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The FDA approved the Pfizer COVID-19 jab for those 16 and older. Now to be known as Comirnaty, the FDA says the shot proved effective in a clinical trial of some 44,000 people. FDA’s acting commissioner Dr. Janet Woodcock, stated, “As the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product. While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get...

Sen. Ron Johnson: 5 Questions for FDA About Pfizer Vaccine ApprovalSen. Ron Johnson (R-Wis.) on Thursday sent a letter to Dr. Janet Woodruff, acting commissioner of the U.S. Food and Drug Administration (FDA), demanding answers to five questions pertaining to the FDA’s approval of the Pfizer Comirnaty COVID vaccine. The FDA on Aug. 23 granted full approval to Pfizer’s vaccine, over the objections of some scientists who pointed out that full approval was based on only six months’ worth of data — despite clinical trials designed for two years — and that there was no public discussion of the data....

The Food and Drug Administration’s “full authorization” for the Pfizer-BioNTech vaccine for Covid-19 was announced with a fair amount of hooplah and fanfare. The President of the United States announced the monumental development and touted it as rationale for the vaccine mandates to commence in the private sector, throughout the government, and in the U.S. military. President Joe Biden was on the spot Monday morning with a quick reaction to the FDA’s “full authorization” of the Covid-19 vaccines. But a closer examination of the “full authorization” documents has some Americans feeling deceived. There is the matter that Pfizer-BioNTech still appears...

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...

FDA Pfizer authorization (Comirnaty): Key points to consider and discuss. These points are an aggregate of many minds, including Dr. Robert Malone. 23 Aug 2021 General talking points • Why mandates if herd immunity isn't possible? • What happens 8 months after boosters? • What's the plan for the next variant? • Why we're messing with vaccine injury liability if the vaccines are safe and effective? • DOES NOT GIVE FULL APPROVAL • Extends EUA to allow supply of current Pfizer under EUA because limited supply of BioNTech version. More at PDF link...

...Between July 27, 2020 and October 29, 2020, 45,441 ≥16-year-olds were screened, and 44,165 randomized at 152 sites (US [n=130], Argentina [n=1], Brazil [n=2], South Africa [n=4], Germany [n=6], Turkey [n=9]) in the phase 2/3 portion of the study. Of these participants, 44,060 were vaccinated with ≥1 dose (BNT162b2, n=22,030; placebo, n=22,030), and 98% received dose 2 (Fig.1). During the blinded period, 51% of participants in each group had 4 to ...Figure 2 Efficacy of BNT162b2 against COVID-19 Occurrence after Dose 1 During the Blinded Placebo-controlled Follow-up Period. ...VE=vaccine efficacy...... During the blinded, controlled period, 15 BNT162b2 and 14 placebo...

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What is going on here? Are we being lied to? Specifically check page 2 and page 12. Page 2: On August 23, 2021, 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 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in...

--------------------------- INDICATIONS AND USAGE ---------------------------- 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.... ------------------------------ ADVERSE REACTIONS ------------------------------ • In clinical studies of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%). (6.1)...The safety of COMIRNATY was evaluated in participants 16 years of age and older in...