FDA study links Pfizer jab with pulmonary embolism

A study by the US Food and Drug Administration using data from Medicare showed a statistically significant increased risk of pulmonary embolism in the elderly who received Pfizer jabs.

This FDA and Centers for Medicare & Medicaid Services COVID-19 vaccine safety study is one of the largest studies of elderly persons aged 65 years and above. It includes approximately 34 million doses administered to more than 17 million Medicare-insured persons since December 11, 2020.

The study authors are from the US FDA, Stanford University, Centers for Medicare & Medicaid Services, and Acumen, an FDA contractor. The research was recently released this November 5, 2022, as a preprint at MedRxiv.

Vaccine Safety Surveillance Method

Weekly vaccine uptake was monitored by brands (Pfizer, Moderna, and Janssen). The number of complications was compared to an expected number from the 2017-2019 (pre-COVID-19, unvaccinated population)

High-Risk Signals for four serious outcomes

Initial statistical analysis showed modestly elevated risk signals (Relative Risk < 2) from four life-threatening conditions following the Pfizer-BioNTech jabs.

A relative risk higher than 1.0 means a greater likelihood of that event happening compared to the unvaccinated group. 

  1. Pulmonary Embolism  (RR)=1.54) means a 54% higher risk of getting PE
  2. Acute Myocardial Infarction (RR=1.42)
  3. Disseminated Intravascular Coagulation (RR=1.91)
  4. Idiopathic Thrombocytopenic Purpura (RR=1.44)

The tables below show the Distribution of Days to Diagnosis of Acute Myocardial Infarction, Pulmonary Embolism, Disseminated Intravascular Coagulation, or Immune Thrombocytopenia in 20 days after Pfizer-BioNTech Vaccination (First Dose) in Adults Aged 65 Years and Older. 

Source: Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older

Pulmonary Embolism

A pulmonary embolism (PE) is a blood clot in the lungs’ blood vessels. The clots prevent the blood from getting oxygen from the lungs. Symptoms are chest pain and shortness of breath. Some just “die suddenly,” which is happening a lot lately.

There are several mechanisms why blood clots can happen after COVID shots. I talked about them at:

Myocardial Infarction

Myocardial infarction is commonly known as a heart attack. It occurs when a coronary artery gets blocked by an atherosclerotic plaque and blood clot. A paper published in the Circulation journal shows an increased risk of cardiovascular disease with mRNA shots (Pfizer and Moderna). I discussed that at:

Disseminated Intravascular Coagulation

Disseminated Intravascular Coagulation (DIC) is a condition in which blood clots form throughout the body, blocking small blood vessels. At the same time, the patient can bleed all over because the blood clots use up the platelets that are supposed to initiate clotting to stop bleeding. 

Damage to the inner lining of the blood vessels induces clot formation. Foreign bodies in the shots are bound to scratch the endothelial linings too.

Idiopathic Thrombocytopenic Purpura

Idiopathic Thrombocytopenic Purpura (ITP) is an abnormal decrease in the platelet count. It can become dangerously low and put a patient at risk for bleeding. The worst bleeding can happen in the brain or the gastrointestinal tract. Once a brain bleed happens, surgery cannot be done unless platelets are transfused emergently.

Antibodies formed against the spike proteins can cross-react with the platelets and lower their number. –

Curiously, no risk signals were elicited from the Moderna (mRNA-1273) and Johnson and Johnson (Janssen Ad26.COV2.S) jabs. Maybe the patients who had the adverse events did not make it to the hospital.

There are several studies that showed adverse events due to the Moderna and Janssen COVID shots.

 Adjustments for confounders

After the authors made further evaluations, only the relative risk for pulmonary embolism met the statistical threshold for a signal and not AMI, DIC, and ITP. 

The statistical signals of the four serious outcomes (AMI, PE, DIC, and ITP) are not necessarily causal and may be due to unrelated factors to vaccination.

Additional analyses indicated that the potential association was less than twice the historical rates and may be associated with factors not accounted for in the near real-time surveillance methods. 

With background rates from the flu-vaccinated population as the historical comparator, DIC and ITP no longer met the signal threshold, while signals for AMI (RR=1.41) and PE (RR=1.48) remained.

When rates during the peri-COVID (jab) period were used as the historical comparator (January 1, 2020–December 10, 2020), PE and DIC no longer met the signal threshold.

After further evaluation, only the RR for PE met the statistical thresholds for a signal; however, the RRs for AMI, DIC, and ITP no longer did. 

Adjustment for monthly variation in the background rates resulted in statistically non-significant associations for AMI, DIC, and ITP following Pfizer-BioNTech vaccination.

Comments

The results of this study are as expected since it came from the FDA, which is controlled by big pharma. The FDA threw the public a bone by saying there is a statistically significant increase in pulmonary embolism with the Pfizer COVID shots.

No increased risk with Moderna and Johnson and Johnson? That’s hard to believe. Bear in mind that this study did not include the following:

  1. Those who died suddenly and do not have any diagnosis.
  2. Autopsy results of vaxxidents
  3. Nursing home patients who refused further work-up (comfort care) died at home, in hospice, or in the nursing homes.
  4. Those under age 65. The highest number of excess deaths

More studies should be done, and I believe the truth will come out.

 

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Reference:

Wong et al. Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older

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