Part One of a three part series explaining why some Vermonters won’t ‘take the jab’
By Alison Despathy
When news of the Food and Drug Administration (FDA) approval of the synthetic mRNA Pfizer Comirnaty ‘vaccine’ broke on August 23, many Americans felt a level of comfort and security with their ‘vaccine’ plans. The approval also offered hospitals, businesses, institutions and government entities – including the Pentagon – a sense of justification to move forward with highly debated and unethical ‘vaccine’ mandates. Yet the FDA decision does not offer any added fact-based security, safety, justification or comfort. For starters:
This FDA approved product is still currently enrolled in a Phase Three clinical trial that will not end until May 2, 2023.
How can a supposedly approved product still be in clinical trials? How is this possible? That question alone is enough to justify ‘vaccine’ hesitancy and concerns regarding lack of adequate data and proper analysis on safety and effectiveness.
But there is more. Other ‘vaccine’ safety and efficacy problems remain, resulting in legitimate and justified hesitancy of many to “take the jab.” For example:
The actual FDA-approved product Comirnaty will supposedly not be available until May, 2024.
This FDA approval has offered no further safety verification or any layer of added responsibility or manufacturer’s liability compared to the Emergency Use Authorization (EUA) Pfizer BioNTech ‘vaccine’ that is now available. All we have is a rushed approval of a product – a completely new gene therapy vaccine technology product at that – with no liability to the manufacturers. That means no accountability, and no clarity or certainty regarding the safety and effectiveness of these experimental biologics marketed as ‘vaccines.’
This is a problem. An FDA approved product, in this case a biologic that is called a ‘vaccine’, should have rigorous safety data collected and verified not only for the safety and welfare of the recipients but also to make the product “vouch-safe.” Makers are legally held liable in case of reactions, side effects or death. To receive approval, a company must stand behind their product and personally vouch for the safety and effectiveness of their product.
The only exception to this is a vaccine that falls into the children’s vaccine schedule and is liability-free for the makers because it lands in the realm of the 1986 National Childhood Vaccine Injury Act. That’s a different, important conversation for another time. For the moment, consider this:
The public has no ‘vouch-safe’ protection for the Pfizer Comirnaty Covid ‘vaccine’ just approved for adults.
Due to the Public Readiness and Preparedness Act (PREP) Act of 2005, both the EUA experimental injection Pfizer BioNTech and the FDA approved ‘vaccine’ Comirnaty both have a liability shield in which manufacturer Pfizer cannot be held responsible for any adverse reaction or deaths from either ‘vaccine’. Normally with an FDA approved ‘vaccine’ like Comirnaty, Pfizer would be held liable for any adverse reactions caused by this FDA approved product.
Unfortunately and quite disturbingly, due to the PREP Act amendment enacted on February 20, 2020 and published on March 17, 2020 by Health and Human Services Secretary Alex Azar, both the EUA Pfizer BioNTech and the FDA approved Comirnaty ‘vaccines’ include liability protection because they fall under the umbrella of Medical Countermeasures against Covid -19. Thus the only avenue for potential compensation of injury by these products is through the Countermeasure Injury and Compensation Program (CICP) which is limited in its reimbursements and is paid by government taxpayers, not Pfizer.
Currently there are 686 claims under the CICP for adverse events and deaths due to Covid ‘vaccines.’ To date, there has been no compensation paid. Due to the PREP Act, at this point any Covid ‘vaccine’ does not come with the liability protection that an FDA approved product would and should offer.
On one hand, we have the FDA-approved Comirnaty ‘vaccine’ for which Pfizer should be held liable. On the other hand, we have a liability-free EUA vaccine. We are told they are interchangeable. We are told they are the same formulation. And both of them are fully shielded from liability due to the declaration of the PREP act. This is unacceptable, unethical and potentially fraudulent.
It is difficult to understand what substantial change the FDA approval actually offers for ensuring safety or actual manufacturer responsibility and liability.
It does not seem acceptable, realistic or even remotely possible that the record high levels of adverse events and deaths due to the experimental injections reported to Health and Human Services Vaccine Adverse Event Reporting System (VAERS) have been properly assessed in this short amount of time in which they have been collected. These numbers continue to rise. VAERS data raise legitimate concerns about safety, risk-reward ratios and new ‘vaccine’ technology impacts, both short and long term. Also based on the high level of Covid transmissibility and positive cases in the vaccinated, questions regarding effectiveness need to enter into the conversation.
Breakthrough cases are not rare at this point. This is evident in Vermont and all around the world, with tremendous amounts of raw data coming out of Israel. So what foundation did the FDA approval of the Pfizer ‘vaccine’ stand upon? What actual evidence supported its movement into an FDA approved product – especially since this product as mentioned previously is still currently enrolled in a phase three clinical trial?
Let’s keep in mind that the FDA also approved aspartame, genetically modified foods, some of which have been banned at this point, Vioxx,and many other products that have been withdrawn from approval. How has the FDA approval process actually changed the current status of the EUA experimental injection Pfizer BioNTech, because it has not in any way seemed to offer anything other than a rushed approval process to attempt to create a higher level of comfort with the ‘vaccine’ or maybe to falsely drive the justification of vaccine mandates.
According to many studies, most notably the Cleveland Clinic study as well as the recent research shared in medRxiv, natural immunity offers the highest level of sustained immunity and protection. Natural immunity has always been the gold standard of protection, and should remain so with Covid, especially with risky synthetic genetic material vaccines, insufficient data to determine safety and effectiveness and potential vaccine mandates which violate health privacy, health choice, and body autonomy.
Tomorrow – Government and Big Pharma relationship and ethics, FDA approval process concerns, Pfizer’s criminal track record
Thursday – Potential ‘vaccine’ health risks, avenues for alternative treatment, health choice, body autonomy and medical freedom
The author is a mother, clinical nutritionist, and teacher living in Danville, VT. She has had a clinical nutrition practice in St. Johnsbury and has taught nutrition for over twenty years.