August 24, 2021 | By Robert F. Kennedy Jr. and Meryl Nass M.D. | The Defender | Photo Image: Source
“Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.
Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine.
The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now requiredthe vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.
But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.
First, the FDA acknowledges that while Pfizer has insufficient stocks of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — available for use.
The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.
Second, the FDA pointed out that both the licensed Pfizer Comirnaty vaccine, and the existing vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”
There is a huge real-world difference between products under an EUA compared with those that 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-licensed 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.”
Link To Read Full Article @ Source_The Defender
The Defender is experiencing censorship on many social channels. Be sure to stay in touch with the news that matters by subscribing to our top news of the day. It’s free.
FDA Pfizer authorization (Comirnaty): Key points to consider and discuss.
These points are an aggregate of many minds, including Dr. Robert Malone., 23 Aug 2021
General talking points
- Why mandates if herd immunity isn’t possible?
- What happens 8 months after boosters?
- What’s the plan for the next variant?
- Why we’re messing with vaccine injury liability if the vaccines are safe and effective?
There are now TWO LEGALLY distinct (Pfizer vs. BionTech), but otherwise identical products, based on two FDA letters, as well as a press release. The analysis of these FDA products below is preliminary and subject to change.
An analysis of the these FDA letters and press release is linked here.
Breaking: FDA gives full approval to COVID vaccines; no public hearing; no transparency; no open review of vaccine data
It all happened behind closed doors Link
(To join our email list, click here.)
“The fix is in.
We raced from “emergency use authorization” of experimental vaccines  [1b] to “full approval.” Boom.
Despite the promise of “transparency” prior to giving full approval to the COVID vaccines, the FDA gave its final green light today . Slam-dunk.
And there was NO public hearing.
“Full approval” means the vaccine marketing/intimidation/mandate campaigns will ramp up much higher. “Well, now there is NO reason for anyone to refuse the shot. The FDA states it is completely safe and effective.”
Obviously, the FDA didn’t want to allow even mainstream “experts” to speak in a public hearing before approval; the agency is running a very tight ship. No slip-ups. No defections.
An 8/20 article in the BMJ (“Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data”)  quotes a few of these dissenting mainstream pros. For example:
“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 scrutinising the data.”
“’These [FDA] public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,’ 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 scrutinised 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 [public FDA] 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’.”
Understand—this devastating criticism of the FDA is coming from a person who operates WITHIN the public-health establishment.
Amidst a tsunami of reports of vaccine injuries and deaths from around the world, the FDA is proving it is an agency that will certify maiming and killing without hesitation.”
Link To Full Article_No More Fake News