Comirnaty

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News

FDA report finds all-cause mortality higher among vaccinated – Israel Nation News

FDA report shows Pfizer’s clinical trials found 24% higher all-cause mortality rate among the vaccinated compared to placebo group.

The clinical trials of Pfizer’s coronavirus vaccine found that the all-cause mortality rate of the vaccinated group was higher than that of the control group, months after the trials were launched, according to a recently released FDA report.

According to the report, which was released by the US Food and Drug Administration to provide background information on its August 2021 decision to grant full approval for the Pfizer-BioNTech coronavirus vaccine after offering limited emergency authorization of use in last December, six months after the vaccine’s clinical trial began, the total number of deaths reported in the vaccinated group was nearly one-quarter higher than the number of deaths in the placebo group.

http://archive.today/2021.11.19-040650/https://www.israelnationalnews.com/News/News.aspx/317091

Categories
Publications

November 8, 2021 Summary Basis for Regulatory Action – Comirnaty – FDA

Introduction

BioNTech Manufacturing GmbH (in partnership with Pfizer Inc.) submitted a Biologics License Application (BLA) STN BL 125742 for licensure of COVID-19 Vaccine, mRNA. The proprietary name of the vaccine is COMIRNATY. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The vaccine is administered intramuscularly (IM) as a series of two 30 μg doses (0.3 mL each) 3 weeks apart.

For commentary, see FDA report finds all-cause mortality higher among vaccinated – Israel Nation News.

http://archive.today/2021.10.11-032110/https://www.fda.gov/media/151733/download

Categories
Opinion

No FDA-Approved COVID-19 Shots Available – Liberty Counsel

WASHINGTON, D.C. – There are currently no fully FDA-approved licensed COVID shots available. All COVID shots remain under federal Emergency Use Authorization, meaning individuals have the “option to accept or refuse” the product.

On September 22, 2021, the Food and Drug Administration (FDA) sent a follow-up letter to the original approval to Pfizer pharmaceutical company that stated, “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 23, 2021 letter of authorization in its entirety with revisions incorporated to authorize for emergency use the administration of a single booster dose of COMIRNATY.”

On page 6, footnote 12 of that letter the FDA clearly states, “Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or to provide: an additional dose to the immunocompromised population, or a booster dose to the authorized population described in this EUA” (emphasis added). 

https://lc.org/newsroom/details/100821-no-fda-approved-covid19-shots-available

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Videos

Winning the War Against Therapeutic Nihilism & Trusted Treatments vs Untested Novel Therapies – Dr. Peter McCullough, AAPS

Peter McCullough, MD, MPH speaks at the 78th Annual Meeting of AAPS on October 2, 2021.

Presentation notes:

  • 1min: Something was going very wrong very early in 2019.
  • 2m: The threshold for shutting down a new biologic product is just a few cases.
  • 3m: Covid-19 was going to be the showcase of what we could do for biotech.
  • 5m: The spike protein created by the new Covid-19 is a deadly protein.
  • 11m: Our institutions are all culpable in medical malfeasance.
  • 13m: We have the biggest biological catastrophe on our hands with a medicinal product in human history…and no-one knows how to stop it.
  • List of risk
  • 14m: 86% of deaths have no other explanation other than the vaccines.
  • 20m: We are in freefall into a lawless state. The Vaccines are not safe for use on either side of the Atlantic. It’s clear that this first generation of [Covid-19] vaccines is not safe.
  • 22m: The FDA did not approve Pfizer. The gave a continuation of the emergency use authorization and then conditionally approved Comirnaty with BioNTech which is legally and potentially medicinally distinct. The Pfizer approval is a false talking point.
  • 23m: When Pfizer came up for boosters, McCullough and his team presented at the FDA showing that death with the vaccine is greater than death just taking your chances with the infection. The vaccines aren’t safe across the board and the panel agreed 16:2 against the booster.
  • 26m: Data for the efficacy of the vaccines do not take into account the Delta variant. These vaccines have failed against Delta and other variants. Two-thirds who get sick with Delta are fully vaccinated. Data shows that the vaccines can’t stop transmission.
  • 27m: Effectiveness for Pfizer is at 42%. A vaccine that falls below 50% protection and can’t last a year is not a viable product. Pfizer has failed as a commercial product.
  • 29m: The CDC was telling us in May 2021 that the vaccines were failing. They started to do asymmetric reporting to craft a narrative that this was going to be a crisis of the unvaccinated but the CDC data showed the opposite. The ineptitude and willful misconduct of the people running our public health agencies is astounding.
  • 32m: The ‘99% of hospitalized were unvaccinated’ message was a propagandized false talking point because the data is not there.
  • 33m: The vaccines have had zero impact on the epidemic curve. Mortality is a function of treatment.
  • 34m: Many experts have been warning that we shouldn’t vaccinate into a pandemic because it creates resistance. As soon as we started vaccinating, the number of strains starting falling. The virus was figuring out how to thrive in the vaccinated.
  • 36m: The Delta variant has achieved antigenic escape. The data shows that the vaccinated is an equal threat to the unvaccinated.
  • 38m: Early home treatment is the only thing that makes sense. That’s what it should have always been.
  • 40m: Doctors at my institution cannot look me in the eye because they are so ashamed of what they’ve done during the course of this pandemic.
  • 44m: If you look through the clinical records [of those who have died] and I will tell you they were all inadequately treated.
  • 50m: Natural immunity is superior to vaccine immunity. If we vaccinate people who are covid-recovered, we harm them considerably. The only backstop is natural immunity.

File download:

A Guide to Home-Based COVID Treatment from the Association of American Physicians and Surgeons – PDF (1.4MiB)

Slides:

https://rumble.com/vnbv86-winning-the-war-against-therapeutic-nihilism-and-trusted-treatments-vs-unte.html

Backup mirrors:

Categories
Publications

Nosocomial outbreak caused by the SARS-CoV-2 Delta variant in a highly vaccinated population, Israel, July 2021 – Eurosurveillance

This nosocomial outbreak exemplifies the high transmissibility of the SARS-CoV-2 Delta variant among twice vaccinated and masked individuals. This suggests some waning of immunity, albeit still providing protection for individuals without comorbidities. However, a third vaccine dose may be needed, particularly in individuals with risk factors for severe COVID-19. Appropriate use of masks, especially in high-risk settings is advised.

https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2021.26.39.2100822#html_fulltext