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To: Bob Ireland; ransomnote; greeneyes

Hubby won’t accept that comirnaty vaxx is different from the version people were given. Do you have anything definitive to prove that?


1,144 posted on 09/11/2021 7:59:45 AM PDT by Melian (Faithless is he that says farewell when the road darkens. ~ Gimli)
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To: Melian

I have a friend who didn’t understand the differences between the two vaccines. Here’s my response to him:

On 23 August 2021 the FDA sent out two letters, one to Pfizer (https://www.fda.gov/media/150386/download) and one to BioNTech (https://www.fda.gov/media/151710/download). What follows is my summary of the letters.

Pfizer (U.S.) and BioNTech (Germany) trade as separate companies on the stock markets. The two companies have partnered with one other on vaccine development, and each has a COVID vaccine. The two vaccines, while not exactly the same, are similar. The Pfizer vaccine is available in the United States, but the BioNTech vaccine (now called CORMIRNATY) has yet to be marketed in the United States. When COMIRNATY becomes available the manufacturing and marketing will be done by Pfizer. The FDA letter to Pfizer makes clear (footnote 8) that the two vaccines are “legally distinct.” That is an important point.

The letter to Pfizer extends the EUA (Emergency Use Authorization) to their vaccine, which is identified by the name “Pfizer-BioNTech COVID-19 Vaccine.” It will continue to be made available to those over 12 years old. Under the EUA Pfizer has a liability waiver (or shield), meaning that you cannot sue them if you are adversely affected by the vaccine. According to the two letters, the supplies of the Pfizer vaccine will be exhausted before we get to the COMIRNATY vaccine. Thus, at least in the near future, the vaccines and boosters given will be the Pfizer-BioNTech COVID-19 Vaccine and will be given under the EUA with the liability waiver. In this letter (and also the one to BioNTech) the FDA provides a warning about myocarditis, pericarditis, and other complications. The letter does NOT give full FDA approval for the Pfizer vaccine. (See page 12 in the Pfizer letter: “This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA...”)

The letter to BioNTech approves the biologics license application (BLA) submitted by BioNTech, meaning that it has “full FDA approval” and can be given to those aged 16 and over. The official name of the vaccine seems to be “COMIRNATY (COVID-19 Vaccine, mRNA).” The FDA bypassed the normal advisory committee and public comment process for this license. It is not clear when this vaccine will be available, but when it is there will be no liability shield. That is, the vaccine providers can be sued if something goes wrong.

Most likely, Pfizer will not make the COMIRNATY vaccine available until they can somehow arrange for a legal shield from liability. So it appears that the Pfizer vaccine will continue to be given for some time. It seems to me that under this arrangement people are likely to misconceive that the vaccine has been fully approved, and Pfizer can rest assured that they won’t have to go to court to defend their product.

Conclusion: Any claim that the Pfizer vaccine (i.e., the Pfizer-BioNTech COVID-19 vaccine that has been given over the last year and will continue to be given) has “full FDA approval” is blatantly false, as evidenced by the letters from the FDA to the two companies. The COMIRNATY vaccine does have FDA approval, but at this time it is not available in the United States. It will not become available until either Pfizer gives up its liability waiver or somehow manages to have its waiver extended to the COMIRNATY vaccine. My understanding is that this extension would be difficult to obtain.


1,165 posted on 09/11/2021 8:44:51 AM PDT by econprof
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To: Melian
***Hubby won’t accept that comirnaty vaxx is different from the version people were given. Do you have anything definitive to prove that?***

I am not real clear on that -- do you mean 'comirnaty' different from Pfizer–BioNTech? ...or different from Moderna mRNA-1273 sold under the brand name Spikevax? As to comparison to Moderna, my understanding is that they are separate vaccines although using similar technology. The Moderna was modified to where it did not need such deep freezing.

Concerning 'comirnaty' and Pfizer and BioNTech, the FDA states: On August 23, 2021, the FDA 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, for the prevention of COVID-19 disease in individuals 16 years of age and older..

You can read much of the information for the 'comirnaty' and Pfizer BioNTech vaccine on Wikipedia.

1,216 posted on 09/11/2021 12:31:02 PM PDT by Bob Ireland (The Democrap Party is the enemy of freedom.They use all the seductions and deceits of the Bolshevics)
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