Free Republic
Browse · Search
Bloggers & Personal
Topics · Post Article

Skip to comments.

Vaccine Not Approved, Simple EUA Is Extended
FDA ^ | 08/23/21

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


TOPICS: Chit/Chat; Conspiracy; Health/Medicine; Miscellaneous
KEYWORDS: 1takeit; 2andlikeit; antivaxxcult; assdr; comirnaty; eua; extended; fakenews; notapproved; obsession; vaccine
Navigation: use the links below to view more comments.
first previous 1-2021-4041-6061-74 next last
To: EEGator
"On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

Cool! It will now PREVENT Covid instead of just lessening the severity of the symptoms. Says so right there.

41 posted on 08/23/2021 4:20:33 PM PDT by Hatteras
[ Post Reply | Private Reply | To 3 | View Replies]

To: JD_UTDallas

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?


42 posted on 08/23/2021 4:22:51 PM PDT by TexasGurl24
[ Post Reply | Private Reply | To 40 | View Replies]

To: JD_UTDallas

Just so there isn’t any confusion about what was said, clown:

https://freerepublic.com/focus/news/3984543/posts?page=33#33


43 posted on 08/23/2021 4:24:30 PM PDT by TexasGurl24
[ Post Reply | Private Reply | To 40 | View Replies]

To: Hatteras

Hot damn, it’s magic!

https://www.youtube.com/watch?v=E0Kv6vxZwL8


44 posted on 08/23/2021 4:24:59 PM PDT by EEGator
[ Post Reply | Private Reply | To 41 | View Replies]

To: gas_dr

Now more will die. Tell the truth for once in your life.


45 posted on 08/23/2021 4:31:14 PM PDT by roving
[ Post Reply | Private Reply | To 10 | View Replies]

To: All

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.


46 posted on 08/23/2021 4:31:51 PM PDT by TexasGurl24
[ Post Reply | Private Reply | To 43 | View Replies]

To: gas_dr

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.


47 posted on 08/23/2021 4:35:01 PM PDT by dforest (huh)
[ Post Reply | Private Reply | To 10 | View Replies]

To: TexasGurl24; Enlightened1
"We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our 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"

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

48 posted on 08/23/2021 4:35:39 PM PDT by rxsid (HOW CAN A NATURAL BORN CITIZEN'S STATUS BE "GOVERNED" BY GREAT BRITAIN? - Leo Donofrio (2009))
[ Post Reply | Private Reply | To 7 | View Replies]

To: Enlightened1
Well actually they revised it to include product usage with children 12-15.

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.

49 posted on 08/23/2021 4:42:23 PM PDT by Robert DeLong
[ Post Reply | Private Reply | To 1 | View Replies]

To: Enlightened1; All

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).


50 posted on 08/23/2021 4:46:29 PM PDT by Drago
[ Post Reply | Private Reply | To 1 | View Replies]

To: rxsid

Thank you!


51 posted on 08/23/2021 4:47:33 PM PDT by Enlightened1
[ Post Reply | Private Reply | To 48 | View Replies]

To: Robert DeLong

I did not catch it. Someone else did.

I reposted it because I figure people could clarify it since it is legalese.


52 posted on 08/23/2021 4:48:36 PM PDT by Enlightened1
[ Post Reply | Private Reply | To 49 | View Replies]

To: Robert DeLong
Oops, on FDA website:

Acting FDA Commissioner Janet Woodcock and CBER Director Peter Marks discuss FDA’s approval of the first COVID-19 vaccine, August 23, 2021.

Advance to about 1:45

53 posted on 08/23/2021 4:54:53 PM PDT by Robert DeLong
[ Post Reply | Private Reply | To 49 | View Replies]

To: Drago

Bingo


54 posted on 08/23/2021 5:04:06 PM PDT by Enlightened1
[ Post Reply | Private Reply | To 50 | View Replies]

To: Enlightened1

Approved and with an EUA for young people.

Maybe try another line of work. Gaslighting, it’s not good.


55 posted on 08/23/2021 5:21:05 PM PDT by romanesq (TRUSTY THE PLAN! ChiCom Joe is the Plan? Que magnificent! 👹)
[ Post Reply | Private Reply | To 1 | View Replies]

To: Enlightened1

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.


56 posted on 08/23/2021 5:29:26 PM PDT by Drago
[ Post Reply | Private Reply | To 54 | View Replies]

To: gas_dr

So with approval are they liable for damages now?


57 posted on 08/23/2021 5:29:56 PM PDT by MercyFlush (The First Amendment Doesn't Care About Your Feelings)
[ Post Reply | Private Reply | To 10 | View Replies]

To: Drago

The 3rd jab is proof it the first 2 did not work.

All those that submit. The jabs will never end.


58 posted on 08/23/2021 5:33:52 PM PDT by Enlightened1
[ Post Reply | Private Reply | To 56 | View Replies]

To: Enlightened1

Typical government flim flam.


59 posted on 08/23/2021 5:37:16 PM PDT by cp124 (Focus on treatment and not an experimental vaccine/flu shot.)
[ Post Reply | Private Reply | To 1 | View Replies]

To: TexasGurl24; Enlightened1

That appears to just be a license to manufacture it, probably under agreement with Pfizer...


60 posted on 08/23/2021 5:47:46 PM PDT by Axenolith (WOOT! Another day without False Vacuum Decay!!!)
[ Post Reply | Private Reply | To 21 | View Replies]


Navigation: use the links below to view more comments.
first previous 1-2021-4041-6061-74 next last

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.

Free Republic
Browse · Search
Bloggers & Personal
Topics · Post Article

FreeRepublic, LLC, PO BOX 9771, FRESNO, CA 93794
FreeRepublic.com is powered by software copyright 2000-2008 John Robinson