The Mega-Thread for COVID Evangelists

Ekklesian said:
Apparently the licensed dose doesn't come out for many more months or years, and the current jab simply had an EUA extension indemnifying Pfizer for any adverse reactions.

www.americanthinker.com

The FDA did NOT grant full approval to the Pfizer shots

You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remain...
www.americanthinker.com www.americanthinker.com
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Moderna is seeking non approval for their vaccine as well! They should read Rockwell’s blog!😉
www.google.com

Moderna completes submission for full FDA approval of Covid-19 vaccine; Pfizer seeks approval for booster dose

Moderna announced on Wednesday it has completed its submission to the US Food and Drug Administration for full approval of its Covid-19 vaccine for people age 18 and older, and Pfizer and BioNTech announced they have begun submitting data for full FDA approval of a third dose of their vaccine.
www.google.com www.google.com
 
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Ekklesian said:
Apparently the licensed dose doesn't come out for many more months or years, and the current jab simply had an EUA extension indemnifying Pfizer for any adverse reactions.

www.americanthinker.com

The FDA did NOT grant full approval to the Pfizer shots

You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remain...
www.americanthinker.com www.americanthinker.com
Click to expand...
The newly named vaccine is fully approved for the two shot series to those 16 and up. The new EUA for the the newly named vaccine covers those 12-15 and immune compromised individual for a third shot. All the vaccine produced up through August 23 was made under the EUA license so it would make sense that they would continue to follow the terms of that agreement.
 
tmjbog said:
The newly named vaccine is fully approved for the two shot series to those 16 and up. The new EUA for the the newly named vaccine covers those 12-15 and immune compromised individual for a third shot. All the vaccine produced up through August 23 was made under the EUA license so it would make sense that they would continue to follow the terms of that agreement.
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'The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.'
 
tmjbog said:
The newly named vaccine is fully approved for the two shot series to those 16 and up. The new EUA for the the newly named vaccine covers those 12-15 and immune compromised individual for a third shot. All the vaccine produced up through August 23 was made under the EUA license so it would make sense that they would continue to follow the terms of that agreement.
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'The EUA extension letter extends the term of the EUA for the current drug and authorizes (licenses) the experimental use of the brand-name drug COMIRNATY. In the first paragraph on page 2, this letter references the license approval letter. In the second paragraph on page 2, the August 12 EUA is re-issued to include the name-branded drug in the emergency use authorization, and to add "language regarding warnings and precautions related to myocarditis and pericarditis." In the last paragraph on page 4, the EUA nature of the drugs is re-iterated, and COMIRNATY is additionally authorized for use for individuals aged 12 through 15 years.'
 
www.theepochtimes.com

Pfizer COVID-19 Vaccine Linked to Heart Inflammation Risk in Real-World Study

www.theepochtimes.com www.theepochtimes.com


'Real-world data from Israel linked Pfizer’s COVID-19 vaccine to an elevated risk of heart inflammation, researchers said this week.​
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'Israeli scientists found that vaccination likely caused myocarditis, or heart inflammation, in one to five people per 100,000 who wouldn’t have otherwise suffered the condition.​
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'However, they also said that getting COVID-19 was linked to a higher risk—with 11 inflammation events out of 100 attributed to the disease.'​
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...​
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'Dr. Grace Lee, of the Stanford University School of Medicine, highlighted how the risk of myocarditis was higher among COVID-19 patients than the vaccinated in an editorial accompanying the new study.'​

It doesn't prevent infection, but it relieves symptoms probably by preventing infection.

'“What is even more compelling about these data is the substantial protective effect of vaccines with respect to adverse events such as acute kidney injury, intracranial hemorrhage, and anemia, probably because infection was prevented. Furthermore, the persons with SARS-CoV-2 infection appeared to be at substantially higher risk for arrhythmia, myocardial infarction, deep-vein thrombosis, pulmonary embolism, pericarditis, intracerebral hemorrhage, and thrombocytopenia than those who received the BNT162b2 vaccine,” Lee wrote.'​
 
'Not everyone was enthused by the research, however.​
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'Dr. Vinay Prasad said issues in the study included the lack of a one-dose cohort, as Pfizer’s regimen requires two doses, and it not identifying people who recovered from COVID-19 but didn’t get vaccinated.​
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'“You need to report separately for boys aged 16-24, who face a vastly higher rate of myocarditis and may not gain much beyond 1 dose,” Prasad, an associate professor in the Department of Epidemiology and Biostatistics at the University of California–San Francisco, wrote on Twitter.'​
 
Ekklesian said:
'The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.'
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You are partially correct. Those would be called phase 4 trials. What is a phase 4 trial? It's clinical trials done after FDA approval. If you are going to call Pfizer's vaccine not fully approved based on that, then there are several other approved drugs you would have to designate as not fully approved as well. The FDA does not license a drug than ignore it. They monitor everything about it. How it's packaged, how and where it's manufactured, and in some cases require phase 4 trials. Nothing unprecedented about that.
Attached is information on the phase 4 clinical trials for the Chicken Pox vaccine, Nasonex.

Nasonex and Chickenpox, a phase IV clinical study of FDA data - eHealthMe

Chickenpox is found among people who take Nasonex, especially for people who are female, 40-49 old, have been taking the drug for 6 - 12 months
www.ehealthme.com
 
Ekklesian said:
'The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.'
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The FDA thinks they approved the vaccine. You should contact them and tell them what the good people of the Land of Make Believe think they missed.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

www.fda.gov

FDA Approves First COVID-19 Vaccine

FDA approved the first COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.
www.fda.gov www.fda.gov
 
tmjbog said:
The FDA thinks they approved the vaccine. You should contact them and tell them what the good people of the Land of Make Believe think they missed.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

www.fda.gov

FDA Approves First COVID-19 Vaccine

FDA approved the first COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.
www.fda.gov www.fda.gov
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Ummm, which is what I said, months or years. Wait for the vial labeled Comirnaty. The jab under any other name is not FDA approved, and Pfizer is shielded from any liability.

The FDA is a bureaucracy. Labels count.
 
Ekklesian said:
Ummm, which is what I said, months or years. Wait for the vial labeled Comirnaty. The jab under any other name is not FDA approved, and Pfizer is shielded from any liability.

The FDA is a bureaucracy. Labels count.
Click to expand...
Ekklesian said:
This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.'
Click to expand...
 
That's a quote from the article. MY words were "Apparently the licensed dose doesn't come out for many more months or years, and the current jab simply had an EUA extension indemnifying Pfizer for any adverse reactions."
 
The 'fully' vaxxed are more vulnerable to covid variants.


'This study demonstrated that natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity. Individuals who were both previously infected with SARS-CoV-2 and given a single dose of the vaccine gained additional protection against the Delta variant.'


About medRxiv

Advancing the sharing of research results for the health sciences

medRxiv - The Preprint Server for Health Sciences
www.medrxiv.org www.medrxiv.org
 
Ekklesian said:
That's a quote from the article. MY words were "Apparently the licensed dose doesn't come out for many more months or years, and the current jab simply had an EUA extension indemnifying Pfizer for any adverse reactions."
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Ok. Well you quoted in your post so I assumed you were in agreement with it. It appears that we agree then. Pfizer vaccine produced after August 23rd is FDA approved with the exception of those being used for people under age 16 and 3rd shots, which are still covered by EUA.
 
Ekklesian said:
The 'fully' vaxxed are more vulnerable to covid variants.


'This study demonstrated that natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity. Individuals who were both previously infected with SARS-CoV-2 and given a single dose of the vaccine gained additional protection against the Delta variant.'


About medRxiv

Advancing the sharing of research results for the health sciences

medRxiv - The Preprint Server for Health Sciences
www.medrxiv.org www.medrxiv.org
Click to expand...
Now if only it was peer reviewed and a double blind study. It opens up a possibility but too early to tell if it holds up to scrutiny.
 
tmjbog said:
It appears that we agree then. Pfizer vaccine produced after August 23rd is FDA approved with the exception of those being used for people under age 16 and 3rd shots, which are still covered by EUA.
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Produced, not given. It has to have the right label. The devil is in the details.
 
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