Two years after censored experts made the connection between blood clotting disorders and COVID-19 vaccines, researchers with the U.S. Food and Drug Administration (FDA) have acknowledged the link between Pfizer’s vaccine and blood clotting disorders in “older” individuals. They’re just not going to do anything about it.
In a new study published Dec. 1 in Vaccine, FDA researchers and researchers with the Centers for Medicare & Medicaid Services (CMS) analyzed data from the CMS nationwide database. They found that pulmonary embolism—blood clots in the lungs—met the requirements for a statistical signal in those 65 years of age and older. They’re just not going to do anything about it.
Three other outcomes of interest—a lack of oxygen to the heart, immune thrombocytopenia, and intravascular coagulation—initially raised concerns, but after in-depth analysis and comparison to those who received influenza vaccines, researchers concluded the three conditions no longer met the statistical threshold for a signal.
Researchers used probability testing to detect an increased risk of 14 outcomes following vaccination. The goal was to see whether receiving a COVID-19 vaccination increased the risk of adverse effects, such as blood clotting.
Researchers said their surveillance monitoring did not detect statistical signals for Moderna’s COVID-19 vaccine or the Johnson & Johnson shot.
According to the paper, this FDA and CMS COVID-19 vaccine safety study is one of the largest studies of those aged 65 years and above and assessed 17.4 million elderly Americans who received 34.6 million vaccine doses between Dec. 10, 2020, and Jan. 16, 2022.
There is no equivalent database for children the FDA can assess (unless they want to stop ignoring VAERS). Still, it’s logical to assume if a COVID vaccine could cause a blood clotting disorder in an older adult, it could do the same in a child. At the very least, it should be completely ruled out before giving a COVID shot to a kid.
To the surprise of nobody, the FDA said it was not taking any action on the results of the study despite what its own researchers concluded because the study does not “prove” Pfizer’s vaccine caused any of the four outcomes and because the findings “are still under investigation and require more robust study.”
Supposedly, this issue has been “under investigation” for over a year and a half now. The FDA, in July 2021, announced the initial results of a similar surveillance screening showing an increased risk of all four conditions outlined in the new study for the same age group.
Although the FDA said at the time it would “closely monitor the safety of the COVID-19 vaccines,” would “further investigate these findings by conducting more rigorous epidemiological studies,” and would “share further updates and information,” this is the first update the agency has issued on the matter since.
According to the most recent data from the Vaccine Adverse Event Reporting System (VAERS) released on Friday, 44,602 reports of blood-clotting disorders following COVID-19 vaccines have been reported. Of those, 30,578 reports were attributed to Pfizer, 10,084 reports to Moderna, and 3,869 reports to Johnson & Johnson. Given the significant underreporting factor associated with VAERS, the actual number of people who have likely experienced a blood clot after receiving a COVID-19 vaccine is likely staggering.
Studies link mRNA COVID-19 vaccines to blood clots
Vaccine-induced thrombotic thrombocytopenia (VITT) is a blood clotting phenomenon secondary to “inoculation with the COVID-19 vaccine.” At this point, there are too many to count studies you can’t possibly ignore the risk of getting VITT or the reality that the vast majority of people who do . . . die.
A study released in April 2021—just 4 months after the COVID vaccine rollout—by Oxford University found the number of people who developed cerebral venous sinus thrombosis (CVST) blood clots after COVID vaccines were about the same for Pfizer, Moderna, and AstraZeneca. (Johnson & Johnson wasn’t authorized in the EU at the time of the study.)
According to the study, 4 in 1 million people experienced CVST during the two weeks following vaccination with the Pfizer or Moderna vaccine versus 5 in 1 million people for the AstraZeneca vaccine.
Although there was a significantly higher incidence of blood clots in people infected with COVID, the incidence of blood clots following vaccines was much higher than the background incidence of 0.41—a powerful signal that COVID vaccines pose this specific risk.
A study published in February 2021 in the Journal of Hematology examined thrombocytopenia (low platelets occurring with COVID vaccine-induced blood clotting) following Pfizer and Moderna vaccination in response to the death of a 56-year-old Florida physician, Dr. Gregory Michael—the first identified patient who died from a brain hemorrhage after receiving Pfizer’s vaccine. (His story was actually covered by the media before Pfizer started pressuring media companies to ignore the vaccine injured.)
Researchers examined 20 case reports of patients with immune thrombocytopenia (ITP), including 17 without pre‐existing thrombocytopenia using data from the Centers for Disease Control and Prevention, FDA, U.S. Department of Health and Human Services, VAERS, published reports, and communications with patients and treating providers.
After analyzing data, researchers could not exclude the possibility that the Pfizer and Moderna vaccines had the potential to trigger ITP and recommended additional surveillance to determine the incidence of thrombocytopenia post-vaccination.
The Association of American Physicians and Surgeons (AAPS) said in an April 5, 2021, press release that Pfizer, Moderna, and Johnson & Johnson cause human cells to manufacture the spike protein, which then induces the immune system to make antibodies to that protein.
AAPS physicians and scientists informed the FDA that mRNA vaccines may have “the potential to cause microvascular injury [inflammation and small blood clots called microthrombi] to the brain, heart, liver, and kidneys in ways that were not assessed in the safety trials.” The FDA never responded.
On April 13, Dr. Hooman Noorchashm, a physician-scientist, joined Tucker Carlson on his show to discuss blood clots and COVID vaccines.
Noorchashm said the FDA, while acknowledging the ability of Johnson & Johnson’s vaccine to cause blood clots, was missing similar thrombotic complications with Pfizer and Moderna. We now know the FDA wasn’t just “missing” similar blood clotting events; they were just ignoring them.
On Dec. 8, 2020, before any COVID vaccines received Emergency Use Authorization, J. Patrick Whelan, M.D., Ph.D., wrote the FDA about the potential for vaccines “to cause microvascular injury and blood clots throughout the body including the brain, heart, liver, and kidneys in ways that were not assessed in the safety trials.”
Whelan cautioned that hundreds of millions of people could potentially suffer long-lasting or even permanent damage to their brain or heart microvasculature as a result of failing to appreciate an unintended effect of full-length spike protein-based vaccines on other organs.
We now know that the SARS-CoV-2 spike protein is capable of traveling through the body (a concept known as biodistribution) and can bind to ACE-2 receptors, activating a host of cell-signaling pathways capable of triggering a wide range of adverse events.
It’s only logical to assume that when the vaccine creates the identical spike protein that occurs with infection—which is blamed for a number of serious and life-threatening injuries— that we could see the same injuries in those who receive COVID-19 vaccines.