Vaccine Not Approved, Simple EUA Is Extended

FDA ^ | 08/23/21

[Hatteras]

"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.

[TexasGurl24]

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?

[TexasGurl24]

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

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

[EEGator]

Hot damn, it’s magic!

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

[roving]

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

[TexasGurl24]

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.

[dforest]

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.

[rxsid]

"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

[Robert DeLong]

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.

[Drago]

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).

[Enlightened1]

Thank you!

[Enlightened1]

I did not catch it. Someone else did.

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

[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

[Enlightened1]

Bingo

[romanesq]

Approved and with an EUA for young people.

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

[Drago]

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.

[MercyFlush]

So with approval are they liable for damages now?

[Enlightened1]

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

All those that submit. The jabs will never end.

[cp124]

Typical government flim flam.

[Axenolith]

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