By Alison Despathy

Tuesday night, November 16, I joined the Vermont American Academy of Pediatrics zoom call with Dr. Rebecca Bell and a local pediatrician, Dr. Josh Kantrowitz. I have been deeply concerned about the lack of safety data for the Covid experimental vaccines for everyone, but especially for children, ages 5-11, which were recently granted Emergency Use Authorization status.

There are also many questions surrounding the efficacy of these vaccines, and it appears, based on data and research out of the Israeli Ministry, the Mayo Clinic, and the Imperial College of London, that these vaccines can potentially be considered a failure since they offer less than 50% protection, do not prevent infection or transmission, any level of effectiveness wanes after several months, and the vaccine does not appear to be protective against the dominant delta strain. Questions arise, as well, to the potential role of vaccines in creating vaccine resistant strains of coronaviruses. Since new genetic vaccines are currently in clinical trials, it is crucial to focus on all possibilities related to outcomes and impacts of this global clinical trial.

There is a very evident one size fits all, blanket-approach that is happening with these experimental vaccines, and there are so many unknown risks and questions surrounding this plan.  After after listening to the FDA Panel discussion on October 26, and looking through the briefing documents and the FDA benefit-risk analysis, I was really curious to hear how Dr. Bell and Dr, Kantrowitz were going to present the fact that there was a very short and small clinical trial design for children, and a lack of real data to properly assess the safety and efficacy of these experimental injections intended for children.

In particular, given the fact that close to 100% of children, unless specifically immunocompromised, are not struggling with Covid and Covid recovery, I wondered why these experimental genetic vaccines would even be considered on a broad scale with this age group. After close review of the clinical trial design and results, it became very evident that the benefits did not outweigh the risks since there was no clear way to assess true risk, especially long-term risks and complications, and there was no actual evidence for efficacy.

I had thirteen questions that were submitted, and unfortunately, none of them were addressed in the hour and a half long zoom call. There was total of 23 questions asked by participants.  It is also important to note that Allison Cassavechia was on the call and asked about the fact that there have been zero deaths and zero hospitalizations in this age group, according to Vermont Department of Health. She also brought up the FDA panel meeting on October 26 and some of the scientists’ questions regarding concerns on the one size fits all mass vaccination of children. Neither of her questions were answered.

Question 1– These are brand new technology genetic vaccines, with a small, short trial, and the follow-up was only 17 days and 2 months. How are you offering parents informed consent without adequate data to determine safety?

Question 2- Are you informing parents about the new ingredient tromethamine in this experimental genetic vaccine? Although the intention of this ingredient is a buffering agent, it is also a very potent drug.

Question 3– There were no children with severe Covid or any hospitalizations in the placebo or vaccinated group, thus there is no way to truly assess efficacy. The use of immunobridging to “infer” efficacy or benefit is unacceptable. Are you actually comfortable that immunobridging was used to “infer” the “likelihood” of efficacy?

Question 4 -The most vaccinated countries, Iceland, Israel, Singapore, Gibraltar, and UK, as well as Vermont, the most vaccinated state, have the highest level of covid caves. According to the CDC, 99% of covid strain right now is delta. Never before have we had this narrow-limited amount of ecological diversity with coronaviruses. There is research demonstrating that we now have antigenic escape variants and many researchers and scientists are looking at the vaccines as the cause for pushing this dominant delta strain that is highly prevalent in the most highly vaccinated states and countries. Given the validity of this possibility based on accumulating evidence, do you still believe that we should be using these on a large mass scale without further information and actual results of the current clinical trial?

Question 5-Natural immunity is the gold standard and repeatedly shows in the research, both historically and currently, as the most highly effective and durable form of immunity. Why would one need a vaccine after natural immunity? This is highly risky and dangerous given we have never had successful vaccines against coronavirsues and the clinical trial did not specifically assess the impacts of vaccinating those with natural immunity.

Question 6– The one abstainer in the FDA panel was Michael Kurilla, and he called for a “more nuanced approach” and questioned if the statutory criteria for EUA was met for children in this age group. He questioned if we should be vaccinating those at high risk compared to vaccinating all eligible children in this age group. Your thoughts?

Question 7- Was the vaccine with tromethamine actually used in the clinical trial? If this is the case, then immunobridging efficacy, according to the FDA, would not be appropriate because it can only be done with the “same vaccine”.

Question 8– Based on the clinical trial, there is no way to directly assess efficacy, why are we seeing hospitals say that these are 90-100% effective?

Question 9– The spike protein in a covid infection causes damage and problems in many. Why would it not be the case that the spike protein that our cells are supposed to make from the vaccine would not create problems? There seems to be a large body of research supporting this.

Question 10– We are using biotechnology in this vaccine (foreign synthetic genetic material is being used to tell cells to make a foreign protein). Human bodies are designed to react to foreign proteins. Do you believe that this could create any autoimmune response?

Question 11- Mayo Clinic, Imperial College of London and the Israeli Ministry all have Pfizer efficacy at 39-44% and maybe six months of protection. This is the definition of a failed vaccine. When will it be discussed that these vaccines are not offering what was marketed?

Question 12– Why does an experimental vaccine as the solution have to be the only answer? It does not seem logical that we would not be offering and discussing other avenues for prevention and treatment, especially early outpatient care to not overwhelm the hospitals and to prevent hospitalizations, especially given these protocols are in place and established and peer-reviewed.

Question 13 – Are you considering the fact that our high level of vaccination rate is driving the dominant delta strain that is affecting both vaccinated and unvaccinated people in VT? We all know about MRSA and VRSA and the antibiotic resistant strains of bacteria and what about the possibility of vaccine resistant viruses? There is data supporting this to be considered.

The clinical trial used to assess safety and efficacy of a brand-new experimental vaccine technology for children lacks in many regards, and both the clinical trial design and the actual data to make determinations regarding safety and efficacy are not significant enough to draw conclusions. At this point, assumptions are being made in place of direct comprehensive evidence.