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Keyword: fda

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  • Landmark Study Vindicates Everyone Who Touted Natural Immunity to COVID-19

    02/17/2023 8:54:09 AM PST · by george76 · 43 replies
    Red State. ^ | February 17, 2023 | Bonchie
    We are going to need a new industry that simply spends its time fact-checking the so-called “fact-checkers.” That’s the story after a new landmark study published in The Lancet offered vindication to everyone who touted natural immunity to COVID-19 as an alternative to vaccination. For years, the powers that be, including Dr. Anthony Fauci, the White House, and the press, dismissed the idea of taking natural immunity into account when debating vaccine mandates and vaccine passports. They were wrong, so much so that even the mainstream media are having to admit it. ... This study also puts to rest another...
  • Panel backs moving opioid antidote Narcan over the counter

    02/15/2023 7:10:31 PM PST · by Olog-hai · 51 replies
    Associated Press ^ | February 15, 2023 | Matthew Perrone
    The overdose-reversing drug naloxone should be made available over the counter to aid the national response to the opioid crisis, U.S. health advisers said Wednesday. The panel of Food and Drug Administration experts voted unanimously in favor of the switch after a full day of presentations and discussions centered on whether untrained users would be able to safely and effectively use the nasal spray in emergency situations. The positive vote, which is not binding, came despite concerns from some panel members about the drug’s instructions and packaging, which caused confusion among some people in a company study. The manufacturer, Emergent...
  • Booster Shots May Trigger Stroke Incidents, According to CDC and FDA

    02/12/2023 8:07:24 AM PST · by E. Pluribus Unum · 40 replies
    The Epoch Times ^ | Feb 11 2023 | Dr. Yuhong Dong
    In addition to cardiac events, another life-threatening side effect has been associated with the Pfizer-BioNTech vaccine. When is the risk period? Does the flu shot play any role in these events? What actions should we take to better protect ourselves? Summary of Key Facts An increased risk of stroke events has been identified with the Pfizer COVID-19 bivalent vaccine, according to a joint statement from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). The onset time in people aged 65 years and older was 1–21 days after the booster, with a significant cluster...
  • mRNA Injections are a Threat to Public Health per New York State COVID-19 Hospital Data

    02/06/2023 9:57:17 PM PST · by george76 · 19 replies
    Karen Kingston ^ | 2/6/2023 | Karen Kingston
    NY state's hospital data of fully-vaxxed adults and children is incriminating evidence that the COVID-19 injections are bioweapons and the cause of severe COVID-19 disease and hospitalizations. ... Data from Pfizer, the FDA, and the Cleveland Clinic demonstrate that the COVID-19 mRNA injections increase the for risk COVID-19 infection, and therefore can increase the risk for severe COVID-19 disease and hospitalizations due to VAERD (vaccine-associated enhanced disease). If we follow the science and real-world evidence, this means that the mRNA injections themselves pose a threat to public safety and should be removed from communities to avoid the risk of overwhelming...
  • They knew: why didn't the unvaccinated do more to warn us?

    01/27/2023 9:02:17 AM PST · by EBH · 59 replies
    The unvaccinated knew what we didn't. Some of them said too little. Most said nothing at all. A lot of blood is now on their hands. As the world struggles to come to terms with the devastating effects of the COVID-19 pandemic, one question that continues to surface is why the unvaccinated didn't do more to warn us about the potential dangers of being injected. While well intending citizens lined up, did the right thing, and received their COVID19 vaccinations -- now seeming to do more harm than good -- their unvaccinated friends stood by and let them do it....
  • FDA will ease ban on monogamous gay and bisexual men donating blood

    01/26/2023 5:09:50 PM PST · by fruser1 · 51 replies
    UK Daily Mail ^ | 1/26/2023 | Manshur Shaheen
    Gay and bisexual men will soon no longer have to abstain from sex in order to donate blood in the US, the Food and Drug Administration (FDA) said Thursday. The move comes after widespread calls from members of Congress, the American Red Cross and LGBT organizations to drop the ban put in place during the 1980s AIDS epidemic. Men who had sex with another man (MSM) in the past three months, or women who had sex with one of those men, are not allowed to donate blood under current rules. This is because those men were struck hardest by America's...
  • US proposes once-a-year COVID shots for most Americans

    01/23/2023 10:59:06 PM PST · by Olog-hai · 59 replies
    Associated Press ^ | January 24, 2023 | Matthew Perrone
    U.S. health officials want to make COVID-19 vaccinations more like the annual flu shot. The Food and Drug Administration on Monday proposed a simplified approach for future vaccination efforts, allowing most adults and children to get a once-a-year shot to protect against the mutating virus. This means Americans would no longer have to keep track of how many shots they’ve received or how many months it’s been since their last booster. The proposal comes as boosters have become a hard sell. While more than 80% of the U.S. population has had at least one vaccine dose, only 16% of those...
  • FDA to propose yearly COVID vaccines like annual flu shots for Americans

    01/23/2023 3:31:33 PM PST · by Golden Eagle · 62 replies
    Fox News ^ | January 23, 2023 | Bradford Betz
    The Food and Drug Administration on Monday proposed approaching COVID-19 vaccines like the annual flu shot many Americans receive in order to protect against mutations of the virus. The proposal aims to simplify future vaccination efforts. Under this strategy, most adults and children would get a once-a-year shot to protect against the mutating virus. They would no longer have to keep track of how many shots they’ve received or many months it's been since their last booster. In documents posted online, FDA scientists say many Americans now have "sufficient preexisting immunity" against the coronavirus because of vaccination, infection, or a...
  • US FDA, CDC see early signal of possible Pfizer bivalent COVID shot link to stroke

    01/16/2023 3:29:17 PM PST · by Twotone · 11 replies
    Jerusalem Post ^ | January 15, 2023 | Reuters
    A safety monitoring system flagged that US drugmaker Pfizer Inc PFE.N and German partner BioNTech's BNTX.O updated COVID-19 shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by US health authorities. What are the potential health consequences of the vaccines? The US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said on Friday that a CDC vaccine database had uncovered a possible safety issue in which people 65 and older were more likely to have an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent...
  • Moderna Withheld Data From FDA Regulators to Get Covid Bivalent Booster Approved

    01/16/2023 6:39:06 AM PST · by SeekAndFind · 15 replies
    PJ Media ^ | 01/16/2023 | Ben Bartee
    How many times have we been treated, in the era of the New Normal, to exasperated corporate media hacks complaining about “misinformation” pushed by “conspiracy theorists” regarding the COVID-19 mRNA gene therapies deceptively marketed as “vaccines”?As it turns out, the biggest purveyor of misinformation is the pharmaceutical industry, followed closely by the government and corporate media.Via CNN:The pharmaceutical company Moderna didn’t present a set of infection data on the company’s new Covid-19 booster during meetings last year when [FDA] advisers discussed whether the shot should be authorized and made available to the public… That data suggested the possibility that the...
  • FDA Adviser Says Young And Healthy People Shouldn’t Get Latest COVID Boosters

    01/14/2023 8:42:18 PM PST · by SeekAndFind · 8 replies
    Epoch Times ^ | 01/14/2023 | Jack Phillips
    A vaccine adviser to the Food and Drug Administration is questioning whether young, healthy people should get new COVID-19 boosters, arguing those shots should be used for older individuals.“I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later,” wrote Dr. Paul A. Offit, an FDA vaccine panel adviser and professor of pediatrics at the Children’s Hospital of Philadelphia, in New England Journal of Medicine on Jan. 11.In his article, Offit cited two studies suggesting that bivalent boosters, which target...
  • CDC and FDA find no increased risk of ischemic stroke for elderly who get Pfizer’s bivalent booster

    01/14/2023 8:09:37 PM PST · by blueplum · 29 replies
    The Hill ^ | 13 Jan 2023 | JOSEPH CHOI
    Following an analysis of vaccine surveillance data, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) say they have found no evidence of increased risk of ischemic stroke among people 65 and older who receive Pfizer’s bivalent booster..... ... researchers and physicians have repeatedly stressed that the risk of stroke due to COVID-19 infection is higher than the risk caused by immunization.
  • FDA and CDC Vaccine Experts Now Claim They are “Outraged” at Government and Moderna for Allegedly Hiding Key Data About Updated Booster Effectiveness – Moderna Responds

    01/14/2023 9:19:50 AM PST · by bitt · 44 replies
    gateway pundit ^ | 1/14/2023 | jim hoft
    In August 2021, the Food and Drug Administration (FDA) gave emergency authorization to the new booster shot called “bivalent.” The new vaccine contains two messenger RNA (mRNA) components of the coronavirus. Half of the vaccine targets the original strain, and the other half targets the BA.4 and BA.5 Omicron subvariant lineages. The new COVID boosters were not tested on humans at the time, only on mice. FDA was only relying on the mice trial data. The CDC panel then voted to recommend the shots for people over the age of 12 and for children as young as 5 to 11....
  • Proof that the CDC, FDA, and NIH are corrupt and/or incompetent

    12/22/2021 11:41:00 AM PST · by ransomnote · 30 replies
    substack.com ^ | 12/22/2021 | Steve Kirsch
    An article for those people who are not already convinced of this (you know, like every member of Congress and the mainstream media). My regular followers will find nothing new or surprising here.I wanted to start a placeholder article of examples of corruption and/or incompetence at our favorite 3-letter agencies. The lists will likely grow much longer over time.Sadly, AFAIK, nobody in Congress is interested in looking at this. They all would rather look the other way and pretend there is no problem here. They refuse to discuss any of these points.Feel free to suggest your favorite examples in the...
  • How Bill Gates and Other Private Interests Used Legal Loopholes to Corrupt FDA

    01/10/2023 3:39:43 PM PST · by george76 · 8 replies
    Children's Health Defense. ^ | 12/06/22 | Dr. Joseph Mercola
    Millions trust the U.S. Food and Drug Administration to regulate Big Food and Big Pharma without realizing that Bill Gates and other members of the private sector are pulling the strings behind the scenes. ... While the U.S. Food and Drug Administration (FDA) itself does not accept corporate money, it does receive money funneled via a nonprofit foundation, which receives money from other nonprofits funded by private interests. The Reagan-Udall Foundation is a nonprofit foundation created by Congress in 2007 to support scientific research that is of interest to the FDA. It accepts grants from the government, individual donors and...
  • Health Care Workers Cry Foul on FDA Claiming It Didn’t Prohibit Ivermectin for COVID-19

    01/04/2023 1:46:52 PM PST · by DFG · 55 replies
    The Epoch Times ^ | 01/03/2023 | Katie Spence
    Dr. Yusuf Saleeby has practiced medicine for more than 30 years. He serves patients in South Carolina and until recently had never faced an investigation from his state medical board. But after Saleeby started prescribing ivermectin to his patients, he was reported to the board, which opened an investigation, despite the state’s attorney general’s promise that his office wouldn’t prosecute doctors who prescribed off-label medications. Jennifer Wright, a nurse practitioner and clinical director who practices in Florida, but can prescribe across state lines, told The Epoch Times she received a letter from the Office of the Attorney General of New...
  • FDA Approves Abortion Pills to Be Dispensed at Pharmacies

    01/04/2023 1:34:03 PM PST · by Olog-hai · 23 replies
    Cybercast News Service ^ | January 4, 2023 | 10:53AM EST | Michael W. Chapman
    Because of a new FDA ruling, the abortion pill Mifeprex (mifepristone) may now be obtained directly through retail pharmacy stores instead of directly from a doctor. The drug still requires a prescription, however, from a physician or certified prescriber. On its webpage about mifepristone and “medical termination of pregnancy through 10 weeks gestation,” the FDA on Jan. 3 announced that it was modifying its rules for obtaining the abortion drug. Under the new modification, “Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber,” said the FDA. In the...
  • Weight loss 'magic bullet' Wegovy approved by FDA for children as young as 12

    12/28/2022 6:48:20 PM PST · by algore · 51 replies
    The popular weight loss drug Wegovy is now available to children as young as 12. Danish manufacturer Novo Nordisk announced that the Food and Drug Administration had extended the drug's approval to include children. It had previously received regulatory approval for use in adults last year. In clinical trials, teens aged 12 to 17 who took the weekly injection lost 14 percent of their body weight over 64 weeks. This nearly matches the trials for adults, where recipients lost 15 percent of their weight after 68 weeks. Wegovy, and its sister drug Ozempic, have rocketed to popularity in 2022 because...
  • FDA Approves Monoclonal Antibody To Treat COVID-19 For First Time

    12/23/2022 6:38:16 PM PST · by SeekAndFind · 49 replies
    Epoch Times ^ | 12/23/2022 | Mimi Nguyen Ly
    The U.S. Food and Drug Administration (FDA) has, for the first time, approved a monoclonal antibody to treat COVID-19 in hospitalized patients.Healthcare company Roche’s Actemra (tocilizumab) intravenous (IV) was approved by the FDA to treat severe COVID-19 in adults, the company announced on Wednesday.Specifically, the drug is approved in cases where the patient is hospitalized and is receiving systemic corticosteroids, as well as requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.It is the first FDA-approved monoclonal antibody to treat COVID-19, the company stated.Monoclonal antibodies are laboratory-created proteins that mimic natural antibodies the body produces to fight...
  • Pfizer’s COVID-19 Vaccine Linked to Blood Clotting: FDA

    12/19/2022 5:01:04 AM PST · by george76 · 47 replies
    The Epoch Times ^ | Dec 17 , 2022 | Zachary Stieber
    Pfizer’s COVID-19 vaccine has been linked to blood clotting in older individuals, according to the U.S. Food and Drug Administration (FDA). FDA researchers, crunching data from a database of elderly persons in the United States, found that pulmonary embolism—blood clotting in the lungs—met the initial threshold for a statistical signal and continued meeting the criteria after a more in-depth evaluation. Three other outcomes of interest—a lack of oxygen to the heart, a blood platelet disorder called immune thrombocytopenia, and another type of clotting called intravascular coagulation—initially raised red flags, researchers said. More in-depth evaluations, such as comparisons with populations who...