A SEVERE ERROR IN FEDERAL PUBLIC HEALTH POLICY: Antibody Testing Is Critical For Determination of COVID-19 Vaccine Necessity and Efficacy in Every American.

The Biden Administration’s FDA has made a dangerous error by closing the door to individual American citizens using COVID-19 antibody testing liberally to assess both vaccine necessity and efficacy.

Dr. Janet Woodcock permitted an incorrect and dangerous FDA guidance on May 19, 2021 discouraging use of COVID-19 antibody testing to assess either necessity or efficacy of COVID-19 vaccination. Why?

On May 19, 2021 the United States Food and Drug Administration (FDA) released a dangerous and totally inappropriate guidance advising against COVID-19 antibody testing pre- or post-vaccination.

This FDA guidance is dangerous because it discourages and blocks most American physicians from using the gold standard assay for immunity to COVID-19.

But, it is of paramount importance for every American citizen and resident and his/her physician to be able to assess the status of one’s immunity to COVID-19 during this pandemic — for two reasons.

First, if a persons is found to have no COVID-19 antibodies prior to vaccination, that persons will know that he/she is at high risk of developing an infection. In other words, antibody testing would allow determination of medical necessity of COVID-19 vaccination — and being that most persons act rationally given correct information, it is anticipated that most non-immune Americans will seek vaccination, or take other precautions to protect themselves, when confronted with a negative antibody test.

I have, on multiple occasions now, publicly called on the Biden administration, the FDA commissioner and the CDC to open the door to antibody testing for establishment of medical necessity as a means of combating vaccine hesitancy. Because I believe Americans to be a rational people and, I know from personal experience in medical practice, that when most hesitant Americans are confronted with the FACT that they are NOT immune, a majority choose to get vaccinated. Americans are a rational people and want to protect themselves from harm. But, by placing barriers to pre-vaccination antibody testing for determination of medical necessity, the Biden administration’s FDA is dangerously stoking further vaccine hesitancy through this very specific and misguided policy against antibody testing. And fundamentally, when federal executive agencies act to limit citizens access to their own highly relevant health information, especially in a national medical emergency where their lives could depend on it, a terrible dereliction of duty is at hand.

Second, the mRNA vaccine is a highly unstable preparation. Thus, it is very likely that a significant number of mRNA vaccine doses entering individual American arms are either partially or completely spoilt — and, thus, ineffective. The fact that FDA’s May 19 guidance is placing a barrier in the way of post-vaccination antibody testing, effectively blocks determination of vaccine efficacy in individual Americans. This inappropriate and dangerous FDA action very likely leaves a substantial number of vaccinated citizens susceptible to what would have otherwise been preventable COVID-19 infections, had these citizens been provided a pathway to confirm the efficacy of their vaccination.

Because the mRNA vaccines are likely to be susceptible to a significant rate of spoilage, it is a statistical certainty that some vaccinated Americans will be either partially or entirely un-immunized against COVID-19 - even though they are fully vaccinated. And because millions of American have already been vaccinated, tens if not hundreds of thousands of inadequately immunized people are likely to be roaming around our nation at the moment. These suboptimally immune, or un-immune, individuals would be susceptible to what would then be labeled “breakthrough infections” - but not because the COVID-19 vaccine is generally ineffective, but because they are actually suboptimally immune due to a spoilage of one or both of their vaccine doses. It is, thus, an unassailable clinical fact that Americans would benefit from knowing the status of their COVID-19 antibody immunity after vaccination— in order to either take extra precautions or to get re-vaccinated, if the vaccine has not induced the expected IgG antibody response. Of course, unfortunately, the FDA has discouraged vaccinated Americans from confirming the efficacy of their vaccination. This Biden administration policy effectively leaves the subset of Americans subjected to bad vaccinations open to the risk of infection — because these people are trusting and confident in the efficacy of what is essentially a dead vaccine. This is a regulatory travesty being committed by the Biden FDA

The incorrect May 19 FDA guidance blocking antibody testing was a shocking pronouncement from a medical perspective. Specifically because antibody testing is the gold standard medical test for immunity against EVERY viral and bacterial pathogen known to humankind — SARS-CoV-2 is NOT an exception. The fact that the medical community has not unanimously objected to this dangerous FDA guidance is a powerful testament to the tragic and dangerous “group-think” governing our medical establishment, and compromising American lives every day in many corners of the healthcare sector. “Group-think” kills — especially in medicine!

So the question is: why would FDA and it’s commissioner, Dr. Woodcock, make such a terrible error in policy judgement?

Unfortunately, my only answer is that this is a deliberate deceptive action by FDA — specifically because the agency is concerned that letting individual Americans gain access to information about the status of their own immunity to COVID-19 would either slow or discourage COVID-19 vaccination.

But, of course, like other deceptive federal policies, FDA is again ignoring the rights, intelligence and free-will of the American people. The May 19 FDA guidance, discouraging COVID-19 antibody testing, is a radical and dangerous public health sin against Americans. Is it a wonder that so many Americans simply do not trust our executive agencies anymore?

It has been my experience that at this point in the pandemic, many of the vaccine hesitant in America do actually make a rational and informed decision to get their shots, when they are given access to objective data about the status of their antibody immunity and are provided the means to establish the medical necessity of vaccination. Furthermore, because mRNA is such an unstable material, it is inevitable that many “fully vaccinated” Americans are only partially immunized, or not at all. Thus, it is a matter of public safety for the the Biden FDA to facilitate American citizens and residents making a determination as to whether their COVID-19 vaccine dose has worked for them or not.

Here, I am publicly calling on the FDA commissioner and her colleagues to urgently cease and desist in stoking vaccine hesitancy and leaving some “fully vaccinated” but un-immune Americans susceptible to infection, by continuing to insist that individual Americans NOT be tested for the status of their antibody immunity to COVID-19 — pre- or post-vaccination, respectively.

It is the right of every American to be informed about the status of their own body’s immunity to a potentially deadly pandemic virus. The May 19, 2021 FDA advisory has created a major challenge to Americans (and their doctors) making an informed personalized decision — both to establish the medical necessity of vaccination AND to ensure that the vaccine doses they have received effectively have induced the expected protective antibody response.

As an immunologist and physician, on this record I express my professional opinion that FDA’s May 19, 2021 advisory guiding against COVID-19 antibody testing is a severe hazard to American public health and a serious cause of vaccine hesitancy in this pandemic.

I shall hope that the Biden administration and FDA commissioner Woodcock are able to heed my warning here and call to immediately eliminate the dangerous May 19th FDA guidance on COVID-19 antibodies.

In defense of US public health,

Hooman Noorchashm MD, PhD

noorchashm@gmail.com

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.