Safety
As we move further away from the COVID-19 pandemic, more troubling details emerge about how federal public health officials have handled safety issues related to the COVID-19 vaccine.
Investigations in the Senate have shown that officials from the Biden administration minimized the risks associated with vaccine-induced myocarditis—heart inflammation—and did not adequately warn the public about these risks. This situation has understandably led to a significant decline in trust towards health authorities.
Recently, Sen. Ron Johnson, R-Wis., who heads the Senate’s Permanent Subcommittee on Investigations, informed Robert F. Kennedy Jr., the Secretary of the U.S. Department of Health and Human Services, that records indicate Biden officials neglected to inform the public about serious safety signals regarding ischemic strokes—caused by blood blockages to the brain—among older adults who received the Pfizer COVID-19 bivalent booster.
Safety Signals Ignored
After examining roughly 2,000 pages of documents, Senate investigators disclosed that Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) officials were aware of these safety concerns but chose not to share them with the public.
In fall 2022, as noted in Johnson’s communication to Kennedy, CDC officials recognized a “statistically significant safety signal” linked to ischemic strokes in individuals aged 65 and older. Between November 2022 and March 2023, multiple analyses identified this early warning for the elderly population.
Johnson pointed out that records indicate federal health officials recognized a potential connection between the Pfizer booster and ischemic strokes as early as October 2022. Yet, despite identifying this safety issue, they did not issue any formal warnings or alter their recommendations for this demographic.
According to CDC communication, there were 226 reported stroke cases between August 2022 and February 2023, with more incidents surfacing in the following years. Acknowledging the limitations of the Vaccine Adverse Events Reporting System (VAERS), officials understood the necessity for deeper analyses. Consequently, in February 2023, HHS contracted a private firm to delve into the data more thoroughly under “The Stroke Project.”
Johnson noted that despite ongoing evaluations of the safety signal, recommendations for older adults receiving the booster remained unchanged. From the initial detection of the signal through various studies, health officials continued to assert the vaccine’s safety while searching for confirming evidence.
A communications plan addressing stroke-related vaccine concerns was developed, even including a segment for “Tough Questions and Answers” for President Biden and his team. Interestingly, the language in the final draft changed from indicating a “moderately elevated” risk for stroke to “slightly elevated,” suggesting an intent to minimize perceived risks. Johnson expressed uncertainty about who made these edits.
Rushed Decisions
House investigators reported in 2024 that the Biden administration expedited the booster program process without proper evaluations. When Biden announced on August 18, 2021, that booster shots would be available for all Americans, it was ahead of the FDA’s final review and CDC recommendations.
It’s worth noting that two senior FDA officials resigned, feeling the booster rollout should focus on the most vulnerable populations due to insufficient data for a broader recommendation. This led the House Select Subcommittee on the Coronavirus Pandemic to conclude that the Biden administration’s announcement of universal COVID-19 vaccine boosters lacked scientific support.
The failure to disclose the full scope of potential risks and benefits associated with the COVID-19 vaccines has seriously undermined public trust in federal health agencies. Currently, less than half of Americans have confidence in the CDC and FDA to operate without external influence.
Senator Johnson has requested Kennedy to provide all communications related to the identified stroke risks, records concerning the Lukos LLC “Stroke Project,” and any remaining analyses related to vaccine safety signals.
Kennedy has proposed sensible adjustments to the COVID-19 vaccine policy, aiming to align U.S. practices with broader international agreements. Unlike the previous administration, he is committed to “radical transparency” in working with Congress, so it seems likely he will comply with these requests.
However, it’s clear that restoring trust in federal public health will require substantial time and effort—an essential focus before any future pandemics arise.
