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The US Food and Drug Administration announced yesterday (Sunday) together with the Centers for Disease Control and Prevention (CDC) that there is a possibility of a link between Pfizer's corona vaccines and strokes in adults.
Both bodies said that on Friday, a monitoring system found a possible problem with the company's updated corona vaccines, when it examined the CDC's database.
From the database it emerged that those 65 and older who received the vaccine were more likely to have a stroke in the 21 days after.
The FDA and the CDC said that other studies done on the subject and databases of other countries did not find a similar effect of the vaccine, and therefore the matter requires further investigation.
So what does the report really say and should we be concerned?
We dived into the few published details and asked experts what they thought.
Here are some of the things that came up:
Let's start with the American health authorities who stated that "although the totality of the data currently does not indicate that this is a real clinical risk, we believe it is important to share this information with the public."
The health authorities said that this concern is not found in Moderna's corona vaccines.
The authorities also recommended that every person six months of age and older should continue to get vaccinated against Corona if necessary.
The companies Pfizer and BioNTech that created the vaccines said in a statement that they learned about the new finding, but added that "similar findings have not been observed from other monitoring systems in the United States and the world, and there is not enough evidence to conclude a connection between the corona vaccine and stroke."
do not panic
So let's put the latest announcement in proper perspective.
The CDC found in their Vaccine Safety Datalink (VSD) surveillance system that in those 65 and older, a higher-than-expected number of people had an ischemic stroke within 21 days (versus 22 to 44 days) of receiving the Pfizer booster vaccine.
They did not find the same increase in other corona vaccines as the Moderna booster.
It is important to understand that this observed increase in ischemic stroke alone does not prove anything, and it is not enough to conclude that the Pfizer vaccine somehow caused the additional strokes.
Just because things happened at the same time, doesn't mean they were necessarily related, and the slight increase in ischemic stroke could have been completely coincidental.
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To the full article
Does the vaccine cause a stroke?
Brain imaging photo (Photo: ShutterStock)
"The FDA reports that in one of the ways of monitoring the safety of vaccines, there was a concern about a possible link between the new bivalent vaccine against corona (containing the original sub-strain and the micron strain) from Pfizer and stroke events in people over 65 years old 21 days after the vaccine," explains Dr. Oren Kobiler, a virologist and senior lecturer at Tel Aviv University's School of Medicine and a member of the Madaat association. The information found is inconclusive, since various factors that could influence the results have not yet been tested."
Dr. Kobiler added that the FDA issued a notice to the public in order to allow full transparency, but there is no change in the recommendations and currently the likelihood that the vaccine actually causes this phenomenon is not very great.
This publication proves the effectiveness and importance of monitoring and the safety of the vaccines so far," said Dr. Kobiler, adding that on January 26, another meeting will be held and then perhaps more details will be given on what exactly was observed in the findings.
The epidemic is not over
Either way, the CDC and FDA cannot simply ignore such oversights in the monitoring system.
A stroke is a life-threatening medical emergency that occurs as a result of a disruption of blood flow, carrying oxygen, to the brain tissue.
Brain cells need oxygen and nutrients present in the blood to function properly.
If the blood supply is interrupted or cut off, brain cells begin to die, which may cause temporary or permanent neurological damage, paralysis and even death.
In the case of an ischemic stroke, a local blood clot can form in an area of the brain due to arteriosclerosis, blocking the blood supply to a local area and causing brain tissue damage.
According to estimates, about 87 percent of stroke cases are cases of ischemic stroke.
The next step for the CDC and FDA will be to perform a series of analyzes on different data sources to reach a stronger conclusion.
So far, no problem has been observed in other data sources, which is why these organizations will continue to recommend "everyone 6 months of age and older to be vaccinated with the updated vaccines," they said.
This is a reasonable approach as the benefits of the vaccines are still far and far outweigh the risks.
The corona epidemic is not over, and the proof is all around you.
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