J&J’s COVID-19 Vaccine Data (Table 14): Natural Immunity Is Equally Protective, If Not Better Than, Vaccine Immunity.
Here, I write to urgently reiterate my warning to the American public and the U.S. Food and Drug Administration about a potential hazard from indiscriminate COVID-19 vaccination in those persons who are recently infected by the SARS-CoV-2 virus.
But at the outset of this article, let me me be clear:
Every American who is NOT immune to COVID-19 at present should consider quickly and safely undergoing vaccination to protect themselves and their community from natural infection. Additionally, no reader of this article should assume that I am even remotely suggesting that the United States rely only on natural infection as the dominant pathway to herd immunity — because the, overall 0.5% mortality and 10–20% morbidity associated with so doing would be simply catastrophic to our nation. Reliance on natural immunity as a pathway to herd immunity would be a dangerous and costly error. Therefore, I firmly believe that it is our civic duty as citizens of the United States to use the COVID-19 vaccines quickly and rationally, in ALL non-immune persons, to protect our nation from any further peril
Having stated the above, here, I am writing to urgently inform the American public that indiscriminate, one -size-fits-all, vaccination of persons recently naturally infected and immune is unnecessary and potentially dangerous to, at least, a non-negligible minority subset of unsuspecting persons in harm’s way. Unfortunately, despite its Herculean effort to roll out the COVID-19 vaccine to all Americans, the Biden administration is making exactly this critical public health error.
But, the fact that nearly 20–30% of Americans are already recently naturally infected as of this writing, makes my public health concern about these persons of critical importance to every American — especially to those with know or occult COVID-19 infections.
So, I sincerely hope that the American people and the press can provide the Biden administration with the kind of democratic “market” feedback that is at times necessary to correct the course of improper and dangerous government policies and practices.
I have described my reasoning for a more nuanced and circumspect approach to population level vaccination during the COVID-19 pandemic in letters of warning to FDA and the vaccine manufacturers — as well as, in letters of concern to the public.
Of course, as expected, the critics of my perspective, some of them colleagues with MDs, PhDs and claims to “expertise”, have vocally and mindlessly shouted me down, as though my position is one of an anti-vaccine activist.
But nothing can be further from the truth.
I am a deeply trained immunologist and physician with a clear understanding of the critical importance and mechanistic power of vaccines in controlling epidemics and pandemics. I know clearly that we must vaccinate the population as rapidly and as safely as is possible in America.
Additionally, on a personal level, I and all of my immediate family who are candidates for the COVID-19 vaccine, have already been vaccinated. And, I plan to vaccinate my children, over 16 years old, as soon as possible — if they are NOT naturally immune to the SARS-CoV-2 virus.
This said, I am nearly certain, as an immunologist, that recently naturally infected persons, especially those in this category with pre-existing conditions (e.g., cardiovascular disease, autoimmune diseases in remission, vaculitides, pregnant women, etc.). are very likely to be at an increased risk of harm from indiscriminate vaccination. I state this as an immunological prognostication.
Of course, I also know with certainty that the vast majority of naturally infected persons are also naturally immune — many of them quite robustly. And, therefore, that vaccinating such persons, if recently infected, is not only potentially dangerous, it is an unnecessary, and thus unethical, medical treatment. Because, it imposes the risks associated with vaccination on persons in whom the treatment is unnecessary.
Here, my critics shout me down again stating that I have “no evidence” that the naturally immune are equally protected when compared to those vaccinated — and that therefore, my claim that vaccinating the naturally immune is an unnecessary medical practice, at best, is unfounded.
But, this critique of my position is a radically disingenuous, intellectually lazy, political and dangerous criticism of a clearly true medical, scientific and ethical position, for two reason.
For starters, this critique entirely ignores the basic facts of immunological science, from time immemorial, that natural infection with a virus promotes powerful and long lasting immunity in the infected host. In fact, this can be demonstrated using simple blood antibody tests, which serve as the gold standard measure of immunity.
But more importantly my critics are ignoring the actual data presented to the United States Food and Drug Administration by Johnson & Johnson on February 26, 2021 in a document entitled “ FDA Briefing Document: Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19”. This document served as the basis for FDA granting J&J Emergency Use Authorization for that company’s version of the COVID-19 vaccine.
In Table 14 of this document, J&J’s Janssen vaccine development unit almost definitively demonstrated that naturally immune persons are protected from SARS-CoV-2 infection — AND that this natural immunity is nearly 5X greater than that achieved from the vaccine.
Of a total of 4051 naturally immune (i.e., seropositive) persons undergoing placebo treatment, only 6, or 0.14%, acquired clinically significant COVID-19 disease within 28 days. This was in contrast to the finding in non-immune (i.e., seronegative) persons, who received the COVID-19 vaccine, 286 of whom developed clinically significant COVID-19 disease within 28 days of vaccination: that is, 0.73%. Therefore, the data presented show that the naturally immune are nearly 5X more protected from COVID-19 disease as compared to those vaccinated.
There is no reason to believe that the other COVID-19 vaccines from Pfizer, Moderna or Astra-Zeneca, would be significantly different from the J&J vaccine in this regard.
Let me be clear, these data do NOT show that the COVID-19 vaccine is ineffective against SARS-CoV-2. It clearly is - as Table 14, among other data presented, demonstrates!
The data also do NOT suggest that we should use natural immunity as a means of achieving herd immunity. As I stated before, the morbidity and mortality cost of acquiring natural immunity, when integrated across the nation, is simply catastrophic from an economic and social perspective.
BUT, the data DO demonstrate that those persons naturally immune are at least as protected, if not more so, that those vaccinated.
I want to be very clear that Table 14 presented to FDA by J&J is VERY clear demonstration that the COVID-19 vaccine is an unnecessary medical treatment in Americans who are naturally immune.
Because every medical treatment, including vaccination, has an inherent risk of complications to at least a minority subset of people, offering these to persons in whom they are known to be “unnecessary” is a critical lapse of ethical medical practice — because it risks harming the unnecessarily treated persons.
Let me be clear, again, FDA and the vaccine manufacturers are aware that indiscriminate vaccination of the recently infected and naturally immune persons is an unnecessary medical treatment with risks of complications.
It is time for the American public, the press and the United States congress to question why we are NOT being more circumspect and careful in deployment of our national vaccine program. It is not a tenable position to place unsuspecting and trusting Americans who are recently infected or naturally immune at risk of harm by exposing them to an unnecessary, and therefore unethical, medical therapy.
It is my sincere hope that the Biden administration, FDA, the vaccine manufacturers, the mainstream press and the American people all recognize the need for immediate implementation of the proposed #ScreenB4Vaccine approach to maximizing vaccine safety during the COVID-19 pandemic.
It is bad government to impose or facilitate indiscriminate application of an unnecessary, and thereby dangerous, medical treatment using a “one-size-fits-all” policy directed at ALL American citizens.
I write here in friendship to the American people, in defense of US public health and in the name of Dr. Amy Josephine Reed of Yardley, PA.
Hooman Noorchashm MD, PhD