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jswirs 08-25-2021 05:02 AM

Quote:

Originally Posted by roscoguy (Post 1993541)
Sorry GE, but you're most likely wasting your breath & unnecessarily raising your BP. Several weeks ago, I watched a video* of an interview with (IIRC) a psychologist who explained why conspiracy theories are nearly impossible to disprove; they are basically self-healing. When confronted with a provable fact, the narrative just changes to something like 'well then, what about this (tangent/segue)' or 'we all know that (fill in the blank) has lied to us before, so I don't trust anything they say', etc, etc, etc. Once people have bought into the cult mantra, it's exceptionally difficult to 'deprogram' most of them.

* I should try to find the link to the video, but it really doesn't matter...

"The best predictor of future behavior is past behavior", re: Agent Orange, etc., etc.

Bill14564 08-25-2021 06:17 AM

Quote:

Originally Posted by drducat (Post 1993889)
More conspiracy info from the FDA.

Anyone caring to read up on the BioNTech COVID-19 Vaccine Comirnaty (the fully approved vaccine, which is not available yet) and the Pfizer-BioNTech vaccine which has not been approved and is still under EUA (Emergency Use Authorization). Take a look at the fact sheets FDA has on the two.

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA


/// a lot removed to save space ///

Well, you read far enough to find those paragraphs. Too bad you didn't understand the very clear English in them.

There are NOT two vaccines, there is the ONE Pfizer vaccine that has been administered since 2020.

The vaccine is the same, they chose a name to put on the box and they changed the label to note the approval. Boxes shipped before Monday don't have the new name or the new label but "have the same formulation and can be used interchangeably to provide the COVID-19 vaccination." (that was from the paragraph you chose to copy)

Some try to make mountains out of molehills - there isn't even a molehill here.

drducat 08-25-2021 07:27 AM

Quote:

Originally Posted by Bill14564 (Post 1993955)
Well, you read far enough to find those paragraphs. Too bad you didn't understand the very clear English in them.

There are NOT two vaccines, there is the ONE Pfizer vaccine that has been administered since 2020.

The vaccine is the same, they chose a name to put on the box and they changed the label to note the approval. Boxes shipped before Monday don't have the new name or the new label but "have the same formulation and can be used interchangeably to provide the COVID-19 vaccination." (that was from the paragraph you chose to copy)

Some try to make mountains out of molehills - there isn't even a molehill here.

You better read it again! The same formula different vaccines...period.

drducat 08-25-2021 07:29 AM

Quote:

Originally Posted by drducat (Post 1994016)
You better read it again! The same formula different vaccines...period.

Go ahead and see if you can get the BioNTech vaccine.....not available.

Bill14564 08-25-2021 07:33 AM

Quote:

Originally Posted by drducat (Post 1994016)
You better read it again! The same formula different vaccines...period.

Quote:

Originally Posted by drducat (Post 1994017)
Go ahead and see if you can get the BioNTech vaccine.....not available.

If you honestly don't understand, I will try to help you. If you are just trolling, I have better things to do.

drducat 08-25-2021 08:20 AM

Quote:

Originally Posted by Bill14564 (Post 1994022)
If you honestly don't understand, I will try to help you. If you are just trolling, I have better things to do.

What I am seeing is the original Pfizer is still EUA only and the BioNTech is fully approved. My understanding the BioNTech is not yet available and the pfizer is.

Pfizer is still not liable and BioNTech will be once on market. The FDA sent out 2 different letters, one for each product.

Nothing about swapping labels which is not legal is it?

Bill14564 08-25-2021 08:41 AM

Quote:

Originally Posted by drducat (Post 1994052)
What I am seeing is the original Pfizer is still EUA only and the BioNTech is fully approved. My understanding the BioNTech is not yet available and the pfizer is.

Pfizer is still not liable and BioNTech will be once on market. The FDA sent out 2 different letters, one for each product.

Nothing about swapping labels which is not legal is it?

Of course swapping labels is not legal which is why the extra language exists and, if you are being sincere, why you are confused.

Product shipped prior to FDA approval was labeled for the EUA use. Much of that product was shipped and is now waiting for arms. Product produced now that the approval has been granted will be labeled accordingly. A short name, Comirnaty, has been chosen (and most likely licensed) for the product and will appear on the new label. Nothing has changed in the product itself but the labeling needed to be changed to reflect the new status with the FDA.

Note that since the approval was for 16 and over it was necessary to state that the product with the new name is covered by the EUA for 12-15 year olds and for third shot boosters. Otherwise, when the product with the old labeling was gone there would be no vaccine available for the 12-15 range.

I did not see separate letters for the two names or separate FAQ sheets for the two names or anything at all that implied there were two separate vaccines. All I found was clarification that the formulation was the same and that despite the name difference, each could be used under the EUA for the 12-15 range and "boosters" and each could be used for the 16 and over range.

The following sections from the revised EUA LOA may help explain things:
8. 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.
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of Pfizer-BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses (i.e., for use to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise).
BB. This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine, mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Conditions A through W in this letter apply when COMIRNATY (COVID-19 Vaccine, mRNA) is provided for the uses described in this subsection III.BB, except that product manufactured and labeled in accordance with the approved BLA is deemed to satisfy the manufacturing, labeling, and distribution requirements of this authorization.

drducat 08-25-2021 09:55 AM

Quote:

Originally Posted by Bill14564 (Post 1994068)
Of course swapping labels is not legal which is why the extra language exists and, if you are being sincere, why you are confused.

Product shipped prior to FDA approval was labeled for the EUA use. Much of that product was shipped and is now waiting for arms. Product produced now that the approval has been granted will be labeled accordingly. A short name, Comirnaty, has been chosen (and most likely licensed) for the product and will appear on the new label. Nothing has changed in the product itself but the labeling needed to be changed to reflect the new status with the FDA.

Note that since the approval was for 16 and over it was necessary to state that the product with the new name is covered by the EUA for 12-15 year olds and for third shot boosters. Otherwise, when the product with the old labeling was gone there would be no vaccine available for the 12-15 range.

I did not see separate letters for the two names or separate FAQ sheets for the two names or anything at all that implied there were two separate vaccines. All I found was clarification that the formulation was the same and that despite the name difference, each could be used under the EUA for the 12-15 range and "boosters" and each could be used for the 16 and over range.

The following sections from the revised EUA LOA may help explain things:
8. 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.
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of Pfizer-BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses (i.e., for use to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise).
BB. This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine, mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Conditions A through W in this letter apply when COMIRNATY (COVID-19 Vaccine, mRNA) is provided for the uses described in this subsection III.BB, except that product manufactured and labeled in accordance with the approved BLA is deemed to satisfy the manufacturing, labeling, and distribution requirements of this authorization.

Thank you!

The fact sheets are here:

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA

The letters I need to find again.

Aloha1 08-27-2021 04:47 PM

Quote:

Originally Posted by Byte1 (Post 1991988)
An interesting point:
Only about 20-30% of U.S. doctors are paying members of the AMA. SO, I am curious if they are speaking for ALL doctors in regards to having been vaccinated or just members?

Not since the AMA went "woke". They no longer represent the majority of Physicians in the U.S. and haven't for years.

larbud 08-27-2021 04:56 PM

I need to sh1t,All this smoke blown up My a@@ has aggravated My intestinal fortitude..Just sayin..


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