To all mothers, fathers, and guardians of minor children:
I sincerely urge you to consider the following information, written with candor, in order to guide you in your decision-making as you are presented with the Pfizer SARS CoV-2 vaccine for your child(ren).
Given the unanimous decision by the CDC’s Advisory Committee on Immunization Practices to vaccinate children ages 5-11, after the FDA’s authorization (on 10/29/21), mass pediatric vaccination strategies are occurring throughout the nation from private clinics to school-based vaccine administration sites.
This is a great effort to vaccinate a population in which the disease has minimal to nil risk of severe infection. We have witnessed this over the course of nearly 2 years now. Thus, one must ask – Are we prudently and judiciously, without bias, comparing the benefits and risks of vaccinating children for SARS CoV-2? Are parents being truly informed before providing consent?
It is imperative to know all the aspects of a treatment or intervention so that one may deliberate before deciding. Another important point, not to be minimized, is that the CDC states that the mRNA vaccine is “a new type of vaccine.” Vaccine in the truest sense of the definition has been known as “an antigenic preparation of a typically inactivated or attenuated pathogenic agent or one of its components or products.”
Per the CDC, the definition of vaccine now includes “a preparation of genetic material,” which is synthesized messenger RNA in the case of the Pfizer product. This will then be utilized by the individual receiving the injection to produce the protein (spike protein in this case) that will trigger the body to produce an antibody in response to that protein. This is not like any other vaccine on the immunization schedule for children.
With the roll-out of the vaccine and the subsequent mandates, the principle of informed consent, a crucial element of the profession of medicine, has simply been disregarded.
Given the oath I have taken to uphold the dignity of humanity, to do no harm, and to heal and restore health, it would be extremely remiss of me to set aside this principle and not present my serious concerns.
Truly informed consent must consist of the following conditions to be valid and achieved when an intervention is being considered. As I address each condition, I will apply the current situation we are facing – the injection of a separate formulation of the Pfizer-BioNTech COVID-19 vaccine containing one-third of the adolescent/adult dose, 2 doses, separated by a period of 3 weeks for children ages 5-11.
- The individual giving consent must be competent, able to understand the issue at hand, and possess the ability to exercise sound judgment.
This is where you, as a parent, are vital. Since parents are the protectors of their children and presumed to have their best interests at heart, they are, and should be, the “consenters.” In the current situation, children ages 5-11 do not have the capability to understand the consequences of receiving the Pfizer injection. They cannot assent, or provide genuine approval, which is typically allowable for a mature adolescent. Competence entails that the individual consenting is capable of doing so rationally.
My concern with the EUA (emergent use authorization) in children is the plain fact that it is still experimental. According to the FDA’s regulatory terminology, the process of obtaining EUA is
different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence [emphasis added] that would be needed for FDA approval or clearance.
The occurrence of COVID-19 has not demonstrated an emergency in children. Per the CDC’s own data, children ages 5-11 have a greater than 99.99 % chance of survival if infected by SARS CoV-2. The risk is nil. Children are noted to have a protective factor in their innate immunity that likely contributes to their low risk of severe COVID infection.
The U. S. Department of HHS (Human and Health Services) clearly states that research involving children entails special requirements, including the assent of the child in addition to parental consent. In addition the risk of the intervention should not be more than minimal.
From an ethical perspective, it is very concerning that these trials of vaccination, involving children age 5-11, were even performed because there is no evidence of direct therapeutic benefit and these children are unable to assent. The actual estimated study completion date for the Pfizer BioNTech product is not until May, 2023; yet the plan is to inject millions of children prior to this date.
Never, and I repeat never, should children be a part of an experiment to benefit adults. And, as we have witnessed, the vaccines have not proven interruption in transmission as the induced immunity from the vaccine is not sterilizing. Then the question remains – Who is benefitting?
- The benefits and risks of the intervention must be provided along with the opportunity to ask questions.
The benefits of a vaccine is to mitigate severity of disease, boost herd immunity, and decrease transmission. According to the CDC’s Evidence to Recommendations (EtR) Framework the benefits purported to be obtained from vaccinating children with the Pfizer product is prevention of COVID-19 cases, likely [emphasis added] prevention of hospitalizations, MIS-C (multisystem inflammatory syndrome in children) and post-COVID conditions, possible [emphasis added} prevention of transmission, and greater confidence in safer return to school and social interactions.
The emphasis on prevention of cases in children should be based on the severity of the disease a “case” imposes. Per the CDC, the severity of COVID-19 is “comparable among children hospitalized with influenza” and “cumulative hospitalization rate is similar to pre-pandemic influenza seasons.”
Not to belabor the point but healthy children are not going to benefit statistically from receiving this vaccine since COVID-19 is not severe in this population. To put it in perspective, the risk of death in the elderly is nearly 1000 fold that of children.
There is no guaranteed certainty that the prevention of hospitalizations and MIS-C will occur (as noted by the CDC’s use of the word “likely.”) There already exists reports of MIS-C post vaccination (here, and here).
Vaccinating children is not the confidence we need to reopen schools, either, as some schools have remained open successfully. Children should not bear the burden nor be the victim of a politically-influenced disruption of the education system.
The risks the CDC listed in its EtR Framework were short-term reactogenicity (physical manifestations soon after the injection) and myocarditis or other rare events after mRNA. We are well aware of the immediate side effects of any injection – pain and redness at the site, fever, possible headache. However, the risk of myocarditis (here and here) after administration of this product (over 500 cases per VAERS database), primarily in young males, has to be underscored.
Serious adverse events was one of the listed outcomes of the trial (in ~ 3100 vaccinated children) to be evaluated, but the trial was “not powered to asses rate of rare adverse events.” So, how can the CDC claim that the benefits outweigh the risks when the number needed is insufficient.
The deaths attributed to COVID-19 in children need to be fully investigated. Did other comorbid conditions contribute to the passing of these children? In the 5-11 age cohort, the CDC (at this time) is attributing 100 deaths from COVID in the U.S. from 1/1/20 – 10/30/21 (22 months). For comparison, the influenza-associated pediatric deaths in the age 5-11 population for the 2019-2020 season (12 month period) was reported to be 72.
According to VAERS (a passive reporting system), the number of deaths reported thus far after receipt of the Pfizer BioNTech product in the 12-17 age range is 26. The deaths can not be conclusively attributed to the vaccine but warrant further in-depth investigation, as well.
These numbers are provided to assist you with risk assessment. For, should a child suffer a serious adverse event attributed to the vaccine, the pharmaceutical company will not be held liable. This is a concern given Pfizer’s projection of 36 billion dollars in revenue this year.
- The one consenting must be aware of alternative available treatments including not receiving the treatment.
The alternative is for the child to not receive the vaccine. If your child has tested positive for COVID-19 or had a viral illness that was not formally diagnosed, then it is reasonable to consider obtaining an anti-SARS-CoV-2-specific antibody to assess the immune response to a prior infection with SARS CoV-2. Another test to assist with detecting previous SARS CoV-2 infection is the T-Detect COVID. However, this is only available for individuals 18 and older at this time. There are now over 100 documented research studies affirming immunity naturally acquired after COVID-19. This is effective immunity.
In addition, this pandemic should motivate all of us to take better care of our health and the health of our children, since obesity and chronic medical conditions are known risk factors for development of COVID. By making wiser decisions – healthy eating, exercising more, less screen time, adequate sleep – children will be less likely to suffer severe complications from COVID and other illnesses now and in the future.
- The one consenting must be allowed to come to the decision about the treatment or intervention without coercion.
Consent must be free and voluntary. COVID-19 vaccine mandates imposed on families in order for children to attend school violate this free decision-making . . . especially when the study has not even reached its completion date.
Since this is a global concern, it is necessary to consider what is happening in other countries. The UK chose not to vaccinate most children under 18 as of mid-July this year as per the recommendations of their expert advisory panel. And, European countries are split on whether/not to vaccinate children.
In conclusion, children are considered to be a vulnerable population since they are still growing and maturing and do not have the mental capacity to make decisions that may alter their development. We, as pediatricians and physicians caring for children, in conjunction with you, as parents, must safeguard the welfare of our young generation. In order to do so, you must be fully informed about intended medical treatments and interventions . . . without fear-mongering or coercion. We, as a medical community, must have the humility to declare what we do not know and not subject our patients to unnecessary risks.