Unapproved by the FDA for distribution in the US. All Covid vaccines in use in the U.S. are under an Emergency Use Authorization. Even though they claimed to have approved Comirnaty, it is not acually available in the US.

@BDair
Why do you believe that? IDGI
The FDA says otherwise:
“On January 31, 2022, the FDA announced the second approval of a COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine, and will now be marketed as Spikevax, for the prevention of COVID-19 in individuals 18 years of age and older.”
[fda.gov]

.

Clear as mud. Lies and obfuscation. Searching for COMIRNATY in the US
Pfizer’s information hotline says it has no specific information on when COMIRNATY will be available. The CDC’s website states that COMIRNATY is “not orderable.” [brownstone.org]

@BDair
Are you saying that the FDA is claiming it has given full approval to the Moderna vaccine when it actually hasn't?

They did a 'bait and switch'. They approved Spikevax and Comirnaty, but they are saying they can continue using the EUA products interchangeably. Relabling makes the 'approved' vaxs technically a legally distinct product, so they are pulling some shenanigans and ignoring their standard protocols.
I do not know for certain whether or not Spikevax or Comirnaty are actually available in the U.S., but their sticking point is that a fully approved product loses the the liability shield they have enjoyed under the EUA. Pfizer and Moderna would be bankrupted if they were held liable for all of the vaccine injuries that are occurring.

@BDair
What standard protocols?

@BDair

With just a couple of quick Google searches I was able to trace this “bait and switch” language to its original source.

As has been known since at least August 30, 2021, this claim of lack of liability protection is false, as its originator has admitted.

“Malone, a physician who bills himself as having played a key role in creation of mRNA vaccines, is a prominent skeptic of the coronavirus vaccines that have been crafted using the technology. Shortly after the Food and Drug Administration fully authorized the Pfizer-BioNTech vaccine, he appeared on a program hosted by Stephen K. Bannon, a one-time adviser to former president Donald Trump, and claimed that the full authorization was a bait-and-switch game played by the FDA.”

“In essence, his argument was that the approved vaccine would no longer have liability protections so Pfizer would simply keep distributing in the United States the product that had been authorized for emergency use.”

“These claims are false, based on a misunderstanding of the law, as Malone acknowledged after we contacted him.”

“Malone quickly conceded his statement on the Bannon show was wrong. “When one is doing rapid analysis on the fly, one does not always get everything right,” he told The Fact Checker. “On this particular legal liability issue I did not hunt down the details myself, and relied on comments from a third party lawyer which were not fully correct.” He said the statements we received from Pfizer and HHS “are consistent with my current understanding.””

The Pinocchio Test
“As regular readers know, we generally do not award Pinocchios when a person admits error. Otherwise, this would be a Four-Pinocchio claim. Malone was too quick to embrace false information (while bashing the mainstream media at the same time). The liability protection for Comirnaty is the same as the vaccine that was previously approved under emergency authorization, so that is not a bar to distributing the fully-approved vaccine in the United States”
[washingtonpost.com]

This is the problem with conspiracy hysteria. It's easy to carelessly generate misinformation, even with the best of intentions, but extremely difficult to retract once it's set loose on the internet.

@BDair
Looks to me like Malone was the bait-and-switcher. What do you think?

Show me where you can get Comirnaty in the US. The US Navy seems to agree that none of the 'approved' vaccines are available in the US.

@BDair
We’ll get to that. Let’s take one issue at a time. Do you acknowledge, as Malone himself has, that this claim of lack of liability protection is false?

@BDair
Will you publicly acknowledge that one piece of information that you helped propagate was found to be not true?

It is not proven untrue unless you can provide evidence that Comirnaty and Spikevax are available for use in the U.S. I can can not find any proof of that.

@BDair
That's just a legal matter of registering names. It's the same formula. If it turns out the first batch legally labeled with the new name hasn't been distributed yet, it doesn't prove that it's because of lack of liability protection. It could be for other reasons. This is a different issue. You claimed, based on Malone's comment, that the product couldn't get liability protection. Malone has now acknowledged he had no basis for that claim. Will you also, or will you say what that basis is? The product not having been distributed yet, if that is indeed the case, is not sufficient evidence.

As long as they are using the previous EUA product, which they are, it has a liability shield. If they have a fully approved product, then they lose it unless they get it on to the children's schedule. It is all sleight of hand and skull duggery. It is all more or less moot, since the vaccines have proven to be useless and demand for them is cratering.

@BDair
I see you are unwilling to acknowledge what Malone acknowledged.

I can't acknowlege what I can't clarify or completely understand. Why did the FDA reissue the EUA for the Pfizer CV 19 vax if Comirnaty is fully approved? I believe they are legally distinct products.
As I understand it, if there is a proven 'approved' product available, then no other product can be used under an EUA. But the FDA has abandoned all reason and protocol.
'On July 8, 2022, having concluded that revising this EUA is appropriate to protect the public health
or safety under Section 564(2) of the Act, FDA is reissuing the June 17, 2022 letter of
authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place
for the Pfizer-BioNTech COVID-19 vaccine for the previously authorized indication and uses, and
to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses
that are not included in the approved BLA.' [fda.gov]

@BDair
I really don’t understand what your concern is. What specifically do you suspect is afoul, and what specifically will prove or disprove it?