by Brenda Baletti, Ph.D., Childrens Health Defense:
Among about 5 million Medicare beneficiaries who received the Pfizer or Moderna COVID-19 boosters, at least 11,001 had strokes within 90 days of receiving the vaccine. An FDA-backed study published Tuesday in the Journal of the American Medical Association said the flu vaccine, administered along with the boosters, caused the strokes.
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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.
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