Senator Ron Johnson Says Biden Administration Failed To Immediately Warn About Stroke Risk From Pfizer Vaccine

Senator Ron Johnson received nearly 2,000 pages of records showing that there was a known safety concern associated with the Pfizer-BioNTech bivalent COVID-19 vaccine that was not disclosed to the public. Senator Johnson alleges that the Biden administration downplayed the statistically significant risk of ischemic stroke while simultaneously reviewing the potential harms without notifying the public.

The safety signal was detected in October 2022 for individuals over 65 and persisted across multiple vaccine safety databases for months, yet the administration didn’t issue any public health alerts or change the booster recommendation guidelines. Senator Johnson said they were conducting independent studies behind closed doors and investigating the concern until at least September 2025, without ever reaching a conclusion.

There was a December 15, 2022 email from CDC official Michael Bell that was edited earlier in the day by Tom Shimabukuro. In the email, they flagged the safety signal and stated “wanting you to be aware, given the WH and HHS intense push to increase uptake of the booster in [the 65 years and older] age group.

Vaccine Safety Database monitoring continued to show a statistically significant association between individuals 65 and older and ischemic stroke throughout December and into January. CDC Director Rochelle Walensky received a draft “communications plan” that included edits to change “moderately elevated” to “slightly elevated,” an apparent attempt to downplay the association.

In February, an empirical Bayesian (EB) data mining analysis of VAERS data of the vaccine up to that point confirmed a statistically significant signal for ischemic stroke for the 65+ age group. That is despite a known “masking” effect that can occur, which was acknowledged by CDC officials in private communication. In an email published by Senator Johnson, Tom Shimabukuro said he is “perplexed” that there isn’t a safety signal for myocarditis and said, “I’m wondering if it’s getting washed out in the half million reports.”

In March, an independent contractor conducted two different data mining operations of the VAERS data and found a statistically significant link to ischemic stroke. The FDA reviewed summaries of three notable deaths that included a 13-year-old female, an 8-year-old male, and a 61-year-old male. The “healthy 8-year-old boy” was diagnosed with four cases of transient ischemic attacks after receiving the booster.

In April, 59 new cases of ischemic strokes were identified. Shimabukuro wrote to another CDC official in May that there is “insufficient data” to conclude that a safety problem exists with the Pfizer bivalent vaccine and ischemic stroke. In June, FDA officials claimed the previous safety signal for ischemic stroke had resolved in the agency’s quarterly surveillance report.

Despite multiple confirmations that there was a link between the Pfizer-BioNTech vaccine and patients 65 and older, the administration didn’t make any changes to its recommendations. Senator Johnson is now requesting additional documents to investigate why the Biden administration continued to recommend the booster shot before completing its review of the ischemic stroke safety signal.

In a letter to HHS Secretary Robert F. Kennedy Jr., Senator Johnson also asked that Dr. David Menschik, Dr. Tom Shimabukuro, and Dr. John Su be available for an interview with the subcommittee. He asked for all communications between administration officials about the decision to inform or not to inform the public, as well as all documents related to the safety signals and investigation. Senator Johnson asked that the information be produced as soon as possible, no later than April 6, 2026.

The communication plan shared by Zachary Stieber of the Epoch Times shows that the White House made several edits to the document, changing certain phrases, before communicating with reporters about the safety signal. The edits on January 11, 2023, show the White House asking, “But we found there was no risk?” in response to the document’s mention of a “potential risk.” A follow-up comment from Kamara Jones at HHS notes that they have now removed “potential risk” in favor of “preliminary signal.” In another section, the “statistical” signal was changed to a “preliminary” signal.

Another page shows that a phrase was omitted after Steven Anderson said, “This is an overly broad statement. I don’t think we should make it.” The omitted phrase appears in a section discussing the importance of transparency and stating that the agency will continue to review data to determine whether there is a true association.

In a section of the document discussing potential risks of myocarditis and thrombosis detected by vaccine surveillance systems, the White House asked for examples of “false flags” so “people can understand the value of the signals.”

Another document showed the Biden administration planned a private briefing with “trusted reporters” and “key vaccine experts,” including many who have received payments from vaccine manufacturers. The White House also suggested doing one story first to “see how it lands” before doing broader media outreach.  

The Epoch Times reported that officials later stated the safety signal appeared to result from receiving the influenza vaccine on the same day as the Pfizer bivalent COVID-19 vaccine.