Pfizer's COVID Shot Granted Full Approval

* August 23, 2021, the U.S. Food and Drug Administration granted full approval to the COVID-19 mRNA injection developed by Pfizer/BioNTech, sold under the brand name Comirnaty, for use in people aged 16 and older

* Normally, the FDA will hold a formal hearing and allow for public and expert input before a drug is moved from emergency use authorization to full approval but, in this instance, no such hearing was held

* The notion that a “vaccine” that has killed more people in nine months than all other vaccines combined in three decades is considered safe stretches beyond the bounds of credulity and further undermines public trust in the FDA

* The approval is based on six months’ worth of data from 44,047 people aged 16 and older. Half of them got the shots and half initially received a placebo. However, in early December 2020, Pfizer unblinded the control group and 93% of controls opted to get the real injection. This means we’ve had no control group since December 2020 and have nothing to compare the treatment group against

* The FDA’s prescribing information for Comirnaty includes the risk of myocarditis and pericarditis, two types of heart inflammation that typically develop within seven days after the second injection

“Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinizing the data.

‘These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization,’ she said.

‘The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinized in advance of an approval.’

Witczak is one of the more than 30 signatories of a citizen petition calling on the FDA to refrain from fully approving any COVID-19 vaccine this year to gather more data. She warned that without a meeting ‘we have no idea what the data looks like.’

‘It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,’ she said. ‘There is no control group after Pfizer offered the product to placebo participants before the trials were completed.

Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.’”

“The little trick that they’ve done here, is they’ve issued two separate letters for two separate vaccines. The Pfizer vaccine, which is what is currently available, is still under emergency use authorization and it still has the liability shield. Once again, the mainstream media have lied to you …

The product that’s licensed is the BioNTech product, which is substantially similar but not necessarily identical, called Comirnaty, and it’s not yet available. They haven’t started manufacturing it or labeling it. And that’s the one the liability waiver will no longer apply to.

So, the one that’s actually licensed is not yet available, and when it does become available it will no longer have the liability shield. In the interim, the one that does have the liability shield is the Pfizer product and that is what is currently available and it’s still under emergency use authorization.”

“There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed. EUA products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment.

Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), ‘authorization for medical products for use in emergencies,’ it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines. U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.

EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability.

The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.

The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program, to redress injuries from all EUA products …

At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products …

Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages. And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.

Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.

Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.

The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.

Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.

The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product … Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says ‘Comirnaty,’ it’s a licensed product.

If it says ‘Pfizer-BioNTech,’ it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse. If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.

The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.”