FDA Does a Bait and Switch with COVID Shots

FDA Does a Bait and Switch with COVID Shots

Aug 27, 2021

WASHINGTON, D.C. – The Food and Drug Administration (FDA) has done a bait and switch by announcing it approved its “first COVID-19 vaccine” in order to push the “vaccine” mandates and protect the Pfizer pharmaceutical company from legal liability. However, there is currently no fully licensed COVID shot on the United States market.

Albeit confusing, and probably intentionally so, this summarizes the current status of the Pfizer-BioNTech shots:

  1. All existing Pfizer vials (in the hundreds of millions), remain under the federal Emergency Use Authorization (EUA) (meaning people have the “option to accept or refuse”);
  2. The third or “booster” Pfizer shot is identical to the above and remains under the EUA with limited use to certain categories of people;
  3. BioNTech received FDA approval for people ages 16 and above under the name Comirnaty, but there are no Comirnaty doses available in the United States;
  4. In other words, there is currently NO FDA approved COVID-19 injection available anywhere in the United States. Every COVID shot in America remains under the EUA law and thus people have the “option to accept or refuse” them; and
  5. Even when an FDA approved COVID shot becomes available, individuals are protected by federal law and many states laws from being forced to get these shots based on their sincere religious beliefs or conscience rights.

On August 23, the FDA issued two separate letters for two separate injections. There are now two legally distinct (Pfizer vs. BioNTech), but otherwise identical products.

The first letter is regarding FDA’s biologics license application approval for the Pfizer Inc/BioNTech COVID-19 injection which has been named Comirnaty. Yet Pfizer has not started manufacturing or labeling this drug for U.S. distribution, so it is not even available in the U.S. It is unclear whether or not it is protected by a liability shield, but web-based U.S. government communication indicates that the same program that provides compensation for COVID vaccine-related injuries will apply Countermeasures Injury Compensation Program (CICP) rather than the National Vaccine Injury Compensation Program).  At this point, there apparently has been no compensation paid to people injured by one of the COVID shots via the CICP.

The Pfizer injection, on the other hand, is still considered experimental under U.S. law. There is a legal difference between products approved under authorization of emergency use (EAU) compared with those the FDA has fully licensed. The FDA issued another letter for the existing Pfizer shots which confirms they are still under EUA, are not fully approved, and has a liability shield.

EUA-approved COVID shots have a liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. People who have been injured can file a lawsuit if they 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.

That means people must be told the risks and benefits, and they have the right to decline a medication that is not fully licensed. The federal Emergency Use Authorization law and the FDA, including the FDA Fact Sheet, state unequivocally that each person has the “option to accept or refuse” the shots. In addition to federal law, the FDA includes the Nuremberg Code and the Helsinki Declaration on its website, emphasizing the fact that people cannot be forced to take experimental drugs without their full consent.

The FDA’s approval letter to Pfizer regarding the BioNTech injection, Comirnaty, states: “Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.”

This letter affirms the FDA has not approved the Pfizer/BioNTech injections for the 12- to 15-year age group, nor any booster doses for anyone.

Regarding the Comirnaty injection, the FDA admits, “We have determined that an analysis of spontaneous post marketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.”

Therefore, follow up studies will be required with children six months to 15 years as well as six studies for up to five years regarding the adverse effects of myocarditis and pericarditis.

In addition, the FDA bypassed and disregarded the normal advisory committee and public comment process for this license. 

The letter states, “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion” (emphasis added).

The FDA also acknowledges that while Pfizer-BioNTech has “insufficient supplies” (in other words, it is not currently available on the U.S. market) of the newly licensed Comirnaty vaccine actually available. However, the letter also states there is “a significant amount” of the Pfizer-BioNTech shots which has been produced under the EUA and will continue to be offered under the same EUA status. In its approval letter, the FDA specifies the Pfizer shot under the EUA should remain unlicensed, is still available for use, and can be used “interchangeably” with the newly licensed Comirnaty product. According to the FDA, the newly licensed Comirnaty injection and the existing Pfizer shot, while “legally distinct,” are not any different in terms of their “safety or effectiveness.”

Despite whether these COVID shots are licensed or not, they cannot be mandatory under Title VII. In general, employee vaccine religious exemption requests must be accommodated, where a reasonable accommodation exists without undue hardship to the employer, pursuant to Title VII of the Civil Rights Act of 1964. Many people hold sincere religious beliefs against taking the COVID shots or taking those derived from or which used at any stage of the development aborted fetal cell lines.

Title VII defines the protected category of religion to include “all aspects of religious observance and practice, as well as belief.” 42 U.S.C. § 2000e(j). Moreover, as the EEOC has made clear, Title VII’s protections also extend nonreligious beliefs if related to morality, ultimate ideas about life, purpose, and death. See EEOC, Questions and Answers: Religious Discrimination in the Workplace (June 7, 2008), (“Title VII’s protections also extend to those who are discriminated against or need accommodation because they profess no religious beliefs…Religious beliefs include theistic beliefs, i.e. those that include a belief in God as well as non-theistic ‘moral or ethical beliefs as to what is right and wrong which are sincerely held with the strength of traditional religious views.’ Although courts generally resolve doubts about particular beliefs in favor of finding that they are religious, beliefs are not protected merely because they are strongly held. Rather, religion typically concerns ‘ultimate ideas’ about ‘life, purpose, and death’”).

Liberty Counsel Founder and Chairman Mat Staver said, “The FDA has apparently tried to deceive people by issuing its two confusing letters without proper explanation. Despite the FDA’s slight of hand, there is currently no FDA approved COVID shot available in the United States. Even if there were an FDA approved COVID shot available, people still may request that employers, schools, and the military accommodate their sincerely held religious beliefs.”

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DEPOPULATION MRNA VACCINES WILL START WORKING IN 3-6 MONTHS

EXPLAINS HOW THE DEPOPULATION MRNA VACCINES WILL START WORKING IN 3-6 MONTHS [2021-07-07] (VIDEO)

181 People Die After COVID Vaccine in US “Adverse Events”, Nurses Refuse to Give Vaccines for Ethical Reasons

At least 181 people have died in the US according to the federal Vaccine Adverse Event Reporting System (VAERS), after taking experimental vaccines meant to combat a 99.4% to 99.8% survival rate virus, the death toll for which a team of researchers in one state found may be inflated by as much as 40%.

A number of international groups of doctors and scientists have issued warnings over the vaccines, which are still in the experimental stage and have not been approved by the FDA for general use, but are being injected under FDA “emergency use authorization.” The UK Guardian reports that in UK, health authorities warned people with food or other allergies not to take the Pfizer BioTech vaccine. Severe allergic reactions have also been noted in the Moderna experimental vaccine.

A CDC registry reports that, as of the end of December, experimental COVID vaccinations have so far caused over 7,844, adverse reactions, at least 3,150 of which have rendered people “unable to work,” or perform “daily activities.”

Last February, Health and Human Services Secretary Alex Azar granted blanket immunity from lawsuits to COVID vaccine manufacturers, so that companies “cannot be sued for money damages in court” over injuries related to the administration or use of products to treat or protect against COVID.

In Miami, a healthy 56-year-old doctor died after a strange reaction to the Pfizer COVID vaccine, involving blood blisters. Although Pfizer has made only politic statements, the doctor’s wife is certain his death was caused by the vaccine.

In Portugal a 41-year-old health worker died after taking the Pfizer vaccine. The father of Sonia Acevedo told a Portuguese daily last week:

“She was okay. She hadn’t had any health problems…I just want answers. I want to know what led to my daughter’s death.”

A former Chief Science Officer and VP for Pfizer has called the widespread rollout of experimental vaccines for COVID “nonsense.”

Dr. Micheal Yeadon writes in “What SAGE Got Wrong”:

“There is absolutely no need for vaccines to extinguish the pandemic. I’ve never heard such nonsense talked about vaccines. You do not vaccinate people who aren’t at risk from a disease. You also don’t set about planning to vaccinate millions of fit and healthy people with a vaccine that hasn’t been extensively tested on human subjects.”

SAGE is the UK Scientific Advisor Group for Emergencies, the UK agency steering the coronavirus response.

Dr. Yeadon says that some level of herd immunity to the virus is much closer than health authorities are saying, due to T-cell immunity and antibody responses to at least four prior coronaviruses in circulation. Like flu, people will always catch,and a very small percentage will die, of COVID. But the pandemic stage is over, says Dr. Yeadon and his colleagues, but for the continuous announcement of “new cases” mostly based on false-positive test results.

As will be discussed later, official COVID death reporting policies make it difficult to determine what the US COVID death toll actually is. The problem also arises in other countries.

Dr. Yeadon writes:

“SAGE says everyone was susceptible and only 7% have been infected. I think this is literally unbelievable. They have ignored all precedent in the field of immunological memory against respiratory viruses. They have either not seen or disregarded excellent quality work from numerous, world-leading clinical immunologists which show that around 30% of the population had prior immunity.”

COVID Deaths Openly Inflated Internationally.

Underscoring the difficulty of tracking how many deaths are actually due to COVID is the disingenuous, but openly admitted, policy of the CDC of counting any death which takes place “with COVID” as being “of COVID.” Dr. Deborah Birx of the White House Coronavirus Task Force said in April:

“to mark it as COVID-19 infection the intent is right now that those if someone dies with COVID-19 we are counting that as a COVID-19.”

In Minnesota a team of researchers, led by two state legislators one of whom is a medical doctor, found that, in a study of nearly 3,000 death certificates, up to 40% of the deaths were primarily caused by factors other than COVID, including vehicle accidents, fatal falls, drownings, and gunshot wounds, but were marked down as COVID anyway. By December, the CDC had listed hundreds of thousands of deaths counting as “COVID” which were also confirmed heart attacks, flu, terminal cancer, and poisoning.

Last March it was reported that Italy was using the same language, indicating an open deception international in scope. The UK Telegram reported “that Italy’s death rate may also appear high because of how doctors record fatalities.” Prof. Walter Ricciardi, scientific adviser to Italy’s minister of health, told the Telegraph:

“The way in which we code deaths in our country is very generous in the sense that all the people who die in hospitals with the coronavirus are deemed to be dying of the coronavirus.”

In Louisiana, a woman had a severe reaction to a Pfizer vaccine which caused her to go into uncontrollable convulsions. RT reports the reaction is being investigated (video below.)

https://youtu.be/kf6NDIiE3Tw

Screenshot of CDC Co-morbidites listings for COVID deaths, including "poisoning."

Screenshot of CDC Co-morbidites listings for COVID deaths, including “poisoning.” CDC

In Norway, Bloomberg News reports that health authorities expressed concern after 29 elderly people died after receiving the Pfizer vaccine. Bloomberg reported on January 16:

“Until Friday, the vaccine produced by Pfizer and BioNTech SE was the only one available in Norway, and “all deaths are thus linked to this vaccine,” the Norwegian Medicines Agency said in a written response to Bloomberg on Saturday.”

Dublin University Immunologist Says Large Number of Vaccinated Will Die from Mutant Strains in Months, Will Be Blamed on COVID

Dublin University professor has said that, due to well-known dangers in previously attempted coronavirus vaccines, vaccinated people with the first mRNA vaccine will start dying in great numbers, in a few months, upon exposure to wild, mutated COVID viruses. (See: Prof. Dolores Cahill: Why People Will Start Dying A Few Months After The First Mrna Vaccination)

Prof. Dolores Cahill received her PhD in Immunology from Dublin City University, and was leader of the Protein Technology Group in the Max-Planck-Institute of Molecular Genetics, Berlin. She is Professor of Translational Science at the UCD School of Medicine and Medical Sciences.

Prof. Cahill’s contention that those who have received COVID vaccines will begin dying in great numbers after 3 to 6 months is echoed by Dr. Sherri Tenpenny D.O., an American physician. A D.O. is a physician who completes medical school the same as an MD, who may perform surgery and prescribe medications the same as an MD.

Both Prof. Cahill and Dr. Tenpenny say that previous attempts to formulate coronavirus vaccines have, after some apparent short-term success, run into the problem of hyper-immune response when exposed to the wild, mutated virus.

Robert F. Kennedy Jr., founder of Children’s Health Defense, writes:

“Scientists first attempted to develop coronavirus vaccines after China’s 2002 SARS-CoV outbreak. Teams of US & foreign scientists vaccinated animals with the four most promising vaccines. At first, the experiment seemed successful as all the animals developed a robust antibody response to coronavirus. However, when the scientists exposed the vaccinated animals to the wild virus, the results were horrifying. Vaccinated animals suffered hyper-immune responses including inflammation throughout their bodies, especially in their lungs. Researchers had seen this same “enhanced immune response” during human testing of the failed RSV vaccine tests in the 1960s. Two children died.”

At a nursing home in New York, 24 seniors have died of COVID since COVID vaccinations began on Dec. 22. There had been no COVID deaths before that.

(CLICK HERE TO SEE BELOW VIDEO, PROF. DOLORES CAHILL SAYS WAVE OF DEATHS OF VACCINATED PEOPLE AFTER MUTATED VIRUS EXPOSURE)

Professor Dolores Cahill, Dublin University, say wave of vaccine recipients will die within months

 

Comparisons to Spanish Flu Neglect Population Difference

COVID is now being compared to the Spanish Flu, because the US reported death toll is allegedly 400,000, but this neglects that the Spanish Flu was nearly a magnitude worse in per capita terms, as the population of the US was about 100,000 million at the time, less than one-third of today, and the death toll was nearly 700,000.

Better comparisons are the 1957 Asian Flu and the 1968 Hong Kong Flu, the latter of which, in that same summer, the country had the largest mass gathering in US history, Woodstock.

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Nurses Refuse to Administer Vaccine, FDNY Firefighters Say They’ll Refuse COVID-19 Vaccine

In Coffey County, Kansas, county health department nurses have declined to perform injections of the coronavirus vaccines, citing ethical concerns. On January13 health department administrator Lindsay Payer told WIBW News:

“I will tell you we will have to contract staff outside of our staff to give that vaccine because my staff is not comfortable with that…It’s a new technology. We’ve never seen it before….all liability is gone from them. So, if there’s anything bad about the vaccine it doesn’t go back to them. That’s widely known, and it’s somewhat discomforting to a nurse who has to put that in people’s bodies. So, we will find nurses that are willing to do that. I am not. My staff is not at this time.”

In New York City, more than half of FDNY firefighters have said in an internal poll that they will not take a COVID-19 vaccine when it becomes available to first responders.

The poll was of the oldest and most prestigious first responders union in the country, the Uniformed Firefighters Association.

2020 Comes in at 12% Excess Deaths, How Many Due to Lockdowns?

In a first good end-of-year measure of how 2020 fared in terms of overall deaths, the CDC reports that excess deaths, which is the number over the average of the previous five years, is 12%, or about 330,000 deaths. Thus even with the shell game of counting any death possible as COVID, something killed more people than usual last year. The question is was it COVID, COVID policies, something else, or a combination of all three?

Each year about 40,000 more people are expected to die than the previous year due to the aging Baby Boomer demographic. In addition, a study published by the Journal of the American Medical Association estimated that 20% of excess deaths over and above previous years were due not to COVID, but to the effects of the lockdowns.

Medical News Today reported:

“Some people who never had the virus may have died because of disruptions caused by the pandemic,” says Dr. Steven H. Woolf, the director emeritus of the Virginia university’s Center on Society and Health and first author of the study. “These include people with acute emergencies, chronic diseases like diabetes that were not properly cared for, or emotional crises that led to overdoses or suicides.”

If the 20% of excess deaths figure is extrapolated, then nearly 70,000 deaths could be due to the effects of lockdowns such as deferred critical care for other conditions. Supporting that the number may be high, in December the New York Times reported “40,000 extra deaths from diabetes, Alzheimer’s, high blood pressure and pneumonia”alone.

Sustained Pandemic in the US Took Off with Governors’ Orders of COVID Patients into Nursing Homes in Populous States

One characteristic which is said to distinguish the coronavirus from other viruses is transmissibility. But if this is the case, then the effect of the orders of governors from NY, NJ, MI, PA, and CA cannot be discounted, which sent recovering COVD patients into nursing homes.

Most especially in New York, on March 25, Governor Andrew Cuomo resisted the loud objections of nursing home executives, and sent hundreds of COVID patients into the nursing homes where the frailest of the frail were housed. Just days later, the exponential phase of the pandemic in New York hit, at the same time as New Jersey’s.

One nursing home executive told the NY Post:

“Cuomo has blood on his hands. He really does. There’s no way to sugarcoat this,”

Cuomo’s order was followed by NJ Gov. Phil Murphy on March 31, PA Gov. Tom Wolf on March 31, MI Gov. Gretchen Whitmer on April 15, and CA Gov. Gavin Newsom on March 30.

Would the pandemic in the US, and the excess deaths, have turned out as it did had these orders not been given? Which Cuomo himself likened to touching fire to “dry grass?”

In any accounting for last year’s excess deaths, these orders must bear their share of accountability, regardless of where the political chips may fall.

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Yale Epidemiologist Says Hundreds of Thousands of Lives Could Have Been, and Could be Saved with Remedies

Last April the FDA issued a warning that the use of hydroxychloroquine (HCQ) in the treatment of COVID could cause heart arrhythmia. The warning neglected to mention, as Dr. Lisa Koche, a family medicine doctor in Florida pointed out, that the study the warning was based on gave the study subjects up to 12 times the recommended dose for Plaquenil, a brand name for HCQ. This would almost pre-ordain a negative heart reaction. The dosage instructions for Plaquenil for malaria read:

“Adults: 800 mg followed by 400 mg at 6 hours, 24 hours and 48 hours after the initial dose.”

The study administered as much as 1200 mg a day for 10 days. What would be the purpose of publishing a study designed to fail?

This is one of the intriguing questions surrounding last year’s drama over HCQ, in which the medical establishment seemed determined to prove that something didn’t work that did, according to reams of evidence.

One doctor singing the praises of HCQ is Dr. Harvey Risch, at the Yale School of Public Medicine, who believes judicious use of HCQ could save “75,000 to 100,000 Lives.”

Another remedy which has shown enormous promise, but again is suppressed for mysterious reasons, is Ivermectin, an anti-parasite drug with, like HCQ, a long safety record. One might almost conclude that the interest of the highest health authorities is in people dying, not living, and shepherding the population toward inadequately tested vaccines.

Under-Reported News in the US

Finally in under-reported news, Newsweek last summer ran an in-depth investigation which explored Dr. Anthony Fauci’s role in “off-shoring” dangerous coronavirus research in bats to the Wuhan laboratory, although the research had been banned in the US. The Newsweek piece is entitled: “Dr. Fauci Backed Controversial Wuhan Lab with U.S. Dollars for Risky Coronavirus Research.”

Also recently breaking from Newsweek is a peer-reviewed, Stanford-based international study which shows “no clear” benefit, in slowing COVID, from business closures and lockdowns.

And unreported in the US, in Belgium, a lawsuit is underway, including a criminal complaint, against Bill Gates, a funder and investor in almost every aspect of the pandemic response, and Prof. Neil Ferguson, the Imperial College epidemiologist known as “Professor Lockdown.” The Brussels Times reported last July:

“The group are attacking Gates in court because of his status as a top contributor to the World Health Organisation (WHO) and over his various funding projects into coronavirus treatments and vaccines, while they are going after Ferguson — a top advisor to the WHO and, until recently, to the UK government — for producing mortality and infection rates estimates which they say are “completely wrong.””

Ferguson co-founded the MRC Centre for Global Infectious Disease Analysis, based at Imperial, which, according to Business Insider, gets “tens of millions of dollars in annual funding from the Bill & Melinda Gates Foundation.”