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.
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.”
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.
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.”
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.
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.
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.
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.
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.
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.
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.
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.