Vaccinating The COVID-19 Infected: A Dangerous Clinical And Regulatory Misstep For the Elderly and Frail.

If it is potentially dangerous to vaccinate those with KNOWN SARS-CoV-2 infections, why is it safe to indiscriminately vaccine those with UNKOWN (or hidden) infections — especially in the elderly and frail population with cardiovascular disease.

Current CDC guidelines for administration of the COVID-19 vaccine states that “vaccination of persons with KNOWN current SARS-CoV-2 infection should be deferred.”

The reason for this guidance is that CDC public health experts and the vast majority of Infectious Disease and Immunology experts understand that vaccinating the infected poses a risk of exacerbating illness by stimulating an inflammatory response in individuals who are infected.

The terrible and dangerous misstep in this regulatory guidance from CDC is this: it entirely discounts the fact that a vast number of people carry UNKOWN mildly symptomatic or asymptomatic infections in a pandemic.

And there is no medically rational reason for anyone to assume that people with UNKNOWN (or hidden) SARS-CoV-2 infections are any less susceptible that the KNOWN infected to a vaccine-related complication. Such an assumption is simply medically and legally irresponsible and potentially dangerous.

The problem of UNKNOWN (or hidden) SARS-CoV-2 infection is particularly critical during the current pandemic. Because, as millions are being indiscriminately vaccinated, hundreds of thousands are acquiring infections daily.

CDC Guidance on COVID-19 Vaccination last updated January 21, 2021: “Vaccination of persons with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and criteria have been met for them to discontinue isolation. This recommendation applies to persons who develop SARS-CoV-2 infection before receiving any vaccine doses as well as those who develop SARS-CoV-2 infection after the first dose but before receipt of the second dose.

While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Thus, while vaccine supply remains limited, persons with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination, if desired, recognizing that the risk of reinfection, and therefore the need for vaccination, may increase with time following initial infection.”

Now, from a clinical perspective, it’s also more likely than not that otherwise young and healthy person with an UNKNOWN infection would tolerate any vaccine related inflammatory reaction well.

But, we cannot state the same of the elderly and frail — and especially those with underlying cardiovascular disease.

So, really, the legal, clinical and ethical question for the leadership of CDC, FDA, Pfizer and Moderna is this:

If you all know that during this pandemic, millions of people, and especially many institutionalized elderly and frail, will carry UNKNOWN (or hidden) SARS-COV-2 infections, why are you taking no steps to protect such persons?

Is the CDC, FDA, Pfizer and Moderna’s failure to protect those with UNKNOWN (or hidden) SARS-CoV-2, because:

1. such persons are at lower risk or at no risk compared to counterparts with KNOWN infection who are vaccinated? If so, where is the data?
2. attempting to protect such infected UNKNOWN infected individuals by placing efforts into identifying them would slow the necessary fast pace of vaccinations to defend against the pandemic?
3. in the medical utilitarian equation, the fact that a greater majority will certainly benefit from the vaccine, ethically absolves government and corporate entities from protecting what will be a minority subset of citizens with UNKNOWN (or hidden) infections?

Of course, I posit these questions knowing the answers — as I am sure most reasonable readers in the public, the profession and in government do too.

In fact:

1. It is NOT known whether persons with UNKOWN (or hidden) SARS-CoV-2 infections are at lower or no risk of a vaccine reaction than counterparts with KNOWN infections. And, if anything, it is very likely that such individuals, especially in the elderly and frail subsets with underlying diseases, are at equal or even higher risk of a vaccine related complication.
2. attempting to identify persons with UNKNOWN (or hidden) SARS-CoV-2 infections, especially in the elderly, frail and institutionalized subset, would not slow the pace of vaccinations. Specifically, because most people are in reality NOT infected and the vaccine is still a limiting resource, so demand is currently well outpacing supply at a population level. Keeping the infected, KNOWN and UNKNOWN, safe is not going to slow the pace of vaccination — for demand far outpaces supply at present.
3. Medical utilitarianism does NOT ethically (or, likely, legally) justify ignoring risks of harm to specific identifiable minority subsets of people at risk of harm.

Now, my critics, some highly decorated academic physicians and legal scholars, are vocally (and at times belligerently) pointing out that my concern about indiscriminate vaccination of The Infected is concocted, in order to serve an “Anti-Vaccine” agenda.

Aside from the defamatory nature of the criticism, given my strong understanding of the necessity for efficient and widespread vaccination during this pandemic, my critics are at best guilty of intellectual laziness and, at worst, overt unethical institutional protectionism. A brief look at my Twitter feed might make to the point clear for some.

But, this criticism of the safety concern I’ve raised here and elsewhere in the public and regulatory domain, by a few well decorated physicians, academics and politicians, is floridly irresponsible and dangerous — because:

1. it ignores the fact that in this unprecedented new pandemic we are deploying an equally unprecedented and highly immunogenic vaccine into a population in which the numbers of recently infected are daily increasing — and many of these infected will be mildly symptomatic or asymptomatic.
2. it ignores the fact that CDC, FDA, Pfizer and Moderna themselves understand that vaccinating infected people carries and unacceptable risk of harm, leading them to formally contraindicated vaccinating such KNOWN cases — while failing to consider and recognize the potential risk to persons with UNKNOWN (or hidden) infections.

In the end, it is FDA, CDC, Pfizer and Moderna that bear the burden of liability for negligence in not protecting those persons with UNKNOWN (or hidden) SARS-CoV-2 infections— it is simply the logical extrapolation from their own deficient regulatory language, which is demonstrating this dangerous error.

I write here, again, for the public record and for the benefit and consideration of Drs. Woodcock and Marks at FDA — as well as CDC Director, Dr. Wollensky.

Certainly, I also write for the public record, because I do believe that Pfizer and Moderna might be legally (and certainly ethically) exposed, knowing that insufficient mitigation has been deployed to protect The Infected, all those infected and not just the KNOWN, from vaccine harm.

Here is my respectful suggestion to FDA, CDC, Pfizer and Moderna leaders: Simply change the language of your contraindication to read:

“vaccination of persons with KNOWN or SUSPECTED current SARS-CoV-2 infection should be deferred.”

Adding these two words, “or SUSPECTED”, to your regulatory language would free physicians to evaluate their patients more carefully and patients to choose. For who are the “SUSPECTED” infected — and how we identify them?

In my opinion, as an immunologist and physician, #ScreenB4Vaccine is a public safety device in this pandemic, to protect The Infected from vaccine harm — and especially those who are elderly and frail with cardiovascular disease.

In friendship to public health in the United States and globally,

Hooman Noorchashm MD, PhD

noorchashm@gmail.com.