After FDA approval of Comirnaty, antivaxxers claim it’s still “experimental”

I do grudgingly have to hand it to antivaxxers. No matter how often their BS talking points based on bad science, pseudoscience, and conspiracy theories are debunked with science, evidence, events, and reason, they’re always ready with a Talking Point B (and C and D and E) to replace the debunked talking point with a new one. So it is with Comirnaty, (the rather awful name decided upon for the COVID-19 vaccine developed by BioNTech and Pfizer), which was granted full FDA approval on Monday.

Ever since the FDA granted emergency use authorization (EUA) status, first to the COVID-19 vaccine developed by BioNTech and Pfizer, then to the Moderna vaccine, and then to the Johnson & Johnson vaccine, one consistent antivax talking point has been that the COVID-19 vaccines were “experimental” (and therefore dangerous). Never mind that all the vaccines granted EUA had gone through phase 1, 2, and 3 clinical trials, with phase 3 trials involving tens of thousands of people. Never mind that these vaccines have now been administered to billions of people worldwide, with over 360 million doses in the US alone, with an excellent safety record. In other words, they are not “experimental” any more and have not been since their successful phase 3 studies, and the continuing claim that the vaccines are “experimental” conflate a legal definition of a drug or biologic (like a vaccine) that hasn’t obtained full FDA. So it was yesterday, when, less than a day after the FDA had finally granted full approval to Comirnaty (the rather awful name for the COVID-19 vaccine developed by BioNTech and Pfizer), antivaxxers were ready with a new talking point and conspiracy theory claiming that in reality Pfizer’s COVID-19 vaccine was not really FDA-approved at all, that Comirnaty is not the same as BNT162b2, the designation for the Pfizer/BioNTech vaccine that has been distributed since December under an EUA.

The origin of this conspiracy theory, as is the case with most antivax conspiracy theories in the age of COVID-19, appears to be a bit murky. I first saw it on the website of Children’s Health Defense, the antivaccine organization founded by a longtime antivaccine “thought leader” (if you can call it that) Robert F. Kennedy, Jr., whose original name was the World Mercury Project because back then RFK Jr. was firmly in the “mercury militia” camp; i.e., the faction of antivaxxers who were convinced that mercury in the thimerosal preservative that was in several childhood vaccines until around 2001-2002 was The One True Cause of Autism. Of course, as an example of just what I’m talking about with Comirnaty, as years went by after the removal of mercury from childhood vaccines and there was no sign of autism prevalence falling (as would be predicted by the hypothesis that mercury in vaccines were The One True Cause of Autism), RFK Jr. pivoted effortlessly from that falsified hypothesis to a new narrative in which it was the vaccines themselves that were The One True Cause of Autism, not to mention the “sickest generation” and, seemingly, every chronic illness in children.

However, this talking point about Comirnaty appears to have originated with Robert Malone (remember him?), the conspiracy mongering “inventor of mRNA vaccines” who is not. I first saw Malone’s version on—where else?—Mike Adams’ website NaturalNews.com. There’s also a video out there:

Yes, Malone is claiming that the approved vaccine does not yet exist.

There are versions on other conspiracy sites, too, such as Greg Hunter’s USA Watchdog:

The big news the FDA had given “full approval” to the Pfizer CV19 vaccine is a HUGE lie.  The FDA has granted approval to some future vaccine called “Comirnaty.” (FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA).  (Here’s the letter from the FDA to Pfizer) You cannot get Comirnaty now because it does not exist.  Who knows when, in the future, they will manufacture it so you can get this vax.  What you can get is the same old experimental Pfizer vaccine that is under Emergency Use Authorization (EUA).  All the FDA did was extend the EUA for the crap they were already injecting.  This is the vaccine that is available for the forced mandates to civilians and military alike.  It’s a total experimental vaccine, and they lied to the public and said it was “fully approved” and “safe and effective.”  In a letter to Pfizer on Monday, the FDA said, “. . . the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses. . .”  There it is in black and white from the criminal Nuremberg Code violating liars at the FDA.

Don’ take my word for it.  Dr. Robert Malone, inventor of the mRNA (that is found in the so-called vaccines), says there are “two vaccines.”  Today, Dr. Malone explained what the FDA did on Steve Bannon’s “War Room.”  There was one approval for a future vaccine, and one extension of the Emergency Use Authorization for the vaccine being used now.  There is little doubt this will continue to be used for all the upcoming mandates.  Is this a huge lie to trick the public into taking the experimental shot?  I say yes.

So what is going on here? This certainly sounds quite dire, doesn’t it? Let’s go to the source and look at the FDA letter. (There is a second FDA letter that provides the biologics licensing approval here.) The letter, of course, states that the FDA has “approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.” No surprise there. Now this passage appears to be where the conspiracy comes in:

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID- 19 Vaccine, mRNA).

So what does this mean? The language about Comirnaty is, as is often the case, confusing legalese and jargon. First of all, what this means is that, while Comirnaty is now fully FDA-approved for use in people age 16 and older to prevent COVID-19, its use in those aged 12-15 will fall under an updated EUA rather than full FDA approval, just as the Pfizer/BioNTech vaccine’s use has since the EUA was issued for this indication in May. The reason is simple. Approval of a biologics license application (BLA) requires more followup data than an EUA, and insufficient time has passed since the clinical trial upon which the FDA based its May EUA that authorized use of the Pfizer vaccine in children aged 12-15 was concluded. As the FDA put it in a press release, the vaccine will be “available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals” and that the BLA was granted under “Priority Review.”

Now if you really want to see some serious nonsense, take a look at the video that goes with the story. You only have to see the first few minutes to get a full dose of the burning stupid based on the passage from the FDA letter that I just quoted above:

So what is Greg Hunter going on about? Basically, besides the FDA extending the EUA on the Pfizer vaccine (now called Comirnaty) for indications not covered in the BLA (children age 12-15 years and the third dose for immunosuppressed people), the FDA also extended the EUA for existing stocks of vaccines, leading Hunter to rant that it’s a “huge lie” that the Pfizer vaccine has been “fully approved” and said:

While they did approve the biologics license, the BLA submitted by BioNTech manufacturing for Comirnaty, they didn’t approve the Pfizer vaccine, what we already have…And…Comirnaty, you can’t get that now. That’s not out for a few years. So what did they do? Oh, here’s what they really did.

Funny, but someone on Twitter pointed out:

So Comirnaty is indeed available and does exist now, albeit in Europe. Sorry to ruin a good conspiracy theory.

Hunter then quotes the part in the passage above about the FDA “reissuing the August 12, 2021 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.” He then goes on to rant:

Can you get the Comirnaty now? Can you get that now? No, that’s the only license they gave. You can’t get that right now. What you can get is what’s in the emergency use authorization. That’s what they’re going to inject everyone with. You can’t get the new approved vaccine. It’s not been created yet, and it’s only for the BioNTech manufacturing of Comirnaty. I believe that’s how you say it. It doesn’t matter; you can’t get it for a couple of years. What you can get is the crap they’ve already been injecting into us, and they’ve extended the emergency use violation, meaning that when you have the Pentagon mandating vaccinations and mandating for state and federal workers they’re mandating the forced participation in an experimental drug trial—and a dangerous one at that. Shame on you, FDA, for lying! You didn’t give full approval for the crap that they’re going to use in the next couple of years.

Truly, this is burning stupid so intense that I fear it might go supernova and destroy the solar system. It’s so stupid that, believe it or not, Ethan Huff at NaturalNews.com, ranting about the same talking point, concedes:

On the flip side, Pfizer’s own labeling suggests that its current jab authorized under EUA is the same as Comirnaty, and that the two are basically interchangeable.

“The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series,” the Pfizer document states.

And:

An FDA release on August 23 further suggests that the agency considers Comirnaty and the current Pfizer injection being administered to be one and the same, and that the name is merely changing because the drug has received full approval.

“The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older,” the agency says, seemingly supporting what the media is claiming about the approval.

“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”

Indeed, there is a footnote in the FDA letter (apparently missed by Greg Hunter) that states that Comirnaty is the same as the existing Pfizer vaccine:

The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

So basically, the EUA-authorized Pfizer COVID-19 vaccine is exactly the same vaccine as the now FDA-authorized Comirnaty. So why would the FDA have extended the EUA on the existing Pfizer vaccine? Obviously, the first reason is to extend the EUA on the vaccine for indications not covered in the BLA (again, children 12-15 years old and the third dose for the immunosuppressed). What about other reasons? According to the FDA, the EUA was extended also for use of the Pfizer vaccine in people ages 16 and above for “logistical reasons“:

The EUA will continue to cover adolescents 12 through 15 years of age and the administration of a third dose to certain immunocompromised individuals 12 years of age and older. Additionally, for logistical reasons, the EUA will continue to cover the use of the Pfizer-BioNTech COVID 19 Vaccine in individuals 16 years of age and older; this use is also now approved.

What are these “logistical reasons”? I’ve had a hard time figuring it out, but if you believe RFK Jr., the Pfizer has said that it does not yet have sufficient stocks of Comirnaty yet, while a large stock of existing vaccine is still out there and available:

But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.

First, the FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use.

The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.

Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

If you believe people like Greg Hunter (and RFK Jr., who makes basically the same claim in a less hysterical manner, consistent with how he tries to sound more “reasonable,” even though he’s been known to liken vaccine mandates to the Holocaust), the reason is, of course, a conspiracy theory. Specifically, the FDA is engaging in a “monster criminal act” because Comirnaty (as a fully FDA-approved vaccine) will be covered under the National Childhood Vaccine Injury Act of 1986 and those injured by it can apply to the Vaccine Court for compensation, whereas the question of how injury by COVID-19 vaccines distributed under an EUA is compensated, which is under a less generous program created by the PREP Act. (Further explanation can be found here.) Unsurprisingly, Hunter spends the rest of his 18 minutes ranting about all the claimed harms of COVID-19 vaccines that I’ve been debunking for several months. I also can’t help but chuckle merrily to think that NaturalNews.com would acknowledge something that Hunter does not, namely that the formulations of Comirnaty and existing Pfizer vaccine are the same. The only things that will be different are the label and the name.

Indeed, RFK Jr. takes it a bit farther, claiming that, in the time between now and when Pfizer vaccines with the Comirnaty label hit the clinic, of course the government will have to find a way to “immunize” Pfizer and BioNTech from liability:

Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.

Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.

Here’s the funny thing. I suppose that Pfizer could take all those vials out there of its vaccine and slap the “Comirnaty” label on them, but that would be expensive and pointless. I’m also guessing that there must be legal or regulatory reasons why the FDA, instead of granting full BLA to existing stocks of the Pfizer COVID-19 vaccine, instead just extended the EUA on the vaccine while approving Comirnaty (which, once again, has the same formulation as existing stocks). Perhaps someone with more knowledge of FDA law and regulations can explain. Whatever the reason, I just don’t see the nefarious intent. Moreover, I’m guessing that if the FDA had approved existing stocks antivaxxers would have come up with a different conspiracy theory.

One last thing, Malone claims that Comirnaty is “substantially the same but not necessarily identical to” the current Pfizer vaccine. Nowhere can I find evidence for his claim, given that Pfizer and the FDA both say that Comirnaty and the existing Pfizer vaccine both “have the same formulation and can be used interchangeably.” Once more, as they have long done when they refer to COVID-19 vaccines distributed under an EUA as “experimental” or “investigational,” it appears that antivaxxers are conflating legal definitions with scientific ones. Again, the FDA has stated that Comirnaty and the current vaccine have the same formulation but are “legally distinct with certain differences that do not impact safety or effectiveness.” Perhaps it’s something about the manufacturing process. Perhaps it’s something about how giving the product a different name for approval has legal implications. Perhaps it’s manufacturing the vaccine at different sites. Again, I don’t really know for sure, as I’m not a legal expert.

What I do know is that everything I can find about Comirnaty tells me that it’s the same vaccine as the existing Pfizer/BioNTech vaccine, just with a new trade name now. (True, it’s not a good trade name compared to the Moderna vaccine, which will be called by the coolest and most metal of names, SpikeVax, but it’s a trade name.) Whatever the reason for continuing the EUA for existing vaccine stock, it doesn’t appear to be anything nefarious, although it might be for reasons embedded in the complicated law and regulations of the FDA. As for Robert Malone, the “non-inventor of mRNA vaccines,” he’s just gone a bit further down the rabbit hole of conspiracy theories by claiming that the FDA-approved COVID-19 vaccine doesn’t yet exist and feeding a narrative to people like RFK Jr., Greg Hunter, and Mike Adams.