Concerns about the safety of COVID-19 vaccines have been a recurring theme throughout the pandemic and newly released documents suggest the Biden administration may have subtly altered public messaging regarding a potential link between the vaccines and an increased risk of stroke. Records indicate that White House officials edited communications about ischemic stroke—stroke caused by blood clots—following COVID-19 vaccination, changing the description from “moderately elevated” to “slightly elevated” and removing the phrase “potential risk.” This scrutiny of messaging comes as officials continue to emphasize the importance of vaccination, even as new data emerges regarding potential, albeit rare, adverse events.
The edits, first reported by Sen. Ron Johnson (R-Wis.), chairman of the Permanent Subcommittee on Investigations, occurred in January 2023, according to an email sent to then-Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky. The email stated, “Edits reflected from the [White House]. They don’t want to witness this document again.” While one official reportedly found some of the changes helpful, another believed “some of their other edits are overkill.” This incident raises questions about transparency and the balance between communicating potential risks and maintaining public confidence in vaccination efforts. Understanding the nuances of COVID-19 vaccine safety remains a critical public health concern.
Initial Safety Signal and White House Review
The CDC initially identified a safety signal for ischemic stroke in people aged 65 and older following receipt of the Pfizer-BioNTech bivalent COVID-19 vaccine. This signal emerged from the Vaccine Safety Datalink (VSD), a system used to monitor vaccine safety. The agency, in conjunction with the Food and Drug Administration (FDA), announced the finding publicly, but the initial communication was reportedly subject to review by White House officials. The edited document was intended to inform both the public and state health officials about the potential risk.
The timing of this signal is significant. According to the released documents, the initial indication of a potential issue with the bivalent vaccines was identified as early as November 2022. Dr. Michael Ball, a CDC official, wrote in a December 15, 2022, email to colleagues, expressing concern given “the WH and HHS intense push to increase uptake of the booster in that age group.” This suggests awareness within the administration of the potential safety signal coinciding with efforts to promote booster shots. The Department of Health and Human Services (HHS) did not respond to a request for comment on the matter.
Further Investigation and Conflicting Data
The CDC and FDA stated that while the signal appeared in the VSD, it was not observed in other monitoring systems, and other countries had not reported similar findings. They emphasized that the data “currently suggests that it is exceptionally unlikely that the signal in VSD represents a true clinical risk,” but acknowledged the importance of sharing the information with the public. However, further investigation revealed a similar signal in the Vaccine Adverse Event Reporting System (VAERS) in March 2023. VAERS is a passive reporting system, meaning reports are submitted by individuals and healthcare providers, and do not necessarily indicate a causal relationship.
Dr. Tom Shimabukuro, a CDC official, initially presented data to a federal panel suggesting no evidence of a safety concern regarding ischemic stroke. However, subsequent analyses indicated that the signal in the VSD was primarily observed among elderly individuals who received both a Pfizer COVID-19 shot and an influenza vaccine on the same day. Specifically, 40 cases of stroke occurred within 21 days among those who received both vaccines simultaneously, compared to 20 cases in the 22- to 42-day window following vaccination. For those who received the Pfizer vaccine alone, the numbers were 60 and 58, respectively.
Influenza Vaccine as a Contributing Factor
A March 2024 study by FDA researchers further refined the understanding of the risk. The study identified an elevated risk of non-hemorrhagic stroke in elderly people following vaccination with both Pfizer and Moderna COVID-19 vaccines, but found the risk persisted only among those who received an influenza vaccine concurrently. Researchers concluded the risk was “likely driven by a high-dose or adjuvanted influenza vaccination.”
Despite these findings, the government continued to recommend COVID-19 vaccination for nearly all Americans, including those previously vaccinated, and advised receiving influenza vaccines at the same time as COVID-19 shots. This consistent recommendation, even as safety signals emerged, has drawn criticism from some, including Senator Johnson, who stated that “Biden HHS officials continued to urge people to get vaccinated, jeopardizing the health of millions of Americans.” In a March 22 letter to Health Secretary Robert F. Kennedy Jr., Johnson accused health officials of continuing to assert the vaccine’s safety while simultaneously seeking evidence to support that claim.
Looking Ahead
Senator Johnson has requested additional records related to a “Stroke Project” conducted by a CDC contractor and has requested interviews with Dr. Shimabukuro and other officials involved in vaccine safety monitoring. The ongoing investigation aims to determine the extent to which the administration was aware of the potential risks and whether public messaging was appropriately tailored to reflect those risks. The FDA and CDC continue to monitor vaccine safety data and provide updates as new information becomes available. For the latest information on COVID-19 vaccines and safety, please visit the CDC’s COVID-19 vaccine website.
This situation underscores the complexities of balancing public health imperatives with the require for transparency and open communication about potential risks. As the pandemic evolves, continued vigilance and rigorous scientific investigation are essential to maintaining public trust and ensuring the safety of vaccination programs.
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