URGENT FDA COMMUNICATION — Catastrophic Blood Clot Risk & Absent Medical Necessity of COVID-19 Vaccination in The Naturally Immune/Infected

It’s unlikely that the blood clotting complications associated with the COVID-19 vaccines are limited to the Cerebral venous ones only. In my opinion, from a scientific and clinical perspective, it is very likely that systemic arterial blood clots that cause strokes and heart attacks are also happening following vaccination, but are being missed or mis-classified by FDA, CDC and the vaccine manufacturers.

Dear Dr. Woodcock and colleagues,

I am sure by now, in addition to your knowledge of the problem we have with the J&J COVID-19 vaccine, you’ve studied results emerging from Oxford University regarding the risk of Cerebral Venous Thrombosis from the other COVID-19 vaccines:

https://www.ox.ac.uk/news/2021-04-15-risk-rare-blood-clotting-higher-covid-19-vaccines

It appears that it’s not just the J&J vaccine that has these problems and that, in fact, Pfizer and Moderna’s vaccine also exhibit a rate of CVT on the order of 4 in one million cases.

Of course, you are well familiar with my opinion that your agency and the vaccine manufacturers are vastly underestimating (and missing) the thromboembolic complications associated with the indiscriminate use of these vaccines — and specifically those affecting the central and peripheral arterial side of the systemic circulation: that is, strokes, heart attacks and peripheral vascular thromboembolic complications.

Nevertheless, being well familiar with the utilitarian trade-off equations the FDA and CDC use to favor “majority benefit”, even in cases where “minority harm” is quite clear cut and visible, I know that the American people should not expect much from your agency — especially, since the stakes are so high and these vaccine are clearly necessary for our nation to acquire herd immunity to the SARS-CoV-2 virus. So I do anticipate that despite these very serious complications, CDC and FDA will continue to endorse speedy population level vaccination.

Of course, if FDA and CDC do so WITHOUT any measure to keep the American population as safe as possible and minimize these complications, you must understand that trust in our government agencies will erode even further. And you may agree with me that recent events and unrest in our nation indicate that the American democracy may be at a dangerous inflection point in its trust in government. The pandemic is your test — not only as public health officials, but as leading citizens of the United States.

Therefore, I urge you to seriously consider my respectful vaccine policy suggestion here — please understand that my perspective is borne out of a struggle with personal tragedy in the medical harm space (which you know well) and my knowledge as a physician and cellular immunologist — so I hope that you are not carelessly brushing it aside:

Somewhere upwards of 20–30% (i.e., likely upwards of 100 million people) of the American population has been naturally infected already. The vast majority of these individuals are, thus, naturally immune to COVID-19 — and it is likely that most of these persons are quite robustly immune to the virus, perhaps even more so than the vaccine immunized, as the principles of immunology predict. It is a simple and clear clinical and medical ethical fact that vaccinating this subset of the population is an unnecessary medical treatment. Certainly indiscriminate vaccination of the infected at the time of immunization is highly likely to pose a serious risk of harm. Therefore, it follows that either offering such persons the vaccine or mandating that they get the vaccines is not only medically unethical, because no added benefit is expected in the vast majority, but vaccinating this population exposes these persons to the possibility of all the complications one could expect from vaccination — including those severe and devastating ones specific to the COVID-19 vaccines. Therefore, it is not only the clinically and ethically correct action, but it is also the duty of our federal public health agencies, to exclude all Americans who are naturally infected and immune, using the #ScreenB4Vaccine approach, from the pool of COVID-19 vaccine candidates at this time.

Dr. Woodcock and colleagues, America is a heterogeneous, robust, resilient and capable nation. But if we continue to ignore minority subsets of people in harm’s way, or downplay the plight of the “negligible” numbers of people falling to complications/harm — and especially if we continue to accept the collateral damage to such minority subsets unmitigated and unavoided when we become aware of the risks, for the sake of “majority benefit” in our utilitarian equations. Then America herself will be undermined and damaged at its root. Why? Because irreplaceable and precious American lives will be lost to our mindless and ethically and scientifically unmitigated utilitarianism. But, especially in this mass scale pandemic, where everything in your power must be done to minimize and avoid avoidable risks to ALL persons, trust in American federal government will erode precipitously, as it has already.

Let me be clear on this record, in summary: indiscriminate COVID-19 vaccination of the naturally infected and immune in the midst of this pandemic outbreak risks severe, and at least partially avoidable, harm to a non-negligible minority subset of Americans, as it has already — but more importantly, it risk severe harm to American national security but causing a dramatic erosion of public trust in our republic. Therefore, it is your duty to STOP indiscriminate vaccination of the recently infected and already naturally immune.

I write hoping that you and colleagues at FDA and CDC have enough foresight, courage and clarity to see that exclusion of the naturally immune and recently infected from vaccination, using #ScreenB4Vaccine, is an almost certain safety mitigation approach to protecting many American’s in harm’s way.

I pray that you see the path forward clearly.

Hooman.

Hooman Noorchashm MD, PhD is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.