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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 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...

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. “The FDA is committed to helping our youngest patients with serious medical conditions have treatments that are relatively...

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...

https://static1.squarespace.com/static/550b0ac4e4b0c16cdea1b084/t/6124fdd27da16f3e2c51aecb/1629814226387/Key+points+to+consider+FDA+letters+and+press+release.pdf

Jesse Jackson and his wife are the latest victims of our government's refusal to focus on early treatment. After having been fully vaccinated, they are the latest high-profile people to be hospitalized with the virus. Based on the government's own narrative, there is now nowhere for the lockdown/mask/shot cartel to run or hide from their failure nor their continued denial of the efficacy of prior natural immunity and early treatment for those without prior infection. Even for those vaccinated, the safest and most effective way forward is to test for prior immunity and treat pre-emptively or early those who have...

President Joe Biden is speaking after the Food and Drug Administration announced it has granted full approval to Pfizer and BioNTech for their COVID-19 vaccine to be given to Americans as young as 16, the first COVID-19 vaccine to receive full FDA approval. Health officials hope the new status will encourage more unvaccinated people to get the jab.

The Food and Drug Administration (FDA) on Monday granted full approval to Pfizer's COVID-19 vaccine for individuals 16 years and older.

FDA is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine Monday, further expediting earlier timeline for licensing shots, according to people familiar with the agency’s planning. Regulators working to finish process by Friday but were still working through substantial paperwork and negotiation with the company. People familiar with planning, who weren't authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time. An F.D.A. spokeswoman declined comment. The agency had recently set an unofficial deadline for approval around Labor Day. The approval expected to pave the way for series...

Transparency advocates have criticised the US Food and Drug Administration’s (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine. Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.

The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning. Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company. The people familiar with the planning, who were not authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time. An F.D.A. spokeswoman declined to comment. The agency had recently set an...

But since all phases of clinical trials have already been done for the COVID-19 vaccines on the market, and the FDA has reviewed the safety and manufacturing data provided by the pharmaceutical companies, the formal approval process could happen “very soon,” Fauci, director of the National Institute of Allergy and Infectious Diseases, said. Moving from EUA to full approval means that the drug companies will have the power to market and distribute their products themselves.

The Federal Drug Administration Saturday night approved an Emergency Use Authorization for an antibody treatment President Donald Trump received shortly after being diagnosed with the Wuhan coronavirus. The manufacturer, Regeneron, received the green light for their cocktail of two antibodies – or casirivimab and imdevimab – that appear to be effective for those with mild to moderate coronavirus. The two antibodies, referred to as monoclonal antibodies, are created in a lab and mimic the human body's natural immune system. When administered the cocktail prevents the virus from attaching to human cells. In order to receive the treatment, a patient must...

The U.S. Food and Drug Administration (FDA) on Saturday granted emergency authorization for the antibody treatment praised by President Trump. The antibody cocktail from Regeneron is authorized for treating mild to moderate COVID-19 in adults, as well as pediatric patients at least 12 years old who have a high risk of progressing to..

WEDNESDAY, March 22 (HealthDay News) -- OsmoPrep tablets (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) have been approved by the U.S. Food and Drug Administration to cleanse the bowel before a colonoscopy, a test to detect colon cancer. The tablet's maker, Salix Pharmaceuticals, said OsmoPrep had been approved for people 18 and older as an alternative to high-volume liquids taken before the procedure. In a statement, the company cited a Mayo Clinic study's conclusion that unwillingness to take a bowel preparation was "the single largest barrier to colorectal cancer screening." Still, more than 10 million uses of bowel...