The analysis also revealed that the risk is greater if a person receives a COVID-19 vaccine the same day as a high-dose or adjuvanted flu vaccine.
The Medicare-FDA analysis is the second study to have found a possible link between stroke and COVID-19 and flu vaccines, but the medical establishment still claims that the risk is small.
However, Cleveland Clinic cardiologist Dr. Steve Nissen declared that the "absolute risk is minuscule," especially compared to the risk for those over 85 of dying from COVID-19.
Marco Cavaleri, the head of the office of biological health threats and vaccines strategy at the European Medicines Agency, explained that administration of flu and COVID-19 vaccines at the same time is a common strategy with health officials who want to boost vaccine uptake and address any logistical burdens.
Like other so-called experts, Cavaleri said that he still wasn't convinced that the increase in stroke risk was real. He also noted that stroke and related health issues are more common among those aged 85 or older.
U.S. officials first reported a possible association sometime around 2022.
At the time, data from the Vaccine Safety Datalink suggested that Americans aged 65 or older might be at increased risk of an ischemic stroke, which interrupts the blood supply to the brain, within 21 days of receiving Pfizer's bivalent COVID-19 vaccine offered last fall.
The Vaccine Safety Datalink is a federal safety surveillance system.
In the recent study, researchers at the FDA and the CMS assessed stroke risk among nearly 5.4 million Medicare beneficiaries aged 65 years or older. The research team examined the health records of those who received a COVID-19 bivalent shot either on its own or along with the flu vaccine between Aug. 31 and Nov. 6, 2022.
An initial analysis did not find a statistically significant increase in stroke with the COVID-19 vaccines administered by themselves. When federal researchers broke down the data by age, they discovered an increased risk of stroke among those who were 85 years or older who received Pfizer's COVID-19 vaccine, and in those who were 65 to 74 who received Moderna's.
The link was most consistent when the bivalent COVID-19 vaccine was given at the same time as a high-dose flu vaccine or one containing an adjuvant, which is a chemical added to elicit a stronger immune response.
People who received both COVID-19 and flu vaccines experienced a 20 percent increase in the risk of ischemic stroke with Pfizer's bivalent vaccine and an increase of 35 percent in the risk of transient ischemic stroke after the Moderna bivalent vaccine.
The bivalent shots were replaced in September with new formulations.
The scientists also studied the link between the flu vaccine and stroke in nearly seven million Medicare participants who received a high-dose or adjuvanted flu vaccine. They discovered that there was a small but statistically significant increase of about nine percent in the risk of stroke after receiving the flu vaccine alone.
Another FDA analysis has revealed that there is a small increase in the incidence of seizures after COVID-19 vaccinations in children aged two to five.
While the papers were posted online last October, they are still not vetted for publication in a scientific journal. Experts in vaccine safety commented that the studies were well done.
According to experts, neither study is definitive and even if these links were confirmed, the increases are negligible and the benefits of vaccination still outweigh the risks, especially among the elderly. They added that both the flu and COVID-19 also raise the risk of stroke.
In a statement, FDA spokeswoman Cherie Duvall-Jones said that it was "making this information known at this time through publication of this paper for transparency."
Both studies are based on observational data, which are not enough to identify cause and effect. The FDA has plans to study the occurrence of seizures in children after vaccination "using a more robust design," added Duvall-Jones.
Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health, said that the findings indicate that the high-dose flu vaccine itself may be behind the increase in strokes observed in the study.
Federal researchers also calculated a separate measure called attributable risk, which is the increase in risk that can be attributed to the exposure. Except in people 85 or older, the attributable risk was roughly three additional cases of stroke for every 100,000 people who received the COVID-19 vaccine.
Salmon said the numbers are too small to warrant alarm, particularly since the diseases themselves also carry a risk of stroke. (Related: VAERS data show COVID vaccine deaths SURPASS those caused by other shots.)
Experts also insisted that they were not surprised or concerned by the findings regarding seizures among vaccinated children. Experts said that children are at much smaller risk of COVID-19 than older adults, so many parents have chosen not to vaccinate them. The low numbers make it challenging to study potential risks, they added.
Read more articles about the dangers of COVID-19 vaccines at VaccineDamage.news.
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