One week ago today, the FDA granted full approval to Comirnaty, the mRNA-based COVID-19 vaccine developed by BioNTech and Pfizer, and there was much rejoicing. One reason for the rejoicing was the belief, widespread among health authorities, that one thing holding many back from getting vaccinated against COVID-19 was the knowledge of how the three COVID-19 vaccines currently available in the US (made by Pfizer/BioNTech, Moderna, and Johnson & Johnson) had been distributed under an emergency use authorization (EUA). Because this was less than full FDA approval in that it is a mechanism which permits the FDA to “allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives”, so the thinking goes, many vaccine-hesitant didn’t trust the vaccines but would trust them once the FDA formally approved them, as Steve Novella discussed last week. To some extent, this might be true, although I rather suspect that the number of vaccine-hesitant who will be persuaded by full FDA approval of Comirnaty to get the shot will be relatively small compared to what was hoped for. I also know that full FDA approval won’t sway antivaxxers in the least.
Indeed, it was almost as though antivaxxers were ready with a line of propaganda about Comirnaty and the Pfizer/BioNTech vaccine. Just to be transparent, I will note that I wrote about this last week for my not-so-super-secret other blog, but this bit of misinformation has gone viral to the point where I thought it very much worthwhile to cover it for Science-Based Medicine as well. Obviously, there will be overlaps between my previous post and what I’m writing now, but there have also been developments since last week that weren’t covered, and as a result this post is substantially different from the previous one. (Also, if you don’t read my other blog, this will be all new to you anyway.) Moreover, since I wrote that post, I think I’ve found an element from FDA messaging that left the door open to a new conspiracy theory that builds on this one. As I’ve said before, I do grudgingly almost have to hand it to antivaxxers. No matter how often their misinformation based on bad science, pseudoscience, and conspiracy theories is 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. In this case, after Comirnaty had been approved on Monday, antivaxxers came up with this conspiracy theory by Tuesday.
But what is this conspiracy theory? Follow me down the rabbit hole.
“The FDA pulled a bait and switch”
Although the sources that led me to this particular conspiracy theory were articles posted by Tuesday, I’ll begin with a Tweet from antivax “thought leader” Robert F. Kennedy, Jr.:
Here's my latest with @NassMeryl… Buried in fine print of Monday's approval by FDA of Pfizer Comirnaty COVID vaccine are 2 critical facts that affect whether vaccine can be mandated + whether Pfizer can be held liable for injuries.https://t.co/QtpHufCKDI
— Robert F. Kennedy Jr (@RobertKennedyJr) August 25, 2021
The article linked to claims:
The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now requiredthe vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.
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.
So what does that particular footnote in the FDA letter say? Let’s quote it:
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 the licensed vaccine (Comirnaty) has the same formulation as BNT162b2, the designation for the Pfizer/BioNTech vaccine that has been distributed since December under an EUA. However, for reasons not described in the FDA letter, the FDA says that the two are “legally distinct,” and there is the phrase that’s launched a major conspiracy theory among antivaxxers.
RFK Jr. and Meryl Nass continue:
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.”
There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.
EUA products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.
U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.
I’ve pointed out, here and elsewhere, many times before that the “Nuremberg Code gambit” is nothing more than a convenient way of comparing vaccine advocates and those favoring vaccine mandates to Nazis. First, it deceptively conflates a legal definition of “experimental” or “investigational” (basically any drug or biological that hasn’t yet received full FDA approval) with a scientific definition of “experimental”. The way I like to show the deception is to point out that a product that has gone through phase 1, 2, and 3 testing involving tens of thousands of subjects, over 300 million doses of which have been administered with an excellent record of safety and effectiveness in just the US alone, is not, by any reasonable scientific definition, “experimental” any more. It’s just not yet FDA-approved. Moreover, the “Nuremberg Code gambit” intentionally ignores more recent statements of ethics regarding human subjects research, such as the Belmont Report in the 1970s and the Declaration of Helsinki, which was most recently updated in 2018. Why would antivaxxers ignore a more recent and comprehensive statement on the ethics of human subjects research in favor of a 75 year old code that, while historically very important, is not the current standard? Isn’t it obvious? The more recent reports don’t involve a judgment against Nazis, and antivaxxers are about nothing if they aren’t about comparing doctors to Nazis and vaccine mandates to the Holocaust.
You can see the conspiracy theory here. To sum up its essence, antivaxxers are claiming that the FDA did a “bait and switch,” approving Comirnaty, the Pfizer vaccine given a trade name while leaving BNT162b2, the designation of the vaccine that had been granted an EUA under the same EUA, all in order to not just give the “appearance” that COVID-19 vaccine mandates are now legal but to allow the old BNT162b2 not to have to be covered under the National Childhood Vaccine Injury Act of 1986, the law that created the Vaccine Court and mandates that all claims of vaccine injury go through the Vaccine Court first before they can go through regular federal courts.
Of course, antivaxxers frequently forget to mention that the Vaccine Court is rather lax. The Vaccine Court was designed, if anything, to err on the side of paying out, as the Daubert standard for admissibility of expert witnesses isn’t always enforced, leading sometimes to “expert” witnesses who would never be allowed in regular courts. Speculation is permitted, and all that is required to potentially win a settlement is a “biologically plausible” mechanism, rather than a scientifically demonstrated mechanism. Also, it’s a civil court, and the standard of evidence for compensation is what some have called “50% and a whisker”. Moreover, compensation is automatic for so-called “table injuries” (known injuries that science attributed to vaccines listed on the Vaccine Injury Table). Indeed, I frequently suspect that what drives so much of the antivax hatred towards the Vaccine Court is not just that it has rejected claims of causation of autism by vaccines, but from trial lawyers. Even though they can get a lucrative steady paycheck billing their hourly rates while representing families taking their case to the Vaccine Court, trial lawyers who want to sue vaccine manufacturers for fantastical “vaccine injuries” will never get a massive contingency fee percentage of a huge headline-making award.
In any event, UC-Hastings law professor Dorit Reiss has explained that vaccines issued under an EUA are probably not covered by the NCVIA of 1986 and the Vaccine Court, but under a much more restrictive system:
In essence, COVID-19 vaccines manufacturers, distributors, and administrators are currently almost completely exempt from liability because the vaccines – and other COVID-19 products – are under a Public Readiness and Emergency Preparedness Act (PREP) declaration.
The only exception – the only situation where you can sue these actors – is if you can show they engaged in “willful misconduct”.
The conditions are rather restrictive, too. The vaccine maker must have acted:
- intentionally to achieve a wrongful purpose;
- knowingly without legal or factual justification; and
- in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
Reiss further notes:
People harmed by a vaccine covered by the declaration may turn for compensation to the Countermeasures Injury Compensation Program – which is hard to use.
So there you have the conspiracy theory in a nutshell. Ironically, RFK Jr.’s version of the conspiracy theory is the least wild one.
Robert Malone and Greg Hunter crank the conspiracy up to 11
Although I don’t know for sure, I think that this particular conspiracy theory originated with Dr. Robert Malone. Perhaps you’ve heard of him. He’s a scientist who’s made a name for himself in crank circles by claiming to be the “inventor of mRNA vaccines”. He isn’t, as far as I can tell, although that doesn’t stop him from ranting about how his contributions to the vaccine are “being erased from Wikipedia” for going against orthodoxy on COVID-19 and mRNA vaccines against the disease. Amusingly, it appears that his wife got busted editing his Wikipedia entry under the ‘nym Glasspool1 and that there were a lot of other suspicious edits to his entry, leading Wikipedia editors to take action to put the kibosh on this attempt to use Wikipedia for self-promotion.
In any event, the first instance of this conspiracy theory that I saw was published last Tuesday on Greg Hunter’s USA Watchdog as a post titled “FDA Lied–Vax Not Approved Still Experimental“:
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.
Unsurprisingly, Hunter (whom I had, oddly enough, never heard of before encountering this article) invoked the Nuremberg Code gambit, because of course he did. Unlike RFK Jr., though, Hunter completely ignored the footnote in the FDA letter stating that Comirnaty and BNT162b2 have the same formulation and can be used interchangeably, and instead went right for this rather confusing passage:
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 continue to 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 follow-up 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“.
If you have the stomach for it, here is the video of Malone’s claims (four minutes out of a much longer interview):
And here is Greg Hunter’s rant:
Hunter takes Malone’s conspiracy theory and runs with it, cranking the conspiracy up to 11 by claiming that, besides the FDA’s extension of 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.” Not only that, but he claims that Comirnaty doesn’t exist yet:
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.
Before I go on, though, I can’t help but point out that Comirnaty is indeed available and being used in Europe under that very name, making Malone’s point seem rather silly:
Here's all the proof that you should need that this vaccine already exists. My vaccination record (all I've done is scrubbed identifying information as I prefer to be anonymous on twitter). Will you now accept that this vaccine DOES exist and your sources are liars? pic.twitter.com/LOEXV3FbgJ
— Metatherian (@Metatherian10) August 25, 2021
None of this, of course, deters Hunter. 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.
It’s not just Hunter, either, who picked up this conspiracy theory and ran with it. For example, Robert Barnes, a conservative lawyer who has worked for Alex Jones and has been a regular contributor to Jones’ conspiracy website Infowars, Tweeted:
There is no *available* FDA approved licensed vaccine. Here's what is happening. If FDA approved & licensed COVID19 vaccine, it would have to revoke the EUA vaccines & subject the vaccine maker to more liability risk. So it only approved a future vaccine that isn't "available".
— Robert Barnes (@barnes_law) August 25, 2021
Again, this doesn’t make sense, given that Comirnaty is clearly already available in Europe, at least. Indeed, when RFK Jr. sounds less out there than you do, you really should rethink, but rethinking is not what conspiracy theorists do. Instead, they double down. Where RFK Jr. only says that the FDA has stated that supplies of Comirnaty are simply constrained right now and that the FDA is taking advantage of this to allow the old vaccine to continue to be distributed under the EUA and thereby supposedly escape falling under the NCVIA of 1986, Malone and Hunter go far beyond that and much deeper into the rabbit hole of conspiracy mongering by saying that this was intentional all along.
But what’s really going on?
The FDA’s action, explained
Last Thursday (after I had written the first version of this post in which I expressed a bit of puzzlement over why the FDA would have chosen this route), Aaron Blake wrote an excellent explainer for The Washington Post titled “Vaccine conspiracy theorists become even more desperate after full FDA authorization“. (That is, of course, a great title and very accurate.) Blake, as I did, notes first about the claim that the FDA never really approved the Pfizer vaccine:
It’s a claim many of the most prominent vaccine skeptics you might have heard of are pushing with increasing gusto. It’s just not something that, according to experts, actually lines up with the FDA’s announcement.
Some of these claims are rather inscrutable. But they boil down to the idea that the FDA has engaged in a bait-and-switch. While it fully approved the Pfizer-BioNTech vaccine that will be marketed under the name Comirnaty, the FDA also extended the emergency-use authorization for the same vaccine under the existing name.
Some have gone so far as to ignore the former and claim this was strictly about extending the emergency-use authorization (EUA). But most of it involves suggesting the full authorization provides a pretext for mandating the emergency-use version (which some wrongly suggest is different). Others have wrongly claimed that if this was truly a real, full authorization, the EUAs would have to be voided — so the fact that they aren’t means it isn’t a full authorization.
Blake then cites a different footnote that I should have cited:
Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised population described in this EUA.
This is actually quite clear and I should have noticed it in my first version. There isn’t enough Comirnaty to take care of the entire population that needs to be vaccinated. That is a very different claim than saying that Comirnaty is not available and even more different than the claim made by Hunter and others that it won’t be available until 2023, which appears to have come out of thin air. (At least, if there is a basis for it, I haven’t been able to find it in nearly a week.)
Blake then goes on to explain why the FDA acted as it did, pointing to another claim by antivax conspiracy theorists that came out of thin air:
As for the idea that they simply wouldn’t be allowed to continue the EUAs if they truly had a fully approved version? That comes out of thin air. The FDA is allowed to continue with EUAs even if a fully approved treatment is available, as long as there isn’t an “adequate” amount of the fully approved treatment available. (The above footnote is appended to the FDA using this precise language.)
What’s more, the full authorization doesn’t include some groups in the EUAs, such as those between 12 and 15 years of age — meaning those groups won’t yet have access to the fully authorized version.
“That language gives FDA a tremendous amount of flexibility to continue to issue EUAs, or to retain existing EUAs, even after one or more products are approved,” said Patricia J. Zettler, a former FDA attorney and law professor at Ohio State University. “For example, remdesivir is fully approved for the treatment of covid-19 requiring hospitalization, but there remains an EUA for the product for pediatric patients outside the scope of the approval.”
Zettler added: “There is nothing suspicious going on here; this is just regulatory language explaining why a legal standard is met.”
In other words, the FDA phrased its letter as it did in order to explain that it was meeting the standard of the law. Basically, even though Comirnaty is available now, it’s not available in sufficient supply to meet current need, and the FDA is allowed to continue the EUA for BNT162b2 until supplies of Comirnaty are sufficient. Also, by law, the FDA couldn’t yet approve BNT162b2 for the other uses covered by its EUAs, namely children 12-15 years old and third “booster” doses for people with weakened immune systems for whatever reason, be it disease, cancer chemotherapy, or whatever.
If you want a more step-by-step explanation, I found a great Twitter thread explaining the situation:
I also like how he finishes thusly, one might say…insolently:
Truly, I couldn’t do better myself, other than to reference this particular post on Robert Malone. You’ll excuse me if I couldn’t resist, but, whatever role Malone might have played in developing lipid nanoparticle-encapsulated mRNA as a means of getting cells to make a desired protein, right here, right now, in 2021 he has become a full-on conspiracy crank.
I will conclude by circling back to a rather cryptic comment that I made near the beginning of this post about a “key element behind the FDA messaging” that might explain more fully why there might have been a legal difference between Comirnaty and BNT162b2. Amazingly (to me, anyway) Robert Malone didn’t pick up on it, nor did any other antivaxxers other than one:
So they are saying Comirnaty has "optimized codons to improve antigen expression" while the "V8" formulation that was used on the animals during the trial does not contain that.
This is one I found intriguing, but not entirely sure it is a cause for immediate concern.
— Amanda Jones 🐼🐾🇺🇸 (@MsPandaJones) August 25, 2021
Again, I hesitate to bring this up because doing so risks giving antivaxxers another talking point. On the other hand, it’s always better to be proactive, so that if one of the bigger antivax social media influencers picks up on this a refutation will be ready.
First, though, what does this mean?
As I’ve explained before, in brief, DNA replicates from a DNA template and results in a double-stranded molecule that is very stable, as it has complementary sequences that tightly bind to each other in a sequence-specific fashion. This DNA template is unwound by enzymes that use the template to make RNA strands, which are single-stranded, which is then used by a ribosome to make protein out of amino acids. Again, to put it simply, each nucleotide equals one letter of the code; each three-nucleotide sequence (codon) equals one “word” that translates to an amino acid. Given that there are four nucleotides, there are 64 possible codons. Since there are only 20 amino acids, that means that most amino acids are encoded by more than one combination of nucleotides or more than one codon, leaving aside codons that code for “start” and “stop”; i.e., the genetic code is redundant.
What this regulatory statement seems to be saying is that Comirnaty, while using an mRNA sequence that produces exactly the same amino acid sequence for the SARS-COV2 spike protein using “optimized codons.” It turns out that the use of certain codons can be more efficient at producing the desired protein than the use of others; again, even though the codons used might be different, the amino acid sequence, and thus the protein produced, is exactly the same. What isn’t entirely clear to me is when the decision to use the optimized codons referred to was made. There is an article I found dating back to May 2020 that states:
Nucleoside modified mRNA (modRNA) candidate encoding an optimized SARS-CoV-2 full-length spike protein antigen. COMIRNATY is the lead candidate of the Pfizer/BioNTech BNT162 program, which includes another modRNA candidate that encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen antigen; a uridine containing mRNA (uRNA) candidate; and a candidate using self-amplifying mRNA (saRNA). The other candidates are known as BNT162a1, BNT162b1, and BNT162c2.
The Pfizer-BioNTech COVID-19 vaccine (also known as BNT162b2, Tozinameran, and Comirnaty), is one of four advanced mRNA-based vaccines developed through “Project Lightspeed,” a joint program between Pfizer and BioNTech.
And this makes it clear that Comirnaty and BNT162b2 are one in the same vaccine:
On July 1, 2020, the manuscript describing the preliminary clinical data for BNT162 was available online for scientific peer-review for potential publication.
On July 27, 2020, the Companies advanced nucleoside-modRNA candidate BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30µg dose level, in a 2-dose regimen, into Phase 2/3 study of up to 30,000 participants aged 18 – 85 years, and is expected to include approximately 120 sites globally.
And this report in USA Today:
The Food and Drug Administration issued full authorization Monday for the Pfizer-BioNTech COVID-19 vaccine. Soon, millions of Americans will face a confusing, difficult task: How in the heck do you pronounce Comirnaty?
That’s the brand name for the Pfizer-BioNTech vaccine. It’s pronounced “co-MER-na-tee” according to Scott Piergrossi, president of creative for the Brand Institute, which crafted the name.
It’s a little easier to say than BNT162b2, the research name of the vaccine while it was first being studied, but not much.
I predict that other antivaxxers will make an attempt to quote mine that part of the FDA letter to imply that Comirnaty is chemically different than BNT162b2, but it’s not. BNT162b2 is Comirnaty, and Comirnaty is just the trade name for BNT162b2. Not that that will stop conspiracy theorists.
The bottom line
The conspiracy theories being spread by the likes of Robert Malone, RFK Jr., and Greg Hunter (among many other antivaxxers and COVID-19 conspiracy theorists) falsely claiming that the FDA never really approved the Pfizer vaccine with a full BLA are just that—conspiracy theories. They’re predicated on a misunderstanding or intentional misrepresentation—take your pick—of EUAs versus full FDA approvals, such as the BLA issued for Comirnaty. From what I’ve been able to gather, legally the FDA, if it wanted to keep the Pfizer vaccine available to children aged 12-15 and to keep allowing immunosuppressed people to receive a third “booster” dose of the vaccine, it had to act the way that it did. Moreover, although the Pfizer BioNTech vaccines under two names (Comirnaty or BNT162b2 or just the “Pfizer vaccine”) are legally distinct, they have the same formulation. They are the same vaccine.
Unfortunately, this conspiracy theory sounds very convincing. It even had me scratching my head for a while; that is, until I started doing some digging. The bottom line is that the FDA and press are not lying. The Pfizer vaccine is fully FDA-approved.