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The Food and Drug Administration is grappling with field mice at its headquarters, an infestation exacerbated by food left behind in offices that have been largely unoccupied during the Covid-19 pandemic, the agency confirmed to POLITICO. Pest-control problems in Washington-area buildings were not unusual prior to the pandemic; indeed, mouse traps are frequently spotted inside the Capitol. And two former FDA officials told POLITICO that mice have long taken refuge inside the agency’s sprawling Silver Spring, Md., campus, known as White Oak. But the rodent problem worsened during the pandemic, forcing the agency to assign some employees returning to the...

Beginning in June 2023, farmers won’t be able to buy any over-the-counter antibiotics for their animals. This will be a big change for farmers, many of whom are accustomed to doing much of their own veterinary care. Like it or not, farmers need to be prepared. [snip] The new FDA guidance recommends manufacturers of “medically important antimicrobials” that are currently available over-the-counter label their drugs available by prescription only. The guidance was finalized in June 2021 and will take effect in June 2023 nationwide. That means farmers will need to have a veterinary-client-patient relationship, or VCPR, in order to get...

Lack of data and open-ended questions from FDA frustrate membersAll the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) could agree about on Wednesday in terms of a plan for COVID boosters is that they need more data. The 8-hour meeting, broadcast over YouTube, was riddled with technical glitches early on, and ended with some frustration over the open-ended questions the agency posed. FDA staff charged VRBPAC members with discussing what considerations should inform strain composition decisions for COVID boosters, how often should these be assessed, what would indicate a need for an updated strain composition, and what considerations...

Vaccine MalpracticeGovernment pharmacists, physicians, and nurses have violated their oaths and obligations to protect patient safety. Adverse cardiovascular, thrombotic, and neurologic events related to the Covid vaccine have occurred around the world. As I and others have noted before, the Food and Drug Administration’s (FDA) own vaccine adverse event tracking system (the Vaccine Adverse Event Reporting System, or VAERS) shows substantial and serious risks from the vaccine, even though the FDA only collects an estimated 10 percent of all adverse events.Still, federal agencies and manufacturers aren’t officially warning American public about these risks, despite having known this information for almost...

The Food and Drug Administration is expected to approve a fourth dose of Pfizer and Moderna's Wuhan coronavirus vaccine this week, despite a lack of clinical data showing they are effective or necessary. "Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults," CBS News reported late last week. "The request is broader than rival pharmaceutical company Pfizer's request earlier this week for the regulator to approve a booster shot for all seniors." Doctors truly focused on following the science, not political science, are...

The U.S. Food and Drug Administration has authorized Americans who are 50 years and older to receive a second booster of the COVID-19 vaccine from either Pfizer-BioNTech or Moderna.The authorization makes millions more Americans eligible for a fourth dose. Currently, the U.S. urges two primary shots followed months later by a booster dose for everyone age 12 and older. The second booster approved Tuesday for those 50 and up should be administered at least four months after the previous booster, the FDA said. A fourth dose had only been recommended for people with severely weakened immune systems, who need three...

FDA and CDC pharmacists, physicians, and nurses have violated sacrosanct academic oaths and state licensure obligations to protect their patients’ safety. Will they try the Nuremberg defense of “just following orders?” Today, unquestionably serious cardiovascular, thrombotic and neurologic adverse events related to the vaccine have occurred around the world. The FDA’s own vaccine adverse event tracking system (the Vaccine Adverse Event Reporting System or VAERS) shows substantial and serious risks from the vaccine, even though the FDA only collects an estimated 10% of all adverse events. Still, federal agencies and manufacturers aren’t officially warning the American public about these risks,...

Despite the mildness of the dominant omicron variant and the evidence that the Pfizer COVID-19 vaccine hasn’t stopped infection or transmission of SARS-CoV-2 while posing serious health risks, the company’s CEO is asking the FDA to grant emergency use authorization for a second booster, a fourth shot.“Clearly there is a need in an environment of omicron to boost the immune response,” Albert Bourla, CEO of Pfizer, said Friday on CNBC’s “Squawk Box.”Bourla claimed the data indicate the protection against severe disease after three doses is “very good.” But the protection wanes after only three or four months, he acknowledged.In January,...

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A court order forced Pfizer to release 55,000 pages of documents about its Wuhan coronavirus (Covid-19) “vaccine,” and already the bombshells are dropping. Naomi Wolf of DailyClout.io spoke with Steve Bannon on his “War Room: Pandemic” program to reveal that members of the “posse,” meaning the worldwide movement of volunteers poring over the released documents, have learned that the Pfizer injection does not stay in the bicep muscle as claimed. “Already what I saw that people have submitted looks like Pfizer knew that the injection material, which includes lipid nanoparticles, wouldn’t stay in the bicep,” Wolf explained. “All these doctors...

Since the start of 2020, shares of Novavax (NASDAQ: NVAX) have soared by more than 1,600%, making the S&P 500's 30% returns during that period look minuscule. And the main reason for all that bullishness has been the COVID-19 vaccine the company has been developing, which could lead to billions in revenue for the business. The company only recently filed for an Emergency Use Authorization (EUA) of its vaccine, and if it obtains it, shares of the stock could once again go soaring. Is approval imminent for Novavax, and is now a good time to buy shares of the healthcare...

Pro Football Hall of Famer and Jackson State football coach Deion Sanders suffered the amputation of two toes on his left foot and narrowly escaped a lower leg amputation after contracting severe blood clots in his leg. The 54-year-old coach had entered a Mississippi hospital with three “life-threatening” femoral arterial blood clots, and at one point, he feared that he would lose his lower leg to the condition. Sanders told fans of his medical issues in which he said he is “thankful for GOD” for getting him through the frightening times. “I endured a lot while I was in the...

It shouldn't have been hidden from the public.

Dr. Andrew Hill, tasked with studying the cheap, widely available drug, undermined his own findings.. LIVERPOOL, England — Providence will occasionally place a man at a key juncture of history, a position of great moment where the fate of millions lies in his hands. Andrew Hill, M.D., was just such a man, in just such a position. In October 2020 he was asked by the WHO to review the rapidly accumulating evidence that Ivermectin was a safe and effective treatment for COVID. To say there was a lot riding on Hill’s findings was an understatement. If it turned out that...

Study after study is coming out that ought to provoke media curiosity. But the press remains indifferent. COVID vaccines were developed in record time, one might say at “warp speed,” the name of the operation instituted by President Trump in 2020. We were assured by those in whom we place trust that these vaccines were “safe and effective.” In August 2021, President Biden told us, “After a strict process, the FDA has reaffirmed its findings that the Pfizer COVID-19 vaccine is safe and effective, and the FDA has given its full and final approval.” The CDC said the same, and...

WASHINGTON— Today, Republican Study Committee Member Rep. Yvette Herrell introduced legislation to require the Food and Drug Administration to produce a report and recommendations on regulatory barriers to domestic manufacturing of medical products that are critical to public health during public health emergencies. In the earliest days of the pandemic, China threatened to halt lifesaving supplies of medicine to the United States. This highlighted a glaring need to reshore our supply chains and make sure Americans would have access to lifesaving medicine and medical supplies during public health crises. The Protecting American Lives Act (PAL) Act of 2022 would help...

The U.S. Food and Drug Administration on Tuesday released a 10,000-page cache of documents pertaining to the Emergency Use Authorization of Pfizer’s COVID vaccine. An initial review shows the documents contain details about animal studies, adverse events experienced by trial participants, the makeup of Pfizer’s internal review committee … and more. The U.S. Food and Drug Administration on Tuesday released a 10,000-page cache of documents pertaining to the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID vaccine.The documents provide more insights into the FDA’s process for approving the vaccine, and may also shed more light on the safety and efficacy...

[H/T rodguy911]Press ReleaseFor Immediate ReleaseWashington, DC, March 03, 2022 — In a 55,000-page set of documents released on Tuesday, the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is for the first time allowing the public to access data Pfizer submitted to FDA from its clinical trials in support of a COVID-19 vaccine license. This follows U.S. District Judge Mark T. Pittman’s decision on January 6 to deny the request from the FDA to suppress the data for the next 75 years which the agency claimed was necessary, in part, because of its “limited...

It’s pretty straightforward. When everyone is looking up. Keep your eyes in the ground. Just a reminder: Pfizer documents the FDA wanted sealed until 2097, are being released today. The war is a distration. I am not going to get my two bits in about, but can’t help feel something unusual in regard to the timing if it all.. I find it amazing how Putin has managed to eradicate Covid in just a few days, but it’s important to keep a close on on what’s slipping under the radar. On Page 3 of the following document, the judge orders for...

GlobeNewswire CHD Says Pfizer and FDA Dropped Data Bombshell on COVID Vaccine Consumers Children's Health Defense March 3, 2022, 3:54 pm Clinical trial data contradicts ‘safe and effective’ government/industry mantra Washington, DC, March 03, 2022 (GLOBE NEWSWIRE) -- In a 55,000-page set of documents released on Tuesday, the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is for the first time allowing the public to access data Pfizer submitted to FDA from its clinical trials in support of a COVID-19 vaccine license. This follows U.S. District Judge Mark T. Pittman’s decision on January 6 to...