COVID-19 Vaccinated Americans Are Sitting Ducks When a Variant Bypasses Vaccine Immunity.

When, not if, a SARS-CoV-2 variant emerges to bypass vaccine immunity, our only hope will be a specific and effective anti-inflammatory therapy: cyclosporine!

The SARS-CoV-2 virus mutates in naturally infected people. And eventually a variant will emerge that can bypass the immunity generated by the current vaccine. When, not if, that happens vaccinated people will be sitting ducks — and the solution will be specific and effective generic anti-inflammatory treatments like cyclosporine.

For the record, in early 2021, I got my COVID-19 vaccine shots uneventfully. I suggest that all persons over age 16 get this shot, IF they are not already immune to SARS-CoV-2.

Back in May 2021, I tested my blood for antibodies at Labcorp to make sure that the vaccine had worked for me. As expected, I have over 1000 U/ml of SARS-CoV-2 Spike antibodies in my blood. The vaccine worked!

I didn’t have a prior COVID-19 infection, so unlike naturally immune people from a prior infection, I don’t have immunity to any other part of the virus — as expected.

The problem is that if and when the SARS-CoV-2 virus mutates to a novel variant, as it’s doing with the Indian Delta variants, the virus can “bypass” the antibody immunity generated in my body by the vaccine.

This means that if I get exposed to a strain of the virus whose spike protein is sufficiently different than the one that was used to make the vaccine, I am very likely to get infected and ill.

It’s anyone’s guess whether the current vaccine is able to provide any degree of protection at all against a new SARS-CoV-2 variant, like Delta, capable of “vaccine bypass”.

I suppose even if the vaccine antibodies don’t protect me against a “vaccine bypass” variant, maybe the vaccine T-cells will. But that’s just a guess! Wishful thinking, really!

And if this guess is wrong….well, literally millions of vaccinated Americans, and many worldwide, are just sitting ducks for this likely “vaccine bypass” variant virus.

To make matters worse, because the folks who are vaccinated have been reassured that they are immune to COVID-19, most aren’t taking ANY precautions against the virus….So when, not if, the “vaccine bypass” variant emerges, these folks are LITERALLY unsuspecting sitting ducks.

So, yes, with at least half the US population carrying vaccine immunity, and no natural immunity to SARS-CoV-2, somewhere upwards of 100 million vaccinated Americans are sitting ducks for such a “vaccine bypass” variant.

Of course, I’m quite confident that the vast majority of my friends and family, and the millions of folks who are naturally immune to SARS-CoV-2 from a prior infection, will be resistant to infection by most variants. Simply because their immune systems fought off the whole virus, not just the spike protein in the vaccine, and remember it.

Naturally immune people are likely to be far more robustly immune to SARS-CoV-2 variants than vaccinated folks. And that is a basic and unassailable scientific prediction that is highly likely to bear out. In fact, it may be the reason why the Chinese population is so resistant to COVID-19 — their population is likely to be immunized against prior iterations of SARS-CoV viruses.

To be clear, I am not suggesting that un-immune folks in America and the rest of the western hemisphere not get vaccinated. The risk cost of natural immunity from an actual infection is much higher than the cost of vaccination. I am simply sharing my analysis of what we are highly likely to confront soon: A “vaccine bypass” variant of SARS-CoV-2.

So what’s the solution if/when a “vaccine bypass” strain does emerge — as the Indian “Delta Plus” variant seems to be promising? How can millions of vaccinated sitting ducks be saved? Is there a solution?

The answer is yes! THERAPEUTICS! And specifically, generic and vastly available anti-inflammatory therapeutics with well known and mechanistically relevant cellular targets involved in the pathogenesis of COVID-19 disease.

It’s a travesty that for a whole year now, FDA and NIH have been resisting development, testing and repurposing of some of our staple generic anti-inflammatory drugs to treat COVID-19 disease, which is AN INFLAMMATORY DISEASE!

The reason they’ve resisted, is that Dr. Fauci and his crew placed their bet on the vaccine — and doggedly pursued its rapid development and deployment en mass. As an immunologist, I don’t think this was an entirely incorrect bet — Fauci probably fashioned himself a bit of a hero in single-mindedly advocating for vaccine development with minor attention to anti-inflammatory drugs. But the Fauci crew’s catastrophic error was that they almost entirely ignored development and rapid testing of some of our staple generic anti-inflammatory drugs. Ones with powerful and scientifically grounded rationale for use against COVID-19 disease.

It has been my prejudice and expert opinion as an immunologist, since March 2020, that the generic outpatient drug cyclosporine is a lock-and-key fit for the immunological fingerprint of COVID-19 disease.

So, as I write here in late June 2021, it remains my opinion that when the current COVID-19 vaccine is bypassed by an emergent SARS-CoV-2 variant, early treatment using cyclosporine will highly likely save millions of lives on our planet.

The reader might know that since March 2020, I have been doing all I can to get cyclosporine to come into the limelight of COVID-19 therapeutic testing by NIH, FDA and academic institutions.

Sadly, neither the NIH, nor the FDA responded efficiently to my calls for immediate testing and emergency use of this staple generic anti-inflammatory drug. I believe this failure was related to Dr. Fauci’s prejudice for development of a vaccine, over treatment of COVID-19 inflammatory disease.

But recently, my colleagues at the University of Pennsylvania, led by Professor Carl June, finally published the results of a phase 1 trial of cyclosporine in patient with moderate to severe COVID-19 disease. I was privileged to have contributed to the development of this project, which met enormous resistance to get off the ground — both locally and at the level of FDA.

You may now read a pre-print version of this paper from Penn, HERE.

In this paper, we demonstrated that cyclosporine blood levels hit a therapeutic plateau by 48 hours after start of treatment in COVID-19 patients with moderate COVID-19 disease requiring supplemental oxygen.

Amazingly all 10 COVID-19 patients treated at Penn, all moderate to severely ill and a few with high risk co-morbidities, were discharged from the hospital within a week — none required ICU level care.

I do not find this picture terribly surprising, because cyclosporine is literally a lock-and-key fit, from a cellular mechanistic perspective, for the immunological fingerprint of COVID-19 disease.

Most impressively, cyclosporine, quite dramatically turned off the hyper-inflammatory syndrome characteristic of COVID-19 disease in all 10 of the patients tested.

The figure to the left here, shows that by days three after start of treatment, most the inflammatory markers associated with the COVID-19 disease had started to normalize (Going from a Red to a Blue state in Panel A). And by day 7 of treatment almost all markers were back at baseline.

Impressively, the the C-Reactive Protein (CRP) level, which is a very sensitive marker of inflammation in COVID-19 disease, almost entirely normalized by day three following the start of cyclosporine therapy (See green graph — panel D).

These are powerful results. All ten patients were discharged home without a visit to ICU. All had their hyperinflammatory markers shut off starting at day 2, when cyclosporine levels in the patients’ blood were therapeutic.

Additionally, I personally treated a few COVID-19 patients with cyclosporine off-label, including my own sister, early as outpatients. As you will see in the below CBS News video, she recovered her sense of taste and smell within 48 hours of starting cyclosporine — exactly when the drug starts turning off the inflammatory response in our study.

Not to belabor this point, but only to summarize, as an immunologist I can confidently state that the COVID-19 vaccines developed by Operation Warp Speed are an important scientific and clinical contribution.

Unfortunately, I am also certain that because of the pandemic nature of the SARS-CoV-2 virus, a “vaccine bypass” variant will almost certainly emerge soon, if it hasn’t already— and that the millions of vaccinated Americans will become sitting ducks for this new variant.

When, not if, this happens, it is a mere certainty that cyclosporine could play a dominant role in saving tens or hundreds of thousands of lives. IF American regulators and doctors listen and look with care and mental acuity at the clinical mechanistic rationale and the existing data — instead of accusing me and any others warning about “vaccine bypass” SARS-CoV-2 variants as “fear mongering, or thinking about cyclosporine within the constraints of our profession’s jargon as a “powerful immunosuppressant”. Both these criticisms are incorrect and will lead us to failure against emerging variant SARS-CoV-2 strains capable of “vaccine bypass”.

Let us not ignorantly engage in wishful thinking and the waste precious time we’ve earned at this point in the pandemic, by not thinking rationally and projecting our scientific prognostication capacities forward.

Cyclosporine’s therapeutic signal and the mechanistic rationale for blocking progression of COVID-19 disease is simply way too loud and precise to ignore.

Of course, I continue to be shocked by the inability of Dr. Fauci and his crew at the NIH to redirect our nation’s public health machinery onto repurposing of some staple generic anti-inflammatory drugs for the early treatment of COVID-19 disease — most notably cyclosporine.

Worse than any of the sins politicians in Washington are accusing Dr. Fauci of for the sake of politics, he should not get a free pass on having ignored our generic anti-inflammatory therapies for COVID-19 treatment.

Dr. Fauci and his crew at NIH, should get fully interrogated on why they ignored cyclosporine. Because many of the over 600,000 dead Americans could have been saved — that, is nearly certain.

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.