A newly published preprint shows the higher incidence of ischemic strokes among the recipients of the Pfizer bivalent “vaccine.”[1]
The authors are from Northwest Permanente in Portland, Oregon.
Why did they make the study?
According to the authors, a previous Vaccine Safety Data report of the Centers for Disease Control and Prevention found a statistical signal (excess rate ratio) for ischemic stroke and TIA in individuals 65 years and older who received the bivalent Pfizer-BioNTech (Pfizer) COVID-19 vaccine.[2]
The study aims to know the absolute occurrence of ischemic stroke and transient ischemic attack (TIA) after a COVID-19 bivalent vaccination in Kaiser Permanente patients.
They examined patients 18 years and older vaccinated with either the Pfizer or Moderna formulation of the COVID-19 bivalent vaccine between September 1, 2022, and March 1, 2023.
Bivalent vaccines contain mRNA sequences derived from the spike protein of the Wuhan type and Omicron variants of the SARS-CoV-2, the cause of COVID-19.
Method
The method is a copy of the CDC’s Vaccine Safety Datalink (VSD) rapid cycle analysis and searched for possible ischemic stroke or TIA cases in the 21 days following vaccination.
Patients were followed for 21 days after their bivalent shots and then another 90 days to account for the lag in processing outside hospital claims.
One hundred five thousand one hundred seventy-one patients 18 years and older vaccinated with at least one dose of Pfizer or Moderna COVID-19 bivalent vaccines were followed: 85,535 (81.3%) received Pfizer, and 19,688 (18.7%) received Moderna.
Two physicians adjudicated possible cases by reviewing the clinical notes in the electronic health record. The review of the cases is essential because some of the diagnosed strokes or TIAs may be from other causes. Two cases are from dizziness or sepsis.
Those with a current risk factor for strokes like atrial fibrillation, sickle cell anemia, primary thrombophilia, prior history of TIA, or sequelae of cerebrovascular disease were excluded.
Results
The incidence of ischemic stroke or TIA was 34.3 per 100,000 (95% CI, 17.7 to 59.9) in patients 65 or older who received the bivalent Pfizer vaccine.
Estimating the incidence based on the primary position agreed closely with estimating the incidence based on any position and physician adjudication: 37.1 per 100,000 (95% CI, 19.8 – 63.5), which is a 50% increase in incidence as presented by the VSD at ACIP for
this same population (24.6 cases per 100,000 patients vaccinated (non-adjudicated).
This is where it gets confusing. I read the CDC report that they referred to [2], including the tables, discussion, and conclusion, and did not find the quoted 24.6 cases per 100,000 patients vaccinated.
Doing calculations is impossible since the CDC uses the number of doses administered as the denominator instead of people injected.
To my surprise, the CDC did not detect any safety signal! Here is the CDC’s conclusion.
VAERS monitoring: COVID-19 mRNA bivalent booster
vaccination and ischemic stroke▪No unusual or unexpected reporting patterns observed, and no
evidence of a safety concern detected for ischemic stroke with either
mRNA COVID-19 bivalent boosters in VAERS monitoringhttps://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-04-19/03-COVID-Shimabukuro-508.pdf page 21
To make sure, I downloaded the CDC report and searched for 24.6, 24.6 per 100,000, and read the report several times and still came out with nothing. I even looked at the other CDC report published on February 24, 2023 [3], which essentially came to the same conclusion and said that the boosters are safe
To support their claim, the CDC even cited other institutions saying there were no safety signals in the bivalent boosters.
COVID-19 mRNA bivalent booster vaccination safety – data
from other monitoring systems and programs*▪ FDA monitoring in the CMS data and Department of Veterans Affairs monitoring in the VA system have not detected any safety signals for ischemic stroke following COVID-19mRNA bivalent boosters using historical comparator designs
▪ Surveillance conducted by international regulatory and public health partners has not detected a safety concern for ischemic stroke following bivalent COVID-19 mRNA booster vaccination
▪ No evidence of a safety signal for ischemic stroke in Pfizer’s global monitoring of bivalent COVID-19 mRNA booster vaccination
▪ No safety signals were detected for ischemic stroke for primary series or monovalent boosters for Pfizer-BioNTech or Moderna COVID-19 vaccines in U.S. and global monitoring
But, when I was looking at my previous articles about COVID-19 shots and strokes, I found this – CDC & FDA: Preliminary COVID-19 Vaccine Safety Signal for Strokes for Persons Aged 65 Years and Older
My previous article opened with this,
The US Centers for Disease Control and the US Food and Drug Administration identified safety concerns in Bivalent Pfizer shots.
Following the availability and use of the updated (bivalent) COVID-19 vaccines, 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.
Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination.
I clicked on my referenced CDC link, but it did not show the same report. It’s gone!
So, who is telling the truth?
According to the Northwest Permanente authors, their study has a Positive Predictive Value of 100% in patients 65 years and older because their cases were adjudicated by two physicians who reviewed the patients’ charts.
In comparison, the CDC method, which was non-adjudicated because they used VAERS data, is only 92%.
Anyway, here is their conclusion.
We identified a 50% increase in the incidence of ischemic stroke per 100,000 patients ages 65 and older vaccinated with the Pfizer bivalent vaccine compared to the data presented by the Vaccine Safety Datalink.
I think the risk of strokes and Transient Ischemic Attacks is probably more than 50% since the CDC found none.
This is in addition to the deterioration of the immune system, the production of immune-tolerant genes, myocarditis, and many more. Please refer to the related articles.
Truth heals. Lies kill. Don’t Get Sick!
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References:
- Risk of Ischemic Stroke after COVID-19 Bivalent Booster Vaccination in an Integrated Health System. medRxiv
- Tom T. Shimabukoro, Centers for Disease Control and Prevention (CDC). (2023, April 19). COVID-19 Vaccine Safety Update: April 2023 [PDF slides]. Retrieved from
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-04-19/03-COVIDShimabukuro-508.pdf [accessed 9.11.23] - Klein et al. Centers for Disease Control and Prevention (CDC). COVID-19 Vaccines Safety Monitoring – Rapid Cycle Analysis (RCA) Protocol. JAMA. [Online]. [Accessed June 27, 2023]. Available from: https://www.cdc.gov/vaccinesafety/pdf/covid19-rca-protocol-1342-508.pdf
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