Did the US FDA finally admit that the Pfizer COVID-19 vaccine causes dangerous blood clots?!
Take a look at the viral claims, and find out what the facts really are!
Claim : FDA Finally Admits Pfizer Vaccine Causes Blood Clots!
Anti-vaccination activists have recently been claiming that the US FDA finally admitted that the Pfizer COVID-19 vaccine causes dangerous blood clots on social media.
It did not help that Elon Musk amplified one of the claims to his millions of followers:
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Truth : FDA Did Not Admit Pfizer Vaccine Causes Blood Clots!
This is yet another example of FAKE NEWS created and propagated by anti-vaccination activists, and here are the reasons why…
Fact #1 : Study Shows FDA Vaccine Surveillance At Work
Anti-vaccination activists have long claimed that the US FDA is colluding with Big Pharma companies like Pfizer and Moderna.
But the truth is – this study is evidence that the US FDA is doing its job by continuing to monitor the safety of the four approved COVID-19 vaccines in the United States.
Fact #2 : The FDA Study Is Available Online
The FDA study in question is available online, and I strongly encourage you to read it for yourself, but here is a quick summary:
- The study is called “Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older“.
- It was published in the journal Vaccine on 1 December 2022.
- It looked at data from the US Centers for Medicare & Medicaid Services (CMS) covering 30,712,101 elderly persons, from December 11, 2020 until January 15, 2022.
- Out of 30.7 million participants, about 17.4 million persons were vaccinated with a total of 34,639,937 doses.
- It looked at 14 outcomes of interest, and initially four outcomes met the threshold of a “statistical signal”, but after further evaluation, only one outcome met the “statistical threshold for a signal”.
- No signals were detected for the Moderna mRNA-1273, or the Janssen Ad26.COV2.S vaccines.
Fact #3 : Study Looked At Elderly Population
I should point out that the FDA study looked at people who are 65 years and older, many of whom have pre-existing co-morbidities, or other risk factors like being in assisted living facilities.
- 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
In other words – this population has a higher risk than normal for developing blood clots. That’s likely one of the reasons why the FDA team chose to look at the elderly population.
I should point out that the Pfizer cohort comprised of particularly old people (85 years and older) who were nursing home residents (implying that they have cognitive or mobility issues), and had a higher percentage of previous COVID-19 infections.
Fact #4 : Increased Risks Were Only Modestly Elevated
Initially, the CMS database showed four outcomes that met the threshold for a “statistical signal” of modestly elevated risks (RR of less than 2) after vaccination with the Pfizer vaccine.
But after further evaluation, only one outcome ultimately met that statistical threshold for a signal – pulmonary embolism (PE).
|Outcome of Interest||Overall
|Rate Ratio of
|Pulmonary Embolism (PE)||1.15||1.54 on 27/2/2021|
|Acute Myocardial Infarction (AMI)||0.97||1.42 on 27/2/2021|
|0.92||1.91 on 13/2/2021|
|Immune Thrombocytopenia (ITP)||1.26||1.44 on 24/4/2021|
Fact #5 : The Study Did Not Say Pfizer Vaccine Causes Blood Clots
Let me be clear – the study did not say that the Pfizer vaccine causes blood clots.
The study authors pointed out that these statistical signals do not necessarily mean that the Pfizer COVID-19 vaccine causes them, as the potential association was less than twice that of historical rates, and may be associated with other factors:
- many of those who received the Pfizer vaccine were much older (85 years+) nursing home residents, and people with more co-morbidities
- these outcomes may be explained by co-morbidities that existed before vaccination, including previous COVID-19 infections
In fact, they warned against any conclusion that the Pfizer vaccine caused those outcomes:
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Fact #6 : No Signals For Other Clotting Disorders
What anti-vaccination activists gloss over as well, is the fact that the FDA study showed NO SIGNALS for other clotting, or clotting-related, disorders like deep vein thrombosis (DVT), heart attacks, and non-hemorrhagic stroke.
It should be noted that pulmonary embolism often happens when a blood clot in the leg (like in a DVT!) breaks free and gets lodged in the lungs. How likely is it for a person to develop pulmonary embolism without a deep vein thrombosis?
Fact #7 : FDA Is Not Taking Any Action
The study also notes that the FDA is currently not taking any regulatory actions based on these signal detection activities, because they need further study to determine if they are causal or merely coincidence.
These signal detection studies are part of the FDA’s active surveillance systems, and serve to identify potential adverse outcomes for further study. They cannot be used to make regulatory decisions.
Just because these signals were detected, does not mean they were caused by the vaccine. Until there is proof that the Pfizer COVID-19 vaccine causes blood clots, there is simply no reason for the FDA to take any action.
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Don’t forget to protect yourself, and your family, by vaccinating against COVID-19!
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