Did the CDC and FDA warn that the new Pfizer bivalent vaccine can cause a brain stroke?!
Take a look at the viral claims, and find out what the facts really are!
Claim : CDC + FDA Just Warned Of Stroke From Pfizer Vaccine!
People are sharing various articles about a new CDC and FDA notification on the new Pfizer bivalent COVID-19 vaccine, together with alarming comments, like:
Truth : CDC + FDA Did Not Warn Of Stroke From Pfizer Vaccine!
It is true that the CDC and FDA released a notification about the new Pfizer bivalent COVID-19 vaccine. However, it has been twisted to falsely claim that the CDC and FDA are warning people about the risk of stroke from the COVID-19 vaccine.
Fact #1 : CDC + FDA Notification Is Available Online
On Friday, January 13, 2023, the CDC and FDA published a notification on a “preliminary safety signal” involving the new Pfizer COVID-19 bivalent vaccine, which is available online.
I strongly encourage you to read it for yourself, but for your easier understanding, here is a quick summary:
- the CDC and FDA use multiple, complementary safety monitoring systems to look for potential “safety signals” in vaccines and other medicine.
- the CDC Vaccine Safety Datalink (VSD) surveillance system detected one safety signal, which met the statistical criteria to trigger further investigation.
- the safety signal involved only the new Pfizer bivalent COVID-19 vaccine, and people who were 65 years and older.
- the preliminary signal “appeared” to show that people who were 65 years and older were “more likely” to have an ischaemic stroke in the 21 days after receiving the Pfizer bivalent vaccine, compared to days 22-42 after vaccination.
- only VSD surveillance has detected this safety signal – no other safety system has shown a similar signal.
- multiple, subsequent analyses failed to validate this safety signal
- the CDC continues to recommend that people get the bivalent vaccine.
Fact #2 : Multiple Analyses + Studies Fail To Validate This Signal
While the CDC and FDA will continue to evaluate the data, they pointed out that multiple analyses and studies failed to validate this safety signal.
- A large study of bivalent vaccines from Pfizer-BioNTech and Moderna using the Centers for Medicare and Medicaid Services database show no increased risk of ischemic stroke
- A preliminary study using the Veterans Affairs database do not show an increased risk of ischemic stroke after receiving the bivalent vaccine
- The Vaccine Adverse Event Reporting System (VAERS) has not seen an increase in reporting of ischemic strokes following the use of the bivalent vaccine
- Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the bivalent vaccine
- Other countries have not observed an increased risk for ischemic stroke with bivalent vaccines
Again, the VSD surveillance system was the only one producing this safety signal. No other surveillance system or study has been able to confirm or validate this safety signal.
In fact, the CDC made a point in their notification to say that “it is very unlikely that the signal in VSD represents a true clinical risk“.
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Fact #3 : Safety Signals Are Not Evidence Of Causation
Safety signals function like tripwires, alerting health authorities into taking a close look at potential issues with vaccines or medicines.
Just because a safety signal was detected, it does not mean there is an actual problem. Like actual tripwires can be accidentally triggered by animals or falling branches, safety signals may be the result of random chance or other factors (see next fact).
The detection of any safety signal merely means that the CDC and FDA should take a closer look.
Fact #4 : Elderly Population At Higher Risk Of Stroke
I should point out that the safety signal was identified only in elderly people who were 65 years and older.
The VSD system, in this case, found that 130 people who were 65 years and older had a stroke within 21 days of receiving the new bivalent vaccine, out of about 550,000 senior citizens. It should be noted that no deaths were reported.
That may sound alarming, but this population segment is itself at significantly higher risk of developing blood clots, which can cause ischaemic stroke:
- hospital stay
- major surgery – abdominal / pelvic surgery, or knee / hip replacement surgery
- major trauma : automobile accident or fall
- nursing home living
- 65 years or older
- trips over 4 years by plane, car, train or bus
- co-morbidities like heart failure, obesity, cancer
That is why such safety signals have to be investigated, as it is still not certain if the 130 senior citizens who suffered a stroke had higher risk factors like surgery or immobility.
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Fact #5 : CDC Still Recommends Getting Bivalent Vaccines
The CDC issued that notification as a matter of transparency, and not because there was a genuine reason for concern.
If the CDC and FDA had any reason to believe that the Pfizer bivalent COVID-19 vaccine can cause stroke in senior citizens who receive it, they would have at least amended their vaccine recommendations.
Yet, the CDC continues to recommend that people who are eligible to receive the updated bivalent COVID-19 vaccine should continue to get them.
The CDC also stressed that multiple studies have shown that “staying up-to-date with vaccines is the most effective tool we have for reducing death, hospitalisation, and severe disease from COVID-19“.
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