FDA

FDA Approves First Treatment for COVID-19, Remdesivir

The U.S. Food and Drug Administration on Thursday approved Gilead Sciences’s antiviral drug remdesivir for the treatment of adults with COVID-19, making it the first and only FDA-approved treatment for the disease in the United States. Gilead Sciences has branded its version of remdesivir as “Veklury.” It is administered intravenously to hospitalized patients. “Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care,” the FDA announced, noting that the drug is being formally approved—beyond an emergency use authorization—for use in patients aged 12 and older, weighing at least 40 kilograms (about 88 pounds). The FDA also on Thursday issued a new emergency use authorization (EUA) for remdesivir to treat hospitalized pediatric patients under age 12 who weigh at least 3.5 kg—enough to receive an intravenous drug. Gilead Sciences Inc pharmaceutical company is seen after they announced a Phase 3 Trial of the investigational antiviral drug Remdesivir in patients with severe coronavirus disease (COVID-19), during the outbreak of the coronavirus disease (COVID-19), in Oceanside, California, U.S., April 29, 2020. (Mike Blake/Reuters) Velukry has been available under an FDA EUA since May, after a study (ACTT-1 trial) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) showed it reduced hospital stays by five days from an average of 15 days. Read More Remdesivir Study Finally Published—an Expert in Critical Care Medicine Gives Us His Verdict “The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Stephen Hahn said in a statement. “As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.” The FDA said on Thursday that it gave Veklury approval after analyzing data from three randomized, controlled clinical trials of patients hospitalized with mild-to-severe COVID-19. One of the three studies was the NIAID-sponsored ACTT-1 trial, while the other two studies were sponsored by Gilead. The World Health Organization (WHO) last week said on Oct. 15 that its COVID-19 therapeutics trial of multiple treatments for COVID-19 found that remdesivir did not have a substantial effect on patients’ length of hospital stay or chances of survival. That study has not been peer reviewed. Gilead has questioned the potential for bias in the WHO study, which was not “blinded,” meaning that patients and their doctors were aware of which treatments were being used. The company told the Financial Times on Oct. 15, “The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies validating the clinical benefit of remdesivir. We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.” An ampule of Gilead Sciences COVID-19 antiviral remdesivir is pictured at the University Hospital Eppendorf in Hamburg, Germany, April 8, 2020. (Ulrich Perrey/Pool via Reuters) Merdad Parsey, Chief Medical Officer of Gilead, said that remdesivir is “the first antiviral treatment proven to help patients hospitalized with COVID-19 recover more quickly.” “In less than one year, the world has moved from a sense of desperation to understand an unknown disease spreading all too quickly and taking lives, to one of hope that we now have enough knowledge and a growing set of tools to help fight COVID-19,” he said in a statement. “With today’s FDA approval, and regulatory approvals or temporary authorizations in approximately 50 additional countries around the world, Veklury (remdesivir) is one of the tools available today.” Parsey said that the WHO’s study “provided information about Veklury in real-world settings in the early days of the pandemic,” but “does not negate other study results—particularly from a trial designed with the strictest of scientific standards, as is the case with ACTT-1.” Gilead is charging government health programs in the United States and other developed countries $2,340 for a typical five-day treatment course, and private insurance companies $3,120 for the same treatment. The amount that patients pay out of pocket depends on insurance, income, and other factors. President Donald Trump was treated with remdesivir earlier this month when he contracted COVID-19. He also had other treatments, including an experimental antibody cocktail treatment from Regeneron Pharmaceuticals Inc., which he credited for his recovery. Trump was also on other medications and supplements at the time, including “zinc, vitamin D, famotidine, melatonin, and a daily aspirin,” according to his physician. So far, only steroids such as dexamethasone have been shown to lower the risk of dying of COVID-19. The FDA also has granted EUAs to using the blood of survivors (convalescent plasma), and two companies are currently seeking similar emergency authorization for experimental antibody drugs. Isabel van Brugen, Reuters, and The Associated Press contributed to this report. Read More Steroids Cut COVID-19 Death Rates, but Not for Everyone Remdesivir Explained—What Makes This Drug Work Against Viruses?

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Watchdog to Probe Whether CDC, FDA’s Scientific Integrity Was Undermined By Political Interference During Pandemic

Watchdog to Probe Whether CDC, FDA’s Scientific Integrity Was Undermined By Political Interference During Pandemic

An independent government watchdog agency on Monday agreed to investigate whether the scientific integrity and communications policies of the Food and Drug Administration (FDA) and Centers of Disease Control and Prevention (CDC) has been violated during the COVID-19 pandemic. The Government Accountability Office (GAO), an independent legislative agency that probes, audits, and evaluates government operations on behalf of Congress, said Oct. 16 (pdf) it had accepted a request from Democratic senators and would examine “whether the CDC and FDA’s scientific integrity and communications policies have been violated and whether those policies are being implemented as intended to assure scientific integrity throughout the agency.” The request came from Sens. Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.) and Gary Peters (D-Mich.) on Oct. 8. The Democratic senators alleged that the Trump administration had politically interfered in the FDA and CDC’s work. They pointed to September media reports citing anonymous bureaucrats who said that Trump-appointed bureaucrats—like HHS Assistant Secretary for Public Affairs Michael Caputo, the top communications official at the health department—were changing language in the CDC’s COVID-19 reports because they “wrongly inflated the risks of COVID-19,” according to POLITICO. That same week, Caputo had accused a group of career scientists at the CDC of plotting against Trump, himself claiming that agency bureaucrats were politicizing their work. Caputo also denied allegations of political interference made in the POLITICO report, saying that his office “clears virtually all public facing documents for all of its divisions, including CDC.” “Our intention is to make sure that evidence, science-based data drives policy through this pandemic—not ulterior deep state motives in the bowels of CDC,” he said. The CDC falls under the responsibility of HHS. HHS told The Epoch Times in September: “Mr. Caputo is a critical, integral part of the President’s coronavirus response, leading on public messaging as Americans need public health information to defeat the COVID-19 pandemic.” The Democratic senators made their request to the GAO on Oct. 8 (pdf). “The CDC and FDA’s independence as scientific agencies is crucial to safeguarding the public health and saving lives,” they said. “These agencies must be able to develop, review, and disseminate public health data, guidelines, and other information that are based on science, facts, and medical principles—and not the political imperatives and moods of a president and his advisors.” The senators alleged that officials within the Trump administration sought to interfere with the CDC’s flagship “Morbidity and Mortality Weekly Reports,” citing another POLITICO report which reported that the actions were so as not to undermine “President Donald Trump’s optimistic messages about the outbreak,” citing internal emails from anonymous sources. Warren, Murray, and Peters also asserted that the Trump administration pressured the CDC to ease guidelines on re-opening schools as Trump called on governors to get children not in virus hotspots back to in-person learning. They cited the second POLITICO report that accused Health and Human Services Secretary Alex Azar of leading an “an escalating pressure campaign” on the FDA to “abandon its responsibility” for ensuring the safety and accuracy of a range of COVID-19 tests in August. Meanwhile, The Washington Post reported that supporters of move to block the FDA’s review process for lab-developed tests were expecting the change to help remove impediments to getting “new and more innovative tests to market more quickly” after the review process slowed down COVID-19 testing at the beginning of the pandemic. “The GAO’s decision to conduct an independent audit is a good first step towards making sure that guidance coming from federal agencies is based on science and facts, not on the Trump Administration’s political agenda or the President’s whims,” the senators said in a joint statement on Monday. “Health and science experts should be able to do their jobs to steer us through crises like this pandemic without political interference and we must ensure that the American people receive fact-based information so that they can make well-informed decisions for themselves and their families amidst this national public health emergency,” they stated. Trump made his own accusations of political interference involving the FDA in August, claiming at the time that the “deep state” or others at the FDA were delaying the availability of a COVID-19 vaccine before the Nov. 3 election. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” the president wrote in a controversial Twitter post. A GAO spokesman told USA TODAY that the agency would have capacity to start the probe into political interference in January “as staff who cover those issues become available.” The Trump campaign and the White House did not immediately respond to a request for comment by The Epoch Times.

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Cuomo: Be Skeptical Of Any Vaccine Approved By FDA And CDC

Cuomo: Be Skeptical Of Any Vaccine Approved By FDA And CDC

New York Gov. Andrew Cuomo said he is not confident in the Trump Administration’s creation of a vaccine, urging Americans to remain skeptical about its viability. “I’m not that confident, but my opinion doesn’t matter. I don’t believe the American people are that confident,” he said to George Stephanopoulos on ABC News on Monday. “You are going to say to

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White House Tries To Ensure Vaccine Is Available Before The Election

White House Tries To Ensure Vaccine Is Available Before The Election

Mac SlavoOctober 6th, 2020SHTFplan.com The White House has taken even more steps to ensure a vaccine for the COVID-19 scamdemic will be available by the election, which is scheduled to take place on November 3. The Trump administration has removed Food and Drug Administration regulations that would prevent a vaccine from being ready before November. Time is running out. There will be a vaccine and you will be expected to take it voluntarily. If you don’t, you will be punished until you comply. This has become all to obvious, but people are still under some delusion that they will be offered a reasonable alternative to accepting this vaccine. At issue was the FDA’s planned instruction that vaccine developers follow patients enrolled in their trials for at least two months to rule out safety issues before seeking emergency approval from the agency. A senior administration confirmed the move Monday evening, saying the White House believed there was “no clinical or medical reason” for the additional requirement. –Market Watch This means the safety rules in place (which aren’t that stringent for vaccines to begin with) are going to be removed in order to make sure a vaccine is pushed through by the election. Operation Warp Speed will be rolled out as soon as possible. Trump: “The Military Is Ready To Deliver A Vaccine” Only one drugmaker, Pfizer, has suggested it could have data on the safety and effectiveness of its vaccine before Election Day. And a number of variables would still have to align for the company to submit, and the FDA to review and approve, a vaccine application before Nov. 3. Pfizer’s competitors Moderna, AstraZeneca, and Johnson & Johnson are working on longer researcher timelines.-Market Watch Moderna Says Their COVID-19 Vaccine Will NOT Be Ready Before The Election Just because the vaccine may not be available by November 3, doesn’t mean one won’t be rolled out shortly afterward.  The Trump administration seems intent upon releasing a vaccine to the public before the election. Trump Administration Is Stockpiling 3 Different Types Of COVID-19 Vaccines If you intend to deny this vaccine, prepare. Stock up food and water because you probably won’t be allowed in stores or to work. It will not be voluntary by any measure of the definition of the word.  You will be forced to take it one way or another and if you don’t expect punishment.  Get ready if you don’t want it. It is coming and it will be shoved down our throats. Medical Journal: Get The COVID-19 Vaccine, Or Be Punished HARSHLY Brace yourselves. This is going to get ugly in the next 30 days. Not just with the election, ut with this vaccine.  And any number of other calamities that could creep up before then. Prepare, be aware, and remain unafraid. President Trump is Breaking Down the Neck of the Federal Reserve! He wants zero rates and QE4! You must prepare for the financial reset We are running out of time Download the Ultimate Reset Guide Now! Author: Mac SlavoViews:Date: October 6th, 2020Website: www.SHTFplan.com Copyright Information: Copyright SHTFplan and Mac Slavo. This content may be freely reproduced in full or in part in digital form with full attribution to the author and a link to www.shtfplan.com. Please contact us for permission to reproduce this content in other media formats. SHTFPLAN is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.

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Tyrants: “Prepare To Wear Masks & Socially Distance Even After Getting COVID-19 Vaccine”

Tyrants: “Prepare To Wear Masks & Socially Distance Even After Getting COVID-19 Vaccine”

Mac SlavoSeptember 23rd, 2020SHTFplan.com Doctors are now saying we should expect to practice social distancing and wear masks even after everyone is vaccinated.  Talk about moving the goalposts in an epic fashion! They have warned us of this in the past too: They Moved The Goalposts…AGAIN!: “It’s Not Over When The Vaccine Arrives” There is no going back. It’s not going to be “normal” again. Dr. Paul Offit of the Children’s Hospital of Philadelphia, who also co-invented the rotavirus vaccine (is in the back pocket of Big Pharma) suggests that even after you’re injected with the horrific concoction of whatever is going to be in the COVID-19 vaccine, you’ll still have to socially distance and wear a face mask.  In other words, get used to living life as a slave because it’s not going back to “normal” as we knew it. As a “vaccine expert,” Offit helped develop the rotavirus vaccine, which supposedly protects young children against infections with the virus that can cause severe diarrhea. He also sits on the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, according to Market Watch. So he’s got a vested interest in making sure you take the vaccine. Offit is now keeping a close eye on the clinical trials underway for COVID-19 vaccine candidates and the Trump administration’s potential influence on federal agencies closely involved in the pandemic response. “The government has shown its capacity to impose its will on science-based federal agencies”, he said. “There is a reason to worry.” Of course, there’s a reason to worry. A vaccine will come and this one will be like nothing ever released or used on human beings before. Offit then says that Moderna would normally wait to see whether a vaccine works and was safe before they mass-produced it. What the government said is, “Look, we’ll take the risk out of it for you. We’ll pay for the Phase 3 trial. We’ll pay for mass production.” That’s good, actually.” So the government has already made certain that vaccine manufacturers cannot be held liable for the side effects, or even death of those who take the vaccine. “A vaccine is a part of what’s going to get us out of this mess,” says Offit. But we still have to wear masks and social distance. Get used to the new normal, or wake up. President Trump is Breaking Down the Neck of the Federal Reserve! He wants zero rates and QE4! You must prepare for the financial reset We are running out of time Download the Ultimate Reset Guide Now! Author: Mac SlavoViews:Date: September 23rd, 2020Website: www.SHTFplan.com Copyright Information: Copyright SHTFplan and Mac Slavo. This content may be freely reproduced in full or in part in digital form with full attribution to the author and a link to www.shtfplan.com. Please contact us for permission to reproduce this content in other media formats. SHTFPLAN is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.

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