⚒️ULTRA NUCLEAR MAGA PATRIOT LUIS M.⚒️
@Luisjr40
23 August, 09:00
THE VAX IS NOT FULLY APPROVED
IT IS JUST AN EXTENSION OF THE EMERGENCY USE AUTHORIZATION, NOT A FULL APPROVAL. READ THE FDA'S STATEMENT.
https://www.fda.gov/media/...
IT IS JUST AN EXTENSION OF THE EMERGENCY USE AUTHORIZATION, NOT A FULL APPROVAL. READ THE FDA'S STATEMENT.
https://www.fda.gov/media/...
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Nancy Dyan
@LightHolder113
23 August, 09:07
In response ⚒️ULTRA NUCLEAR MAGA PATRIOT LUIS M.⚒️ to his Publication
It is approved, and the emergency use has been kept: “clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.”
It’s on page 2 of the FDA link you shared. I also included a second pic here of what a BLA is. I have seen so many people posting this, and saying it hasn’t been approved. I am only saying this so we don’t look ridiculous running around saying it’s not approved, when it 100% is.
It’s on page 2 of the FDA link you shared. I also included a second pic here of what a BLA is. I have seen so many people posting this, and saying it hasn’t been approved. I am only saying this so we don’t look ridiculous running around saying it’s not approved, when it 100% is.
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⚒️ULTRA NUCLEAR MAGA PATRIOT LUIS M.⚒️
@Luisjr40
23 August, 09:20
In response Nancy Dyan to her Publication
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Nancy Dyan
@LightHolder113
23 August, 09:28
In response ⚒️ULTRA NUCLEAR MAGA PATRIOT LUIS M.⚒️ to his Publication
The BLA screenshot I shared with you is from the FDA website. It’s the last one. Is this what you are referencing in your reply?
https://www.fda.gov/drugs/...
https://www.fda.gov/drugs/...
Types of Applications | FDA
Types of Applications
https://www.fda.gov/drugs/how-drugs-are-developed-and-approved/types-applicationsNotice: Undefined index: tg1tga_access in /home/admin/www/anonup.com/themes/default/apps/timeline/post.phtml on line 396
HOW TO GET AN EXEMPTION FROM THE PFIZER JAB:
(seven little steps)
1) The approval, including safety, is associated with National Clinical Trial (NCT) numbers: NCT04368728 and NCT04380701.
2) The committee who approved it did not referred the Pfizer product to the Vaccines and Related Biological Products Advisory Committee because their "review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues
that would have benefited from an advisory committee discussion".
3) This means their approval is based on the inclusion criteria within the two clinical trials.
(seven little steps)
1) The approval, including safety, is associated with National Clinical Trial (NCT) numbers: NCT04368728 and NCT04380701.
2) The committee who approved it did not referred the Pfizer product to the Vaccines and Related Biological Products Advisory Committee because their "review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues
that would have benefited from an advisory committee discussion".
3) This means their approval is based on the inclusion criteria within the two clinical trials.
09:33 PM - Aug 23, 2021
In response Nancy Dyan to her Publication
Only people mentioned by Luisjr40 in this post can reply
Un_ Qnown
@UnQnown
23 August, 10:39
In response ⚒️ULTRA NUCLEAR MAGA PATRIOT LUIS M.⚒️ to his Publication
ty sir!
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Nancy Dyan
@LightHolder113
23 August, 09:49
In response ⚒️ULTRA NUCLEAR MAGA PATRIOT LUIS M.⚒️ to his Publication
Interesting... What does this have to do with the FDA approval? I’m just trying to help eliminate fasle information 🤷🏼♀️ I tried.
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⚒️ULTRA NUCLEAR MAGA PATRIOT LUIS M.⚒️
@Luisjr40
23 August, 09:33
In response ⚒️ULTRA NUCLEAR MAGA PATRIOT LUIS M.⚒️ to his Publication
4) See the enclosed inclusion and exclusion criteria of both trials.
5) Find an exclusion criteria you belong to.
6) When being told you must get vaccinated, explain that the product approval was based on the exclusion criteria, and therefore, the approval does not apply to you.
7) Provide a conditional approval if they can provide you with evidence that the product is safe for your condition(s).
ENJOY!!!
https://clinicaltrials.gov...
https://clinicaltrials.gov...
https://www.youtube.com/wa...
5) Find an exclusion criteria you belong to.
6) When being told you must get vaccinated, explain that the product approval was based on the exclusion criteria, and therefore, the approval does not apply to you.
7) Provide a conditional approval if they can provide you with evidence that the product is safe for your condition(s).
ENJOY!!!
https://clinicaltrials.gov...
https://clinicaltrials.gov...
https://www.youtube.com/wa...
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MrE Kuff
@Eikcuf
24 August, 09:26
In response ⚒️ULTRA NUCLEAR MAGA PATRIOT LUIS M.⚒️ to his Publication
Inclusion Criteria:
Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to follow good practices to reduce their chances of being infected or spreading COVID-19), and other requirements of the trial.
They must be able to understand and follow trial-related instructions.
I'm informed - do not consent
I'm unwilling to comply with the requirements of the trial
I don't understand
seems easy enough
Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to follow good practices to reduce their chances of being infected or spreading COVID-19), and other requirements of the trial.
They must be able to understand and follow trial-related instructions.
I'm informed - do not consent
I'm unwilling to comply with the requirements of the trial
I don't understand
seems easy enough
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