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"

[rxsid]

The approval is this injection has nothing to do with science, and everything to do with political science.

[rxsid]

The effectiveness of the injections is waning:

Reports Of Vaccinated Breakthrough Cases/Hospitalizations/Deaths Are On The Rise - Sharply

A sampling of stories from around the country, and world.

When looking at stories, or data, keep in mind the timeframe. Is the data they are sharing/reporting regarding the entire vaccination timeline (from Jan), when there were far fewer variants and far fewer participating in the experimental injections? Or, is it what's happening recently, in the last week or last month with a growing pool of variants and participents in the experiments?

The following are about the current surge and whether or not the EUA injections are loosing effectiveness.

• Reports from July Archived Here: COVID Booster Shots for All Americans, Starting Sept. 20 (Increased risk of severe disease among those vaccinated early).

• SF General and UCSF Staff COVID-19 Infections Raise Concern About Rate of Breakthrough Cases - About 80% new cases in July were vax'd (08.01.2021)

• Sunriver Family Reunion Leads To Breakthrough COVID Cases, Hospitalizations (OR) - 62% of the covid infections from the reunion of 28 were vax'd, some of those hospitalized. (Aug 2 2021)

• Breakthrough COVID Cases Among Those Fully Vaccinated Are Rising In Colorado - 20% new cases in first 3 weeks in July were vax'd. (08.02.2021)

• Ocean County got about 100 COVID-19 ‘breakthrough’ infections in the past week (NJ) - 3X more breakthrough cases in last week, than previous ~28 weeks combined. (08.02.2021)

• Quick update on the Israeli vaccine data - It is bad and getting worse. - Older vax'd - 12 fold increase in "serious illness" in last month (08.03.2021)

• New study shows updated numbers for breakthrough cases in Lexington (KY) - Nearly 30% new cases last month were vax'd. (08.03.2021)

• Massachusetts breakthrough coronavirus cases jump 1,364 in one week, state’s daily infection tally up 883 amid delta spike - About 1/3 of new cases in last few weeks are vax'd. (08.03.2021)

• Despite breakthrough cases and deaths, Utah doctors continue to push vaccination - 3 out of 5 (60%) covid deaths over the weekend were fully vax'd. (08.03.2021)

• Roanoke-area rise in COVID-19 is accompanied by increase in breakthrough cases (VA) - Of the past week’s increase of 371 new cases, and 31 hospitalized, 19% of those two groups are vax'd - Up from 1-3% in previous weeks (08.03.2021)

• Almost 1 in 5 new virus cases in Fredericksburg district are among vaccinated (08.03.2021)

• With 165 cases, Dare County reports 5th highest week of new COVID-19 cases since pandemic began (NC) - 22% were vax'd. The same week last year had a total of 43 positive cases. (08.03.2021)

• S. Korea reports more than 1,100 breakthrough infections, 8 patients in critical condition - The tally is sharply up from 779 a week earlier - A 41% increase from previous week. (08.03.2021)

• Summer volleyball tournaments lead to COVID clusters, including several breakthrough cases - 106 total attendee's from HI, 30 covid positive - 19% and 36% were fully vax'd between two venues. (08.05.2021)

• 8 Mass. fire departments report breakthrough COVID-19 cases - They're seeing a "recent uptick", sent out an alert. (08.06.2021)

• Milton seeing rise in COVID-19 cases, about half in vaccinated residents (MA) - ~65% of town is vax'd. About 50% of new covid cases in last 2 weeks are vax'd. (08.06.2021)

• About Moderna adverse event reports - Received 300,000 reports of side effects after vax over a 3-month period following the launch of its shot, according to internal report from a company that helps Moderna manage the reports.(08.06.2021)

• Majority of Hospitalized COVID-19 Patients at Hospital in Israel Are Fully Vaccinated: Doctor - 85-90% hospitilizations and 95% of severe patients are fully vax'd. Hospital specializes in nursing care for elderly. (08.07.2021)

• COVID: San Francisco Bay Area Restaurants Temporarily Close Due to Breakthrough Cases Among Staff - 100% new covid cases from vax'd. 3 area restaurants in story, 7 total new covid infections among all staff, all staff were required to be vax'd. Citywide, 78% of all eligible SF is vax'd. (08.08.2021)

• State leaders report 36 breakthrough cases at two Southern W.Va. nursing homes - 69% of the 52 "active" cases were vax'd. (08.09.2021)

• Covid Cases Keep Climbing; More Clusters Reported (Martha’s Vineyard) - Of 48 new cases during first week of Aug, 52% were fully vax'd. (08.09.2021)

• CDC Director Admits Claim That Over 99% of In-Hospital Covid Deaths Were Among Unvaccinated People Was Junk - Instead, the actual data was 30X more than stated. 15% of Covid in-hospital deaths in May were vax'd. (08.09.2021)

• [The latest seven-day COVID-19 data for El Paso was released Monday, August 9] - 29% of new cases and 14% death rate were fully vax'd. (08.09.2021)

• NY COVID Hospitalizations Up 229% in Month; Severe Breakthrough Rate Rising in NJ NJ - 18.5% of all new COVID cases, fully vax'd, July 20 - 26. Hospitilization among vax'd Jan - July 26 = 0.004%, from July 20 - July 26 = 3% (74,900% increase). (08.09.2021)

•     **** The Following Is From The Most Recent Week ****

• Don’t Panic, But Breakthrough Cases May Be a Bigger Problem Than You’ve Been Told Current public-health messaging may understate the scale and risk. No good tracking. Every indicator suggests there’s a lot more under the radar than is public. (08.12.2021)

• EXCLUSIVE: At least 74 people on Martha's Vineyard have tested positive for Covid-19 since Barack Obama's maskless 60th birthday bash - the most cases on the island since April (08.13.2021)

• 7 Vaccinated Florida Patients Die of COVID; Nurse Calls Situation 'Disturbing' - All in past 2 weeks. Had treated "hundreds" of COVID patients before & hadn't lost one prior to this.(08.17.2021)

• Hawaii whistleblower: 'More patients dying from vaccine than Covid' - Say's he saw 32 elderly people pass away immediately after taking the Moderna vaccine. Also, medical diagnosis codes changed from other diseases to Covid for billing.(08.17.2021)

• Massive fraud in reporting vaccine injuries; withheld data, pretense of “safe and effective” - EudraVigilance (EU, EEA, Switzerland), MHRA (UK) and VAERS (USA) data, Moderna internal data. (08.17.2021)

• 18 Fully Vaccinated People Die Of COVID-19 In Massachusetts In Past Week - Including 2,500 new breakthrough cases, 496 hospitalizations (in past week). (08.18.2021)

• Israel, Once the Model for Beating Covid, Faces New Surge of Infections - One of the most vaccinated societies, Israel now has one of the highest infection rates in the world, raising questions about the vaccine’s efficacy.(08.18.2021)

• Study: Fully vaccinated people with "breakthrough" COVID Delta infections carry as much virus as the unvaccinated (UK/Oxford) - vaccinated people with "breakthrough" infections could still pose a significant infection risk to those who have not been vaccinated. (08.19.2021)

• Whatcom County’s reported COVID-19 vaccine breakthrough cases nearly double in July (WA) - County breakthrough cases Feburary through June = 98. July cases alone = 95. (08.19.2021)

• In Los Angeles, Breakthrough Infections Are Now 30% Of All New Covid Cases Amid Delta Surge - Fully vax'd infections: March 2021 = 2%, June = 20%, July = 30%. Fully vax'd hospitilizations: April = 5%, July = 13%. (08.19.2021)

• The CDC Only Tracks a Fraction of Breakthrough COVID-19 Infections, Even as Cases Surge - “If you’re limiting yourself to a small subpopulation with only hospitalizations and deaths, you risk a biased viewpoint.” (08.20.2021)

[rxsid]

Ping!

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

[cgbg]

The lab animals are patiently awaiting the results of the human trials.

[EEGator]

Fastest approval ever by years. No F’n way am I taking this nonsense. I will claim religious exemption, and if I get fired I will sue for civil rights discrimination.

[Chode]

[rxsid]

Yes. People have to fight back. Nobody should be forced, coerced or threatened in any way to take any medicine, whether an injection or not.

[erkelly]

This is so wicked! Because this approval is purely political, and apparently financially motivated, and rigorous testing has not been done, this is still a violation if the Nurenberg code.

[EEGator]

There’s scumbags here on FR that are fine with denying liberties to people like us.
“So, get a new job or start your own business.”
It’s rather difficult to start your own utility company or hospital though...
Never mind you won’t be able to work, fly, dine in, or shop for groceries according to the Fascists.

[nascarnation]

Can’t all these objectors just send 20 bucks to Calypso Louie, identify as Black Muslim, and be totally able to avoid the vax?

[ridesthemiles]

DEFINE LONG TERM, please.

[rxsid]

MORE THAN ~1 YEAR.

[WildHighlander57]

Many thanks for gathering those links!

[Does so]

bump, bfl

[Owen]

Who knows how typical this is? Is it typical to demand longer term studies in an approval?

[Karl Spooner]

***Who knows how typical this is? Is it typical to demand longer term studies in an approval?***

“Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.”

https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

[RushIsMyTeddyBear]

Exacly what my pharmacist has said.

[Jan_Sobieski]

Who knows how typical this is? Is it typical to demand longer term studies in an approval?

The shots have been out 7 months and “long term effects” have been satisfactorily analyzed? The Jedi Mind trick only works on those who wish to be deceived

[Enlightened1]

BTTT