Posted on 08/23/2021 3:28:09 PM PDT by Enlightened1
What is going on here?
Are we being lied to?
Specifically check page 2 and page 12.
Page 2:
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to 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. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID19 Vaccine, mRNA).
page 12: This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
https://www.fda.gov/media/150386/download
Cool! It will now PREVENT Covid instead of just lessening the severity of the symptoms. Says so right there.
I never, not once, said full approval wasn’t coming. I told others that it was coming.
You, like the pathetic scumbag that you are, are trying to flip the script.
Your claim, was that there was going to be a nationwide, federal mandate for all citizens to get the vaccine.
I said that there would not be a nationwide federal mandate.
I even offered a very clear a fair bet to you.
You refused to accept my bet like a coward.
I’ll restate my offer, and give you another chance. I’ll even give you to the end of November.
If there is not a federal mandate by November 30th, you agree never to post on FR again.
If there is, I’ll leave.
Are you game, or a coward?
Just so there isn’t any confusion about what was said, clown:
https://freerepublic.com/focus/news/3984543/posts?page=33#33
Now more will die. Tell the truth for once in your life.
Just so we are clear, there are two bets on the table for the coward JD:
Mine and Fury’s
https://freerepublic.com/focus/news/3984543/posts?page=87#87
JD won’t take any of the bets, and in true cowardly form, is lying about what other people have said.
It is not a vaccine. it is also killing people. No thanks to President Trump. This shot has created more turmoil and tyranny in the world than anything we could ever have imagined. Just look at Australia. That is coming here because of this fake and dangerous poison shot. There is no end to the amount of poison shots they will demand people to stick their arm out for. Anyone pushing this is causing this misery for mankind.
It has ruined lives and will continue to cause more pain and suffering than any virus could.
That part is particularly telling.
There are plenty of "concerns or controversial issues" regarding the injection.
For starters, it's clear that the efficacy of pfizer's injection is no where near what their clinical trials state when it comes to Delta, which is the predominant strain now.
Pfizer-BioNTech vaccine recipients have lower antibody levels targeting the Delta variant than other SARS-CoV-2 variants
https://www.crick.ac.uk/news/2021-06-03_pfizer-biontech-vaccine-recipients-have-lower-antibody-levels-targeting-the-delta-variant-than-other-sars-cov-2-variants
Right there in the "approval," they ADMIT there are "concerns or controversial issues." They are REQUIRING them to conduct several studies, over the course of SEVERAL YEARS in order to "assess known serious risks of myocarditis and pericarditis"
POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)
Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological product applications to conduct postmarketing studies and clinical trials for certain purposes, if FDA makes certain findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)).
We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.
Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies:
4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 31, 2021
Monitoring Report Submission: October 31, 2022
Interim Report Submission: October 31, 2023
Study Completion: June 30, 2025
Final Report Submission: October 31, 2025
5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus
Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 11, 2021
Progress Report Submission: September 30, 2021
Interim Report 1 Submission: March 31, 2022
Interim Report 2 Submission: September 30, 2022
Interim Report 3 Submission: March 31, 2023
Interim Report 4 Submission: September 30, 2023
Interim Report 5 Submission: March 31, 2024
Study Completion: March 31, 2024
Final Report Submission: September 30, 2024
6. Study C4591021 substudy to describe the natural history of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: January 31, 2022
Study Completion: March 31, 2024
Final Report Submission: September 30, 2024
7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network).
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021
Study Completion: December 31, 2026
Final Report Submission: May 31, 2027
8. Study C4591007 substudy to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this assessment according to the following schedule:
Final Protocol Submission: September 30, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
9. Study C4591031 substudy to prospectively assess the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021
Study Completion: June 30, 2022
Final Report Submission: December 31, 2022
Please submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN BL 125742 explaining that these protocols were submitted to the IND. Please refer to the PMR sequential number for each study/clinical trial and the submission number as shown in this letter.
Please submit final study reports to the BLA. If the information in the final study report supports a change in the label, the final study report must be submitted as a supplement to this BLA STN BL 125742.
More here: https://freerepublic.com/focus/news/3988135/posts
Page 6 - Pfizer Inc.:
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.
So yes, it does look like we are being lied to. Good catch.
A revision of the EUA to include a 3rd dose for immunocompromised individuals....full approval still ongoing.
“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.”, (and other revisions).
Thank you!
I did not catch it. Someone else did.
I reposted it because I figure people could clarify it since it is legalese.
Advance to about 1:45
Bingo
Approved and with an EUA for young people.
Maybe try another line of work. Gaslighting, it’s not good.
Yeah, but I think they got “full approval” today for “over 16, 2 doses”...according to the radio news report I heard today...still “EUA” for under 16 and 3rd dose for immunocompromised.
So with approval are they liable for damages now?
The 3rd jab is proof it the first 2 did not work.
All those that submit. The jabs will never end.
Typical government flim flam.
That appears to just be a license to manufacture it, probably under agreement with Pfizer...
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