Categories
Antivaccine nonsense Bad science Medicine Politics Popular culture

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

On Monday the FDA granted full approval to Comirnaty, the COVID-19 vaccine developed by Pfizer and BioNTech. By Tuesday, antivaxxers had a propaganda line that the vaccine is 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.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

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

Thank you for this post! I’ve been trying to explain the same to some rabid antivaxxers, but you have explained more clearly. I wish the FDA would publish a clear explanation of what the heck the “logistical” reasons are for its confusing legalese, and also state the bottom line facts clearly instead of leaving room for antivaxxers to spin tall tales.

Rabid antivaxxers… if the vax is so effective, what business is it of yours who else gets it??? I took the Pfizer double jab (let’s stop calling it a vaccine), before all these ridiculous, communist style mandates were used. The FDA lost its control group. It’s trial only lasted five months. Why after all the animals died when they tried to develop a SARS 1 vaccine, did they decide to forego animal testing for SARS 2 “vaccine” development? Recommendation to pregnant women are criminal. Young people are DYING from the Shot, not COVID. I will not get a booster. CAN PFIZER BE SUED NOW???????

If it’s not a vaccine, what is it? And what do you want to sue Pfizer for? What is the source of your data?

Although you hit all the talking points of one, I’m hesitant to call you an antivaxxer because you took the vaccine. But you certainly are of some rabid sort.

There are antivaxxers who will take certain vaccines but are antivax about all the others. Just accepting one vaccine does not make one no longer an antivaxxer.

Animals actually did die during developing SARS vaccine. But none of them died because of vaccine, they were euthanised to get autopsy data. There were clinical trial, none of participants died either because of vaccine

Lori, vaccines are not 100% effective but even if they only prevented infection or transmission half the time or less, it would still save lives. The reason anyone cares about your vaccinated status is that you being vaccinated means that you are less likely to pass Covid along to others. Fewer Covid cases means fewer deaths, fewer long lasting complications and reduced strain on health care resources.

“I took the Pfizer double jab (let’s stop calling it a vaccine), before all these ridiculous, communist style mandates were used.”

Sure you did.

A well-known side effect of Covid-19 vaccination is that it turns certain people into rabid antivaxers.

I blame the spike protein.

communist style mandates

Don’t forget all those capitalist-style ones.

Which bucket would you file restaurant employees’ being mandated to wash their hands after using the bathroom into?

“communist style …”

As soon as you show you don’t know what “communist” means you lose the chance to be taken seriously. Your unsupported whinges about “deaths” that follow simply emphasize how fact free you are.

It’s a “Godwin” when someone inappropriately inserts Hitler into an argument. We need a catchy term for when someone inappropriately calls something “communist” when it has nothing to do with the work of Marx and Lenin.

@Cloudskimmer:

We need a catchy term for when someone inappropriately calls something “communist” when it has nothing to do with the work of Marx and Lenin.

Perhaps “McCarthy”, after the notorious Senator?

Communist style?
Communist style, they just rounded kids up at school, a nurse came and vaccinated everyone. No parental consent needed because fuck you. Don’t talk about communism when people who grew up on the other side of the Iron Curtain are present. You know nothing, you moron.

Agree. This so called vaccine is NOT a vaccine. It is a gene therapy delivering system. It changes genetic make up of cells in your body. It has particularly high affinity to reproduction system of human (25% of the particles of this vaccine associate with women’s ovaries, which Pfizer didn’t tell you). A vaccine is not suppose to change a person’s genetic make up. These so called mRNA vaccine ARE NOT vaccine!

You do realize, don’t you, that I’ve addressed each of your erroneous claims about the vaccine in great detail going back several months, right? I could list several posts I’ve written on the matter, each of which cites the evidence and science, but I rather suspect that you would be totally unreceptive to science, evidence, reason, and logic.

“I wish the FDA would publish a clear explanation ”

Like wise.

They could complement the legal version with a common language version to explain clearly that the Pfizer BionTech vaccine is the same vaccine as the Comirnaty vaccine, just with a different label. And that, for legal reasons, existing stocks of the vaccine with the Pfizer BionTech label will continue under EUA whereas the vaccine with the Comirnaty label will have full approval fro those over the age of 16, and EUA for 12-15 year olds as well as for the third dose for the immuno-compromised.

And that distinction between the two “identical” (except for what’s different; no clear idea what that means) vaccines has important marketing and liability implications. BioNTech can tout the vaccine’s approval and market it, while Pfizer can use up (or continue manufacturing if supplies of the approve vax are otherwise low?: perhaps related to the ill-explained logistical issues in the article) the EUA version without liability in the US due to the EUA status.

They get to market and remain under indemnification (in the US for now anyway) at the same time. They can have their proverbial cake and eat it too.

This to me is the real concern that, though it may be short-lived, is still real and quite discernable from the FDA statements that have so usefully been included in this article.

Here is the deal. The drug companies cannot be sued under the Emergency Use Authorization. They can, however, be sued under the fully authorized version. THAT is why Comirnaty isn’t available. They don’t want to be on the hook for a vaccine they know is dangerous.

Actually, that’s not true. Comirnaty and the Pfizer vaccine packaged under the previous label still fall under the PREP Act:

As for whether the FDA and Pfizer are engaged in a bait-and-switch to preserve Pfizer’s immunity from lawsuits over the vaccine, “the continued existence of the EUA alongside the full approval has nothing to do with liability,” Zettler told me.

Its liability exemption derives from the so-called Public Readiness and Emergency Preparedness Act of 2005, known as the PREP Act, which gives legal protection to products crucial in emergencies for as long as the emergencies continue. Pfizer’s interpretation, for its part, is that the vaccine in all its forms is entitled to all PREP Act liability protections as designated medical countermeasures against COVID-19.

https://www.latimes.com/business/story/2021-09-01/hiltzik-fda-approves-pfizer-anti-vax-conspiracy-theory

I’m comforted by the knowledge that covid shot manufacturers will continue to be immune from liability for deaths and serious injuries caused by their products. There’s a reason vaccines are the only product in the US to be granted that immunity: CARING. The vaccine arm of the pharmaceutical industry cares so much, it’s a sin to make them financially responsible for the fallout.

What tall tale? Comirnaty is approved, but is not available in Canada or the U.S. The only shot you can get here is the EUA version, yet the media only mentions that the Pfizer shot is now fully approved. That is the misleading part. Vaccine mandates will be based on the claim that the shot is fully approved, when in fact what you will get is an EUA version (until Comirnaty is available here, which likely will never happen unless Pfizer is willing to accept the liability risk.). I think this is what Malone and Hunter are upset about.

It’s the same thing. One is a Plymouth Valiant and the other is a Dodge Dart; it’s the same thing with a different label.

JDM, I don’t think you understand my point. The issue isn’t that the two are the same. The issue is that the “fully approved” version is not available in North America, but the public is being fooled into thinking they are getting a “fully approved” vaccine.

To use your example, let’s say the “Valiant” has received “full approval”, which means the manufacturer (Chrysler) now has to accept liability if things go wrong. The “Dart” remains approved only for emergency use, which means the manufacturer continues to be exempt from any liability, no matter how many people it might injure or kill.

The misleading part is that the regulators and the MSM publicly state that the Chrysler is “fully approved”, and further, governments mandate that you buy a Chrysler if you want to drive on the highway. However, when you go to buy your Chrysler, the only one available is the “Dart”, as the “Valiant” is only available in Europe (incidentally in countries where it has not been “fully approved”). You the buyer assume it has been “fully approved” because that is what the regulators and the MSM keep repeating (“the Chrysler has been fully approved”) … but this is a complete deception. Because …

If the “Dart” injures you and you try and sue Chrysler, you will be shocked to find out that Chrysler is not liable, because the “Dart” was not “fully approved” in the U.S.

This is blatantly misleading/unethical all around. Why didn’t Chrysler/Pfizer just submit the “Dart” for approval (since it is the only one available in North America) instead of the Europe-only “Valiant”? It is because they know that neither of them are “safe” and the liability cost could end up being enormous. With the deception, the FDA gets to boost public confidence along with providing the basis for vaccine mandates, while Pfizer assumes no additional liability.

Okay, I just read Dorit’s posting about liability. If I understand what she is saying, even though Comirnaty has received full FDA approval Pfizer still has liability protection? I can understand the protection existing while it is under EUA, but with full approval? That is a bit scary.

Agreed. Everyone keeps saying they’re one in the same but the fda does explain on the patient factsheet that Pfizer-biontech and their re-branded version of this vaccine, COMIRNATY are legally, distinctly different and that the first is EUA approved while the other is FDA approved (pg1 paragraphs 4, 5 and footnotes).

If you care about receiving an fda approved vaccine for the legal rights it affords you, then you absolutely want to ensure you’re receiving the newly branded COMIRNATY shot. They may be the same formulation and can be used interchangeably but the factsheet clearly states that only the newly branded and legally distinct version of this vaccine has been given full approval.

https://www.fda.gov/media/144414/download

This article was absolutely awful 🤣🤣 … Ultimately the “evidence” was “I guess someone could explain it better to me but I just don’t see nefarious intent.” 🤣🤣🤣 Compelling …

Let’s look at vaccines. 95% never pass testing. They average 10 years to make it to market. These vaccines use a novel gene-editing method never used in a human vaccine. The control groups no longer exist—both Moderna and Pfizer decided to offer the actual vaccine to their controls at 3 months. So, there is no way to assess long-term effects. Based on this, and the fact that COVID has a 99.74% survival rate, it makes no sense to be injected by and experimental vaccine. The FDA released no data with their supposed approval. The VAERS database shows multiple times more adverse events for these vaccines than all data gathered for all vaccines in the last 20 years. What is wrong with you people?

You are a fool and ignoramus.

First, even if it were true that the “survival rate is 99.74%” (curiously precise, that), that’s actually a high mortality rate for an infectious disease affecting hundreds of millions and would result in millions of deaths.

Second, regarding the offering of vaccines to the control groups, that was the only ethical thing to do.

https://respectfulinsolence.com/2021/05/03/to-unblind-or-not-to-unblind-covid-19-vaccine-trials/

The only immunity involved with these vaccines is the immunity from liability the pharma companies enjoy. You want it, then take it. But don’t do it because it will stop you from getting covid., it doesn’t do that.

And it has 95 % effiency against COVID. 19/20 change to win is better than zero change, would you think ?

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. I love how you conveniently left that out. They are 2 different vaccines.

“Rabid antivaxxers”, “burning stupid”. This language reflects the thinking of the COVID vaccine hegemony about vaccine hesitancy. It reveals their poor ability to understand and interpret almost anything about this issue. It speaks nothing about vaccine safety and effectiveness and everything about the vax absolutists’ violent, coercive mindset. There’s nothing respectful or scientific about it.

A significant cohort of the ‘hesitants’ are making rational risk assessments, but they’re characterized as selfish knuckle-dragging troglodytes. Not exactly heart-and-mind winning, when, against all ethical standards they’re being coerced.

‘Legally distinct with certain differences” is the most relevant language in the BLA response. It speaks to safety and effectiveness; both questionable issues. What will Pfizer’s liability be, given the poor adverse effect reporting under the EUA? We better hope there are ‘differences’ in effectiveness given the vax waning demonstrated by Israeli and other studies, where the rate of new cases is higher among vaccinated over unvaccinated.

They will never provide a clear explanation bc they can’t. And the reason the Pfizer vax was not used was bc they wanted to maintain their immunity to liability for the thousand that have been injured or killed by the vax. In truth, the manner in which this plandemic has been handled is precisely opposite to how it should have been and was for the past hundred years. At this point, the current vax is completely ineffective at stopping the original virus which has mutated into multiple variants and will continue to do so for as long as we continue to use these leaky vaxed. The vaccinated are actually spreading the new mutations to everyone. Only heard immunity can stop this through development of natural immunities which paradoxically are given no consideration or credit; they need to sell the vaxed to make money. This is purely a source of trillions in income for big Pharma and their cohorts; each new booster amounts to another trillion dollars for these institutions while allowing the government to place unprecedented restrictions on our liberties and freedoms that just a few years ago, even the most fervent pro acres would have considered outrageous. Once you recognize that this was an intentional act from the start, done to stop the phenomenal growth of American strength and leadership under Trump, and to insert globalist authority in place of freedom based constitutional driven governments, it all begins to make sense. Sadly, it is those who gleefully go along with government mandates and CNN lies and tortured logic, bc they don’t want to be out of step with their liberal leaders and propagandists, who are the reason this country is quickly falling into control of jack-booted thugs pretending to be Americans. If the Democrats or left learning people don’t wake up to reality, it will be too late and only civil war will bring back the incredible democratic republic that our founders fought and died for. “…..a republic, if you can keep it.”

Once you recognize that this was an intentional act from the start, done to stop the phenomenal growth of American strength and leadership under Trump

Fuck I’ll alert the media.

If it was a plot against Trump, why it continues after he lost the election ? COVID numbers were really bad after the election., Have you forgot that Trump himself started Operation Warp Speed to develop a vaccine ? It was mRNA, btw.
Robert Kennedy himself promotes study that shows vaccines are 98% effective.

What are the long term effects of these vaccines? Honest concern, if Covid is 99.8% survivable then why risk it on vaccines? Also I have several people around me that used the antibody infusion and never went to the hospital. Not sure why a vaccine is being forced. Just unsure at this point. Israel is reporting 60% Covid deaths as vaccinated people?

John (https://respectfulinsolence.com/2021/08/25/after-fda-approval-of-comirnaty-antivaxxers-claim-its-still-experimental/#comment-450380):

Long term side effects of the COVID vaccines are extremely unlikely. https://thelogicofscience.com/2021/08/30/future-long-term-side-effects-from-covid-vaccines-are-extremely-unlikely
The “99% survive COVID” argument is deceptive and completely misses the point: https://thelogicofscience.com/2021/07/27/the-99-survive-covid-argument-is-deceptive-and-completely-misses-the-point/
Monoclonal antibodies can help substantially, but people getting them already are infected and therefore already have suffered, and continue to suffer, and have been infecting other people. And many of them end up in the hospital anyway. Vaccines prevent most people from getting infected at all, and dramatically reduce infectiousness time and severity of symptoms. I’m baffled that you are baffled. https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/
You are citing an irrelevant statistic. What is relevant is the probability of dying of COVID given that you are vaccinated, versus the probability of dying of COVID given that you are unvaccinated. You must further account for confounds of age and other health. I suspect you are incapable of understanding Bayes’s Theorem, so instead here is a plain language explanation: https://www.covid-datascience.com/post/israeli-data-how-can-efficacy-vs-severe-disease-be-strong-when-60-of-hospitalized-are-vaccinated

Your entire comment is an antivaccine trope.

1) What “long-term effects” of vaccination are likely or even plausible? Antivaxxers insist that vaccines be investigated for ever lengthening periods in the hopes that something will come up, or more usually, that something not related to the vaccine can be blamed on it.
2) The death rate from COVID is much higher than that.
3) Death is not the only possible outcome of a COVID infection.

The bottom line is, two vaccinations against a disease is a vastly lower risk than getting infected.

You realize he walked back this statement immediately? This entire article was written to aggravate, all while not acknowledging the statement was corrected before your massive rant here. There should have been no confusion, but you caused it.

Orac A lot of mumble jumble. I am not anti-vaxer take all the vaccinations you want.
In the USA FDA approved “Comirnaty” vaccine that is not available in the US. The reason why is a FDA approved vaccine makes the manufacture “liable” The only vaccine available in USA is under the EAU with no liability. There is no mandate because JOE Biden can’t mandate a vaccine under the EUA Compish? No one can claim the vaccine is safe because the long term results won’t be available for another 2 years. Do realize that you will be getting a vaccine every six months the rest of your life. No man made vaccine will work as good as Our God given immune system. My immune system works perfectly. No vaccine, No side effects, No covid -19. Hard to beat. But for you keep taking those vaccine. How many people have died or worse from the vaccine?

How many people who thought they had a perfect immunesystem have gotten covid-19, died from it or suffered long-time consequences?
I don’t have the numbers, but I’m pretty sure it is more than the amount of people dieing, or suffering nasty consequences from the vaccine.

I think my immunesystem is pretty good, considering I hardly ever am ill and can’t remember ever having the flu. Nontheless, when I could get a free flu vaccine, which is offered to anyone at the age of 60 and above, I took it and of course, I’m also vaccinated against covid-19 and didn’t have any side-effects.

So Pfizer is going to wait until supplies of its currently labeled vaccine start running low before shipping the vaccine under the Comirnaty label to the US? That makes perfect sense, given that they are the same product. Why risk wasting existing stocks of perfectly good vaccine?

Of course, I look forward to a similar conspiracy theory arising after the FDA finally approves Moderna’s SpikeVax.

As an aside, for regular readers, I have a grant deadline Monday; so blogging will be sparse (possibly nonexistent) until after the grant application is submitted.

Amazingly, this isn’t a piece of performance art — he’s just as incoherent on Tw*tter.

@ Renate:

Same here, my friend.
I have hardly ever been sick ( perhaps flu twice, no doctor), measles ( I missed on the new vaccine by a week or so), no serious infections BUT when I was a student, I got bronchitis, which was an ordeal: I couldn’t breathe normally, the meds made me sick, other meds didn’t work well, it took a long time for me to get better. I really tried to avoid getting respiratory illnesses since then because I fear a replay of those 3-4 months when I struggled to do everyday tasks and attend university ( one month was winter break thankfully).
COVID can affect breathing in people with no history of asthma or respiratory ills of any age.

I hope you’re right and I don’t see you in my ICU. I hope you’re right and you don’t someone else to my ICU when you get it…which YOU WILL.

And one fun fact from the other side of the pond? Over here we’ve been getting Comirnaty vaccine for months! While I got Oxford/AZ, my husband got Pfizer and his vaccine passport (yes, indeed) states that he has been vaccinated with two doses of Comirnaty (mine is Vaxzevria, which is even harder to memorize). So there you have it.

These names are ridiculous. Comirnaty reminds me too much of Cromartie. (“Cromartie High School” which was an insane anime broadcast in the 2000’s.) Vaxzevria sounds like something you need a vaccine against.

The derivation is explained here:

https://www.fiercepharma.com/marketing/pfizer-biontech-select-comirnaty-as-brand-name-for-covid-19-vaccine

“The name is coined from Covid-19 immunity, and then embeds the mRNA in the middle, which is the platform technology, and as a whole the name is meant to evoke the word community … and immunity”

Well, sort of…
The ‘mRNA’ is inserted into ‘COVID-19 immunity’ with the ‘OVID-19 immun’ removed giving us ‘COmRNAity’, and then the ‘i’ from ‘OVID-19 immun’ is inserted into ‘mRNA’ and all the uppercase letters apart form the first are reduced to lower case giving us ‘Comirnaty’.

“Identifying those word parts and plugging into the community … and immunity …concept really executed nicely at the end of the day”

Actually, too clever by half.
Also there is the generic name: ‘tozinameran’

“The tozinameran generic name was established in two parts. The first half, tozina-, is the invented prefix required by the World Health Organization, while the second half -meran is the required suffix for new mRNA vaccines”

So now we are all up to speed 🙂

“Identifying those word parts and plugging into the community … and immunity …concept really executed nicely at the end of the day”

That is a bit glib, do you not think? Orac was unimpressed correct. The naming is rediculous. Who pay they? /f

Also, just as an aside, If people could stop stacking their fucking uncurated chat bots with large natural language processing models and letting them loose all over the www, that might be great. Just for now.

Richard may be a perve. But he was correct.

ps @FAANG stop scraping your own pretrained for personal information. You guys are drawing some very costly regulation.

https://arstechnica.com/information-technology/2021/08/now-that-machines-can-learn-can-they-unlearn/

I think part of the problem is bad writing on page one of the FDA Fact Sheet (https://www.fda.gov/media/144414/download) is a seed of the antivax propaganda. The COMIRNATY bullet list of approvals has this bullet item: “It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older.” But the Pfizer-BioNTech list immediately below that list, lacks that bullet item.

Of course, the other explicit statements that the two-named vaccines may be used identically in effect collapse those two separate bullet lists into a single list.

But the FDA should have explicitly written that as a single list:
The single COVID-19 vaccine known by the two names COMIRNATY and Pfizer-BioNTech is a 2-dose series for prevention of COVID-19.
– It is FDA-approved for individuals 16 years of age and older.
– Also, it is authorized under EUA for:
– individuals 12 through 15 years of age
– third dose to individuals 12 years of age and older who have certain kinds of immunocompromise

RE: “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”

Canadian regulatory affairs (RA) scientist here, who knows a decent amt of the FDA regs. In most parts of the world, one is often allowed to over-label existing (or even recalled) stock of products (drugs, biologics, devices) such as adding additional Caution or Warning info; or new toll-free number for reporting Adverse Events; or revision of volume from 5 to 6 mL. i.e.: things that can’t wait until existing stock is used up.

BUT a brand name is a legal aspect. It would be the equivalent of trying to over-label a product with a new company name. I don’t think that could ever been done via over-labellng, The product would have to be completely repackaged, and for sterile parenterals, that’s not really a logistical option.

In addition, in the cGMP & other regulatory conditions / terms of market authorization (TMA) for the approved product, it most likely states no deviations are allowed for the next X number of months or batches, without the FDA’s express written permission.

Maybe they didn’t collapse them into a single list because there is that pesky “legal distinction” and one of them isn’t approved while the other is despite them being “identical”?

The FDA is being quite consistent here in making a distinction between the two.

FDA said that for logistical reason, vaccines already in circulation are under EUA. Relabelling them would probably damage them.
If Comirnaty would indeed be a new formulation, Pfizer would be mandated to report changes. Otherwise it would be liable under PREP, I think. This is willful misleadibg of the public

FDA said that for logistical reason, vaccines already in circulation are under EUA. This is for logistical reasons, relabelling them would damge them.
If Comirnaty indeed had different composition, Pfizer should have reported it. Otherwise it would be liable under PREP Act (willful misleading),

Except the fact that it isn’t bad writing. That is indeed the case. COMIRNATY is approved, Pfizer-Biotech is not and still under EUA. Both the fact sheet and the FDAs two approval letters dated 8/23 (one to Pfizer, one to BioNTech), say the same thing. So the questions are: 1) why would Pfizer want the vaccine that is unavailable in the states to be the one that is approved (easy, because they avoid liability), and 2) why would the FDA grant approval to the version of the vaccine that isn’t currently available in the states instead of the one that is??

The reason the FDA wants to approve an unavailable vaccine (in legalese) is because it would recondition all COVID vaxxes under EUA. The condition of an EUA is that there is no other AVAILABLE FDA approved treatment. They would have to say Moderna, JJ, and others are no longer able to be administered under EUA. Pfizer would have a monopoly, so this way no one questions preferential treatment of Pfizer by the FDA or any other wrongdoing in this approval process, and we have an approval to lay groundwork for all mandates, but no approval to legally disrupt the current concoction being administered to the masses. I’m surprised this is not being talked about more.

@Will Remdesivir is FDA approved for COVID, and there are many EUAs still. Not having approved treatment is obviously not a condition for EUA.

Not an antivaxer, but The EU,s website does state Comirnaty will not be available to them until, 2023- 2024. Also, every vile has a code, Codes became effective only upon EUA by issuance of the FDA. Meaning all the viles out there are under the EUA, These viles are from before approval so will be used on the EUA, any manufactured after approval, the codes will become effective with the approval.

I don’t know about the EU, though I think that’s incorrect, but the Pfizer vaccine administered in Australia right now is labelled Comirnaty and, as far as I recall, it has been labelled that way since the Pfizer vaccine was first approved for use in Australian in Feb 2021.

This is the Australian Federal Health Department’s general Web page about the Pfizer vaccine:
https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/learn-about-covid-19-vaccines/about-the-comirnaty-pfizer-covid-19-vaccine
This is a PDF of their information sheet given to people who are about to receive the vaccine:
https://www.health.gov.au/sites/default/files/documents/2021/08/covid-19-vaccination-information-on-covid-19-pfizer-comirnaty-vaccine.pdf

On the “why don’t they just re-label the vials”:
From a purely practical perspective, it’s very hard to put a sticky label on something that’s frozen, and it’s not like you could thaw the vials! And I’m not sure you could put frozen vials through the labeling machine and have them stay frozen. So from the simple logistics, re-labeling is right out.

Separately, in GMP and other regulated things, re-labeling stuff is pretty fraught, as there is risk of deception, so it’s generally not allowed unless you have a really, really good reason (like you finally finished a 10 year stability study and can give your material a longer expiration date). And as usual, there’s a lot of paperwork.

As far as I can tell the PREP declaration also covers licensed products. In fact, it says so:
https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures

“A qualified pandemic or epidemic product means a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is (i) manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause; (ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device; (iii) or a product or technology intended to enhance the use or effect of such a drug, biological product, or device.”

The liability situation has not change.

Hmmm, I guess the statement that the two differently named same formulae shots “…are legally distinct with certain differences…” doesn’t matter to those who have swallowed the Kool-Aid. I will gladly take the COMIRNATY labeled shot if mandated by my employer because of those “legally distinct” differences. Liability (read Compensation) for COMIRNATY side effects, if suffered, can be pursued through legal action directly against the big Pharma giant whereas the vials labeled Pfizer-BioNTech still provide Pfizer with complete immunity should one suffer one or more of the side effects.

I’ll take the chance as long as there is a deep pocketed fall guy for adverse reactions.

Comirnaty should be covered under the VICP like other licensed vaccines in the U.S. Your court costs are covered and the standard of proof lower than in regular courts.

If you fail there, you can file a direct suit.

No, it’s still under the PREP act. The PREP act covers licensed vaccines. When RFK jr. said there’s no liability protection there, he was, once again, being at best fundamentally wrong, at worse dishonest.

Dorit said about RFK Jr., “…he was, once again, being at best fundamentally wrong, at worse dishonest.”
After all we’ve seen over the years, when it comes to Junior the vote must go to the “at worse dishonest” option.
I’m beginning to really, really dislike this lying lowlife.
He knows he’s lying and harming others with his lies but it doesn’t matter to him…
What a legacy his kids/grandkids are going to have to live with.

“legally distinct” may effect liability, but “certain differences” just may effect your life.

Ooh! Who doesn’t like a misspelled quip during the 7th inning stretch?

“legally distinct” may effect liability, but “certain differences” just may effect your life.

Say something concrete, Jeff, or you’re just another crotch-sniffing dog.

Isn’t the legal difference between the two sort of the big point? Pfizer did not even attempt to gain full approval of the existing vaccine because they don’t need to. Why would they take an unnecessary legal risk given some of the issues which have shown themselves especially for boys between 12-15. The change to the vaccine ingredients is required to differentiate it legally. Make no mistake about it though the existing vaccine is still under EUA protection and protects the makers from most lawsuits. You are correct that there is no difference in “safety” of the vaccine, but there is a huge difference in the legal parameters surrounding it.

As Dorit said, PREP Act covers approved products, as well as one under EUA. Did you notice that Pfizer did apply for approval and got it ? EUA and approval could be given same product, because EUA is preliminary.

The change to the vaccine ingredients is required to differentiate it legally.

Would you care to document this “change to the vaccine ingredients” and provide citations for your legalizing? Everybody loves the CFR, after all.

I’m sure I’m not alone in not being at all surprised by this–I expected it. It’s the same thing as when bible thumpers predict the end of the world and nothing happens–they just regroup and put out a new Watchtower that goes to great length to explain some intricate “miscalculation”. Bishop Ussher probably did the same thing.

It is like Donald Trump being re-instated as President of the USA. Every time the date passes, it is just pushed back and his supporter base are shorn of more of their cash.

If it looks like a cult and smells like a cult, it probably is. Anti-vaccination is just one more cult where the leaders live a life of luxury using donations from their followers.

According to Mike ( NN, today), the government uses “weasel words” as it grants approval to Comirnaty but keeps the “Pfizer vaccine” ( which isn’t even really a vaccine) under emergency usage when they are two different vaccines and the former isn’t even under production yet!

Comirnaty? Spike Vax? Who are the cool kids now? Well, I had Janssen/ J&J- no word yet what they’ll call that. JAZ vax?

People get emotionally invested in their views, and can’t accept it when they are shown to be wrong. Instead, they grasp at whatever nonsense allows them to continue believing they are right. Look at the idiots who will do ANYTHING to avoid having to acknowledge that getting vaccinated is vital to controlling COVID. They would have to acknowledge that people they don’t like are right. They are willing to not only allow others to die to protect their egos, but even die themselves. So bloody childish.

Billy Joe: I think you repeated the misconception. In fact the vaccine is fully approved regardless of whether it is labeled Comirnaty.

If the non-comirnity-labelled vaccine is also approved, then why is it legally distinct and listed separately multiple times in the FDA’s reauthorization letter and instructed by the FDA to include a statement that it is not approved on the bottle moving forward?

You can follow the link to the letter in the article and read it for yourself.

Because it has a different label. Those labels aren’t just fluff and advertising, they’re legal documents. Since they can’t re-label the vials (for reasons I explained above), it has to be called out separately.

If you’re not used to wading through the epic technical/legal/bureaucratic language that is required by regulations, then it might seem nefarious rather than just deeply persnickety.

In the videos there was one point that even Orac has to acknowledge as true. “Steve Bannon is a simple guy”.

IN RELATED NEWS…

Anti-vax supporters ( RFK jr, Gary Null, etc) called out the troops for a protest at the NYC mayor’s office Wednesday. News sources reported variously that hundreds/ thousands of union members and parents gathered listening to speakers like Mary Holland . ( Yahoo, Daily Fail, AP, others.) A photo from AP and participants’ videos ( such as @ Chris_Spinelli) leave me quite unimpressed**.
School employees and city workers will be required to be vaccinated and most indoor activities will require proof of vaccination in the coming weeks.

Anti-vaxxers are starting to realise that their lives are about to drastically change.

** look carefully at the photo and video

For fairness, it’s not just anti-vaccine activists calling, and there are people who are not anti-vaccine – and might even have gotten this vaccine – who may join this for other reasons.

Of course, the risk is that it will make them vulnerable to the type of misinformation anti-vaccine activists like Ms. Holland promote.

NYC protest ( continued)

Children’s Health Defense.org has a video of the speakers ( about 2 hours!) and is labeled variously as “hundreds: / “thousands” of protestors. I skipped around the tape ( even I can’t tolerate that much BS, confabulation and showboating) and it seems that the protest was so packed with participants that city buses kept running in the street as seen intermittently at the right edge of the screen.

assuming you’re not too dead of spike proteinitis

Highly unlikely.
According to the antivaxers stories, the people suffering from spike proteinitis

1 – are not vaccinated, but have been in close proximity to someone vaccinated
2 – have a vagina

“”There’s lot of good guys out there ready to do bad things soon” — an anti-masker goes ballistic at a Board of Commissioners meeting in Ottawa County, Michigan”

Sounds like the RI poster who predicts his fellow “beasts” are likely to commit violent acts.

Saw a news story about parents in Connecticut surrounding, following, and shouting at the governor over his school mask mandate. I thought the New England states were relatively free of these anti-maskers.

Did notice that once again, many of the people opposing masks were fat. Guess they haven’t noticed obesity seems to be prevalent in people hospitalized with covid. You would think they would want to vaxx, mask up, and maybe back away from the feeding trough a little quicker.

I am flat out of patience and compassion for these folks.

Orac might be pleased to know Christopher Key did not make it to MI. He stayed in Springfield to speak at City Council meeting this week. Hope Key isn’t thinking of setting up shop here; we have way too many crazies as it is. Jim Bakker is just to the south near Branson where he periodically attracts the attention of the MO attorney general.

@ Mary:

Believe it or not, there ARE anti-vaxxers and anti-vaxxers in the North East although they are fewer in numbers. Over the past year plus, because some of these states tried / succeeded curtailing religious exemptions, crowds protested legislatures in CT, NY and NJ/ efforts in MA and ME. AoA’s managing editor is in CT and comments frequently about laws. Anti-mask, anti-shutdown and Covid denialists also show up, as I illustrated concerning a NYC protest Wednesday. But the total number of vaccine exemptions is not high in any of these states and the Covid vaccination rates are high with lower Rt than in other regions.

My own county, near the Great City/ Locus of Evil, dependent upon your perspective, has quite high vaccine coverage in adults- many towns are around 70% . There is not hospital overflow and the obituary columns are average- unlike during the height of the pandemic when they increased to multiple pages ( my SO reads an actual paper newspaper!). Things have improved after vaccines became available and there are less restrictions on business and social activity.

Catie Clobes and others have been tweeting a meme that reads

From Children’s Health Defense:

Here’s what you need to know when someone orders you to get the vaccine:

ASK TO SEE THE VIAL

If it says “”Comirnaty,” it’s a licensed product.

If it says “Pfizer-Biontech,” it’s an experimental product.

& Under 21 U.S. Code $60BBB, you have the right to refuse.

If it comes from Modern or Johnson & Johnson (marketed as Janssen).

YOU HAVE THE RIGHT TO REFUSE.

The FDA is playing a bait & switch with the American Public — but we do not have to play along.

IfIt doesn’t say ”Comirnaty,” You have not been offered an approved vaccine.

I want to remind folks of the planned messaging.

The Anti-Vaxxer Playbook to Destroy Confidence in COVID-19 Vaccines

Major anti-vaccination voices and organizations have coalesced around three key messages to keep people from accepting the COVID-19 vaccine. Their playbook has now been exposed.

Scott Gavura on January 21, 2021

The Center for Countering Digital Hate (CCDH) recently published a report, The Anti-Vaxx Playbook, that describes in detail how key members of the anti-vaccine movement are collaborating and partnering in new ways to exploit the COVID-19 pandemic, create consistent anti-vaccine messaging, and destroy confidence in vaccination. The report is based on observations from the National Vaccine Information Center (NVIC)’s conference held online in 2020. Misleadingly titled “Protecting Health and Autonomy in the 21st Century“, this event brought together a long list of anti-vaccine advocates with the apparent goal of helping participants more effectively push back against science, evidence, and public health measures…..

The master narrative
Despite the disparate group of individuals that are driving anti-vaccine sentiment, messaging has consolidated around a few key messages. NVIC’s virtual conference in October 2020 was accessible to anyone that registered, and CCDH attended. Prominent speakers included Barbara Loe Fisher (NVIC), Joseph Mercola, Del Bigtree, Robert F. Kennedy Jr., Sherri Tenpenny, and Andrew Wakefield. CCDH noted that these speakers see COVID-19 as a historic opportunity:

A number of speakers at the NVIC conference presented the Covid pandemic as an historic opportunity to popularise anti-vaccine sentiment. Robert F. Kennedy Jr. told activists listening to the conference “All of the truths that we’ve been trying to broadcast for many, many years. There are people hearing it and the impact and those seeds are landing on very fertile ground.” The disgraced physician Andrew Wakefield echoed these sentiments, saying “The population who are aware of these issues has grown dramatically in the face of coronavirus, Covid-19. It is now an issue for discussion by everyone.” Other anti-vaxxers such as Sherri Tenpenny highlighted the Covid pandemic as an opportunity to build a wider movement with campaigners against masks and lockdowns: “We need everyone to get politically active, get behind this cause, get behind Hugs Over Masks, get behind MAD, Mothers Against Distancing, get behind the NVIC, the National Vaccine Information Center, get behind the things that we’re doing over at vaxxter.com, and Courses for Mastery, and our boot camp course that open enrolment is coming up again, the end of September. All the things that we’re doing, we need all hands on deck. We need everybody to release their fear from their brains, get rid of their masks, go hug people and absolutely say no. Wake up your community.”

There are three key messages identified by the CCDH that are overlapping and common across these different speakers. They are recurrent and you will see them, in some form, in almost all anti-COVID-19-vaccine messaging:

https://sciencebasedmedicine.org/the-anti-vaxxer-playbook-to-destroy-confidence-in-covid-19-vaccines/

If “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,” then where is this record? The CDC’s last update says 363,000,000 covid shots have been administered and 6,968 deaths reported to the Vaccine Adverse Event Reporting System (VAERS) — a probability of .0019%. That’s much, much higher than for any other vaccine in VAERS 30 year history, most having closer to a .00006% chance of a death report being filed in VAERS. In fact, if you estimate that 10% of vaccine deaths are reported to VAERS (a generous estimate) the risk of the covid shots way outweigh the risks of death “involving” covid-19.

https://www.virginiastoner.com/writing/2021/8/25/death-by-covid-19-compared-to-death-by-vaccine-just-the-numbers

Could you tell us the make of your calculator? Was it one of those big, brightly coloured ones with massive buttons and a sticker instead of an LCD?

The 0.0019% is from CDC: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html

Where the anti-vaccine activist is misleading readers is in pretending that this means the vaccines caused those deaths, where the same source points out:
“FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. A review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines. However, recent reports indicate a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and TTS, a rare and serious adverse event—blood clots with low platelets—which has caused deaths.”

At this point, there are three deaths shown linked to COVID-19 vaccines used in the U.S., to my knowledge, all related to J&J complications – and if the anti-vaccine activists alleges that’s a higher risk than of dying from COVID-19, well, that’s problematic.

Dorit Reiss, your claim that I’m trying to mislead is false and defamatory. In fact, most of my posts include a massive disclaimer right after the title saying that reports to VAERS do not prove the vaccine caused the injury. If it’s not at the top, it’s discussed in the paper.

As you acknowledged, the .0019% probability figure is from the CDC. I am only doing exactly what the CDC is doing, just making it clearer and elaborating on the probabilities.

Where can we find the CDC or FDA analyses of the massive increase in deaths and serious injuries reported to VAERS from the covid shots?

We have had this discussion before. Firstly, just because a death is reported to VAERS it doesn’t automatically follow that the vaccine caused the death.
Secondly, VAERS has been skewed by reports of nonexistent deaths. Just because a death is reported to VAERS it doesn’t automatically follow that that death even happened.

Still think the Indians have done the best with naming: Covishield is far better as a name than Vaxzevria, and Covaxin is pretty good as well.

Zycov-D is a bit of a disappointment.

The last name reminds me on a completely different substance which no-one would like to be exposed with, because lots of people died through it in WWII concentration-camps.

I can post to VAERS that the vaccine turned me into a flying purple elephant-it doesn’t make it so.

It’s really, really common for companies to sell the same thing under different brands. You do not have to get every brand approved by whomever.

Since the vaccine is so safe and effective and have full approval of the FDA, why does Pfizer still have full immunity from lawsuits? yeah the benefits outweigh the risks especially when you’re not the one at risk! Want me to take the vaccine, you want to mandate it for me? Then back up what you say about it being safe and effective and stop covering your asses! Trust the science? I trusted the science when my doctor recommended taking zantac for three years. and now they find out it causes cancer.I’m sure millions of people have taken science trusted medications over the years only to find out later they are dangerous! And you have the audacity to act so shocked and shaken when people don’t want to take the vaccine?The vaccine has proven NOTHING other than people can still get sick! And by the way. the government is the last thing I’d trust when it comes to numbers of whos sick and how they got sick.The problem with vaccines and medications is science only find out they’re deadly years after taking them. years after they’ve been FDA approved…thats why people don’t want the JAB!!!!

Vaccinated people can get COVID, protection is not 100%. It is 95%, which os much better than zero. You would prefer 19/20 change to win to zero.

And their cases are always milder. Many would have died without it. This bs is really getting tiresome.

The reason for liability protection for all products for treating or preventing COVID-19 during the pandemic – vaccines or not, licensed or not – is that Congress decided that during a pandemic it wants products out fast, and it doesn’t want manufacturers slowing bringing them to market because of liability concerns, or doctors hesitating to give it.

To balance that limit a compensation program was created, though in my view, the compensation program is not generous enough.

The broad liability protections were put in place in early 2020. Before any vaccines were out. They don’t imply anything about the actual safety of any of the products, because they’re broad and prospective. The Secretary didn’t know what the safety profile of the vaccines will be then, no one did.

In other words, this is because we are in a pandemic, not because of anything about the specific vaccines.

My link was censored. typical. Ya’ll are still more natuturally dead. For the most part.

GOP done made their bed. Bezos retired so he could file lawsuits. The only way he’ll ever get into orbit is to strap that strap-on to a falcon 9.

Big dick energy. Musk should put one in the cargo bay as a dummy load and land it on the moon as an expression of good faith.

I apologize for my earlier outburst. My bad. I borked the link. Though I would be willing to bet that it was really something nice.

I’m still not over “ inventor of the mRNA”, myself. How do they figure protein biosynthesis worked before he came along?

Here is a tiny bit of explanation from Pfizer:
“‘The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions,’ said Pfizer spokesperson Sharon J. Castillo in an email. ‘Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent.’”

https://www.washingtonpost.com/politics/2021/08/30/false-claim-that-fully-approved-pfizer-vaccine-lacks-liability-protection/

I am curious how the EUA works. Will Moderna/J&J lose their EUA once the fully FDA approved Comirnaty is readily available?

There are red flags from the VAERS data on deaths from Covid vaccines:

That even by the CDC’s own admission, the data is greatly underreported
There is a huge increase, outstripping the deaths attributed to all other vaccines over the past thirty years.
There is an insanely wide range of estimates for deaths due to these vaccines as attested by the arguments on this thread.

VAERS was instituted in the early ’90s and was so inadequate that early on the US health agencies were calling for a vastly improved system. We still don’t have it, and we have people debating whether the deaths might more 100 times what’s reported, or actually less than what’s reported. The disagreements range over two orders of magnitude. This is appalling bookkeeping for such consequential courses of action.

If uncertainty as to the risk ranges over two orders of magnitude, how can one give informed consent based on the risk/benefits of the vaccines?

You do realize, of course, that VAERS is by no means the be-all and end-all of vaccine safety monitoring. I bet you can’t tell me why the other vaccine safety monitoring systems are. (Hint: Unlike VAERS, they’re active surveillance systems and thus don’t have VAERS’ weaknesses.) I also bet you can’t tell me what VAERS’ purpose is relative to the other vaccine safety monitoring systems.

I’ll give you a chance, though, to prove my guess about your ignorance of these issues wrong. I suspect I’m not wrong, though.

Go ahead and inform us. What are those monitoring systems, why aren’t they better-known to us, what data do they provide, what are the hard numbers pertaining to the Covid vaccines. What I have access to are the wildly inaccurate numbers of VAERS.

Chris, thanks for that, I’m also able to Google, but what is needed are hard data that can give, within maybe 10-15%, comparative death and severe adverse events by age group between vaxxed and unvaxxed cohorts.

what is needed are hard data that can give, within maybe 10-15%, comparative death and severe adverse events by age group between vaxxed and unvaxxed cohorts

I, for one, am awaiting the design of your desired cohort study with bated breath.

@John Bleu You know background adverse effects in vaccinated population. Compare this with reported adverse effects.

This is copied from the official FDA Comirnaty Fact sheet dated August 23, 2021: “WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider if you have any side effects
that bother you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System
(VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to
https://vaers.hhs.gov/reportevent.html. Please include either “COMIRNATY (COVID-19
Vaccine, mRNA)” or “Pfizer-BioNTech COVID-19 Vaccine EUA”, as appropriate, in the
first line of box #18 of the report form.
In addition, you can report side effects to Pfizer Inc. at the contact information provided below”

PLEASE explain to me why the VAERS is not seen as any evidence as the official FDA / Pfizer approval has the above written in it? Do the FDA not trust their own website? I am really trying to figure this one out? Is it misleading to put that into the official document? Why would they mention it in their most important legal document?

Link below: https://www.fda.gov/media/144414/download

That even by the CDC’s own admission, the data is greatly underreported

Impressively, it’s overreported, too.

“Amazon strains credulity by suggesting it lacks the resources to analyze SpaceX’s application, especially considering Amazon routinely brings as many as six lobbyists and lawyers to its many meetings with the commission about SpaceX.”

SpaceX concluded its filing by pointing to a recent quote from Amazon founder Jeff Bezos. “As Amazon’s former chief executive has said in the past, procedural maneuvers—like the ones Amazon now deploys—have ‘become the bigger bottleneck than the technology,'” SpaceX told the FCC.

Amazon declined to comment on SpaceX’s filing when contacted by Ars today.

Guh. the missing link.

But while Amazon has filed nothing with the commission to address these conditions on its own license for nearly 400 days, it took only 4 days to object to SpaceX’s next-generation NGSO system. In fact, Amazon has not had a single meeting with the commission this year about how it intends to resolve the commission’s interference or safety concerns, but it has had 15 meetings in that same span just about SpaceX. While Amazon has waited 15 months to explain how its system works, it has lodged objections to SpaceX on average about every 16 days this year.

https://arstechnica.com/tech-policy/2021/09/spacex-slams-amazons-obstructionist-ploy-to-block-starlink-upgrade-plan/

I’m a fanboi. And Jeff can eat bugs all he wants. Skinny bug eating litigious macro-indigenous fucker. What a splash in the pan. What an embarrassment, that guy has made it his legacy to be. Fantastic. I really can’t understate my satisfaction.

https://www.youtube.com/watch?v=kKdDoPw36bU {If one looks away it does not look like a dick so much… until you look back.}

Nice red herring there, Orac. VAERS is “the nation’s early warning system for vaccine safety,” and contains publicly-accessible data–it’s perfectly reasonable to expect an explanation of how VAERS responded to the massive and unprecedented influx of death reports from covid shots, and why. The existence of other monitoring systems doesn’t change that.

So, where are the CDC/FDA analyses of the massive increase in deaths reported to VAERS from the covid shots? Not only do there appear to be none–there aren’t even any acknowledgements from the CDC or FDA that the problem exists. It’s being covered up and almost none of the public is even aware of it.

Dorit Reiss, where are the CDC or FDA analyses–or any analyses–supporting your claim that the massive increase in deaths and other serious injuries reported to VAERS from the covid shots is nothing at all to worry about?

it’s perfectly reasonable to expect an explanation of how VAERS responded to the massive and unprecedented influx of death reports from covid shots

No, Ginny, it’s not. VAERS is not some sort of independent agent that “responds” to things, it’s a database.

there aren’t even any acknowledgements from the CDC or FDA that the problem exists

What problem?

It’s being covered up and almost none of the public is even aware of it.

What is being “covered up”? A secret plan to flush antivax nuts like so many grouse?

@Narad when one resorts to personal insults he immediately forfeits his argument.

Skip the juvenalia. “NWO Reporter” brings nothing to argue about. Moreover, you should have picked one in which I did insult Ginny.

Trust me, at least those are presented in good faith.

On Monday, ACIP had a meeting to discuss COVID-19 vaccines. Among other things, ACIP went over the VAERS and VSD data.

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/03-COVID-Su-508.pdf

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/04-COVID-Klein-508.pdf

In long presentations that lasted hours.

But the antivaccine activists that want to misuse VAERS, apparently, weren’t listening. And then, without listening to those doing the work, want to pretend it isn’t done.

The problem is not with CDC in that.

Dorit–Su’s paper didn’t even mention the massive increase in deaths and other serious injuries reported to VAERS from the covid shots at all–much less explain it or analyze it. It’s just further evidence of the cover-up.

As for the Klein paper, I saw no mention of VAERS data at all–only the Vaccine Safety Datalink.

Once again, the observation remains: There are no FDA or CDC analyses of the massive increase in deaths and serious injuries reported to VAERS from the covid shots–or even acknowledgments of it. Considering those 2 organizations are notorious for their “creative” medical writing, that’s pretty ominous.

Just because you say so? VAERS reports of serious reactions are all followed up on.

And VAERS is just one of many systems that track vaccine safety…but that doesn’t fit your narrative, so you’ll just ignore it.

that’s pretty ominous

Well, for somebody who has a fantasy life as some sort of public figure, sure.

My first thought about “Comirnaty doesn’t exist yet” was that I coul pull my card with batch stickers and the name stated on them but apparently, I was not the only one.
I’ll throw the pic here when I get home.

Narad claimed “VAERS is not some sort of independent agent that “responds” to things, it’s a database.” That’s incorrect.

VAERS is a “hypothesis generating system” that “identifies potential vaccine safety concerns that can be studied in more robust data systems.” VAERS uses data mining to “…identify disproportional adverse event reporting for vaccines, including COVID-19 vaccine.” VAERS also “identifies… adverse event-vaccine pairs reported at least twice as frequently as expected for a COVID-19 vaccine…” https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-01/06-COVID-Shimabukuro.pdf (Pages 11-15)

Oops! Yes, Ginny, VAERS is actually some sort of out-of-control AI system, like in Colossus: The Forbin Project. Sorry about that.

Did you miss the slide where they highlighted “Not designed to assess causality?”

“VAERS is a “hypothesis generating system”

Are you totally deranged? It was more fun when it could be queried for people who developed wallaby fetishes after vaccines. It is totally corrupted now. I don’t care about IBS. Keep that shit to yourself. I am almost tempted to suss out your entry; but have been advised against doing so because mentioning the extreme implausibility may garner slander suits and extra opportunities to behold your unmentionable visage.

This is probably not appropriate. I do not care.

Would it be possible for you to knit me an egg that says “I’m smiling because I just got laid?”

Asking for a control-freak check-out lady.

Lawrence said, “VAERS reports of serious reactions are all followed up on.” Where can we find the reports on those follow-ups?

The massive increase in deaths and serious injuries reported to VAERS is unprecedented in VAERS 30-year history. Does the CDC/FDA have some kind of secret magic formula to make 6,968 death reports disappear? Or is this purely an issue of trust and faith?

Does the CDC/FDA have some kind of secret magic formula to make 6,968 death reports disappear?

Have you found the one-year-old yet, Ginny?

Try this one: In 2019, 2,854,838 Americans died. This means 7821 per day. Half of Americans are vaccinated, so among them one could expect 3911 deaths per day

“VAERS is a “hypothesis generating system”

Are you totally deranged? It was more fun to query it for people who developed wallaby fetishes after vaccines. It is totally corrupted now. I was tempted to peruse your entry but was dissuaded by counsel advising that mentioning your extreme lack of plausibility and general literacy may garner slander lawsuits which I never intend to honor or pay.

In the approval letter for Comirnaty, it specifically states that they cannot distribute any lots of product until they receive a notification of release from the Director, Center for Biologics Evaluation and Research(CBER). Does anyone know if they have received this letter? If not is it reasonable to say that all vaccines are this under the emergency mandate and under the liability protection?

Aarno, is that how you would respond if 6,968 deaths on baby swings were reported to Consumer Protection? Or deaths after eating Southern CA lettuce? After all–everyone eats, every day, and almost 3 million of them are going to die anyway…

If the FDA started getting thousands of reports that eating So. Cal. lettuce had caused infertility and sudden death and that people were getting ill just by being in the same room as someone who ate So. Cal. lettuce, one might be skeptical and check out those reports carefully before reflexively ordering a mass recall.

One might even want to see how many of those reports were traceable back to the Arizona Lettuce Board.

In case of lettuce, there is a probable causal link, salmonella for instance. VAERS cannot establish one.

Dr. Scott Gottlieb, former FDA chief and now on Pfizer’s board says people who had Covid won’t be immune forever, should get vaccinated. Dude is a great businessman however I wouldn’t want him as my doc. It’s obvious the experts don’t know how long the vax lasts b/c they are recommending a 3rd dose? https://www.cnbc.com/2021/09/01/covid-vaccine-dr-scott-gottlieb-says-people-who-had-covid-wont-be-immune-forever.html And now 2 scientists are leaving the FDA over this recommendation.

J & J “One and done” oh no now, two and done? three and done? When will you be done Johnson and Johnson? Because you can’t even make safe sunscreen or talcum powder!

And with Moderna you get a bonus of metal fragments. https://www.japantimes.co.jp/news/2021/08/27/national/moderna-contamination-metal/

All three appear to still be in the experimental phase regardless of FDA “approval”.

Gain of function research is not cause of COVID. Sequence of this virus is very different, Besides of that Fauci (or NIH) does not approve vaccines, FDA does.
Third shot is possible needed because new variants. Nobody can predict what variant will appear

Good point, Mr. Bacon. Why do a recall of potentially deadly lettuce, when we could launch an investigation into who’s reporting these alleged deaths instead–thereby keeping hundreds of bureaucrat investigators busy for months, while the lettuce industry remains happy.

After torturing its citizens under medical tyranny for months

Oh, put a sock on that and do go drink your horse paste.
“Torturing”. Really.
I’m so tired of these snowflakes.
If you were all taking your damn vaccine, this would have been over already.

We have a regular here who can tell you that actual medical tyranny really looks like.

I’m in lockdown in Australia and I don’t in the least feel like I’m undergoing torture by medical tyranny.

It also looks like you’ve picked the wrong state. New South Wales has been under lockdown for longer than Victoria in the current Delta strain wave.

You do not need investigation to prove lettuce can cause food poisoning. Vaccines are another matter.

The argument is not that Comirnaty does not exist. The argument is that is not available currently in the the USA. You mentioned in your article that is only available in EU as of now. Which would mean is not available here and they are trying to say it’s the same, which it is but legally different.

Comirnaty this the brand name and BioNTech is the generic. Though they are both the same formulization, you can’t mandate someone to take the one in place of the other. Someone can volunteer to take one in place of the other.

Did you know if doctors write a script for a specific medication that another script has to be made so they can get the generic one? They are the same formalization, but they are legally different.

And if things go wrong, you can’t sue the manufacturer or get compensated because you chose to take the off label product, instead of waiting for the one with with the correct label.

People are wanting to wait to get the that one when it’s available. As that is the only one that can be mandated.

Why is that hard to understand?

“If you were all taking your damn vaccine, this would have been over already.” Has someone not investigated what has happened in Israel? Also, how is it that China (a country barely mentioned here, if at all) has gotten COVID-19 under control with less than 42% of a 1.4 billion population vaccinated? I think most people just want the whole thing to be over and done with. I’m with you there. Unfortunately, vaccines and ranting on this site are probably NOT going to get us there, so, quite an overstatement, or, maybe, a dream.

I apologize for sounding so simple, but I would like to know the reason the FDA was so purposefully ambiguous in the wording of their approval letter, and why they did not approve both COMIRNATY and Pfizer-BioNTech at the same time. Is this too much to ask? If everyone’s insistence that the two formulations are the “same”, “identical”, “indistinguishable”, and “exact” is true and correct, then why did the FDA not approve both? People, the FDA is on OUR payroll. Don’t we have the right to ask them to do their job and remove any doubt? If they are “exact” then they should say so. If they are NOT “exact”, then they should say so.

The difference is that the QA/QC is significantly improved for the approved vaccine. The product is exactly the same thing, but because Pfizer/BioNTech has improved their quality control (processes that verify the product is within certain parameters) and quality assurance (documentation that those parameters are meaningful and that the procedures are being followed), they no longer have to send samples from every batch produced to a third party testing firm.

W. Kevin Vicklund: That is great info! Do you have a link to an official source, so we can promulgate it?

Inference from the published assessments detailing the justification for granting EUAs by the US, the UK, and the EU. Each assessment included a section on the quality of the product, including that at that stage individual batch testing by an independent lab was required, and the US and the EU had guidelines detailing the QA/QC areas of concern that need to be addressed before full approval would be granted. I think the UK had a separate document with a similar checklist, but I reviewed those documents at the beginning of the year and no longer have all of them in open tabs.

You think that contradicts what Kevin said ? He did not said that vaccines are different, or that quality control was different. He said that quality control was moved in house,

I didn’t read it as Tom thinking it contradictory, but rather pointing out specifics. The differences in handling can logically be traced back to improved QA/QC. I recognize many of the handling changes as topics that were recommended for closer examination.

Aarno Syvanen:

Kevin Vicklund is correct (https://respectfulinsolence.com/2021/08/25/after-fda-approval-of-comirnaty-antivaxxers-claim-its-still-experimental/#comment-450428).

If anybody else finds any official details about the “legal and logistical” differences between COMIRNATY and Pfizer-BioNTech (a.k.a. R174), please post here. I asked the FDA to very publicly and officially describe those differences explicitly and in detail, but don’t expect them to do that, because they seem clueless about the very real consequences of their vagueness.

If the COMIRNATY vaccine was actually FDA approved it should by law automatically cancel or nullify the EUA for Moderna and Johnson and Johnson vaccines! That means only the COMIRNATY vaccines can legally be available to the general public! So either there was no FDA approval for the COMIRNATY vaccine or the FDA is simply breaking the law! It’s just like when the vaccine companies had to do to get the emergency use authorization. That means there could be no other effective treatments for COVID-19 in order to get the EUA!

While the minority of the 1st world casually argue about the vaccines, the majority of the world don’t even have access to vaccines and they aren’t waiting for some one drug savior. They have to fight and have found many many ways to combat Covid-19. Media debunk it all the time that there is no other rescue but the vaccine. I am from South-Africa. We fought against the Delta like no other country. Vaccines was very hard to get. I knew so so many that got Delta. Many died and more survived. They had to use other medicine and it worked and sometimes it didn’t. That is FACT. I lost two very close friends. One had the vax and the other didn’t. There are so many accounts in many parts of the world that didn’t have the vaccine and fought back. Thousands of years of medicine knowledge, millions of doctors, billions of patient data, millions of research and the vaccine is the only answer??? I find that hard to believe. Thousands of years of evolution and there is only one drug savior? Continue to have your arguments – the rest of the world will trust in the diverse genius of medicine and science.

. I am from South-Africa.

So is Elon Musk. Yet even he didn’t take the horse pills.Trust (but verify) me on this one.

Problem is that viruses are difficult to kill. Actually, they are not fully living organisms in the first place. A multidrug therapy is needed for HIV, for instance, Developing it took very long time, False leads to not help here.
Viral diseases could be prevented, though. Prevention is better than cure, even if one is avaiable.

What? It was 8 words. Old man, maybe I’m not familiar with the blink light technology of yesteryear but if I were to emulate it today I don’t think I could have written a more weak sauce sissy bitch reply in Qbasic.

Change my view. Step up to the plate. Tell us to fuck off like you are wearing the daddy pants.

Also, go {whatever you Michigander people call the sports team up there}.

Whitey- I would think there is not a person alive who isn’t grateful for a ‘God given immunity’. But some experiences from early observers and the growth of medical knowledge has resulted in ways we can work with the ‘God’ system and manipulate it, with vaccines, to function in the service of reduced suffering and death of animals and humans. This manipulation has had unprecedented successes

Want to respond to Orac? Here's your chance. Leave a reply! Just make sure that you've read the Comment Policy (link located in the main menu in the upper right hand corner of the page) first if you're new here!

This site uses Akismet to reduce spam. Learn how your comment data is processed.