By Lyn Redwood
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Dr. J. Patrick Whelan, a pediatric rheumatologist, warned the FDA in December that mRNA vaccines could cause microvascular injury to the brain, heart, liver and kidneys in ways not assessed in safety trials.
On Dec. 8, 2020, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) received a public submission from J. Patrick Whelan, M.D., Ph.D. The submission was in response to the agency’s request for comments regarding vaccines against SARS-CoV-2 in advance of the Dec. 10 meeting when the committee would review the Pfizer/BioNTech (BNT162b2) SARS-CoV-2 vaccine for emergency use authorization (EUA).
Whelan’s training (at Harvard, Texas Children’s Hospital and Baylor College of Medicine) includes degrees in biochemistry, medicine and rheumatology. For 20 years, he worked as a pediatric rheumatologist. He currently specializes in treating children with multisystem inflammatory syndrome (MIS-C), which has been associated with coronavirus infections.
In his public submission, Whelan sought to alert the FDA about the potential for vaccines designed to create immunity to the SARS-CoV-2 spike protein to instead cause injuries.
Specifically, Whelan was concerned that the new mRNA vaccine technology utilized by Pfizer and Moderna has “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.”
While Whelan did not dispute the vaccines’ potential to quickly arrest the spread of the virus (assuming that the vaccines prove to actually prevent transmission — also not assessed in the clinical trials), he cautioned that “it would be vastly worse if hundreds of millions of people were to suffer long-lasting or even permanent damage to their brain or heart microvasculature as a result of failing to appreciate in the short-term an unintended effect of full-length spike protein-based vaccines on other organs.”
Unfortunately, Whelan’s concerns were not acknowledged, and the agency instead relied on the limited clinical trial data. The VRBPAC endorsed the use of the Pfizer vaccine on Dec. 10. The following day, the FDA issued the first COVID-19 vaccine emergency use authorization allowing the Pfizer-BioNTech COVID-19 vaccine to be widely distributed in individuals 16 and older without calling for the additional studies that Whelan felt were critical to assure safety of the vaccine, especially in children.
Why was Whelan worried about the mRNA vaccines causing blood clots and inflammation?
One of the peculiar and often deadly findings with regard to SARS-CoV-2 infection is widespread damage occurring in numerous organs beyond the lungs. Clinicians around the world have seen evidence that suggests the virus may cause heart inflammation, acute kidney disease, neurological malfunction, blood clots, intestinal damage and liver problems. Unexpectedly, however, clinicians observe a very limited or non-existent presence of the virus in organs other than the lungs.
Here is what we currently know about the impact of the virus outside the lungs.
Cardiovascular complications from COVID-19
Though COVID-19 was originally thought to be a respiratory infection, it’s since become clear the infection threatens the heart, too.
Dr. Aeshita Dwivedi, a cardiologist at Lenox Hill Hospital in New York City has stated: “As the COVID-19 pandemic has evolved, research has progressively demonstrated this virus’s impact on multiple organs of the body including the heart.”
It has been reported that nearly a quarter of people hospitalized with COVID-19 experience myocardial injury and many develop arrhythmias or thromboembolic disease.
In a prospective study that followed 100 patients who recovered from COVID-19, the investigators found involvement of the heart on MRI scans in 78% of patients, and ongoing myocardial inflammation in 60%. These findings were independent of the severity of the infection, overall course of the illness and time from the original diagnosis.
In October 2020, researchers took a more detailed look at the heart after death from COVID-19 and found “cardiac damage was common, but more from clotting than inflammation” and that “microthrombi (small blot clots) were frequent.”
“We did not expect this,” said study co-author Dr. Renu Virmani, of CVPath Institute in Gaithersburg, Maryland. “It seems to be unlikely that the direct viral invasion of the heart is playing a major role in making myocardial necrosis and microthrombi.”No Evidence COVID-19 Vaccines Will Block Spread of Coronavirus
Dr. Hyung Chun, a Yale cardiologist, suggests that the endothelial cells lining the blood vessels potentially release inflammatory cytokines that further exacerbate the body’s inflammatory response and lead to the formation of blood clots. Chun has stated: “The ‘inflamed’ endothelium likely contributes not only to worsening outcome in COVID-19, but also is considered to be an important factor contributing to risk of heart attacks and strokes.”
A subsequent study published last month confirmed the findings of microthrombi resulting in myocyte necrosis, indicative of a recent myocardial infarction (heart attack), in 40 individuals who died from COVID-19 infection — the studies also identified microthrombi as a major cause of cardiac injury.
Neurological complications of COVID
Individuals with COVID-19 experience a vast number of neurological symptoms, such as headaches, ataxia, impaired consciousness, hallucinations, stroke and cerebral hemorrhage.
But autopsy studies have yet to find clear evidence of destructive viral invasion into patients’ brains, pushing researchers to consider alternative explanations of how SARS-CoV-2 causes neurological symptoms.
In a study of 18 COVID-19 patients with neurological symptoms who died in hospitals last April, Mukerji and colleagues found very low levels of viral RNA — the source of which is a mystery — in only five of the patient brains. Because the low RNA concentration “seems out of proportion to the profound deficits that people are experiencing,” Mukerji said, “I’d be extremely surprised [if] the majority of cases where people are having neurological symptoms are due to direct viral invasion.”