My Response to a Call for Action
A draft letter to potential voters on FDA's Vaccines and Related Biological Products Advisory Committee
[see end for latest update]
Mea culpa. I was not able to turn around an immediate response [my previous post], as many others have been able to do. I’ve spent the week busy with my day job and tired at the end of each day. Who hasn’t? I know, I’m not special.
As the week progressed, I tried to collect my thoughts on what I would write. Today, I revisited the original Call To Action ( here ). Taking some cues from there, I crafted the following letter, which I’m including below. In a day or two, I plan to put this into individual emails to each person on Toby Roger’s list.
I’m interested to know what you think. Misinformation? Corrections? Omissions?
If you think this might be helpful to anyone else, feel free to share the link to give them ideas to put into their own words (or even take a few bits directly if they are any good).
Without further ado…
February 6, 2022
XXPerson name and contact info
Dear XXPerson:
I understand that there is an upcoming meeting on February 15 of FDA’s Vaccines and Related Biological Products Advisory Committee to evaluate Pfizer’s recent application for EUA for their Covid-19 biologic for children six months to four years old. I never thought I would be writing this type of letter, but here I am, writing to you as a father and fellow citizen of other parents.
I ask emphatically that this application to experiment on our very young be DENIED. If you will be voting, I ask you to consider the rationale below and vote NO. If you know people who will be voting, I ask you to encourage them to consider the rationale below and vote NO. We must speak for those who cannot speak for themselves. We are watching to see your decision. We are counting on a DENIAL of this application to protect the health of our most vulnerable.
I offer these five points for consideration as rationale for a denial, followed by related questions, and additional “asks”.
We know that the young are at negligible, near-zero risk of hospitalization and death FROM COVID-19, because the risk lopsidedly occurs in the very old and those with significant co-morbidities. Hence, there is no emergency on which to base consideration of any intervention. This point alone should suffice for a NO vote.
The Pfizer clinical trial failed to show benefit after two shots for this age group.
The medium and long term harms are unknowable in such a short time frame, given that this experimental biologic delivered by novel technology is being considered for toddlers that have their whole lives ahead of them, the risk is unconscionable
The idea of a rolling authorization — “approve now and hope that supporting data of a beneficial and safe third shot arrives in the future” — is not only anathema to public health, but is unjustifiable, particularly when at the time of consideration no benefit has been demonstrated and medium and long term harms are not knowable.
Because EUA biologics are by definition experimental, this proposed use violates the prohibitions outlined in the Nuremburg Code, https://www.ushmm.org/information/exhibitions/online-exhibitions/special-focus/doctors-trial/nuremberg-code, with regard to at minimum the following points:
Preamble. There can be no “results for the good of society” resulting from human experimentation if there is no significant health concern, as is the case with this age cohort.
Principle #1. “The person involved should have legal capacity to give consent; …” is not possible with this age cohort. Further, “all inconveniences and hazards … and the effects upon his health” is not knowable, in part because the existing adverse event signals to-date have not been adequately addressed.
Principle #2. “The experiment should be such as to yield fruitful results for the good of society, …” cannot be satisfied when the level of harm is known to be negligible. With respect to, “… unprocurable by other methods or means of study”, it is unethical to study the harms that might accrue to this cohort when the harm signals in VAERS have not been pursued to their full extent.
Principle #3. This principle, unsatisfiable in the present case, requires that the results of animal studies and knowledge of the history of the disease indicate that performing the experiment will yield likely beneficial outcomes.
Principle #5. The harm signals in VAERS, whistle-blower data, properly conducted autopsies, and many reports of injuries provide a de facto contra-indication for this principle: “No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur;…”
Principle #6. If there is negligible harm, then no benefit can be obtained, and no level of risk, even the most minuscule, can be tolerated: “The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment”
Here are some related questions:
What health emergency among this young cohort is prompting consideration of an EUA for an mRNA Covid-19 biologic?
What statistically significant benefits vs. placebo have been demonstrated to-date?
What short, medium, and long term harms have been identified, vs. placebo?
Is the study control arm a placebo control arm?
Are there harm signals available from any source, that with proper analysis have potential to contra-indicate performing, expanding, or continuing the experiment?
Is the number of study participants sufficiently powered to produce statistical significance for deaths and hospitalization outcomes?
Is the study looking at clinical outcomes?
What have the animal trials shown (were there animal trials) with regard to injecting the very young?
If the medium and long-term risks are unknown, how can one morally and ethically justify injection of novel mRNA technology as a biologic in the very young?
While I am writing, I would like to take the opportunity to encourage a broader focus on public health over a single focus to promote vaccines:
I ask, with utmost urgency as it may represent the most immediate benefit, that early treatment via cheap, effective, established, widely-available medicines with known safety profiles, be promoted with restrictions lifted, even though they may be off-label uses for COVID-19, and even though they may utilize some of WHO’s “essential medicines”.
I ask that the decisions for interventions shall be left to patients in consultation with their doctors, including prophylaxis and treatment.
I ask that the EUAs be terminated for all youth, under 18 years old, who lack any serious co-morbidity of concern.
I ask that the serious adverse event signals in VAERS and other health data systems be transparently and honestly pursued, particularly with regard to the underreporting factor.
I ask that all follow-up, long term studies that were suggested for the conditional licensing of all COVID-19 biologics, past, present, and future, be re-cast as required studies so that the medium and long term health side effects can be properly identified and quantified.
I ask that you encourage a quick end to the COVID-19 emergency.
Thank you very much.
And off they go … (and online docket comment submitted too)
Wonderful. All of it looks great to me. Very detailed and thorough. I have no edits other than typos I caught. ;) In caps below.
What statistically significant benefits vs. placebo HAVE been demonstrated to-date?
I ask that you encourage AN (or THE) end to the COVID-19 emergency.
Thanks again for getting the word out about this. It's so crucial that we do everything we can to stop this.
Touché. If this were a petition, I would gladly sign it.