February 8, 2022
FDA Duplicity on Covid-19 Vaccines
By
Steve McCann
Perhaps the most important long-term fallout of the Chinese Coronavirus pandemic has been the exposure of the venality and politicization within the Food and Drug Administration (FDA) as well as other federal health agencies such as the Centers for Disease Control (CDC).
Nothing personifies this corruption more than the FDA’s absurdly close ties to the pharmaceutical companies. Thus, their refusal to recognize proven inexpensive therapeutics and their unorthodox approach in licensing certain Pfizer and Moderna mRNA Covid-19 -- vaccines that are not offered for sale in the United States.
What was the FDA’s and the pharmaceutical companies’ endgame in this process? Was it to gaslight the American people in order to sell vaccines and achieve mass vaccinations? Was their motive to protect the pharmaceutical companies from exposure to liability and a tsunami of litigation? Was it so the FDA could more easily approve these vaccines for children who are not at risk of Covid-19? Or all the above?
In August of 2021, the FDA, to great media fanfare, granted
permanent approval for a Pfizer Covid-19 vaccine. The catch: it was for a vaccine that was not available to Americans. What the FDA approved and licensed is Pfizer’s Comirnaty vaccine not the Pfizer-BioNTech vaccine that has been continuously in use under Emergency Use Authorization (EUA) since December of 2020. Manufacturers of medicines sold under an EUA are immunized from legal liability.
The FDA decreed that the Pfizer-BioNTech vaccine should remain unlicensed and under the EUA but can be used interchangeably with the licensed Comirnaty vaccine. More importantly, the FDA stated that the Comirnaty vaccine and the existing vaccine are “legally distinct” and that there are slight differences in the vaccines, though their differences “do not impact safety or effectiveness.”
Moreover, the FDA acknowledged that there was no inventory of the Comirnaty vaccine available. Nearly six months later there is still no inventory available and will not be in the foreseeable future. Every vaccination with a Pfizer covid vaccine has been and continues to be with the one under the EUA.
Not to leave Moderna out in the cold, the FDA on January 31, 2022 granted
permanent approval for a Moderna mRNA covid-19 vaccine. But not the one in continual use since December of 2020 under the authorization of an EUA. This approval was for Moderna’s Spikevax Covid-19 vaccine.
Not surprisingly, the FDA in its approval letter to Moderna also stated that the vaccine under the EUA can be used interchangeably with the licensed Spikevax vaccine and that Spikevax and Moderna’s EUA approved vaccine are “legally distinct” but their differences “do not impact safety or effectiveness.”
Similar to Pfizer’s Comirnaty vaccine, the FDA acknowledged there are no stocks of Spikevax available nor will there be for an indefinite period of time. It would be safe to assume, as may be the case of the Comirnaty vaccine, that there may never be an inventory of the Spikevax vaccine available.
EUA products are considered experimental under U.S. law. Federal regulations provide that no one can force a person to participate in being jabbed with an experimental vaccine--
21 U.S. Code Sec.360bbb-3(e)(1)(A) “Authorization For Medical Products For Use In Emergencies.” Potential recipients have an absolute right to refuse EUA vaccines nor can they be denied a job or an education because they refuse to be vaccinated. However, U.S. law permits employers, schools and government agencies to require employees and students to take
licensed vaccines.
What better way to coerce the populace into acquiescing to mandates and societal pressure than to play the shell game of obfuscating the licensing of the covid vaccines? The vast bulk of Americans would assume the approval was for the vaccines in current use. And what better way for both Pfizer and Moderna to reduce the massive inventories of their respective EUA approved vaccines than to have government and employers mandate vaccines together with never-ending covid fear mongering?
There is no FDA licensed and approved Covid-19 vaccine available in the United States today, thus any vaccine mandate is technically illegal.
There is a huge real-world difference between products approved under an EUA as compared to those the FDA has fully licensed. EUA-approved vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness (PREP) Act. Vaccine manufacturers, distributors and government bureaucrats are immune from liability.
On the other hand, any vaccine manufacturers whose vaccines have been licensed and permanently approved by the FDA for use by those above the age of 12 do not have this liability shield. On the surface Comirnaty and Spikevax vaccines would, therefore, have no such liability shield. However, the drug manufacturers and the government
claim that because of the use of the PREP Act for the original vaccines and as Comirnaty and Spikevax are essentially identical, they have the same legal protections as the EUA vaccines.
If that’s the case, why not just license and approve the original EUA vaccines? Why go to all the trouble of submitting another vaccine application for a slightly altered version, particularly as the pharmaceutical companies are now arguing that the vaccines are essentially the same? Why did the FDA go out of its way to highlight “legally distinct” in their approval letters and why are there two distinct products for each company and the fully authorized one not available now or in the future?
I suspect that there always been a concern that a class action lawsuit could pierce the PREP Act argument and open a pandora’s box of massive litigation if the vaccines labeled Comirnaty and Spikevax were used. Perhaps that is why these two vaccines will remain unavailable until they are approved for use by children.
Pfizer and Moderna together with the FDA continue to seek a more permanent solution to the liability question as at some point they will no longer be able to rely on legal hairsplitting and will have to use the Comirnaty and Spikevax labeled products. The potential solution: The National Childhood Vaccine Injury Act (NCVIA).
This law, passed in 1986, provides a legal liability shield to drug manufacturers, if they secure full FDA approval for all age groups. According to
Steve Kirsch, Pfizer is clandestinely working with the FDA and altering the ingredients (which normally requires a new and separate filing and licensing process) to clear the path for approval.
When Comirnaty and Spikevax are approved for children, then the companies will have definitive government-sponsored liability protection if and when their shaky argument that the original EUA approvals extend to these two products is rendered moot. Pfizer and Moderna are apparently waiting for full authorization for children’s shots before they distribute Comirnaty and Spikevax to the masses.
Children, who have near zero risk from Covid but are experiencing
alarming side effects from the vaccines, be damned. Apparently, the bureaucrats are so malevolent, and the pharmaceutical companies so focused on the bottom line that they would essentially sacrifice children in order to protect themselves and promote ineffective and potentially dangerous vaccines.
How ineffective?
Israel, despite 90+% of its population fully vaccinated and nearly 70% having received either the third or fourth booster shot, has just set a record for Covid-19 cases and deaths.
How potentially dangerous? As the information from the CDC and other federal health agencies can no longer be believed, the Defense Medical Epidemiology Database is the most reliable data available.
Based on information from Department of Defense whistleblowers (3 doctors), Senator Ron Johnson of Wisconsin recently penned a
letter to the Department of Defense to confirm the data related to the Covid-19 vaccines that American servicemen and women have been
illegally mandated0 to take. Among the data from 2021 as compared to the five-year period 2016-2020:
- Neurological issues increased tenfold, from 82,000 in 2016-2020 to 863,000 in 2021.
- Hypertension-- 2,181% increase
- Multiple sclerosis-- 680% increase
- Malignant neoplasms of esophagus-- 894% increase
- Guillain-Barre syndrome-- 551% increase
- Breast Cancer-- 487% increase
- Pulmonary embolism-- 468% increase
The registered diagnoses of myocarditis, among the most common and most serious side effects of the vaccines, had been deliberately deleted from the database. A military spokesman implausibly claimed that 5 years of DOD medical surveillance system was mysteriously plagued by a giant glitch. However, these data points also reflect the experience of other countries.
It is little wonder that both the pharmaceutical companies and the government bureaucracies are focused on liability and not the efficacy or the hazards associated with these vaccines. They are caught up in a web of deception, venality and potential legal exposure, therefore they can never admit to their mistakes. Thus, they continue to promote mass vaccinations and by necessity denigrate therapeutics such as Ivermectin.
The FDA and CDC as presently constituted must be abolished and reconstituted as they are joined at the hip with the pharmaceutical industry. Massive class action lawsuits must be filed against the pharmaceutical companies and the government for their collusion in deliberately deceiving the people and promoting ineffective and dangerous drugs. This process must begin with a Republican controlled Congress in 2023.
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