FDA "Approval" of Pfizer Injection COMIRNATY States There Were No Concerns Or Controversial Issues - Yet - Pfizer Is Required To Conduct Several Long Term Studies

https://www.fda.gov/media/151710/download ^ | 08.23.2021 | FDA

[rxsid]

The FDA admits there are "serious" concerns on the safety of the injection, and that there is a need for long term safety data.

From the BLA approval letter:

 

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.

 

Furthermore, they state:

"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"

[Tench_Coxe]

You mean like posting an article on approval and thr first comment is "good news"?

I think that thread got pulled (couldn't find it after reading it).

[Enlightened1]

[Mathews]

BTTT

[EEGator]

I was on that one. Berlin_Freeper posted it.

[EEGator]

What’s RSV and HCV?

[Helen]

The approval is signed by someone name “Malarkey”! How appropriate!!

Thanks for posting this link.

[RushIsMyTeddyBear]

So the approval is not for the one being used on us already?

[Boardwalk]

Only if it goes back to the furure.

[griswold3]

If the therapy is approved then they should lift all liability protections for Pharmaceutical companies.

[cp124]

The “Approval Lite” makes me want to get the vaccine even less.

[reviled downesdad]

I will say I am participating in the vaccine experiment the next time I am asked if I am vaccinated. Last time was at the dentist.

If pressed on it, I will state as seriously as I can that I am officially part the control group of the experiment.

If pressed more I will say it’s not avaccine if you can still catch it and spread it and you have to get jabbed over and over to still be able to catch it and spread it.

It is not going away. It has animal hosts, just like the common cold.

Viruses that were irradicated by vaccines like polio and measles
,animals dont catch, that’s why those vaccines work.

We better learn to live with it. Therapeutics will eventually become available to lessen the symptoms just like the common cold.

[Enlightened1]

This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products during the COVID-19
pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section
564(g) of the Act.

 

They renewed the EUA, while allowing for the branding of the Pfizer "vaccine" to be officially branded as COMIRNATY, with all previous rules and regulations that pertained to the original EUA to also apply to the branded COMIRNATY.

Nowhere does it now say that Pfizer's mRNA "vaccine" is approved for general use (as any other medication is used). It's still covered under a EUA.

[Enlightened1]

The way I read it is the FDA approved the branding of the same vaccine, but the vaccine itself is still under EUA.

[EEGator]

I eat healthy, exercise regularly, get plenty of sleep, and meditate daily.
I take vitamin C, D3, Quercetin, and Zinc.
In the mornings I have a pre/probiotic drink with fish oil.
I typically go for a 3 mile walk daily. (Sun & relaxation)

[Alberta's Child]

Bump for later.

[rxsid]

Thanks for posting that graphic!

[rxsid]

"Therapeutics will eventually become available"

Yes they will, so long as FraudXi et al. stop playing $$$favorites$$$ with the vaccines.

Lots of very promising therapeutics out there and ready for approval.

[rxsid]

Journalist Speaks Out After Being Diagnosed With “Inflammation of the Heart Due to Pfizer Vaccine”

An Australian journalist has taken to social media after being diagnosed withpericarditis, or inflammation of the heart, due to the Pfizer vaccine.

Denham Hitchcock, correspondent and producer for Channel Seven, revealed his condition on Thursday in a post on Instagram, saying no one is talking about the potential side effects of the Pfizer jab amid the current vaccine frenzy.

Hitchcock’s post reads:

I’ve battled over whether to send this post from hospital or not.

But decided after 27 years of being a journalist who’s primary goal is to discover the truth – it would be hypocritical not to.

disclaimer first – I’m NOT anti vax. But I’m really not pro vax either. I’m pro choice – and pro information to make that choice.

above all I’m PRO opening the bloody country up and to do that I don’t see any way around getting the majority of Australia vaccinated.

So I got the Pfizer shot.

The first week was like any vaccine. Feeling off.

But nearing the end of the second week my heart started to race, I was getting pins and needles in the arms, extreme fatigue and a very strange sensation of dizziness. I took nurofen, and I kept working

By the end of the third week i was getting steadily worse – sharp chest pain – cold shivers and chills – and the dizziness was intense.

25 days after the shot and probably a little late to hospital – but here I am – diagnosed with pericarditis – or inflammation of the heart due to the Pfizer vaccine. Since being here I’ve contacted health professionals I know in Sydney and while It’s rare – it’s certainly not isolated. One hospital has had well over a dozen cases like me.

This is not a post for sympathy – the hospital and staff at the Gold Coast uni hospital have been beyond great and although it’s all new territory I’m told I’ll make a full recovery although I could be like this for months.

Thankfully I have the worlds smallest nurse keeping an eye on my ever present ECG.

But my present thought would be – in the current vaccine frenzy, no one is talking about this but it’s clearly happening – and if you want the vaccine and have any heart history it would be worth talking to your GP about your vaccine choice, especially as AZ is readily available and does not have this side effect.

If you don’t want the vaccine – i don’t have a problem with that either – but life and travel will get difficult for you.

The only thing for me that’s dead certain – if they don’t open Australia up when we reach their milestone of 70% – then there will be a lot more people marching in the street. You want the trust ? Keep your damn promise