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The flu vaccine — not the bivalent COVID-19 booster — increased stroke risk among elderly people who took the two vaccines at the same time, according to a study published Tuesday in the Journal of the American Medical Association (JAMA).
Researchers from the U.S. Food and Drug Administration (FDA) headed up the FDA-funded study, which was launched after the agency detected and reported a safety signal among older people taking the boosters in January 2023.
The FDA researchers analyzed data from Medicare recipients to assess the risk of stroke after taking the boosters and when taking them concomitantly with the flu shots.
Among more than 5 million Medicare beneficiaries who received the Pfizer or Moderna boosters, at least 11,001 of them had strokes within 90 days of receiving the vaccine.
“11,001 strokes within 90 days of receiving influenza/COVID-19 vaccines is an astronomical number of avoidable neurological events in our Medicare recipients,” cardiologist Dr. Peter McCullough told The Defender.
“These data should prompt a halt on administration of both vaccines until large-scale randomized trials can be performed in selected populations who would be at risk for hospitalization or death.”
The study analyzed the people who had strokes, using each individual’s data as their own “self-controlled” group.
That means they compared each individual’s risk of having a stroke within different time periods following vaccination. They used that comparison to determine whether vaccination could have caused their stroke and if so, whether it was the booster, the flu shot or the combination of the two that did it.
Strokes that occurred within 42 days of vaccination were deemed related to the vaccination and strokes that occurred 43-90 days post-vaccination were not.
The researchers did not include an unvaccinated control group. They also excluded people who had a stroke following vaccination but had been diagnosed with COVID-19 in the 30 days before their stroke.
The researchers found an elevated risk of non-hemorrhagic stroke or transient ischemic attack in people 85 or older following the Pfizer booster and people 65-74 following the Moderna booster in the first 42 days.
Then, when they analyzed the data of those people who had taken both a bivalent booster and a flu vaccine, they found the elevated risk of stroke persisted only among those who had taken the two vaccines at the same time.
They also found an elevated risk of stroke among those who took only the flu shot.
According to the study, “Among Medicare beneficiaries aged 65 years or older who experienced stroke after receiving either brand of the COVID-19 bivalent vaccine, there was no evidence of a significantly elevated risk for stroke during the days immediately after vaccination,” but there was a small association between stroke and flu vaccine.
“This finding suggests that the observed association between vaccination and stroke in the concomitant subgroup was likely driven by a high-dose or adjuvanted influenza vaccination,” they noted.
The researchers said more studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.
Adjuvanted flu vaccines are typically offered to everyone under age 65. High-dose flu vaccines are given to people over 65, who are at higher risk for flu and for whom the standard flu shot is reportedly not as effective.
A ‘nothing-burger’ study designed to obfuscate
An editorial in JAMA by Vanderbilt University’s Drs. Kathryn Edwards and Marie Griffin, who were not involved in the study concluded, “The study by Lu et al … illustrates the value of a timely, well-designed analysis and has provided reassurance about the COVID-19 boosters.”
Ongoing monitoring of influenza vaccines marketed for older adults, they added, will “provide additional data on stroke risk,” they added.
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense and co-author of “Vax-Unvax: Let the Science Speak,” told the Defender the study was an attempt to cover over the dangers of the vaccine.
“The only conclusion that they can make from this paper is that we don’t know if COVID-19 vaccination causes stroke but it doesn’t cause it more prevalently between 1-42 days as compared to 43-90 days after getting the shot,” Hooker said.
“In other words, you might have a stroke, but don’t worry, it won’t necessarily be early,” he added.
Hooker added:
“This type of nothing-burger study is designed to obfuscate the obvious issues with the COVID-19 vaccine which is thrombotic and has been linked to myriad clotting and heart disorders.
“By focusing on this bogus study, FDA shines the light away from their obvious omission of studies that actually provide answers regarding the sequelae to COVID-19 vaccination.”
FDA continued to recommend concomitant shots after safety signal
The Centers for Disease Control and Prevention (CDC) on Jan. 13, 2023, announced it had identified a preliminary safety signal for the bivalent boosters. The signal, identified through the CDC’s Vaccine Safety Datalink analysis, indicated an increased risk of ischemic stroke in people 65 and older who received Pfizer’s bivalent booster.
At a Jan. 26, 2023, meeting of the advisory committee to the U.S. Food and Drug Administration (FDA), officials from both agencies hypothesized the increased risk of stroke was connected to the simultaneous administration of the flu vaccine.
Despite the safety signal, the committee recommended boosters for older people. They also continued to say it was safe to take the two vaccines simultaneously. They said that because of the safety signal, the agencies would be doing further research into the issue.
“The evidence is not sufficient to conclude there is an association there,” the CDC’s Dr. Tom Shimabukuro said at the meeting. “And given that, I think talking about spacing the vaccine is premature and I’ll just reinforce that the CDC’s recommendation for COVID vaccination and for flu vaccination have not changed.”
The authors of the JAMA editorial noted that public health recommendations suggest the multiple vaccines be given at once as a strategy to increase vaccine uptake in general.
They add that in “some populations (such as in frail older adults) and when vaccines may be quite reactogenic, the tolerability and safety of concomitant administration should be evaluated,” before making such recommendations.
The JAMA study is not the first to find an increased risk of stroke associated with the flu vaccine in older adults. The editorial itself cited five different studies raising similar concerns.
However, Edwards and Griffin wrote, “From a population health perspective, a risk of serious outcomes of 1 per 100,000 vaccinated individuals would be more than balanced by the benefits of most recommended vaccines.”
They also noted the conclusion that the COVID-19 boosters were not related to increased risk of stroke was consistent with findings by researchers in France and Israel.
Following the safety signal reported by the FDA, French researchers analyzed data from the French National Health System to determine whether there was a signal for stroke 21 days following vaccination with the mono and bivalent boosters among people age 50 and over in France between Oct. 6 and Nov. 9, 2022.
They found no signal and reported their findings in a letter to the New England Journal of Medicine.
Israeli researchers analyzed data among people who took the bivalent booster between July 30, 2021, and Nov. 28, 2022, and found no safety signal for stroke. They reported their findings in The Lancet Infectious Diseases.
