Pfizer vaccine gets full FDA Approval in the USA

[cdemundo]

2 hours ago, Ryan754326 said:

That’s a bold claim considering the number of vaccinated people who are still becoming infected. 
 

 

What is the number of vaccinated people who are still becoming infected?

"Breakthrough infections in vaccinated people accounted for at least one in five newly diagnosed cases"

so at least 20% of newly diagnosed cases, so that means 80% of newly diagnosed cases are unvaccinated.

 

Definitely true that a significant number of breakthrough cases are occurring.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was,"

 

But if 80% of cases are still in the unvaccinated that kinda speaks for itself.

[catturd]

Does anyone have knowledge of when/if comirnaty vaccine will be available and where? Anyone been offered this newly branded vaccine?

Hmm, ok, maybe after the FDA mandated comirnaty trials (investigate the risk of inflammation in and around the heart, as voluntary reporting mechanisms are insufficient) conclude June 30, 2025 (FDA accepted Pfizer’s suggested timetable ) will it be offered.

 

For now, If you want FDA cominarty you can have it, but it will be called EUA pfizer.

[mtls2005]

It will be interesting to see if the Thai FDA approves Pfizer for full approval, assuming Pfizer/THL chooses to apply.

 

https://www.thaipbsworld.com/thai-fda-asks-pfizer-thailand-to-seek-full-approval-of-its-mrna-vaccine/

 

We're told that with full approval here, private concerns could order the Pfizer vaccine on their own.

 

In the U.S., it seems like Moderna is looking at a November (soonest) full FDA approval.

 

 

[mtls2005]

3 minutes ago, catturd said:

Does anyone have knowledge of when/if comirnaty vaccine will be available and where? Anyone been offered this newly branded vaccine?

 

You mean in Thailand?

 

So far, just 1.5 mm doses donated from the U.S., most of which have probably been administered. Another 1 mm doses from the U.S are said to be "in the works".

 

The government said they made a firm order with Pfizer for 20 mm doses, these are due from Q4 21. They also sad they were considering another 10 mm order.

 

AFAIK, this is the only vaccine considered appropriate for 12 - 18 year olds.

 

5 minutes ago, catturd said:

For now, If you want FDA cominarty you can have it, but it will be called EUA pfizer.

 

All my Thai MoPH/hospital paperwork refers to my two doses of Pfizer as "Comirnaty" in "Name of Vaccine" and "Pfizer, BioNTech" under "Manufacturer", so not sure what you're on about with these sorts of droppings.

 

[mtls2005]

3 minutes ago, cdemundo said:

Survey suffered from self-selection

Survey probably popped up while these highly educated folks were reading their ivermectin updates.

 

 

[cdemundo]

1 hour ago, cdemundo said:

What is the number of vaccinated people who are still becoming infected?

"Breakthrough infections in vaccinated people accounted for at least one in five newly diagnosed cases"

so at least 20% of newly diagnosed cases, so that means 80% of newly diagnosed cases are unvaccinated.

 

Definitely true that a significant number of breakthrough cases are occurring.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was,"

 

But if 80% of cases are still in the unvaccinated that kinda speaks for itself.

sorry forgot the reference for these quotes

https://www.nytimes.com/2021/08/17/health/covid-vaccinated-infections.html

[catturd]

44 minutes ago, mtls2005 said:

 

You mean in Thailand?

 

So far, just 1.5 mm doses donated from the U.S., most of which have probably been administered. Another 1 mm doses from the U.S are said to be "in the works".

 

The government said they made a firm order with Pfizer for 20 mm doses, these are due from Q4 21. They also sad they were considering another 10 mm order.

 

AFAIK, this is the only vaccine considered appropriate for 12 - 18 year olds.

 

 

All my Thai MoPH/hospital paperwork refers to my two doses of Pfizer as "Comirnaty" in "Name of Vaccine" and "Pfizer, BioNTech" under "Manufacturer", so not sure what you're on about with these sorts of droppings.

 

Seems odd that a thai hospital is the only place on the planet offering Comirnaty. It's not available ANYWHERE  in the US, no pharmacies, hospitals, clinics I checked offer it.

[Ryan754326]

3 hours ago, cdemundo said:

What is the number of vaccinated people who are still becoming infected?

"Breakthrough infections in vaccinated people accounted for at least one in five newly diagnosed cases"

so at least 20% of newly diagnosed cases, so that means 80% of newly diagnosed cases are unvaccinated.

 

Definitely true that a significant number of breakthrough cases are occurring.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was,"

 

But if 80% of cases are still in the unvaccinated that kinda speaks for itself.

I would think that we really have no idea how many breakthrough cases are happening, because most of them will be asymptomatic and undetected. 
 

I don’t deny that most (known) cases happening now are among the unvaccinated, and I don’t deny that being vaccinated might mitigate the spread to a certain extent, but I don’t think it matters; If someone is infected, the virus is replicating inside their body, and if it’s replicating, then the possibility of a mutation is always there. 


 

 

 

Edited September 4, 2021 by Ryan754326

[mtls2005]

4 hours ago, catturd said:

Seems odd

Yep. As are your posts.

 

 

1 hour ago, catturd said:

Cominarty is not available yet as you know.

 

No clue what you're on about? Comirnaty is a brand name for the Pfizer/BioNTech vaccine.

 

North of 200 million doses of Comirnaty have been administered to date.

 

 

1 hour ago, catturd said:

Take a look into it for your own good.

Thanks but advice from you seems, well, downright looney.

 

 

[MrJ2U]

This will help with mandates requiring vaccinations for Federal and State employees in the US.

 

It will also help private companies to require vaccinations for employment.

 

Moderna is next in line.

 

Good news!

 

 

[gargamon]

14 hours ago, Ryan754326 said:

That’s a bold claim considering the number of vaccinated people who are still becoming infected. 
 

 

Really? Let's look at the origins of the variants.

 

Beta       - South Africa, May 2020, little local vaccinations

Gamma - Brazil, Nov 2020, little local vaccinations

Delta      - India, Oct 2020, little local vaccinations

 

Now if you can come up with vaccinated populations that have originated variants you *might* have an argument. It seems to me you may have blinders on and are focusing on some well vaccinated polulations with a very small number of breakthrough infections. In reality, the next variants will come from less developed places where vaccinations are not prevalent.

[catturd]

14 hours ago, MrJ2U said:

This will help with mandates requiring vaccinations for Federal and State employees in the US.

 

It will also help private companies to require vaccinations for employment.

 

Moderna is next in line.

 

Good news!

 

 

If a vaccine attains FDA approval, I argue that all EUA vaccines should be stopped! That includes all vaccines in the US except comirnaty.

[CharlieH]

Post with unattributed content and responses to it removed.

[Rimmer]

A post from with a link to a highly unreliable and suspect source has been removed

[catturd]

1 hour ago, CharlieH said:

Post with unattributed content and responses to it removed.

Is this acceptable?

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

Does anyone know what pfizer's intended meaning of "certain differences" could be?

My employer will/may terminate any unvaccinated employee within 5 weeks of FDA vaccine approval.

Edited September 5, 2021 by catturd

[Someone Else]

The "certain differences" imparted by FDA (not Pfizer) are regulatory differences.  Per the previous para, the EUA covers "...certain uses that are not included in the approved BLA".

 

It's further clarified in FDA's Q&A document https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna:

 

"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."

 

I'm guessing the "logistical reasons" are that PFE doesn't have to label/repackage the already-distributed EUA-approved material with BLA-approval branding/PIL (which would be a logistical nightmare).   Same rationale goes for the expiry extension memo discussed earlier. 

[catturd]

And, as pfizer states "The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably..."

why the notation in footnote 9 stating: "...there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA".

 Like, whats going on with that?

Edited September 5, 2021 by catturd

[placeholder]

9 hours ago, catturd said:

And, as pfizer states "The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably..."

why the notation in footnote 9 stating: "...there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA".

 Like, whats going on with that?

What is so hard to understand about the FDA's statement there is not enough for the entire population. But your misunderstanding of this paragraph does explain why you called for a halt to the distribution of all other vaccines that were approved under the EUA. If that were done, then there wouldn't be enough vaccine to meet demand. Why is this so hard for you to understand?

[catturd]

No premise,  just facts. But okay, so just use Comirnaty then, BUT WAIT....there ain't none yet.

 

But there is a huge elephant in the room.  Under EUAs, the government pays for the product and the manufacturer has NO liability, unless you can prove willful misconduct AND the DHHS Secretary allows you to sue. That has never happened.

But once the product (Pfizer’s vaccine, today) is licensed, the liability shield under EUA disappears. Unless there has a been a secret agreement regarding liability after approval, which is probably not legal, Pfizer will be liable for all injuries sustained by the licensed vaccine. And Pfizer’s vaccine seems to be causing a record number of injuries and deaths, based on the VAERS data.

 

Dr. Nass importantly notes that the new, approved vaccine will carry a brand name (Comirnaty) and have liability attached to its use, whereas the unbranded, emergency-use vaccine didn’t/doesn’t. Would Pfizer risk being liable for its product given its current safety record? (A new bill in Congress is trying to have their liability removed).

 

https://truthpeep.com/tag/comirnaty-brand-name/

https://alethonews.com/2021/08/23/are-the-fda-and-pfizer-biontech-scamming-us-with-a-license-in-name-only-why-do-they-want-us-vaccinated-so-badly/

Edited September 6, 2021 by catturd

[Someone Else]

1 hour ago, catturd said:

No premise,  just facts. But okay, so just use Comirnaty then, BUT WAIT....there ain't none yet.

 

But there is a huge elephant in the room.  Under EUAs, the government pays for the product and the manufacturer has NO liability, unless you can prove willful misconduct AND the DHHS Secretary allows you to sue. That has never happened.

But once the product (Pfizer’s vaccine, today) is licensed, the liability shield under EUA disappears. Unless there has a been a secret agreement regarding liability after approval, which is probably not legal, Pfizer will be liable for all injuries sustained by the licensed vaccine. And Pfizer’s vaccine seems to be causing a record number of injuries and deaths, based on the VAERS data.

 

Dr. Nass importantly notes that the new, approved vaccine will carry a brand name (Comirnaty) and have liability attached to its use, whereas the unbranded, emergency-use vaccine didn’t/doesn’t. Would Pfizer risk being liable for its product given its current safety record? (A new bill in Congress is trying to have their liability removed).

 

https://truthpeep.com/tag/comirnaty-brand-name/

https://alethonews.com/2021/08/23/are-the-fda-and-pfizer-biontech-scamming-us-with-a-license-in-name-only-why-do-they-want-us-vaccinated-so-badly/

The fact and law is that Comirnaty is included by the liability protections in the US conferred by the PREP Act, your suspect sources are peddling falsehoods. 

 

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

 

https://www.factcheck.org/2021/08/scicheck-researcher-distorts-facts-on-covid-19-vaccine-approval-liability/

 

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

 

 

Edited September 6, 2021 by Someone Else

[Rimmer]

A post with a link to a highly questionable source has been removed also a reply

[placeholder]

6 hours ago, Someone Else said:

The fact and law is that Comirnaty is included by the liability protections in the US conferred by the PREP Act, your suspect sources are peddling falsehoods. 

 

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

 

https://www.factcheck.org/2021/08/scicheck-researcher-distorts-facts-on-covid-19-vaccine-approval-liability/

 

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

 

 

As that Washington Post article you linked to points out, this began when Robert Malone made that claim about liability during an interview. Subsequently he explicitly acknowledged that he was wrong:

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

 

[Rimmer]

A couple of misleading posts have been removed

[codemonkey]

It was only a matter of time until someone saw thru the FDA / pfizer confusing vaccine "approval".

 

https://brjm.org/2021/12/federal-judge-rejects-claim-pfizer-comirnaty-same/

 

https://www.technocracy.news/federal-judge-rejects-dod-claim-that-pfizer-eua-and-comirnaty-vaccines-are-interchangeable/

Edited December 2, 2021 by codemonkey

[codemonkey]

On 9/4/2021 at 10:25 AM, mtls2005 said:

Yep. As are your posts.

 

 

 

No clue what you're on about? Comirnaty is a brand name for the Pfizer/BioNTech vaccine.

 

North of 200 million doses of Comirnaty have been administered to date.

 

 

Thanks but advice from you seems, well, downright looney.

 

 

Where in the USA can one find Comirnaty vaccine?

Not loony, unless you are a sheep perhaps |/!

[placeholder]

 

2 hours ago, codemonkey said:

It was only a matter of time until someone saw thru the FDA / pfizer confusing vaccine "approval".

 

https://brjm.org/2021/12/federal-judge-rejects-claim-pfizer-comirnaty-same/

 

https://www.technocracy.news/federal-judge-rejects-dod-claim-that-pfizer-eua-and-comirnaty-vaccines-are-interchangeable/

Maybe you're confused, but the issues raised by this judge are not what you think they are. Basically, it's about a legal technicality. The judge is saying that vials labelled under the old name may not be mandated , despite the FDA certifying that the contents are chemically identical. He clarified that, legally speaking, because they were manufactured before FDA gave full approval (BLA) for persons 16 and older, they may not qualify to be mandated. He made no scientific judgement on whether they are identical, which, of course they are, as the FDA as explicitly stated. It's just a name change to a brand name which Pfizer wasn't entitled to adopt until it got the BLA for the vaccine..

Also, the judge did not issue an injunction against the DOD to stop mandating vaccinations.

And just because one judge has made a preliminary finding, or upholds that plaintiffs' case, doesn't mean that it will be upheld on appeal.

And finally, the judge did explicitly acknowledge that the President does have the authority to require the members of the armed services be vaccinated whether the vaccine is being administered under BLA or EUA rules.

 

 

 

[codemonkey]

Whats clear about the judges ruling is that Comirnaty and Phizer CANNOT be used interchangably: "A federal district court judge rejected a claim by the U.S. Department of Defense that the Pfizer-BioNTech COVID-19 vaccine being administered under Emergency Use Authorization is interchangeable with Pfizer’s fully licensed Comirnaty vaccine.

 

In this case, an EUA is considered illegal and invalid if there is a fully licensed alternative available. This appears to be the case with Pfizer’s licensed Comirnaty while its EUA Pfizer-BioNTech is still on the market.

Pfizer retains EUA status and people cannot be mandated to take it. Comirnaty is FDA approved. It's exactly that, nothing terribly complicated about it. I think you are not seeing the implication here or refuse to admit it, and conveniently confused now that pfizer has EUA and NO FDA approval. Simple simple, no confusion for me. I expected this would come to light eventually. It's a good ruling based on sound legal principles.

 

And, all bidens vaccine mandates are being litigated currently and have all been blocked by all courts to date and will be settled at a later date. If the mandates were so critical, life and death critical path in nature, then maybe the people in the know would support and implemt vaccine mandates. They are not and that's very telling. Time will tell, but don't expect any vaccine mandates anytime soon.

 

FDA committed "bait and switch", the entire FDA pfizer "approval process" was underhanded and they have been called out on it by the courts and should come as no surprise.

Comirnaty case-FDA.pdf

Edited December 2, 2021 by codemonkey

[codemonkey]

2 hours ago, placeholder said:

And finally, the judge did explicitly acknowledge that the President does have the authority to require the members of the armed services be vaccinated whether the vaccine is being administered under BLA or EUA rules.

This is not in dispute and irrelevant to the pfizer vaccine & FDA bait and switch fiasco.

Edited December 2, 2021 by codemonkey

[codemonkey]

 

 

3 hours ago, placeholder said:

they are identical, which, of course they are, as the FDA as explicitly stated

They most certainly are not identical, impossible if they have different properties /additional chemicals.

FDA

If they are identical, why not just grant FDA approval to both Comirnaty and Phizer. Drop the EUA and be done with it and maybe more people would trust pfizer and the FDA.

Edited December 2, 2021 by codemonkey

[Jeffr2]

8 hours ago, codemonkey said:

Where in the USA can one find Comirnaty vaccine?

Not loony, unless you are a sheep perhaps |/!

Jeez.  Give up on this.  You've been going on for a long time.  Stop, please.