Booster Shots May Trigger Stroke Incidents, According to CDC and FDA

In addition to cardiac events, another life-threatening side effect has been associated with the Pfizer-BioNTech vaccine. When is the risk period? Does the flu shot play any role in these events? What actions should we take to better protect ourselves?

Summary of Key Facts

An increased risk of stroke events has been identified with the Pfizer COVID-19 bivalent vaccine, according to a joint statement from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).

The onset time in people aged 65 years and older was 1–21 days after the booster, with a significant cluster of events observed 11–21 days after the booster.

Sixty-four percent had received the flu vaccine on the same day as the COVID-19 booster.

The bivalent booster contains the code of the spike protein, contributing to the increased risk of blood clots. High-risk people should avoid the boosters.

Solution: Remember the five “suddens” of stroke warning signs.

Advice on preventing other risk factors of stroke is also provided in this paper.

On Jan. 13, 2023, the FDA and CDC issued a joint statement that a new “safety signal” for ischemic stroke had been detected in one of the agency’s vaccine safety surveillance systems.

The statement read, in part: “CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 vaccine bivalent.”

The VSD system monitors the electronic health records of 12.5 million Americans served by nine integrated health systems.

The CDC stated that no other safety databases had detected this signal (including the Medicare and Veterans Affairs data sets). Pfizer released a statement that it had not detected this signal in its databases, and no other countries have found a similar signal in their monitoring systems.

The clot risk appears to be greater on days 11–21 after receiving the booster, especially for those who received a high-dose or adjuvant flu vaccine on the same day.

A follow-up meeting was held on Jan. 26, 2023. Despite the identified risk, the CDC continues to recommend booster shots for all people over six months of age.

Increased Risk of Stroke Mostly Found 11 to 21 Days After Booster

The findings presented on Jan. 26, 2023, suggest that more stroke events occurred during days 1–21 post-vaccination than days 22–42 after receiving the shot.

People aged 65 or older who received the Pfizer bivalent booster experienced 130 events during the “risk interval” (1–21 days after the booster) and 92 events during the “comparison interval” (22–42 days after the booster). There was a 47 percent increased risk of ischemic stroke during 1-21 days post-booster, compared to those events occurring during 22-42 days post-booster, with a p = 0.005. In studies, when the P value is less than 0.05, it means the difference is statistically significant.

It is important to note that stroke events occurred throughout the entire 42-day follow-up period after the booster; a cluster of stroke events occurred between 11 and 21 days after receiving the booster.

In a preliminary review of 22 stroke cases in people 65 years or older on days 11–21 after receiving the booster, none of the individuals had a previous history of transient ischemic attack (TIA). Sixty-four percent received the flu vaccine on the same day as the COVID-19 booster (13 high-dose flu vaccines and one adjuvant flu vaccine).

Outcome data of these events shows that 59 percent of the people who experienced a TIA were discharged home, 18 percent were discharged with home health, nine percent were discharged to a skilled nursing facility, and 14 percent (three of the 22) died. The CDC notes that one death was likely related to a stroke.

No safety signal was detected in the VSD database for Moderna; however, the VAERS reported stroke cases related to the Moderna booster. The difference could be due to the number of booster doses administered for the two vaccines. Nearly twice as many Pfizer booster doses had been given as Moderna (549,943 vs. 285,706) as of Jan. 7, 2023.

As of Jan. 8, 2023, 40 ischemic stroke/transient ischemic attack cases after the bivalent COVID-19 mRNA vaccination were detected in the Vaccine Adverse Events Reporting System (VAERS). The median age was 74 years. Nineteen were males, and 21 were females. The median time to onset was four days. Twenty-five cases occurred after the Pfizer-BioNTech bivalent vaccine, and 15 occurred after the Moderna bivalent vaccine.

Receiving a Flu Shot on the Same Day as the Booster Increases Risk

VSD data analysis showed that three people experienced a stroke after receiving the Pfizer booster and a standard dose of flu vaccine on the same day. By contrast, 40 people who received the Pfizer booster and a high-dose or adjuvant flu vaccine on the same day experienced a stroke. Sixty older adults experienced a stroke after receiving only the COVID-19 booster.

Receiving a high dose or adjuvanted flu shot on the same day seemed to double the risk of stroke.

The spike protein in the SARS-CoV-2 virus can significantly increase the risk of arterial and venous clots. A database analysis of 48 million individuals in the United Kingdom found an increased risk of ischemic stroke, especially in the first weeks after COVID-19 infection.

The mRNA vaccine also produces the spike protein. The bivalent booster contains the code for two strains of the spike protein (original Wuhan strain and BA.4/BA.5).

Your blood contains platelets, which form clots to stop bleeding after an injury. The S1 unit of the spike protein hyperactivates these platelets. This can cause the blood to form tiny clots after infection or vaccination. These blockages in blood flow can cause problems throughout the body’s tissues and organs.

The flu shot increases the risk of stroke, possibly because the vaccine provokes an inflammatory response. This increases the risk of ischemic stroke, especially in people with pre-existing coagulation abnormalities. A report from Taiwan indicated that a 75-year-old male patient suffered posterior circulation ischemia after an influenza A/H1N1 vaccination.

Remember the ‘FAST’ Rule

Ischemic stroke occurs when a blood clot blocks or narrows an artery that leads to or is inside the brain. A blood clot often forms in arteries damaged by the buildup of plaques (atherosclerosis). It can occur in the carotid artery of the neck as well as in other arteries.

After vaccination—at a very rare rate—if an adverse stroke event does appear, what signs can alert you in time?

There are five “suddens” of stroke warning signs. If you observe one or more of these signs of a stroke, don’t wait; call a doctor or 911 immediately!

Sudden numbness, weakness, or tingling of the face, arm, or leg, especially on one side of the body

Sudden confusion, drowsiness, or trouble talking or understanding speech

Sudden trouble seeing in one or both eyes, or double vision

Sudden trouble walking, dizziness, or loss of balance or coordination

Sudden severe headache, nausea, or vomiting with no known cause

Sometimes the signs may last only a few moments and then disappear. These episodes, known as transient ischemic attacks or TIAs, are called “mini-strokes.” Paying attention to them can be life-saving.

Remember the FAST (face, arm, speech, time) rule.

F ace drooping? Can’t smile
A rm weakness? Can’t raise above head
S peech difficulty? Can’t repeat simple nursery rhyme
T ime to call 911.

One or more of these signs—face weakness, arm weakness, and speech difficulty—are present in 88 percent of all strokes and TIAs. Getting to an emergency room quickly can save your life or the life of a loved one.

An intravenous injection of recombinant tissue plasminogen activator (rtPA) is the gold standard treatment for selected patients with ischemic stroke. An injection of TPA is usually given through a vein in the arm within the first three hours after a stroke.

Arriving at an emergency room as quickly as possible after noticing symptoms is critical to reducing the odds of disability. A successful rescue of stroke patients includes early identification of signs of stroke and medical care within the first hour of acute stroke.

Recommendations on Vaccinations

It may not be advisable for individuals vaccinated against COVID-19 and who experienced a stroke to take extra COVID-19 jabs such as boosters.

For now, this safety signal looks like a worrisome association with vaccination. Elderly individuals at high risk for severe COVID-19 should check with their physicians for the most appropriate guidance tailored to their risks, given that COVID-19 also increases the risk of stroke and other cardiovascular events for months after infection.

Carefully monitor individuals who received the COVID-19 vaccine or flu vaccine, especially those with high ischemic stroke risk.

https://www.theepochtimes.com/health/booster-shots-may-trigger-stroke-incidents-according-to-cdc-and-fda_5021604.html

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