By Zachary Stieber
Contributing Writer
White House officials edited messaging on the finding that there was a higher-than-expected number of strokes following COVID-19 vaccination, according to newly released documents.
In January 2023, during the Biden administration, the White House changed wording on post-vaccination ischemic stroke from “moderately elevated” to “slightly elevated,” the records show.
Officials also made other changes, including removing the words “potential risk.”
“Edits reflected from the [White House],” health officials said in a Jan. 12, 2023, email to then-Centers for Disease Control and Prevention Director Dr. Rochelle Walensky. “They don’t want to see this document again.”
One official wrote that some of the changes were helpful, but “some of their other edits are overkill.”
Portions of the document were made public the following day, when the CDC announced that one of its monitoring systems had identified a safety signal for ischemic stroke (stroke caused by blood clotting) in people aged 65 and older following receipt of the Pfizer-BioNTech bivalent COVID-19 vaccine.
Other parts were labeled “tough questions and answers” and served as messaging utilized when officials briefed state health officials and others on the findings.
The CDC in early 2022 found hundreds of safety signals for the original COVID-19 vaccines from Pfizer and Moderna in a separate government database called VAERS, according to documents previously released. Safety signals are indications that vaccines may cause certain health issues.
U.S. officials in the fall of 2022 cleared bivalent vaccines from Pfizer and Moderna with no human data available.
The signal associated with the bivalent vaccines was first identified in November 2022, according to records released by Sen. Ron Johnson, R-Wis., chairman of the Permanent Subcommittee on Investigations.
“Wanting you to be aware given the WH and HHS intense push to increase uptake of the booster in that age group,” Dr. Michael Ball, a CDC official, wrote in a Dec. 15, 2022, email to colleagues at the CDC, referring to the White House and the Department of Health and Human Services, the CDC’s parent agency.
The Department of Health and Human Services did not respond to a request for comment by publication time.
“The records provide further evidence of the Biden administration’s awareness of and willingness to downplay the significant safety risks associated with the COVID-19 vaccines,” Johnson wrote in an emailed statement.
Second Signal Found
The CDC, in a joint statement with the Food and Drug Administration, said in January 2023 that the signal for ischemic stroke and Pfizer’s vaccine had appeared in the CDC’s Vaccine Safety Datalink, when comparing the number of strokes in elderly people within 21 days of receiving the vaccine to elderly people who had received a shot 22 to 42 days prior.
The signal was not found in other monitoring systems, and other countries had not identified signs that COVID-19 vaccination caused ischemic stroke, the agencies said at the time.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public,” they said.
The signal for ischemic stroke was still present in VSD in the weeks following the communication, but gradually tapered off, officials said later.
The documents released by Johnson showed that federal officials in March 2023 identified a signal for the Pfizer vaccine and ischemic stroke in a second system, VAERS.
Dr. Tom Shimabukuro, a CDC official, told a federal panel the next month that officials reviewed VAERS data and found “no evidence of a safety concern” for ischemic stroke.
Shumabukuro could not be reached for comment.
Risk Attributed to Influenza Vaccines
In his presentation to the federal panel on April 19, 2023, Shumabukuro said supplemental analyses indicated that the signal in VSD was primarily among elderly people who received an influenza vaccine on the same day as a Pfizer COVID-19 shot.
Forty cases of stroke occurred within 21 days among the elderly who received the vaccines on the same day, compared to 20 in the 22- to 42-day window following vaccination, the analyses found. For the elderly who received a Pfizer vaccine without a same-day flu vaccination, the cases were 60 and 58, respectively.
FDA researchers in a March 2024 study said they identified an elevated risk of non-hemorrhagic stroke in elderly people following vaccination with Pfizer and Moderna COVID-19 vaccines.
The risk only persisted among people who received an influenza vaccine at the same time as a COVID-19 shot, the researchers said, writing that the risk “was likely driven by a high-dose or adjuvanted influenza vaccination.”
Throughout the process, the government continued to recommend that virtually everyone aged 6 months and older receive a COVID-19 vaccine, including those who had been vaccinated before. They had also advised receiving an influenza vaccine at the same time as a COVID-19 vaccine.
“As safety signals for ischemic stroke appeared, Biden HHS officials continued to urge people to get vaccinated, jeopardizing the health of millions of Americans,” Johnson said.
In a March 22 letter to Health Secretary Robert F. Kennedy Jr., Johnson wrote that “from the initial detection of the safety signal in late 2022 … through at least September 2024, health officials continued to say the vaccine was safe while simultaneously searching for evidence to support that assertion.”
Johnson asked Kennedy to provide additional records, including records on the “Stroke Project” carried out by a CDC contractor. The senator also wants to interview Shimabukuro and several other officials who worked on vaccine safety.
