Dr. Peter A. McCullough, MD, MPH, is a board-certified cardiologist who has testified before committees of the US and Texas Senate regarding the treatment of COVID-19 and management of the ongoing pandemic.
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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
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
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
“The [New South Wales Premier] is lying…she’s under an ICAC inquiry that particular lobbyists in Sydney have told her that the ony way she gets out of that inquiry is if she pushes the double-jab…and his clients are AstraZeneca and Pfizer…
Clive Palmer at 9min10sec
…she’s being paid by AstraZeneca and by Pfizer 10’s of millions of dollars to get these policies through to make sure the vaccine is pushed.”
I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”
FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.
Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism.
Germany has recommended the AstraZeneca coronavirus vaccine should only be given to people under the age of 65, according to reports.
The country’s vaccine committee has reportedly said the jab, developed alongside the University of Oxford, should only be offered to people aged between 18 and 64.
It gave a lack of sufficient data on the effectiveness of the inoculation in older people as the reason for the decision in a draft recommendation.
White House chief of staff Mark Meadows told the head of the Food and Drug Administration on Friday to either sign off on Pfizer’s coronavirus vaccine by the end of the day or hand in his resignation, the Washington Post reported, another push by the White House to approve the vaccine as quickly as possible after a panel of scientists ruled it safe this week.