The Critical Importance of COVID-19 Antibody Tests in America — And Why It Matters For Your Health?

Why has Dr. Janet Woodcock allowed a dangerously “misguided” FDA guidance to be issued on the COVID-19 antibody assays? FDA ought not be the purveyor of “anti-science” — especially when it is a certainty that this guidance will promote continued violation of the principle of “medical necessity” — and sustain the indiscriminate and potentially harmful vaccination of recently COVID-19 infected person. JW can do FAR better than this!

On May 19, 2021, the United States Food and Drug Administration, under the leadership of Dr. Janet Woodcock, issued a shocking guidance.

In this “misguided” guidance “FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination”.

For many immunologists, this FDA statement is anathema to a well established immunological principle we ALL know to be 100% true: That the presence of IgG antibodies against viral antigens is the gold standard for determination of whether a person is immune to any given viral or bacterial pathogen.

As an analogy, this FDA statement against use of COVID-19 antibodies to assess immunity is so absurd, it would be like NASA putting out a public statement advising the public that we should no longer assume that the earth is round. The FDA guidance on COVID-19 antibodies is truly that absurd!

Mockery of FDA aside, what is true is that we are not sure exactly what level, if any, of IgG antibodies against COVID-19 is optimally protective — but in general, the mere presence of these antibodies is considered gold-standard demonstration of immunity. My own perspective is that when IgG antibodies against spike protein are present in a person’s blood, that person is immune to the virus. I think most of my colleagues who are honest and not swayed by the politics of professional herd mentality, agree with me.

The fact that FDA is guiding “against” the use of established antibody assays to assess COVID-19 immunity in the midst of a pandemic, is simply shocking, irresponsible and unscientific!

I say this not only because the FDA statement goes in the face of about 100 years of immunological science, but for two very specific reasons having to do with medical ethics and public safety:

  1. The presence of COVID-19 antibodies in unvaccinated persons considering vaccination indicates that they were previously or recently naturally infected. It is almost a certainty that many such persons are already well immune and either do not benefit, or only marginally benefit, from vaccination. In the absence of benefit, ANY medical procedure, including vaccines, can only impose harm. But even more critically, in persons who have had recent infections, vaccination could re-ignite a critical inflammatory disease or blood clotting complications that have proven deadly to some patients. So assessment on COVID-19 antibodies would lead to ethical AND safe medical practice. So why is FDA guiding against their use? It’s shocking!
  2. The COVID-19 vaccines, like any medical product are not perfect — and especially the mRNA vaccines, which we know are more unstable than traditional protein vaccines. As such, out of the millions of doses of these vaccines being administered daily across the world, a fraction, perhaps thousands, can reasonably be expected to be ineffective. So, it is entirely conceivable that some individuals who think they are getting vaccinated, are in fact NOT getting an adequate dose of the vaccine and do not become immune. Performing an antibody test post-vaccination could reassure vaccinated Americans that they, in fact, have developed antibody immunity. But, again, FDA is discouraging antibody levels even after vaccination. Why is that? Why shouldn’t Americans check their blood after vaccination to make sure they’ve mounted a response? It’s shocking!

So, really, by issuing it’s unscientific and clinically irrational guidance on May 19, 2021 FDA has done an enormous disservice to all Americans.

Claiming that COVID-19 antibody tests are not useful in assessing pre- or post-vaccine immunity to SARS-CoV-2 is a dangerous and inaccurate assertion made by FDA. Because it discourages Americans and their physicians to use this gold-standard assay to establish: 1) Medical necessity of vaccination, 2) safety of vaccination, and 3) efficacy of vaccination in individual Americans.

Here, I am writing to inform every American of the critical need to assess the status of his/her antibody immunity to COVID-19. It is neither an unreasonable demand, nor an impossibility, for the Biden Administration to make COVID-19 antibody testing from Laboratory Corporation of America Holdings (LabCorp) easily available to every American using #ScreenB4Vaccine.

In the aftermath of the pandemic’s beginning, the trump administration activated the Defense Production Act to build millions of ventilators. We can do the same to ensure that every American in every corner of the nation has access to #ScreenB4Vaccine via Labcorp and other means. to not do so is an error in regulatory policy and clinical judgement.

The following antibody tests from Labcorp can be very information:

SARS-CoV-2 Spike antigen, IgM (Blood — Labcorp 164034): This type of is produced early in response to a natural infection. It is specific for the SARS-CoV-2 spike protein. This antibody is rarely produced in response to the mRNA vaccines. Is is detectable within the first 6–8 weeks after a natural infection and is usually short lived and remains detectable for 8–12 weeks in most people. This result is a binary result: POSITIVE or NEGATIVE.

SARS-CoV-2 Spike antigen, IgG (Blood — Labcorp 164055): This is the protective antibody type that was used to assess the efficacy of the COVID-19 vaccines. It is the type of antibody that neutralizes and blocks the spike protein of SARS-CoV-2 — so it prevents entry of the virus in cells via the ACE-2 receptor. Importantly the presence of this type of IgG antibody is almost definitive evidence that the person also has T-cell immunity to SARS-CoV-2. This antibody type is produced by plasma cells and memory B-cells and can last for months to years in an immunized person. Its presence s the gold standard for immunity against pathogens. This result is a binary result: POSITIVE or NEGATIVE.

SARS-CoV-2 Nucleocapsid, Ab (Blood — Labcorp 164068): This antibody is specific for the SARS-CoV-2 Nucleocapsid protein. The presence of this antibody definitively indicates that a person has had a natural infection with SARS-CoV-2. This antibody is NOT present in vaccinated persons. However, if a vaccinated person has this type of antibody in their blood, it means that the person has had a prior natural infection. This result is a binary result: POSITIVE or NEGATIVE.

SARS-CoV-2 Semi-Quantitative Spike antigen, Ab (Blood — Labcorp 164090): This assay measures the amount of antibody specific for the SARS-CoV-2 spike protein in Units/ml. It is NOT clear exactly what level, if any, of this antibody is optimally protective. However, it may be reasonable to use this measurement as a way to track the level of immunity a person has over time. In general, the complete COVID-19 mRNA vaccine regimen seems to induce levels >250U/ml on this assay in the vast majority of people.

I have been privileged to interact with hundreds of fellow citizens and help them navigate this testing using these Labcorp. I believe that it is the duty of every American physician and of the Biden administration immediately facilitate such testing for any American who wishes to assess their immunity status.

Furthermore, it is my opinion as a physician and immunologist that any American with evidence of COVID-19 immunity on the above serological assays from Labcorp, is reasonably safe to delay COVID-19 vaccination — because the naturally immune are highly likely to be protected at least as well as the vaccinated, and are thus only being exposed to the risk of vaccine harm.

I write in defense of US public health and of medical ethics and patient safety.

Hooman Noorchashm MD, PhD