Let’s be clear what the issue is here. The issue before the court is not whether vaccination is good or bad. All nine of the Justices have been fully vaccinated and have also received boosters (as I have). It’s fair to conclude that the Justices all think vaccinations are good, at least for people of their demographic.
Nor is the issue whether state or federal government can impose vaccine mandates on the population. They probably can, and occasionally have. In oral argument yesterday, Justice Gorsuch noted in passing that he recently rejected a challenge to a vaccine mandate imposed by the state government of New Mexico. Similarly, Congress could pass a law imposing a vaccine mandate or authorizing the Executive Branch to impose one.
What’s at issue in this case is much narrower. It’s whether the Executive Branch via the Occupational Safety and Health Administration (“OSHA”) can impose vaccine mandates without specific authorization from Congress.
The six conservative justices signaled that they think the answer is no.
Consistent with the ongoing politicization of COVID, oral argument yesterday descended into a cafeteria food fight of hysteria, half-truths and untruths. Justice Breyer implied that because the daily new cases of COVID were now about 750,000, tossing out the OSHA mandates would mean that 750,000 people a day would contract the disease who otherwise wouldn’t – as if the mandate would instantaneously eradicate the disease. Justice Sotomayor suggested that 100,000 children were “in serious condition or on ventilators.” The Department of Health and Human Services says the actual number is only a few percent of that.
In contrast, the six conservative Justices focused not on the disease but on the legal and Constitutional authority of the Executive Branch to impose the OSHA mandates. That’s as it should be. The Court’s job is not to figure out whether vaccine mandates are good or bad, but to figure out whether the government has the right to impose them in the way they did.
It’s not as if mandates are unavailable to fight the pandemic. The Justices confirmed that Congress could impose or authorize mandates, and states could do the same at the state level, as some have.
The response of the liberal Justices to this point – if they were to make a response, which they didn’t – would be, yes, but these mandates are important tools and the states are being inconsistent in imposing them and Congress has failed to act.
Maybe that’s all true. But a failure of the political system does not justify circumventing it. Down that path lies tyranny.
Glenn K. Beaton had a career in law, including practicing at the Supreme Court
the Aspen beat 
I can not grasp how anyone can force someone to take an experimental treatment that the VARS data shows is deadly and causing disabilities let alone the fact that if the person that is forced to take the ‘treatment’ and becomes disabled they have to shoulder the cost. It is not just the VARS data now, I know several people that have ‘autoimmune’ issues causing serious issues.
Your point about forcing a vaccine on people who don’t want it is legitimate. I would note in passing, however, that the Pfizer vaccine is no longer “experimental” now that they’ve received full FDA approval (not just the emergency approval they had originally).
Your statement, while widely believed and repeated, is not accurate. Actually, two of the vaccines (J&J/Janssen and Moderna) have not received FDA approval, and are still being used under the EUA. The Pfizer vaccine Comirnaty has been approved fully by the FDA, but the problem is it’s not available in America. The Pfizer vaccine that is still being used in this country is not marked “Comirnaty”. A lot of people have claimed that the distinction is unimportant, however, the Pfizer vaccines we use are still not marked Comirnaty on the vials. The Comirnaty vaccine is only available in other countries for some reason. Judge Allen C. Winsor noted this fact recently in the legal case Doe v. Austin.
Mac, according to the FDA website, “Comirnaty” is simply a name that has been applied to the Pfizer vaccine — much like a brand or trade name. It’s not a different vaccine. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
Also see, https://www.nebraskamed.com/COVID/you-asked-we-answered-are-pfizers-comirnaty-and-biontech-covid-19-vaccines-the-same-or-different
I think you’re correct that Moderna’s application for full approval beyond EUA has not yet been granted.
The government lawyers are playing the 1984 game of DoubleSpeak. The Pfizer vaccine is 100% definitely EUA, meaning Pfizer is not liable to anyone for any harm caused by it. At the same time, the CDC and FDA are saying it is approved for use. It CANNOT be both. It is either EUA or it is approved. The CDC/FDA and their master, Pfizer, are trying to have it both ways, claiming the “vaccine” is approved for use yet not being liable for harm it causes (which is plenty).
William, you’re confusing a couple of different things. The immunity for vaccine makers preceded COVID by 30-some years. The thinking in passing that shield law back in the 80’s was that vaccines are sufficiently important to public health that the Pharma companies should develop such vaccines without worrying about massive liability to the plaintiffs’ attorney bar. https://www.newsweek.com/fact-check-are-pharmaceutical-companies-immune-covid-19-vaccine-lawsuits-1562793
It has nothing to do with whether the vaccines are experimental-approved or fully-approved.
This is what I have read and copied for you:
The Pfizer-BioNTech vaccine, marketed as Comirnaty, is the only one that has been approved by the U.S. Food and Drug Administration (FDA) for people 16 and older. The approval is only for Pfizer COVID-19 vaccine doses produced in the future, according to FDA documents, while the existing supply of COVID-19 vaccines under Pfizer-BioNTech in the United States continue to be administered under an updated EUA.
Gail, I’m not sure the source of your quote, but, assuming it is accurate, it does not say that Comirnaty is different than what’s now being administered, or that Pfizer will continue to sell EUA vaccines. In fact, I interpret it to say exactly the opposite. It states that only the “existing supply” of vaccines will be used up under the EUA. I take that to mean that the new supplies — what’s now being administered — are under Full Approval.
Agreed. It violates every law of ethics nationally and globally. I fear that the consequences of this largest experiment on unwitting subjects in human history will have dire consequences for generations to come.
What this article misses is that NOBODY, not your employer, not the US government, not your state government, has the right to force you to take an experimental “vaccine”. First, this is not a vaccine. It is not a dead or weakened virus being implanted in you, and it does not prevent you from getting or spreading Covid. At best it is a therapeutic gene therapy. Second, every Covid “vaccine” available in the US is still EUA, meaning taking it is 100% voluntary, requires 100% full disclosure concerns the risks (as opposed to the government doing everything in their power to hide risks), and there must be no other available therapeutics to treat the illness (you know, like Ivermectin and HQC, both which appear superior at treating and preventing the virus). What next, they’re going to force males to take a “vaccine” to prevent toxic masculinity, which they’ll claim is killing millions worldwide? My body, my choice.
I won’t contest your opinion, to which you are entitled, except to note in passing that the Pfizer vaccine is no longer “experimental.” The FDA last year granted full approval — not just the experimental approval it initially granted — for adults.
The Comirnaty vaccine and the Phizer may be identical except for the packaging but they are legally distinct. At the same time the FDA approved Comirnaty for production it reissued the EUA for the Phizer vaccine. The legal distinction is that nobody but the person who lets someone jab them is legally responsible for the consequences that may ensue. You might think that is insignificant or not depending on whether you stroke out, get Bell’s Palsy, heart damage, MSI, or some future autoimmune disease. That is certainly your right, but it is pretty obvious Phizer does not consider the legal distinction as moot or they would distribute the Comirnaty version here.
Another consideration doubtless in the back of Phizer’s decision to only distribute the EUA version is that once there is a fully approved vaccine available the EUA’s for J&J and Moderna have to be revoked and the EUA’s for the Phizer and Merck therapeutics that just recieved EUA authorization. Big Pharma wants a complete liability shield for all of these products and I’d say it is likely because they don’t believe their own safety studies, but then I am a cynical old man.
As the link I provided above discusses, there are not two “versions”, Peter. There are two names for the same identical thing. The FDA does not approve names. They approve compounds. Pfizer has one compound and it’s been fully approved.
As for your discussion of the legal consequences of marketing the same drug under one name in the US and another name in Europe, I think you’re mistaken. Doing so does not expand or reduce the potential liability of the manufacturer. And in fact manufacturers commonly use different names for the same drug in different parts of the world.
I’m not sure where you’re getting your information but if you can supply links to credible sources I’d be happy to review them. Glenn
Nope, it is not. I just responded to another poster about this. The Pfizer “vaccine” is still EUA in the US, period. Comirnaty was approved in the US (but is unavailable in the US). In a sneaky, dishonest, non-transparent way, the FDA/CDC released a statement claiming that since Comirnaty and the Pfizer “vaccine” are similar, you can consider the Pfizer “vaccine” approved as well, yet they quietly allowed Pfizer to keep its EUA status, absolving them of all hard they cause, which is lots. It CANNOT be both EUA and approved. This is classic 1984-esque DoubleSpeak, a government claiming two 100% contradictory things, saying they are both true. Orwell was a genius and a prophet.
Wrong. The “Comirnaty” vaccine is simply the name used in Europe for the same exact formulation approved by the FDA in the US. https://www.nebraskamed.com/COVID/you-asked-we-answered-are-pfizers-comirnaty-and-biontech-covid-19-vaccines-the-same-or-different
I’m not sure where you’re getting your information. If you can supply some links to credible sources, I’m happy to look at them.
The question that really needs answering is whether federal or state governments can mandate a vaccine that does not actually work. If the answer is yes then who cares what power administrative agencies have, we are all just as screwed. We have not yet even gotten a chance to see the evidence the FDA used to issue their EUA nor have competent apolitical independent scientists have had a chance to review the evidence. I would say government mandating medical care a person does not want is as fundamental an invasion of privacy as you can get. Before I would say government can do that I’d need to know that A) it is a solution that actually works and B) The threat to society as a whole is sufficiently high and alternatives few that an existential threat actually exists.
Could the government mandate a vaccine for smallpox? Yes I think so, if the vaccine actually works. Could the government mandate a vaccine for the common cold? I would say no, not even if it were a scientific near certainty that the vaccine was both safe and effective because the existential threat to society does not exist.
BTW there are no fully approved vaccines or boosters for covid19 available in the USA. The Phizer vaccine being distributed is still the legally distinct EUA version and Phizer has no intention of opening itself up to even limited legal liability by distributing the Comirnaty version in the USA. People keep circulating that fake news, in most cases because they actually believe it, but to answer Gearge Costanza’s question, Yes George it is still a lie even if you believe it.
The Pfizer vaccine has received full FDA approval for use in adults.
As for the contention that the FDA approval is for something different, namely the Pfizer “Comirnati” vaccine, those are one and the same. In Europe it’s sold under the brandname “Comirnati” but it’s the exact same thing. https://www.nebraskamed.com/COVID/you-asked-we-answered-are-pfizers-comirnaty-and-biontech-covid-19-vaccines-the-same-or-different
No it hasn’t. The government agencies and their master, Big Pharma, want you to believe that is true, and they have made statements to that effect, but it’s is NOT true, and to this day Pfizer still enjoys its EUA status. A vaccine CANNOT be both approved and EUA.
We’ve already far along the path to tyranny. Apparently none of these vaccines prevent covid and the ballyhooed reduction in symptom severity (RSS) hasn’t, to my knowledge’ been proven.
Moreover, if RSS is the goal, then why the prohibition on other meds that do the same only better with less cost, no aluminum or mercury mixed in, and no mask requirement?
There is just too much doubt about the jab to accept it without strong objections and investigation by qualified researchers with plenary powers into the doubts about it. Our govt has proved that it does not care about us and I refuse to let it cow me into submission. Only by force will a jab or 4 or 5 enter my body.
Known now as the Wise Latinx,
she sits on The Court like a sphinx —
Does a fetus feel pain?
Can’t a virus be slain?
God only knows how she thinks!
This con-Constitutional whore
(whose surname rhymes with “Ee-yore”)
appeals solely to fear
in order to sneer
at rights she can only deplore.
The approved Comniraty vaccine IS different LEGALLY! Look up the FDA documents. It is NOT available! How do we know this? IF there is an approved vaccine available then EUA vaccines are NO LONGER ALLOWED under the law. As per Nuremberg, no one can be forced to take an experimental drug!
No, you’re mistaken. Comniraty is simply a European tradename for the Pfizer vaccine. They’re one and the same. https://www.nebraskamed.com/COVID/you-asked-we-answered-are-pfizers-comirnaty-and-biontech-covid-19-vaccines-the-same-or-different
Are the grey market computer you buy off the back of a truck and the one you buy from the Apple Store “identical”? Well they may be until you try to get coverage under the warranty. All of a sudden you will discover you are holding a brick. Is your jump off the same as your wife. No once you both say “I do” the legal distinction is way more then just a technicality. She may have all the same anatomical parts she had before you got full legal permission to use them but there are a whole bunch of legal obligations that come with that.
I am not sure why you are having such a problem with the concept of legally distinct onthebeatontrack, but you are spreading misinformation. When the FDA grants approval for a drug it applies to everything from the factory it is manufactured in right down to the packaging, info sheets, and name on the bottle. Change anything and it is instantly transformed into an unapproved drug. That is the law and it is enforced. Comirnaty and the Phizer vax are not the same thing legally and Comirnaty is not avaiable in the USA. Case closed. There are no approved vaccines in the USA.
Your analogy to a genuine Apple computer and a knock off would be persuasive if the Pfizer European vaccine and American vaccine we’re not both made by Pfizer and both contained identical ingredients.
I’m still awaiting the links to your sources that I requested in my last reply. Absent those, I think further discussion is probably not productive and so I will bow out now
The Left and their dumb ilk, like Sotomayor, Breyer and Kagan making their stupid claims, seems to think that any government agency is competent to do anything that the political elite deems it should.
Remember the Motor Voter Law? Who was the political dumbass who decided that the Department of Motor Vehicles should have anything to do with voter registration?!? By using that kind of logic we could expect a Registrar of Voters to be administering driving tests to qualify future motorists for drivers licenses.
The same goes for the political dumbasses attempting to get OSHA to enforce the mandatory taking of medications by workers in such a wide variety of occupations, from auto manufacturing factories to real estate offices. What’s next?!? Directing the Centers for Disease Control or the National Institute for Health to enforce lock-out/tag-out safety procedures or fire extinguisher inspections in the workplace?
These bureaucratic agencies need to stay in their own lanes. But as is typical to the Left, government agencies can be hijacked and re-purposed with a diktat and a stroke of a pen.
I hope to see the six Constitutional Justices on SCOTUS take the three dumb Leftists to task for their stupid and grossly inaccurate citations. What’s the point in these three dumb Justices even having their prestigious court clerks if they do not utilize them for even the most basic and simple research into current health statistics?
Excellent, thoughtful, even-handed column. Unfortunate that so man of Glenn’s “fanboys” have stopped reasoning. I. as a thoughtful (mostly) liberal, think this column is even-handed and on-point. I wish we had a workable national vaccine mandate, but this court’s job is interpreting the law and nothing more. If they rule in favor of the mandate, how will my liberal friends feel when future Presidents us that power for purposes they don’t like. Thank you Glenn.
Why do you “wish we had a workable national vaccine mandate”? I certainly don’t.
People who are fully vaccinated get and easily spread covid. According to a recent study in the Lancet, “fully vaccinated individuals with breakthrough infections have peak viral load similar to unvaccinated cases and can transmit infection…” Likewise, “People who get vaccine breakthrough infections can be contagious,” says the CDC. Therefore, vaccinated people Even more compelling, …“vaccinated individuals still have the potential to infect others. Worse, one CDC report shows that vaccinated people can still be superspreaders. If vaccinated people still get and spread covid with the same viral load as unvaccinated people then vaccinated people should be tested for covid in the same manner as unvaccinated people, correct? Correct. CDC also states, “vaccination is NOT sufficient to prevent transmission of covid virus.” If vaccination is not sufficient to prevent transmission of covid virus, then why are employees being fired for not being vaccinated? An irrational fear of covid doesn’t entitle a workplace to discriminate against persons based on vaccine status. Simply put, there are no compelling or extraordinary reasons to selectively discriminate against unvaccinated people when vaccinated people can still infect others, have similar viral load and be contagious. Therefore, given the absence of logical grounds to continue such discrimination employers should immediately cease and desist such discrimination. An unvaccinated person carries the same level of safety as a vaccinated person, given both can get and spread covid. A more rational, fair and least restrictive solution would be to provide rapid covid testing for all employees, both vaccinated and unvaccinated, provide free testing at stores, schools and hospitals and require all people to wear masks indoors until there’s ample evidence of herd immunity. The highly transmissible Omicron variant could help countries reach herd immunity as cases continue to rise, health experts say. More compelling, experts say Omnicrom is, “less severe than other variants” and “delta variant is the most common worldwide variant.” Thus, the Biden admins argument that Omicrom is a threat is a falsehood. Nobody wants to get covid. But it’s going to happen. Thus, it’s more important to take rational, reasonable steps and to put more effort into treating covid, not firing nurses, doctors, teachers, who don’t want to get a vaccine that the sciense itself says, “Is not sufficient to prevent transmission of covid.”
Therefore, someone’s irrational, idiotic, absurd fear of covid does not rise to the level of allowing discrimination. People who are fully vaccinated that claim to be “afraid” of unvaccinated are not following the science. Science says fully vaccinated people can, do and are spreading covid. Finally,
Sources: https://www.msn.com/en-us/news/us/cdc-report-shows-vaccinated-people-can-spread-covid-19/ar-AAML2bE https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00648-4/fulltext
https://www.ibtimes.com/covid-19-herd-immunity-possible-omicron-cases-surge-experts-say-3369737d.
I have travelled by air on multiple occasions, have circulated routinely throughout my (mostly) rural community without a mask (unless compelled to don one) and have not contracted Covid19, or for that matter, any viral or bacterial disease for the duration of the Covid panic. I have not restricted my contact with any family members, even the ones who have contracted the illness (and recovered after a brief period of discomfort) or the ones who work in the medical field or law enforcement, where they come into contact with all manner of germ/virus vectors. My wife, likewise. We are in our early seventies, but in generally good health (save for my wife’s hypertension). We do, however, take Vitamins D3, K2, D, C and a B complex, along with prophylactic Ivermectin and quercetin/bromelain. I survived measles, rubella, chicken pox, mumps and numerous bouts of winter colds and flu. I have been vaccinated against all the typical diseases, have taken the shingles vax as well as tetanus shots without hesitation, since they have a proven track record. We never took the “flu shots,” inasmuch as their efficacy was always in doubt (since it is merely a guess as to what the dominant strain coming out of China will be in each season. All that to say neither my wife nor I will voluntarily accept any of the proffered “vaccines” against SARS CoV-2. Second point, relative to the Supreme Court. As a litigating lawyer, I encountered dozens, if not hundreds of judges in my career, from minor judiciary through the highest appellate court in my state of admission. Therefore, it does not entirely surprise me, although it distresses me greatly that Breyer, Kagan and especially Sotomayor all displayed such an egregious lack of knowledge regarding the actual statistics on Covid infections, hospitalizations and deaths. I must therefore assume that their grasp of legal principles is as circumscribed as their general knowledge of the facts on the ground. Clearly, for them it is a case of coming to a decision first, then looking for a reason later, even if that means fabricating one out of thin air. As the Bible tells us, Proverbs 18: 13 To answer before listening— that is folly and shame. 17 In a lawsuit the first to speak seems right, until someone comes forward and cross-examines. So folly and shame are the legacy our “Wise Latina” and her companions have bequeathed to us.
OK, guys, in your own “cafeteria food fight” over what the FDA has or hasn’t approved, what I am left wondering is why we should trust today’s FDA any more than today’s FBI, or today’s military leadership, or today’s New York Times, or today’s Catholic Church — to name a few former bastions of integrity that now have feet of clay.
Not everyone does, apparently: A federal judge has just granted a FOIA request, compelling the FDA to release all of its records regarding its approval of the Pfizer “vaccine” (a misnomer IMHO) within the next eight months. (The FDA had asked for 75 years!) Transparency seems to be in the public’s interest— who knew?
Meanwhile dark clouds are gathering over this entire business. A storm be a-coming.
Now that select racial and ethnic minorities have been pushed to the front of the line for available Covid meds, thanks to the Biden Admin and . . . wait for it . . . the FDA, I would indeed like to hear what Native Americans have to say, especially after a few fatalities linked to the jabs. Think about it — what could possibly go wrong with this policy?
On February 4, 2020, as the “vaccines” were being developed, Sec. of HHS Alex Azar, issued his Declaration “pursuant to section 319F–3 of the Public Health Service Act to provide liability immunity for activities related to medical countermeasures against COVID–19.” That quote is taken from the actual Declaration that is online at this link to the Federal Register [ 2020-05484.pdf (govinfo.gov)]. The Declaration was issued by Sec. Azar pursuant to the PREP Act and it was subsequently amended several times. The legal basis for distribution and administration of the Pfizer/BioNTech “vaccine” as well as Pfizer’s and BioNTech’s exemption from liability is this Declaration and its subsequent amendments [here is a link to an HHS website with links to the original Declaration and the amendments thereto Public Readiness and Emergency Preparedness Act (hhs.gov)].
On the first page of the Declaration in the section entitled “Supplementary Information”, it explains that
“The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law
113–5, was enacted on March 13, 2013. Among other things, PAHPRA added sections
564A and 564B to the Federal Food, Drug, and Cosmetic (FD&C) Act to provide new
authorities for the emergency use of approved products in emergencies and products
held for emergency use. PAHPRA accordingly amended the definitions of ‘‘Covered
Countermeasures’’ and ‘‘qualified pandemic and epidemic products’’ in Section 319F–3
of the Public Health Service Act (PREP Act provisions), so that products made available
under these new FD&C Act authorities could be covered under PREP Act.” (emphasis added)
The Declaration defines the term “Covered Countermeasures”. The following definition does not get specific about brand names or different branded versions of any such “Covered Countermeasure”. It merely states that
“VI. Covered Countermeasures 42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. 247d–6d(i)(1)
and (7) Covered Countermeasures are any antiviral, any other drug, any biologic,
any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent,
or mitigate COVID–19, or the transmission of SARS-CoV–2 or a virus mutating therefrom,
or any device used in the administration of any such product, and all components and
constituent materials of any such product.” (see page 15202 of the Declaration
linked above)
Even though the BioNtech and Comirnty versions of the Pfizer “vaccines” are apparently the same chemical formulation and that both are both subject to the approval for those 16 yrs and older that was granted by the FDA at the end of last summer, the FDA itself makes a distinction. The FDA issued a letter dealing with this issue which can be found at the FDA website [here is the link Letter of Authorization – Pfizer-BioNTech COVID-19 Vaccine – January 3 2022 (fda.gov)].
Take a look at footnote 9 in the FDA letter. It reads in relevant part,
“In the August 23, 2021 revision, FDA clarified that, subsequent to the FDA approval
of COMIRNATY (COVID 19 Vaccine, mRNA) for the prevention of COVID-19 for
individuals 16 years of age and older, this EUA would remain in place for the Pfizer-
BioNTech COVID-19 Vaccine for the previously-authorized indication and uses. It
also authorized COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for
certain uses that are not included in the approved biologics license application (BLA).”
That doesn’t seem to say that the FDA approval of Comirnty applies to BioNTech. Even if Glenn is right and the FDA approval applies to both branded versions of the “vaccine” why do you think Pfizer would seek FDA approval for the Comirnty branded “vaccine” which they are not selling in the US? Even if the chemical formulation is the same as that of Pfizer/BioNTech branded “vaccine”, they still are only selling the Pfizer/BioNTech branded “vaccine” in the US. Why not just get FDA approval for the Pfizer/BioNTech “vaccine” if that’s all they are selling in the US? At the very least, this is a legitimate question to pose to the FDA. It seems very unclear to me.
Sorry, the hyper links don’t appear in my comment above. Here is the URL for the FDA letter.
https://www.fda.gov/media/150386/download
On February 4, 2020, as the “vaccines” were being developed, Sec. of HHS Alex Azar, issued a Declaration “pursuant to section 319F–3 of the Public Health Service Act to provide liability immunity for activities related to medical countermeasures against COVID–19.” That quote is taken from the actual Declaration that is online at this link to the Federal Register [ 2020-05484.pdf (govinfo.gov)]. The Declaration was issued by Sec. Azar pursuant to the PREP Act and it was subsequently amended several times. The legal basis for distribution and administration of the Pfizer/BioNTech “vaccine” as well as Pfizer’s and BioNTech’s exemption from liability is this Declaration and its subsequent amendments [here is a link to an HHS website with links to the original Declaration and the amendments thereto Public Readiness and Emergency Preparedness Act (hhs.gov)].
On the first page of the Declaration in the section entitled “Supplementary Information”, it explains that
”The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113–5, was enacted on March 13, 2013. Among other things, PAHPRA added sections 564A and 564B to the Federal Food, Drug, and Cosmetic (FD&C) Act to provide new authorities for the emergency use of approved products in emergencies and products held for emergency use. PAHPRA accordingly amended the definitions of ‘‘Covered Countermeasures’’ and ‘‘qualified pandemic and epidemic products’’ in Section 319F–3 of the Public Health Service Act (PREP Act provisions), so that products made available under these new FD&C Act authorities could be covered under PREP Act.” (emphasis added)
The Declaration defines the term “Covered Countermeasures” to the SARS Cov2 virus and the pandemic. The definition does not get specific about brand names or different branded versions of any such “Covered Countermeasure”. It would presumably even cover different chemical formulations of the same brand of “vaccine” given the definition of “Covered Countermeasure” which can be found on page 15202 of the Declaration (see the link above) and which reads in relevant part,
“VI. Covered Countermeasures 42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. 247d–6d(i)(1) and (7) Covered Countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID–19, or the transmission of SARS-CoV–2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.” (emphasis added)
Even though many people seem to think that the BioNtech and Comirnty versions of the Pfizer “vaccines” are exactly the same chemically and that both are both subject to the approval for those 16 yrs and older that was granted by the FDA at the end of last summer, the FDA itself makes a distinction. The FDA issued a letter dealing with this issue which can be found at the FDA website [here is the link Letter of Authorization – Pfizer-BioNTech COVID-19 Vaccine – January 3 2022 (fda.gov)].
Take a look at footnote 9 in the letter. It reads in relevant part,
“In the August 23, 2021 revision, FDA clarified that, subsequent to the FDA approval of COMIRNATY (COVID 19 Vaccine, mRNA) for the prevention of COVID-19 for individuals 16 years of age and older, this EUA would remain in place for the Pfizer-BioNTech COVID-19 Vaccine for the previously-authorized indication and uses. It also authorized COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved biologics license application (BLA).”
That doesn’t seem to say that the FDA approval of Comirnty applies to BioNTech. Even if Glenn is right and the FDA approval applies to both branded versions of the “vaccine” why do you think Pfizer would seek FDA approval for the Comirnty branded “vaccine” which they are not selling in the US? Even if the chemical formulation is the same as that of Pfizer/BioNTech branded “vaccine”, they still are only selling the Pfizer/BioNTech branded “vaccine” in the US. Why not just get FDA approval for the Pfizer/BioNTech “vaccine” if that’s all they are selling in the US?
I don’t have time to go through all the statutes but this letter seems to contradict the claim that the FDA approval of Comirnty applies to the BioNTech version.
1)No discussion on this subject is complete without a study of Dr Robert Malone statements, who PIONEERED mRna technology, has multiple patents related to vaccines, or his well regarded compatriots voices.
Look him up.
2) All evidence, even from the CDC, clearly reveals that only the very ill with multiple cormobidities need fear death from Covid 19.
3) Contrary to what the media says, tens of thousands of solid scientists worldwide signed the Great Barrington Declaration with concerns over the vaccine , and the approach taken to curb the virus spread.
Anyone who reads multiple sources knows that the governmental reaction worldwide to this virus was more appropriate for something similar to the Black Death, not as, what is becoming apparent, to a very flulike respiratory condition.
It is ‘flu like because it is the ‘flu. The ‘flu is the internal toxicosis of the body, mainly via urea, partly due to metabolism of food and partly due to the many poisons in our environment which can and do enter our bodies in the air, food and water.
Vitamin D deficiency is the true pandemic due to indoor working and living away from the sunshine which, if we do the right thing things, will give us vitamin D (free!). Big pharma etc. are not keen on free as they don’t make much money out of it. I can explain further if required.
Please note I do use humour as necessary on posts and pages to lighten the mood and help make the points.
As a general matter, I agree with you. But there’s a tendency by all sides in this subject to overstate one’s position. For example, “only the very ill with multiple comorbidities need fear death from Covid 19.”
I certainly don’t fear death from Covid 19, but your statement reads as if nobody dies of Covid unless they are “very ill with multiple comorbidities.” That’s not so. It’s certainly true that the great majority do, but it’s not true that ALL do.
I would substitute “the great majority” for “only” and then I think I could agree 100%.
(I also think Malone has several axes to grind, but I won’t get sidetracked on that.)