Pfizer vaccine gets full FDA Approval in the USA

[impulse]

7 hours ago, Jeffr2 said:

It's a full FDA approval. Admit it.

 

A majority of us are on the right side of this very complicated issue. And don't let conspiracy theories cloud our judgment nor politics.

The full approval of Pfizer by the FDA follows the same trajectory as the full approval of the 737 Max by the FAA.  They've turned over pretty much the entire testing/evaluation process to the manufacturer.  What could possibly go wrong?

 

We won't know who's on the right side of this until they crash and burn.  Or they don't.  But that'll be after a few years, which is the normal timeline for the approval process for a new vaccine.

 

Edited August 24, 2021 by impulse

[gk10012001]

4 hours ago, impulse said:

The full approval of Pfizer by the FDA follows the same trajectory as the full approval of the 737 Max by the FAA.  They've turned over pretty much the entire testing/evaluation process to the manufacturer.  What could possibly go wrong?

 

We won't know who's on the right side of this until they crash and burn.  Or they don't.  But that'll be after a few years, which is the normal timeline for the approval process for a new vaccine.

 

Yes, years normally.  But some people just seem to ignore that and jump on the current bandwagon

[catturd]

The pfizer booster shot remains under EUA, and is not fully approved.

https://www.newsweek.com/pfizer-covid-vaccine-live-updates-fda-holds-briefing-full-approval-shot-1622078

[Bohemianfish]

Now US military members will have to take it. Many have not.

[placeholder]

3 hours ago, catturd said:

The pfizer booster shot remains under EUA, and is not fully approved.

https://www.newsweek.com/pfizer-covid-vaccine-live-updates-fda-holds-briefing-full-approval-shot-1622078

It is fully approved for 2 doses for those aged 16 and older. EULA does not apply to them. 

[Chomper Higgot]

6 hours ago, gk10012001 said:

Yes, years normally.  But some people just seem to ignore that and jump on the current bandwagon

Jump

on the current bandwagon you say?!

[placeholder]

17 minutes ago, Chomper Higgot said:

Jump

on the current bandwagon you say?!

It turns out that the vast majority of virologists and epidemiologists are possessed of powerful calf muscles. Covid vaccine denialists not so much.

[catturd]

Yes, my understanding is Cominarty has obtained FDA approval, but Pfizer did not and still maintains it's EUA only. Interesting to see who will get cominarty and WHEN as Pfizer is shielded from liability, Cominarty is not.

[placeholder]

48 minutes ago, catturd said:

Yes, my understanding is Cominarty has obtained FDA approval, but Pfizer did not and still maintains it's EUA only. Interesting to see who will get cominarty and WHEN as Pfizer is shielded from liability, Cominarty is not.

False.

 

Researcher Distorts Facts on COVID-19 Vaccine Approval, Liability

The Pfizer/BioNTech COVID-19 vaccine was fully approved by the Food and Drug Administration, though an emergency use authorization also remains in place. Dr. Robert Malone misleadingly said Americans are being offered the shot only under the latter and that it carried different liability ramifications. The liability protections, afforded under a public health law, are the same for the two.

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

 

The false claim that the fully-approved Pfizer vaccine lacks liability protection

“The little trick that they have done here: They have issued two separate letters for two separate vaccines. The Pfizer vaccine which is currently available is still under emergency use authorization and it still has the liability shield … The product that’s licensed … it’s called Comirnaty. … that’s the one that liability waiver will no longer apply to.”

— Robert Malone, interview on Bannons War Room, Aug. 24

These claims are false, based on a misunderstanding of the law, as Malone acknowledged after we contacted him.

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

[catturd]

What I find curious is why is comirnaty required if Phizer is approved, (as they are same ingredients) but not really approved unless it is called comirnaty which is not available (comirnaty) at this time according to pfizer and will be in clinical trials until 2025. Check footnote 9 of the FDA letter sent to pfizer AUG23 attesting to comirnaty availability.

So, keep using EUA pfizer (no liability) until such time after 2025, if comirnaty passes scrutiny and all know risks and side effects are listed into the record at which time liability becomes a huge issue for pfizer,,,,,BUT not/never as long as EUA pfizer vaccine is used. Very sneaky, underhanded.

[placeholder]

7 hours ago, catturd said:

What I find curious is why is comirnaty required if Phizer is approved, (as they are same ingredients) but not really approved unless it is called comirnaty which is not available (comirnaty) at this time according to pfizer and will be in clinical trials until 2025. Check footnote 9 of the FDA letter sent to pfizer AUG23 attesting to comirnaty availability.

So, keep using EUA pfizer (no liability) until such time after 2025, if comirnaty passes scrutiny and all know risks and side effects are listed into the record at which time liability becomes a huge issue for pfizer,,,,,BUT not/never as long as EUA pfizer vaccine is used. Very sneaky, underhanded.

You are batting 100% for falsehoods. 

https://www.reuters.com/article/factcheck-fda-pfizer/fact-check-media-reports-have-not-lied-about-pfizer-biontechs-fda-approval-idUSL1N2PY0OL

If you really had something, you would quote that footnote instead of asking others to look it up.

[gargamon]

On 8/24/2021 at 11:14 AM, i84teen said:

Time for reality.

https://worldmedicinefoundation.com/health-news/pfizer-ceo-says-covid-19-vaccine-resistant-variant-likely-to-emerge/

Yes, time for reality. If everyone was vaccinated, there would be no more variants. The unvaccinated are the source for the variants.

[catturd]

Again, FDA approved comirnaty, on AUG 23 not pfizer which maintains EUA.

Edited September 3, 2021 by catturd

[catturd]

1 hour ago, gargamon said:

Yes, time for reality. If everyone was vaccinated, there would be no more variants. The unvaccinated are the source for the variants.

And since vaccine's don't prevent transmission, herd immunity is a long shot.

[placeholder]

17 minutes ago, catturd said:

Again, FDA approved comirnaty, on AUG 23 not pfizer which maintains EUA.

Lewis Carroll wrote a poem called The Hunting of the Snark. In it is made the assertion that if you say something 3 times it's true. So if that nonsense poem is the source of your authority, you may have a point. Just one more assertion and you've arrived. Otherwise, why not try providing some actual proof? You know, the kind that you yourself provide a verifiable link and not the kind where you ask others to look it up for themselves. 

[catturd]

50 minutes ago, placeholder said:

Lewis Carroll wrote a poem called The Hunting of the Snark. In it is made the assertion that if you say something 3 times it's true. So if that nonsense poem is the source of your authority, you may have a point. Just one more assertion and you've arrived. Otherwise, why not try providing some actual proof? You know, the kind that you yourself provide a verifiable link and not the kind where you ask others to look it up for themselves. 

Prove my statement is false.

As I thought, you won't cuz you can't. Facts are facts, deal with it or get outta the game if you can't hack it.

[placeholder]

2 minutes ago, catturd said:

Prove my statement is false.

As I thought, you won't cuz you can't. Facts are facts, deal with it or get outta the game if you can't hack it.

Intellectually honorable people back up their claims. I've looked in vain for any evidence either for or against your claim and found none. If I were to claim aliens from Alpha Centauri were behind the covid epidemic, I daresay you couldn't find any evidence for or against that. Does that mean it's true?  To put it another old-fashioned way "Where's the beef?"

[catturd]

50 minutes ago, placeholder said:

Intellectually honorable people back up their claims. I've looked in vain for any evidence either for or against your claim and found none. If I were to claim aliens from Alpha Centauri were behind the covid epidemic, I daresay you couldn't find any evidence for or against that. Does that mean it's true?  To put it another old-fashioned way "Where's the beef?"

Go read FDA letter issued to a Ms. Elisa Harkins at pfizer on Aug 23. Quit being obtuse, read the letter, absorb the facts and details and maybe go write a poem about it. 555.

 

[placeholder]

1 hour ago, catturd said:

Go read FDA letter issued to a Ms. Elisa Harkins at pfizer on Aug 23. Quit being obtuse, read the letter, absorb the facts and details and maybe go write a poem about it. 555.

 

Read it. Nothing there. Your claim is ridiculous. Here's a link to the letter. 

https://www.fda.gov/media/151710/download

You've got nothing.

 

[cdemundo]

On 8/23/2021 at 7:52 PM, EVENKEEL said:

You know how childish y ou sound with the constant name calling, you don't stop. But this is the way of extreme leftists. Create boxes to separate the people. Everybody has to belong in a box, no individuality. 

What name calling? You mean "anti-vaxxer"? I don't get it.

[cdemundo]

4 hours ago, catturd said:

Again, FDA approved comirnaty, on AUG 23 not pfizer which maintains EUA.

"Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. 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."

 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

 

Pretty simple statement the vaccine "has been known as the Pfizer-BioNTech COVID-19 Vaccine" and "will now be marketed as Comirnaty".  This vaccine has been approved as of August 23, 2021.

 

[placeholder]

13 minutes ago, cdemundo said:

What name calling? You mean "anti-vaxxer"? I don't get it.

You know how childish you sound generalizing this way about leftists? But that's the way it is with all right wingers. And you know what the difference between you and me is? I know how intellectually bankrupt it is to generalize this way.

[mtls2005]

6 hours ago, catturd said:

Prove my statement is false.

 

Never understood why folks who make this specious argument somehow think it's a "winner"?

 

It's nothing if not the opposite.

 

 

 

 

[Ryan754326]

9 hours ago, gargamon said:

Yes, time for reality. If everyone was vaccinated, there would be no more variants. The unvaccinated are the source for the variants.

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

 

Edited September 4, 2021 by Ryan754326

[EVENKEEL]

4 hours ago, cdemundo said:

What name calling? You mean "anti-vaxxer"? I don't get it.

You prove my point beautifully, you don't get it. Because someone questions, they are put into a labeled box. So much for being an individual. Conform or else.

[placeholder]

1 hour ago, mtls2005 said:

 

Never understood why folks who make this specious argument somehow think it's a "winner"?

 

It's nothing if not the opposite.

 

 

 

 

I recall that Donald Rumsfeld once said "Absence of evidence is not evidence of absence." It turns it that, in fact, it was. 

[cdemundo]

1 hour ago, EVENKEEL said:

You prove my point beautifully, you don't get it. Because someone questions, they are put into a labeled box. So much for being an individual. Conform or else.

I didn't prove your point, you used the phrase "name calling" incorrectly. 

 

It's a question of English usage.

 "Name calling" if you check the definition given by Google is "abusive language or insults."

[Google uses "Definitions from Oxford Languages" for its definitions.]

 

You are objecting to people being classified as "anti-vaxxers", that might be described as "inappropriate labeling" or "pigeonholing".

It isn't name calling.

Name calling would be something like calling someone a "cork sacker" or a "mother flower", or simply "stupid" as some here do.

Edited September 4, 2021 by cdemundo

[cdemundo]

6 hours ago, placeholder said:

You know how childish you sound generalizing this way about leftists? But that's the way it is with all right wingers. And you know what the difference between you and me is? I know how intellectually bankrupt it is to generalize this way.

Don't shoot me, I'm only the piano player.

[MrJ2U]

On 8/23/2021 at 10:06 PM, gk10012001 said:

Trying to generalize what an antivaxer is, or means makes no sense.  Many people object for various reasons

1. Definition of anti-vaxxer noun from the Oxford Advanced Learner's Dictionary

   anti-vaxxer

    noun

    

   /ˌænti ˈvæksə(r)/

    

   /ˌænti ˈvæksər/, 

    

   /ˌæntaɪ ˈvæksər/

   (informal)

   1. a person who is opposed to vaccination, especially a parent who does not wish to vaccinate their child because they believe it could be harmful
      • The outbreak of measles has been blamed on anti-vaxxers who refuse to vaccinate their kids.

    

    

   https://www.oxfordlearnersdictionaries.com/definition/english/anti-vaxxer

Edited September 4, 2021 by MrJ2U
Link added

[placeholder]

1 minute ago, cdemundo said:

Don't shoot me, I'm only the piano player.

Actually, you were an innocent bystander.  I meant my comments for someone else. I only hope that you're guilty of something else truly hidden heinous that will prove what I have long suspected: that even my misfires are doing the Lord's work. Amen.