URGENT WARNING TO FDA COMMISSIONER — On Mandated Booster Vaccination of Young Americans.
This message to FDA commissioner Janet Woodcock is to warn against the lack of medical necessity and potential for harm from indiscriminate mandated vaccination of already well immune young Americans.
Honorable Commissioner Woodcock and Dr. Marks,
I write here for the public record, and as a warning to FDA and the Biden administration.
I trust you will communicate this email to Drs. Collins, Fauci, Walensky and others on the Biden COVID-19 Taskforce.
Please view my interview with FOX News’ Shannon Bream from yesterday regarding the concerns that have emerged over the past 2–3 weeks.
I write here, in light of the rapidly emerging booster vaccine mandates in many of our elite colleges and high schools across the United States, to warn against the danger of “hyper-vaccinating” two very specific categories of younger and already vaccinated persons, by blanket mandate. The Biden administration’s FDA and CDC should move to immediately prevent administrators at such institutions from making what will be a serious error of medical negligence in imposing a mandate that stands only chance of harming, these two categories of young persons in whom vaccine boosters are almost definitely unnecessary:
1) Those who have had a full regimen of vaccination already, in addition to having had a natural COVID-19 infection. I estimate these young persons to constitute upwards of 20% of the vaccinated population amongst college and high school students. As Dr. Fauci himself has said in repeated public comments, and as most rational clinicians and public health experts would honestly attest, individuals in this category are immunologically “ bullet proof”. To expose this category of young persons to a third mandated vaccination in the span of 8–10 months is pure medical insanity and only risks potentially catastrophic harm to some. In our need for speed to protect the nation, we can slow down and think with more care.
2) Those young persons in whom a parent, because of concern from a prior intense vaccine reaction, has opted to assess their children’s COVID antibody levels and in consultation with a clinician deem their blood antibody levels to be stably high in the range of what is seen with optimally vaccinated persons. As you know, I have repeatedly reported to you that the FDA approved Labcorp and Quest semi-quantitative Spike antibody levels over 1000 U/ml represent a well boosted vaccine reaction. To ignore and force vaccinate persons with this high level of existing vaccine immunity is unnecessary to very marginally beneficial. Thus, it only risks harm. FDA and CDC’s failure over the past year to establish a threshold level of antibody immunity associated with a good vaccine response is truly a “colossal” error in policy during a national emergency, where IMMUNITY, not necessarily vaccination per se, should be the primary national strategy.
Commissioner Woodcock, though we all wished that these COVID vaccines were perfectly free of adverse reactions, we all know that this is not the case. In fact, some of the adverse reactions associated with these vaccines have been catastrophic and even deadly. And, as you know, because the vaccine is being deployed on such a large scale and so quickly, there are minority subsets of American experiencing complications — to deny this iatrogenic reality and to label these iatrogenic complications as “rare” ones and accept them in a utilitarian equation for the sake of “majority benefit” is fully unacceptable and insufficient — specifically, because they can be avoided with rational, careful and feasible regulatory conduct. So, in order not to allow these vaccine complications to classify as “HARM”, it is critical to exercise medical ethical reasoning and exclude those persons, whom we know with a high degree of confidence will be as immune as possible. The two categories of young Americans I’ve delineated above are the “low hanging fruit” that FDA and CDC must protect immediately as these booster mandates are being rolled out indiscriminately without a second thought, by administrators at many of our elite institutions of higher education.
To be clear, though I do not agree with mandated boosters in young persons, for all the reasons that Professor Paul Offit has delineated recently for FDA and the public, I can understand why many elite administrators are risk averse when it comes to Omicron and protecting their institutions from potential shut down due to outbreak:
Nevertheless, since these mandates seem to be an inevitability at many elite institutions, it’s even more critically important that unnecessary COVID-19 vaccine boosters be avoided to the best of the Biden administration’s abilities — and certainly if/when an individual American in either category requests an exemption, the off exit ramp should be easily available to them. This is only possible, it appears, if FDA and CDC leaders like yourself elect to act rationally and in accordance with the principles of medical ethics and patient safety.
As it stands the rush to hyper-vaccinating the young, because of our fear of what Omicron might do, and irrespective of rational and feasible determination of medical necessity, will almost certainly cause totally avoidable harm to someone’s irreplaceable loved one, somewhere in America, soon. Will it be at one of my children’s schools or at my neighbors’? I do not believe any rational and ethical clinician or administrator ought to avoid acting on the issue I am warning about here. Our COVID-19 vaccines, you know, are some of the most reactogenic ones in our national arsenal — and, despite the rosy picture some wish to paint, they do cause adverse reactions at a certain rate, some very serious — used rashly, these complications become “harm”.
I write here in friendship to US public health for the public record, and to ask for your agency’s immediate action and a confirmation that you are in receipt of this letter of warning.
With respect,
Hooman Noorchashm MD, PhD,
