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.
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.
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.”
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.
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.
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.