NIH Declines to Comment About Availability of Pfizer’s Fully FDA Approved Vaccine

The National Institutes of Health (NIH) Thursday declined to comment recently revealed revelations that Pfizer is not currently shipping its fully Food and Drug Administration (FDA) approved vaccine called Comirnaty in the United States.

Instead, Pfizer continues to ship – and healthcare providers continue to distribute – the Pfizer BioNTech vaccine, which has only received Emergency Use Authorization (EUA) approval from the FDA. 

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Georgia Receives Oral Antiviral COVID-19 Treatments, But Still No Comirnaty

Georgia Department of Public Health (DPH) officials this week announced they are allocating Merck and Pfizer oral antiviral treatments for COVID-19 to select retail pharmacies throughout the state. “Initial supply of Molnupiravir and PaxlovidTM from the federal government is very limited. DPH anticipates additional allocations in the coming weeks as production increases,” according to a DPH press release.

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Tennessee Receives Oral Antiviral COVID-19 Treatments, But No Comirnaty

Tennessee Department of Health (TDH) officials this week announced they have received shipments of the Merck and Pfizer oral antiviral treatments for COVID-19. “The Tennessee Department of Health coordinated a distribution plan of molnupiravir and Paxlovid with Walmart pharmacies across the state,” according to a TDH press release.

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Twitter Admits ‘Error’ in Suspending Just the News Founder John Solomon’s Account over COVID Facts

Twitter late Thursday acknowledged that Just the News founder and Editor-in-Chief John Solomon’s account was “suspended in error” this week over a post about a COVID-19 vaccine.

The respond follows an appeal earlier in the day by Solomon after his account was suspended Tuesday for his tweet linking to the article “Pfizer to continue distributing version of COVID-19 vaccine not fully approved by FDA.”

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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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New York Times Editor Dies of Heart Attack Day After Moderna Booster Shot

Just a day after taking the Moderna booster shot, a New York Times editor unexpectedly died of a heart attack. 

“This is Carlos’s wife, Nora. It’s with deepest sorrow that I have to share with you that Carlos passed away last night of a heart attack. I’ve lost my best friend and our kids lost a truly great dad. I will be off social media for awhile,” Carlos Tejada’s wife announced on his Twitter account on Dec. 18.

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Department of Defense Silent After Lawyer Told Judge it Had ‘Adequate Supply’ of Unavailable Pfizer Vaccine

The Department of Defense (DOD) declined to comment on whether it had any of Pfizer’s Food and Drug Administration (FDA) approved vaccine called Comirnaty, after one of its lawyers told a federal judge the department had Comirnaty on hand. 

“We don’t have anything for you on this,” a DOD spokesman told The Star News Network by email on Wednesday. 

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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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Exclusive: Nurse’s Affidavit Says She Could Not Get FDA-Fully Approved Pfizer Vaccine for Ohio’s Miami University

According to an affidavit obtained by The Ohio Star, a nurse in Ohio who was in charge of procuring COVID-19 vaccines for Miami University says she was never able to obtain Pfizer’s FDA-approved version of the vaccine, called Comirnaty. 

The affiant is a nurse practitioner and employee of TriHealth, which runs two hospitals and 130 sites of medical care in the Cincinnati area. From June 4 to Nov. 3, she was put in charge of procuring vaccines for Miami University, located in Oxford. The Star has redacted the nurse’s name out of concern of reprisal. 

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Version of Pfizer Vaccine that Predates FDA Approval Still Being Distributed in Pennsylvania

healthcare worker giving vaccination

Of the three companies producing COVID vaccines in the U.S., only one—Pfizer Inc.—has yet gained full FDA approval, and at least some Pfizer vaccines currently being administered in Pennsylvania come from inventory that predates that approval.

On Aug. 23, the U.S. Food and Drug Administration (FDA) approved a Pfizer shot to prevent severe COVID-19 cases. Like Johnson & Johnson and Moderna, Pfizer had been a manufacturing vaccine to fight the coronavirus under federal emergency-use authorization (EUA). The injection produced by Pfizer under EUA is known as Pfizer BioNTech and the company’s post-FDA approval vaccine is called Comirnaty (pronounced kuh-MUR-nit-ee).

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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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Attorneys File Lawsuit Against University of Cincinnati over Vaccine Mandates

Attorneys at Mendenhall Law Group in Akron have filed a lawsuit against the University of Cincinnati over the school’s COVID-19 vaccine mandate. 

“School officials are overriding students’ civil rights to bodily autonomy under the United States and Ohio constitutions.  Young people do not experience this as a grave illness.  It is unprecedented for a university to require students to participate in experimental medical procedures such as injections or masking,” Warner Mendenhall told The Ohio Star Friday.

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Georgia Department of Health Reveals Policy on Shipping in and Distributing FDA-Approved COVID-19 Vaccine Comirnaty

A Georgia Department of Public Health (DPH) official said Friday that her agency currently does not offer the Food and Drug Administration’s (FDA’s) fully approved COVID-19 vaccine, which the manufacturer, Pfizer, calls Comirnaty “Comirnaty has only recently become available, and DPH and its enrolled vaccine providers currently are using on-hand inventory of Pfizer COVID vaccine,” said DPH spokeswoman Nancy Nydam via email.

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FDA-Approved COVID-19 Vaccine Comirnaty’s Availability in Tennessee Unclear

A Tennessee Department of Health (TDOH) official did not say Friday whether his agency currently offers the Food and Drug Administration’s (FDA’s) fully approved COVID-19 vaccine, which the manufacturer, Pfizer, calls Comirnaty. TDOH officials did, however, comment on the matter in October.

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Ohio Health Department Won’t Say Which Version of Pfizer Vaccine It Is Distributing

Following Wednesday’s story in which The Ohio Star reported that Pfizer is currently still shipping it’s Emergency Use Authorization (EUA) COVID-19 vaccine, the Ohio Department of Health (ODH) won’t say which version of the vaccine it is distributing. 

ODH is responsible for acquiring and distributing at least some of the state’s supply of COVID-19 vaccines, though Alicia Shoults of the ODH’s Office of Public Affairs told The Star by phone Thursday afternoon that some healthcare providers procure the vaccine directly from the federal government. 

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Ohio Gov. DeWine Will Veto Bill Banning School Vaccine Mandates

After signing a bill earlier this year that banned Ohio’s public schools and universities from mandating vaccines that have not been approved by the Food and Drug Administration (FDA), Gov. Mike DeWine (R) will reportedly veto a similar bill if it passed by the state Senate. 

“A school, private college, or state institution of higher education shall not require a student to receive any of the following utilizing messenger ribonucleic acid, deoxyribonucleic acid, or any other genetic vaccine technology and for which the United States food and drug administration has not issued a biologics license or otherwise granted full approval,” HB 218 says. 

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Exclusive: Large Ohio Hospital System Still Distributing Pfizer COVID-19 Vaccine Not Fully Approved by FDA

Ohio’s state universities have implemented vaccine mandates, despite HB 244, which bans vaccine mandates for any vaccine that is not fully authorized by the Food and Drug Administration (FDA). 

Ohio State University, Ohio University, and Wright State University all require students to be vaccinated against COVID-19. 

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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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Wisconsin Sen. Johnson Questions Use of COVID Vaccines for Military

Wisconsin Senator Ron Johnson (R-WI) wrote a letter to the Biden Administration questioning their use of COVID vaccinations for military members. Allegedly, military members may not be receiving COVID vaccines that are approved by the FDA.

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