On August 23, the FDA published the following announcement in a letter:
On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.
The letter contains the following pertinent information:
[T]he EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses.
Please notice that there are two vaccines discussed in the letter with two distinct legal identities. The FDA pointed out in a footnote in the authorization letter that the vaccines are not identical. “The products are legally distinct with certain differences that do not impact safety or effectiveness.” The two distinct vaccines are:
1) COMIRNATY (COVID-19 Vaccine, mRNA) and
2) Pfizer-BioNTech COVID-19 vaccine.
The Pfizer-BioNTech COVID-19 vaccine remains unapproved and under its original EUA. At the same time, the FDA has approved COMIRNATY (COVID-19 Vaccine, mRNA).
The FDA states that “Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.” The FDA further explains that “[t]he [approved] vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.” But keep in mind that, while the two vaccines have the same formula, they are not identical. They have “certain differences,” which were not specified; and they are “legally distinct.”
Thus, we have two substantially similar vaccines, one being administered under an EUA and another under FDA approval. The problem is that the approved vaccine, COMIRNATY (COVID-19 Vaccine, mRNA), is now manufactured in Germany by Pfizer and BioNTech, a company that works in partnership with Pfizer. It is not yet available in the U.S. That means that all of the COVID-19 vaccines now being administered in the U.S. under the Pfizer-BioNTech partnership are being administered under the EUA. The effect of that is that the public thinks that it is getting an approved vaccine under the legal standards for an approved vaccine, but in reality, they are receiving an EUA vaccine that comes with all of the legal vulnerabilities of an EUA vaccine.
Why did the FDA not simply approve the Pfizer-BioNTech COVID-19 vaccine? Why are there two vaccines with the same formula made by the same company given different treatment? It makes no logical sense unless you understand the stratagem of Pfizer and the FDA. The FDA has slickly approved a vaccine that is not available. If the vaccine were to be made available, Pfizer-BioNTech and all other COVID-19 makers would lose their EUA’s. The COVID-19 vaccines allowed under EUAs would all be taken off the market. That is because one of the legal requirements for an EUA is “that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition.” 21 U.S.C. § 360bbb–3(c)(3). That means that if the COMIRNATY (COVID-19 Vaccine, mRNA) is made available, all other EUA vaccines would immediately be removed from the market. That would hit Moderna particularly hard since their COVID-19 vaccine is the only product they sell. Indeed, Moderna’s COVID-19 vaccine is the first product they have ever sold.
Albert Bourla, Chairman and Chief Executive Officer of Pfizer, gives a hint to the reason for the strange approval of a vaccine with the same formula as an identical vaccine that remains unapproved: “I am hopeful this approval will help increase confidence in our vaccine.” It is a confidence game, which is popularly known as a con-game. The approval of the COMIRNATY (COVID-19 Vaccine, mRNA) is to increase the “confidence” in the Pfizer-BioNTech COVID-19 vaccine being administered under the EUA. People will be convinced to get the Pfizer-BioNTech COVID-19 vaccine under the mistaken belief that it is approved by the FDA, when in fact it is only authorized under the EUA.
Indeed, the FDA approval of the unavailable COMIRNATY (COVID-19 Vaccine, mRNA) is being used by President Biden to push the COVID-19 vaccine mandate he instituted on September 9, 2021. “[M]any said they were waiting for approval from the Food and Drug Administration — the FDA. Well, last month, the FDA granted that approval. … The vaccine has FDA approval.” It is significant that President Biden did not mention that the FDA approved vaccine to which he referred is not available in the United States.
All the news services reported the approval of the Pfizer COVID-19 vaccine without mentioning that the only vaccine available in the U.S. is the EUA Pfizer experimental vaccine. Fox Business News segued into the motive behind the approval. “Full licensure has been widely anticipated to boost confidence in those otherwise hesitant to receive the shot under emergency approval.” That was the pattern for all of the mainstream news outlets. One of the primary subscription services, the Associated Press (AP) news service, is an example of the kind of propaganda about the Pfizer approval being pushed. The AP did not mention anything about the only available COVID-19 vaccines in the U.S. being EUA experimental vaccines. Instead, the AP pushed the narrative that “[t]he U.S. gave full approval to Pfizer’s COVID-19 vaccine Monday, potentially boosting public confidence in the shots and instantly opening the way for more universities, companies and local governments to make vaccinations mandatory.” The mainstream media outlets are giving people the false impression that the Pfizer COVID-19 vaccine they will be getting is approved. It is not.
Dr. Paul E. Alexander is an expert in clinical epidemiology; he is a former COVID Pandemic Advisor to the WHO and the Pan American Health Organization; he was a former senior advisor on the COVID Pandemic in the Department of Health and Human Services during the Trump administration. He opines that the COVID-19 vaccines are ineffective and unsafe and should be stopped. He explains that the spike protein that is being created by the body via the mRNA code in the COVID-19 vaccines is “the business end of the virus that causes the pathology.” The spike protein is what is killing people and making them ill. That confirms the opinion of Dr. Robert Malone, the inventor of the mRNA technology used in several COVID-19 vaccines. Dr. Malone has stated that the spike proteins generated by the cells through the mRNA code are cytotoxic. Dr. Alexander reveals that the approval of the COMIRNATY (COVID-19 Vaccine, mRNA) is a trick to convince people to be vaccinated with the unapproved and experimental Pfizer-BioNTech COVID-19 vaccine that is being allowed under the EUA. It is a Machiavellian bait and switch. The people will think they are receiving an approved vaccine when, in reality, they will be getting the experimental vaccine.
What does that all mean? The key to understanding what is going on is in the footnote in the FDA approval letter. “The products are legally distinct with certain differences that do not impact safety or effectiveness.” Maintaining separate legal identities for the two vaccines with the same formula has the effect that those injured by the EUA Pfizer-BioNTech COVID-19 vaccine will be subjected to the exacting standards and limited compensation of the Public Readiness and Emergency Preparedness Act (PREP Act), which authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to injured parties. A notable limitation under the CICP is that an injured party will be subjected to the statute of limitations that forecloses all legal actions not filed within one year of vaccination. That is compared with the statute of limitations for an approved vaccine under the National Vaccine Injury Compensation Program (VICP) of 3 years from the occurrence of the first symptom of injury from the vaccine. Experts specializing in vaccine injury cases say that the bar for obtaining compensation is very high under the PREP Act. Over the last ten years, 94% of injured patients who filed claims under the PREP Act received no compensation.
In reference to the virtually insurmountable hurdles erected under the CICP, Renée Gentry, director of the Vaccine Injury Litigation Clinic at the George Washington University Law School, said COVID-19 vaccine claimants have two rights: “You have the right to file,” she said. “And you have the right to lose.” Altom Maglio, whose 22 lawyer law firm, Maglio Christopher & Toale, specializes in vaccine injury cases, says that you’re out of luck if you’ve suffered an injury related to any of the COVID-19 vaccines in receiving any compensation for your injury.
The plan of the FDA and the Pfizer-BioNTech seems to be working. The day the approval was announced on August 23, 2021, the New York Times reported:
Full federal approval for the Pfizer-BioNTech coronavirus vaccine for those 16 and older is opening the way for institutions like the military, corporate employers, hospitals and school districts to announce vaccine mandates for their employees.
Within hours of the announcement, the Pentagon, CVS, the State University of New York system and the New York City school system, among others, announced that they would enforce mandates they had prepared to carry out but had made contingent on the F.D.A.’s action.
It seems that the approval of the COMIRNATY (COVID-19 Vaccine, mRNA) while maintaining the EUA status of the Pfizer-BioNTech COVID-19 vaccine is a gambit to continue giving vaccines under the EUA, so they don’t have to compensate injured patients, while publically representing the vaccines as being FDA approved. That FDA approval gives employers leverage to force employees to get vaccinated while they are shielded from liability by the PREP Act.
It is unclear how the approval of the COMIRNATY (COVID-19 Vaccine, mRNA) was accomplished in nine months, particularly when, as of August 13, 2021, there were reported in the HHS Vaccine Adverse Event Reporting System (VAERS) 13,068 deaths correlated to the COVID-19 vaccines. Recall that the FDA states that “Comirnaty has the same formulation as the EUA vaccine.” The Pfizer-BioNTech COVID-19 vaccine accounted for 9,024 of those deaths. A study funded by HHS determined that the VAERS program only reports 1% of the adverse events from vaccines. Thus, we can extrapolate that the 9,024 deaths reported for the Pfizer-BioNTech COVID-19 vaccine in VAERS represent 902,400 deaths.