DOD ‘Bait and Switch’ with Emergency and Licensed COVID Vaccines Killed Student, Lawsuit Alleges

The Pentagon conducted “human experimentation without consent” by falsely advertising a COVID-19 vaccine under emergency use authorization as fully licensed, a “bait and switch” that killed a college student, according to a new lawsuit against Defense Secretary Lloyd Austin by the student’s estate.

George Watts was waiting for FDA approval of Pfizer’s Comirnaty to fulfill the COVID vaccine mandate at New York’s Corning Community College, which provided a 35-day grace period for compliance following Comirnaty’s Aug. 23, 2021, approval, the filing states.

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FDA Announces Postponement of Approval of COVID Vaccine for Babies and Young Children

Young girl with a blue shirt on getting a vaccine

Pfizer and the Food and Drug Administration (FDA) said Friday they are delaying their plan for Pfizer’s Emergency Use Authorization (EUA) for its coronavirus vaccine for children under five years old due to insufficient data on the efficacy of a third dose.

Pfizer announced February 1 FDA had asked the drug company, and its partner BioNTech, to submit data on a COVID vaccine series for babies as young as six months old and young children up until age five.

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FDA Cites Non-Peer Reviewed Study to Revoke Monoclonal Antibody Authorization

As reported Tuesday by The Florida Capital Star, the U.S. Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) for monoclonal antibodies as a treatment for COVID-19, but did not provide the data is cited in making its decision. 

Without the help of the FDA, which did not return a follow up comment request Wednesday, The Star was able to locate what appears to be the data used in the decision-making process. It is on the website for the National Institute of Health (NIH), which is headed by Dr. Anthony Fauci. 

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Warnings About Myocarditis Differ Between Pfizer EUA Vaccine and Fully-Approved Comirnaty

The Pfizer BioNTech COVID-19 vaccine authorized under the Emergency Use Authorization (EUA) has a different label than the FDA-approved Comirnaty label for the vaccine, and Pfizer has said they will continue to distribute the vaccine made under the earlier label until stocks run out.

The EUA was granted before the risk of myocarditis for men under 40, caused by the vaccine, was known, and the Comirnaty package insert found on the FDA website includes warnings about the rare side effect. A fact sheet distributed with the EUA vaccine also includes a warning about the risk.

On Tuesday, an FDA official told The Virginia Star on background that the FDA has to ensure that EUA vaccine recipients are informed of the EUA, the extent and benefits of the vaccine, that the vaccine is optional, and of alternatives to the vaccine. Normally that data is communicated through a fact sheet for EUA vaccines. A package insert is used with fully approved vaccines like Comirnaty.

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FDA Won’t Say Why Some Non-Approved Pfizer Vaccines Were Deemed ‘BLA-Compliant’

Through Ohio attorneys representing Miami University in a lawsuit against the school over its mandatory COVID-19 vaccine policy, The Ohio Star confirmed that at least none batches of Pfizer’s Emergency Use Authorization (EUA) vaccine were deemed Biologics License Application (BLA) compliant. 

BLA compliance is typically reserved for Food and Drug Administration (FDA) approved drugs. That is the licensing procedure for drugs seeking to become FDA approved. 

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Pfizer’s Comirnaty Available Abroad, Not in U.S.

New York-based Pfizer has sold and shipped hundreds of millions of doses of its Food and Drug Administration (FDA) approved COVID-19 vaccine Comirnaty to the European Union (EU) despite saying last week that it is not being shipped in the United States. 

“Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021,” Pfizer said in an April press release. “This announcement is a result of the European Commission’s (EC) decision to exercise its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement signed on February 17, 2021. This brings the total number of doses to be delivered to the EU to 600 million.”

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Pfizer to Distribute Remaining Stock of Pfizer-BioNTech COVID-19 Vaccine Before Switching to Comirnaty, Pharmaceutical Giant Says

Pfizer is still providing Virginia distributors the Pfizer-BioNTech COVID-19 vaccine allowed by the FDA under the Emergency Use Authorization (EUA), not the Comirnaty-labeled identical-formulation vaccine that was fully approved by the FDA in August. Pfizer says it will use up its existing stock of vaccine made under the earlier label before distributing the new version.

“The FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and, according to the FDA labeling, can be used interchangeably to provide the COVID-19 vaccination series,” a Pfizer statement provided to The Virginia Star said. “The Pfizer-BioNTech COVID-19 EUA labeled product will still be shipped and usable until its expiry date, as long as authorized frozen storage conditions have been maintained.”

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6th Circuit Ruling Restoring Employer Vaccine Mandate Falsely Claims ‘Options Available to Combat COVID-19 Changed Significantly’ When ‘FDA Granted Approval to One Vaccine on August 23, 2021’

The majority opinion released on Friday by the 6th Circuit Court of Appeals, which restored the Biden administration’s Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) requiring employers with more than 100 employees to mandate that all employees take a COVID-19 vaccinefalsely asserts that Pfizer’s Food and Drug Administration (FDA) fully approved vaccine is currently available and in use among the general public.”

“At the same time, the options available to combat COVID-19 changed significantly: the FDA granted approval to one vaccine on August 23, 2021, and testing became more readily available,” the majority opinion asserts on page 24 of the ruling.

The majority opinion was written by Obama-appointed Judge Jane Branstretter Stranch of the United States Court of Appeals for the Sixth Circuit.

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Kentucky Congressman Massie: Comirnaty Not Available in United States

A Kentucky congressman Saturday said that Pfizer’s Food and Drug Administration (FDA) approved COVID-19 vaccine is not available in the United States after The Ohio Star spent a week reporting on that subject. 

“Your first sentence, ‘Comirnaty is available in the US,’ is false. Show us one location it’s available to prove otherwise. The FDA requires Pfizer to disclose to other countries BioNTech is ‘subject to an EUA and is not approved or licensed by the FDA,'” Rep. Thomas Massie (R-KY-04) said on Twitter. 

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Commentary: Defense Department Pulls a Bait and Switch on Vaccines

On August 24, Secretary of Defense Lloyd Austin issued a memo to senior Pentagon leadership announcing that he was implementing a mandatory COVID-19 vaccination policy for all military service members. The day before, the FDA had issued full authorization to Pfizer for their Comirnaty COVID-19 vaccine product (the nomenclature of which is meant to be a mashup of the words “COVID”, “mRNA”, and “community”) . At first glance it would seem that the mandatory vaccination policy, while scientifically unsound and strategically foolish, was at least a policy being implemented according to both the letter of the directive and in accordance with the law. But a further examination of the facts and the manner in which this order is being implemented makes clear that the military’s implementation of this order is illegal and highly unethical.

In the memo, Secretary Austin issued a directive and a promise, that “Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.” The problem with this is that the Comirnaty vaccine product that was approved by the FDA is not available anywhere in the Military Health System. It is not even in production, according to the military’s TRICARE healthcare providers. If a soldier goes to a military hospital or a private provider to receive an approved Pfizer COVID vaccine, he will be administered the unapproved Pfizer-BioNTech vaccine which is a vaccine that is not approved but has been administered under an Emergency Use Authorization (EUA). We are told that this is but a brand name difference, that the formulation is the same, and they can be used interchangeably. But as the FDA was approving the Comirnaty product, they were renewing the authorization for the Pfizer-BioNTech product. If it’s just a matter of brand name, why issue an approval for one brand name and an EUA renewal for the other? This is because they are not actually the same. 

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Ohio Law Banning Mandatory Vaccination in Schools Now in Effect

An Ohio law banning schools from forcing students to take vaccinations that haven’t been fully approved by the U.S. Food and Drug Administration (FDA) took effect Wednesday. 

HB 244 says that primary and secondary schools, along with public universities, may not “Discriminate against an individual who has not received a [non-fully approved vaccine], including by requiring the individual to engage in or refrain from engaging in activities or precautions that differ from the activities or precautions of an individual who has received such a vaccine.” 

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Two Tennessee Colleges Mandating COVID-19 Vaccines: Vanderbilt University and Maryville College

In this 2020 photograph, captured inside a clinical setting, a health care provider places a bandage on the injection site of a patient, who just received an influenza vaccine. The best way to prevent seasonal flu, is to get vaccinated every year. Centers for Disease Control and Prevention (CDC) recommends everyone 6-months of age and older get a flu vaccine every season.

Come fall, Vanderbilt University and Maryville College are requiring students to be vaccinated for COVID-19 – even if the vaccine isn’t fully approved by the FDA. Maryville College was the first to announce a mandate of that nature in this state, issuing their press release late last month. Vanderbilt University issued their announcement on Monday.

Maryville College is the more lenient of the two Tennessee colleges in their mandate: they will allow exceptions for personal preference in addition to medical or religious reasons. The news release didn’t mention an accommodations request deadline. Vanderbilt University made no mention of personal preference-based exceptions – only medical and religious exemptions will be accepted. Their deadline for an accommodations request is June 15.

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Governor Mike DeWine Warns Ohioans to Watch Hospital Capacity as Health Director Mulls Outpatient Treatments for COVID-19

During the Thursday COVID briefing, Ohio Governor Mike DeWine said that he “took an oath to do everything to protect the lives and wellbeing of fellow Ohioans” and that the next three weeks will be the most critical in battling COVID.

DeWine then stressed the importance of Ohioans understanding and keeping an eye on hospital capacity in their respective communities.

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Ohio Governor and Chief Medical Advisor Asked About Speeding Up Delivery of Therapies to COVID Patients

The Ohio Star reported that Ohio Governor Mike DeWine called a special press conference on Monday, November 23 alongside the Ohio Hospital Association leaders to address the state’s COVID hospitalization rise.

As reported, during the briefing doctors who lead each of Ohio’s three zones (the state is segmented into three areas) disclosed staffing shortages due to COVID quarantine orders, which had further depleted caregiving capacity already run thin by upticks in COVID hospital cases around the state.

The Star has received inquiries from readers describing their situations.  One woman told the story of her husband who was alerted that he had been exposed to COVID and within days began exhibiting symptoms. When he called his doctor seeking preventative therapies, he was denied.  The man was later admitted to a hospital for days, where he received therapeutic treatments that aided his recovery.

Consequently, The Star took the opportunity during Governor DeWine’s twice-weekly COVID presser on Tuesday to ask the following question:

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