Coronavirus

xjtony

Well-Known Member
Location
Grantsville, Ut
Why would the FDA approve a vaccine not available in the US? The FDA doesn't have authority to approve a drug only available outside the US. That statements says that the US drug and the EUA approved drug are interchangable.
 
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85CUCVKRAWLER

Active Member
Location
Tooele
I guess you are looking for something that I'm not searching for. I'm not sure what is confusing about this statement from the FDA:
"the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns"

If you simply don't trust the FDA, I get it, but I don't think anything in this discussion is going to help with that.

Well considering every federal organization since the beginning has been lying to us, i dont see why more people arent looking for this stuff.
 

xjtony

Well-Known Member
Location
Grantsville, Ut
Well considering every federal organization since the beginning has been lying to us, i dont see why more people arent looking for this stuff.
I think people are looking, but what you are seeing is just not in that documentation man. I totally understand the mistrust in the FDA and feel that it's probably justified, but the facts still have to be verified.
 

glockman

I hate Jeep trucks
Location
Pleasant Grove
I had covid in November. I got the first Pfizer shot last week. Had a super sore arm and my heart was racing when I went to bed that night, but nothing else. I'm have a pretty low/average resting heart rate and have never had severe anxiety but it was freaking me out a bit.
I also had a bit of anxiety driving down to get the shot. I know it's a 0.0001% change of having an extreme adverse reaction, but I had zero reason to get it other than to keep being able to feed my family so I was irrationally uneasy.
 

Pike2350

Registered User
Location
Salt Lake City
Ok sure.

Then why isnt Pfizer-BioNTech fully approved? Thats the drug they will give you when you go down to get your Pfizer shot.

If Pfizer-BioNTech and COMIRNATY are they "same" then why arent they both fully approved?
The Pfizer-BioNTech is the name that was used to describe the vaccine, because it was a joint venture between US Pfizer and BioNTech company in Europe. Pfizer had to apply for approval under their own brand, in their own country. Pfizer went with the name of Comirnaty for US distribution. It simply branding and Pfizer applying a "retail name" to it.

The quote you posted even mentions that is is basically the same thing. The wording of interchangeable is meant to signify that they didn't alter the formula to get the full FDA approval.

1] COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. • It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. • It is also authorized under EUA to be administered to: o prevent COVID-19

I think you are searching in the weeds for some conspiracy at this point.
 

Pike2350

Registered User
Location
Salt Lake City
I had covid in November. I got the first Pfizer shot last week. Had a super sore arm and my heart was racing when I went to bed that night, but nothing else. I'm have a pretty low/average resting heart rate and have never had severe anxiety but it was freaking me out a bit.
I also had a bit of anxiety driving down to get the shot. I know it's a 0.0001% change of having an extreme adverse reaction, but I had zero reason to get it other than to keep being able to feed my family so I was irrationally uneasy.

not to make light of the anxiety, but I do find it interesting how so many will have anxiety about the shot but NO anxiety about getting Covid and having similar complications. I do get that getting the shot is willing getting it and therefore it increases the risk of the complications (in the persons mind) however it appears that the rate of severe complications with getting Covid are greater then the vaccine....but it is rarely a cause for concern for people.

I fell into this same thing...so not making light of it. I got Covid and never gave it a 2nd thought about it doing anything to me...but the shot had me a little more nervous.
 

glockman

I hate Jeep trucks
Location
Pleasant Grove
not to make light of the anxiety, but I do find it interesting how so many will have anxiety about the shot but NO anxiety about getting Covid and having similar complications. I do get that getting the shot is willing getting it and therefore it increases the risk of the complications (in the persons mind) however it appears that the rate of severe complications with getting Covid are greater then the vaccine....but it is rarely a cause for concern for people.

I fell into this same thing...so not making light of it. I got Covid and never gave it a 2nd thought about it doing anything to me...but the shot had me a little more nervous.
I do lots of risky things, but as you mentioned, I chose to do them and I understand the risk. I did not chose to get COVID. I was actually wearing a mask pretty religiously when I got it. If I'd known, I am going to go get COVID today, I'd probably experience the same anxiety. Having had it at least once and likely twice, I don't have much anxiety about it as I understand how my body reacts to it. The second shot will be much the same and I don't anticipate being nervous about it. But I totally understand it was an irrational emotion to begin with.
 

85CUCVKRAWLER

Active Member
Location
Tooele
The Pfizer-BioNTech is the name that was used to describe the vaccine, because it was a joint venture between US Pfizer and BioNTech company in Europe. Pfizer had to apply for approval under their own brand, in their own country. Pfizer went with the name of Comirnaty for US distribution. It simply branding and Pfizer applying a "retail name" to it.

The quote you posted even mentions that is is basically the same thing. The wording of interchangeable is meant to signify that they didn't alter the formula to get the full FDA approval.



I think you are searching in the weeds for some conspiracy at this point.

Again, for like the third time now. If you go to get a Pfizer vaccine right now, today, you will be given Pfizer-BioNTech, not COMIRNATY. If you ask to be given COMIRNATY, they will tell you it is not available. So you will not be given the "approved" drug and you cannot obtain the "approved" drug.
 

Stephen

Who Dares Wins
Moderator
Again, for like the third time now. If you go to get a Pfizer vaccine right now, today, you will be given Pfizer-BioNTech, not COMIRNATY. If you ask to be given COMIRNATY, they will tell you it is not available. So you will not be given the "approved" drug and you cannot obtain the "approved" drug.
This is like going to a doctor and demanding Tylenol but they only have acetaminophen and you refuse to take it because it's not the name brand.
 

xjtony

Well-Known Member
Location
Grantsville, Ut
Again, for like the third time now. If you go to get a Pfizer vaccine right now, today, you will be given Pfizer-BioNTech, not COMIRNATY. If you ask to be given COMIRNATY, they will tell you it is not available. So you will not be given the "approved" drug and you cannot obtain the "approved" drug.
I'd ask how many times have you asked and been told this? Is it possible that stockpiles of the vaccine were ordered prior to the FDA approval and may not carry the commercial name? The people administering these vaccines in many places are not necessarily experts either and may not understand the connection between the two. My experience is proof of that for sure. Holding our government accountable is very important, but I'm sorry, the documentation that you linked very simply does not say what you believe it does. Do you have other sources to solidify this claim? The documentation you linked states that the FDA approved Comirnaty, the commercial name for the Pfizer-BioNtech vaccine. It states they are interchangable. The EAU doesn't list the commercial name because that name was not applied to the vaccine at that stage.
 
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Mouse

Trying to wheel
Supporting Member
Location
West Haven, UT
This is like going to a doctor and demanding Tylenol but they only have acetaminophen and you refuse to take it because it's not the name brand.
Not sure I agree. When reading the FDA letters, they refer to these two as separate items from Pfizer. They even issued two separate letters, one for Comirnaty one for the "vaccine."
 

xjtony

Well-Known Member
Location
Grantsville, Ut
I had covid in November. I got the first Pfizer shot last week. Had a super sore arm and my heart was racing when I went to bed that night, but nothing else. I'm have a pretty low/average resting heart rate and have never had severe anxiety but it was freaking me out a bit.
I also had a bit of anxiety driving down to get the shot. I know it's a 0.0001% change of having an extreme adverse reaction, but I had zero reason to get it other than to keep being able to feed my family so I was irrationally uneasy.
It's interesting, when I was waiting for the doctor Thursday I was reading the "official" CDC FAQ. Their take is that any high BP issues are from people getting worried because they had the shot, not the vaccine it self. I'll have to grab a sheet when I'm at the VA next and post a picture.
 

N-Smooth

Smooth Gang Founding Member
Location
UT
It's interesting, when I was waiting for the doctor Thursday I was reading the "official" CDC FAQ. Their take is that any high BP issues are from people getting worried because they had the shot, not the vaccine it self. I'll have to grab a sheet when I'm at the VA next and post a picture.
I’ve experienced this with various dr office visits. The worst one was when I got snipped. They were like whoa your BP and heart rate are crazy high right now but they assured me they see that a lot. My numbers have always been good so it’s weird to see them jump up at appointments.
 

Jesser04

Well-Known Member
Location
Kaysville Utah
I’ve experienced this with various dr office visits. The worst one was when I got snipped. They were like whoa your BP and heart rate are crazy high right now but they assured me they see that a lot. My numbers have always been good so it’s weird to see them jump up at appointments.
I deal with this every time I go to the dr office usually goes hand in hand with elevated heart rate.

 

Stephen

Who Dares Wins
Moderator

DAA

Well-Known Member
That's the kind of gov't over reach that could eventually lead to a shooting battle. Telling private business that they have to tell their employees they have to get a series of shots... For covid? That's crossing a line. Maybe not the line, but it's heading in a very volatile, dangerous direction.

I willingly chose to be vaccinated but I'd make them fire me over this. I will NOT get a booster now. On principle. Go ahead and put a hundred million people out of work over this Liberals. See how that works out for you.

- DAA
 
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