FDA’s Advisory Discouraging Americans From Determining The Status Of Their Individual Immunity To COVID-19 Is A Clear And Present National Health Security Threat

The only way for vulnerable Americans to protect themselves from COVID-19 is to know the EXACT status of their immunity to the virus. But on May 19, 2021, the United States Food and Drug Administration placed a significant barrier to Americans and their physicians determining COVID-19 immunity status using the gold-standard antibody test.

The Biden FDA is causing a severe national health security threat by blocking Americans’ access to personal information on the status of their immunity to COVID-19. Without this information Americans are unable to make informed and rational decisions to protect themselves.

In the course of history, nations including our own, have made specific and catastrophic national security blunders leading to great wars and great losses.

In America’s war against the “viral pandemic” we call COVID-19, our federal government is making just such a specific and catastrophic strategic blunder in protecting the people of the United States.

Every reasonable American knows that the only way for us to sufficiently defend and protect ourselves, each other and the nation from any given threat, with adequate granularity and efficacy, is to know who amongst us is vulnerable and who is not.

In the case of the COVID-19 pandemic, IMMUNITY is our one and ONLY defense against the SARS-CoV-2 threat: IMMUNITY, both at the population level and the individual level.

But on May 19, 2021 in a spectacular strategic blunder, the United States Food and Drug Administration blocked Americans from finding out the status of their antibody immunity to SARS-CoV-2. It’s worth knowing that antibody testing is the gold-standard for determination of immunity in standard medical practice.

Shockingly, in the COVID-19 pandemic both reason and medical standards have been suspended, it appears. FDA has abandoned reason, and CDC seems to act more on authoritarian ideology than sound medicine and established medical ethical precepts.

On that day, May 19, 2021, the FDA issued the following guidance:

The adverse consequence of this Federal level blockade of individual Americans finding out the status of their personal immunity to a pandemic virus that has killed nearly 700,000 American, is immeasurable.

What’s more is that based on this terrible FDA error, most American physicians are reluctant to test their patients for their antibody levels — even if patients ask for the information. WHY? For fear of reprisal from their hospital systems, employers or state medical boards.

To be clear, this critically dangerous FDA advisory is preventing individual Americans from obtaining their personal health information about the status of their immunity to COVID-19 — in the midst of a pandemic outbreak when this information is critical to know!

This FDA blunder is harming Americans along five specific axes:

  1. It prevents un-immune Americans from knowing that they are vulnerable.
  2. It exposes already immune Americans to the risk of an unnecessary or marginally beneficial vaccination.
  3. It exposes concurrently infected or recently convalescent Americans to the risk of bodily harm from unnecessary vaccination.
  4. It prevents vaccinated Americans in whom the vaccine has not induced good immunity from knowing that they remain vulnerable.
  5. It discourages a vast majority of American physicians from providing the people with the necessary prescriptions to obtain COVID-19 antibody blood tests and thereby blocks Americans access to the only specific piece of personal health information that can assess their susceptibility to infection.

In short, the May 19, 2021 FDA advisory is blocking Americans from accessing THE specific piece of personal medical information that is directly relevant to the status of their immunity against a pandemic virus that has killed nearly 700,000 of us — and is threatening hundreds of thousands more in the next year.

This dangerous FDA advisory must be immediately rescinded by the Biden administration in order to allow every American to obtain information about the status of their personal immunity to SARS-CoV-2 and assess how vulnerable they may be.

By blocking access to this critical personal information about COVID-19 immunity status, the Biden FDA is catastrophically failing to provide Americans with all the critical necessary piece of information they need to act rationally to protect themselves maximally: the status of their personal immunity to COVID-19.

The Biden FDA and CDC have promoted this disastrous policy, because they seems convinced that a policy of blanket indiscriminate vaccination is the correct and only effective strategy to combat this pandemic.

But the truth is that every American deserves easy access to information about their personal immunity status in order to make a cogent decision to maximally protect themselves.

Am I immune? Did my vaccine work for me? Am I still immune?

These are rational questions every American has a right to know the answer to in the midst of a pandemic outbreak. It is NOT irrational or impossible for Americans to gain access to their information. In fact, it is imminently possible and critically necessary!

If Mr. Biden and his advisors had any real desire to act rationally and prevent harm to EVERY American, they would immediately open the door to COVID-19 antibody testing for EVERY American.

Mr. President, rescind the May 19th FDA advisory and activate the Defense Production Act to allow all of our country-men and -women easy access to their personal immunity status to COVID-19 using outpatient laboratory facilities like Labcorp and Quest. Your failure to do so IMMEDIATELY will become a disastrous error in American public health history. IMMUNITY, Mr. President, is the Achilles heel of this pandemic. So if every American were to be given access to information on the status of their personal immunity, decision making will become optimal, efficient and safe. At the moment your administration is effectively blocking access to this highly relevant piece of personal health information. THIS, is your error, Mr. President.

As it stands, FDA’s May 19, 2021 advisory blocking Americans from testing the status of their immunity is a clear and present national health security threat. It MUST be stopped!

In defense of US public health and of America herself,

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.