J&J’s COVID-19 Vaccine Blood Clotting Complications: Did The Adversely Affected Women Have Previous Natural Infections?
Today, 4/13/2021, FDA is halting use of the J&J COVID-19 vaccine in the U.S., because of six severe complications involving blood clots in young women.
Clearly, this halt is problematic for our vaccine effort in the United States and worldwide. However, because of the severe nature of these complications, it is critical for FDA and CDC to undertake a robust and transparent root cause analysis of the problem. Because it is very likely that these reported complications are the tip of a larger iceberg of hazard.
For those who have been following my public advocacy efforts, since January 2021, I’ve been warning our public health leaders at FDA and the leadership of the COVID-19 vaccine manufacturers about the possibility of thromboembolic events when indiscriminately vaccinating those recently infected with the SARS-CoV-2 virus.
I do not suspect that the clotting complications from the J&J vaccine is specific to that company’s brand. In fact, I am of the opinion that both the Pfizer and Moderna vaccines are also causing blood clotting problems that are being missed and downplayed by FDA and CDC — specifically because of the lax and passive adverse event detection and reporting systems in place, and because of the critical urgency of achieving herd immunity to the virus.
In other words, I am quite confident that the J&J vaccine is NOT intrinsically defective or dangerous— neither are the Pfizer, Moderna or AstraZeneca versions of these vaccines.
Rather, in my opinion, it is highly likely that inappropriate and indiscriminate administration of these vaccines to persons recently or concurrently infected with the natural SARS-CoV-2 virus is the cause of the clotting complications.
From a scientific and mechanistic perspective, there is almost no question that following a natural infection the antigenic footprint of the SARS-CoV-2 virus remains in the infected tissues of the host for some time. These include the inner lining of arteries and veins, the heart muscle and the nervous system. When the vaccine force re-activates the immune system against Spike protein antigens in a recently infected person, the immune response to the vaccine will target these tissues and cause inflammatory damage. In the case of blood vessels, damage to their inner lining from inflammation, could result in acute formation of blood clots.
So, in my opinion, the most critical aspect of the root-cause-analysis FDA and CDC owe the American people in investigating these clotting complications is to determine if the affected women were previously infected with SARS-CoV-2.
Fortunately, there is a simple blood test that can adjudicate this question with a high degree of precision. That is, the presence of blood SARS-CoV-2 “Nucleocapsid” antibodies in the affected persons. These antibodies will only be present in the blood of previously naturally infected persons.
So, it is going to be critical for FDA and CDC to assess the blood from the persons experiencing any clotting complications for the presence the Nucleocapsid antibodies.
In fact, I am of the opinion that ALL persons experiencing ANY adverse events following COVID-19 vaccination should have their blood evaluated for the presence of Nucleocapsid antibodies to determine if they had been previously infected.
This morning, when news of the J&J COVID-19 vaccine pause became public I immediately sent sent two emails to Drs. Woodcock and Marks at FDA in this regard. I have yet to hear a response from FDA.
Irrespective, given the occurrence of the clotting complications at this time, it is my hope that FDA, CDC, J&J and other vaccine manufacturers will work quickly and methodically to determine if indiscriminate vaccination of the recently infected is a safety problem.
I do suspect that if these public health leaders ignore this question and if these clotting complications continue to occur, even further public mistrust in FDA process and in the vaccine’s safety will be stoked.
Imagine, if the recently infected are at higher risk of vaccine complications, and if our FDA and CDC actually do make this determination and then work robustly to mitigate against harm to such recently infected persons….Imagine, the level of public trust and confidence the United States government agencies will re-earn. I have my doubts, based on past in experience, that FDA or CDC can pull out of their draconian and stifled process to think and act cogently in the best interest of public health.
BUT, even if our public health leaders and their “expert” advisors believe these clotting complications to be unrelated to prior recent infection, because my scientific prognostication is actually cogent, it is critical for the following root-cause-analysis questions to be answered by FDA and CDC with all urgency:
Drs. Marks, Wollensky and Woodcock, were the six young American women who experienced the clotting complications following COVID-19 vaccination recently or previously infected — and, specifically, do they carry anti-SARS-CoV-2 Nucleocapsid antibodies in their blood?
Because if the answer to these questions is “YES”, then the United States and the rest of the world should be EXCEEDINGLY cautious about indiscriminately vaccinating the recently infected — as there is good scientific reason to suspect causality and, thus, harm.
If the answer is “NO”, then due diligence has been exercised — and it is likely that the J&J and AstrZeneca vaccines are intrinsically dangerous in some people, likely based on their Adenovirus delivery mechanism. If this is the case, these brands of the COVID-19 vaccine should be entirely abandoned in favor of the mRNA vaccines from Pfizer and Moderna.
As I stated before, my scientific opinion and immunological prognostication is that the COVID-19 vaccines are NOT intrinsically defective or dangerous, but rather that their indiscriminate administration to recently and previously infected persons is the source of a hazard we can easily mitigate in America and the rest of the world by using #ScreenB4Vaccine.
Now, time will tell.
I write in defense of US public health and in the name of Dr. Amy Josephine Reed of Yardley, PA.
Hooman Noorchashm MD, PhD