Keyword: fda
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The U.S. Senate voted… along party lines, 51 to 47, to confirm Susan Monarez as the new director of the Centers for Disease Control and Prevention. Monarez has been serving as the acting head of the CDC since January, and previously worked as the head of the Advanced Research Projects Agency for Health. At her confirmation hearing before the Senate's Health, Education, Labor and Pension (HELP) committee on July 9, Monarez garnered praise from the Republican chairman, Sen. Bill Cassidy, who is a physician, for her commitment to rebuilding public trust in the wake of the COVID-19 pandemic. Democratic Sen....
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Vinay Prasad is returning to the Food and Drug Administration to resume his role overseeing vaccine, gene therapy, and blood product regulation. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Health and Human Services spokesman Andrew Nixon told STAT on Saturday.
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President Trump has just ORDERED all federal agencies to DELETE employees’ COVID-19 vaccination statuses They also must delete any records of vaccine non-compliance and exemptions FINALLY! NOBODY should be discriminated against for refusing the vax! .... never forget the amount of evil that took place during Covid ... It turned neighbors and family members against each other. . ... Crimes against humanity ... Never forget. ... US Employers must do the same. And any Employer who enforced the mandate must pay all vaccine injury related medical bills of past and present employees they forced to get a jab
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HHS Secretary Robert F. Kennedy Jr.’s next step toward making America Healthy again is an outright ban on thimerosal, a mercury-based preservative, found in common vaccines. “I’m proud to finally deliver on a long-overdue promise: protecting our most vulnerable from unnecessary mercury exposure,” Kennedy stated on a video posted on X, noting that the chemical is a known neurotoxin that has been administered to millions of Americans. The former director of the FDA, Willian Egan, admitted in 2001 that the safety of this preservative had never been studied. The government simply allowed the pharmaceutical agencies to incorporate it in vaccines...
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...Some of Loomer’s erstwhile political allies are starting to wonder if there might be a hidden hand behind some of her most influential denunciations. Sommer says the firing in question involves last Tuesday’s ouster of Dr. Vinay Prasad as the head of a key treatment-approval division of the Food and Drug Administration. Prasad was a hero in Secretary of Health and Human Services Robert F. Kennedy Jr.’s MAHA movement because of his criticism of pandemic measures. But Loomer accused Prasad of disloyalty to Trump — even claiming that Prasad had admitted to having a Trump voodoo doll. Stat News reports...
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The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as Director of the Center for Biologics Evaluation and Research, a government spokesperson said. Prasad, an oncologist who was a fierce critic of U.S. COVID-19 vaccine and mask mandates, had been appointed in May by FDA Commissioner Marty Makary. Together they had promised to speed regulatory action and pilot new review pathways. In recent days, criticism of Prasad's tenure has intensified around the agency's handling of a gene therapy for Duchenne muscular dystrophy from Sarepta Therapeutics (SRPT.O), opens new tab. The...
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“I wear no tin-foil hat. I’m asking for the ability to officially document what happened to me.” Three and a half years ago I contracted Guillain Barre Syndrome after getting the Jansen-J&J viral vector vaccine for COVID-19. The neurological disorder has left me hobbled by numb hands and feet, staggering around imbalanced, and battling debilitating fatigue. It has also left me, and thousands of others, feeling ignored and unheard by the government and the public health establishment. I wrote about the experience in 2021 in The Boston Globe, after the FDA attached a warning to the J&J shot, citing an...
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The Food and Drug Administration’s chief medical and scientific officer, Dr. Vinay Prasad, rejected two COVID-19 vaccines in May due to unknown risks despite experts’ confidence that they were safe, documents revealed.While both the Novavax vaccine and the newest generation of the mRNA Moderna vaccines had been signed off on by about 30 FDA vaccine officials, Prasad ended up writing overrides for each, restricting their use. Prasad argued that the threat of COVID-19 had decreased, changing the cost-benefit weight of receiving such a vaccine.“Even rare vaccination-related harms, both known and unknown, now have a higher chance of outweighing potential benefits...
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The U.S. Food and Drug Administration (FDA) under the Trump administration has formally updated the safety labeling on all mRNA COVID-19 vaccines to reflect what many Americans have been warning about for years: a disturbingly high risk of myocarditis—particularly in young men—and the possibility of long-term, irreversible heart damage. The revised warnings apply to both Pfizer’s Comirnaty and Moderna’s Spikevax vaccines and follow months of mounting pressure over transparency and accountability regarding the true risks of these experimental injections. The update stems from new studies and data showing persistent cardiac abnormalities months after vaccination—especially among males aged 12 to 24....
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Moderna on Monday said its experimental mRNA-based flu vaccine produced a stronger immune response than a currently available shot in a late-stage trial, clearing a path forward for the product and the company’s separate combination flu and Covid jab. Moderna in May voluntarily withdrew an application seeking approval of its combination shot targeting Covid-19 and influenza, saying it had plans to resubmit it with efficacy data from the phase three trial on its stand-alone flu vaccine. That decision came after discussions with the Food and Drug Administration, which is grappling with a massive overhaul under Health and Human Services Secretary...
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One of the most powerful figures at the US Food and Drug Administration (FDA) has admitted she refused the Covid-19 mRNA vaccine while pregnant—even as her agency promoted it as “safe and effective” for all pregnant women. Dr Sara Brenner’s explosive disclosure, made on 15 May 2025 at the MAHA Institute Round Table in Washington, DC, is as revealing as it is troubling. A preventive medicine physician, Brenner has worked at the FDA since 2019. As the FDA’s Principal Deputy Commissioner—and briefly its Acting Commissioner—Brenner was at the centre of decision-making. [snip] Brenner explained that her decision was driven by...
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(Conscientious Questions may have importance approaching that of the answers they evoke.) Wilhelm Reich was a Freudian, Marxist and early Sexual Revolutionary. He realized that most people have no interest in religion as such, but most are fascinated by sex. So he counseled that rather than trying to convert a seminarian by logical arguments, you just need to sexually corrupt him. (It's alleged that French students participating in large scale civil disobedience in Paris in 1970, threw copies of Wilhelm Reich's "The Mass Psychology of Fascism" at Police.) Reich died in prison. He was engaged in radiation experimentation which the...
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In a letter to pro-life Senator Josh Hawley of Missouri, FDA Commissioner Marty Makary has committed to conducting a full review of the dangerous abortion pill – which has killed and injured countless women. Makary made the commitment after Senator Josh Hawley sent a letter highlighting new research showing greater risks than the FDA currently acknowledges and urging Makary to reconsider his earlier statement that he had “no plans to take action.” “As Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone,” the FDA chief said in a letter to the senator, who highlighted it...
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The Food and Drug Administration (FDA) issued a Class I recall, the most serious designation, for tomatoes potentially containing deadly bacteria. Class I recalls indicate a potential for “serious adverse health consequences or death.” Williams Farms Repack LLC recalled multiple tomato sizes due to potential salmonella contamination. The FDA updated the recall to Class I designation on Wednesday. Williams Farms Repack LLC Recalls Tomatoes Due to Possible Salmonella Contamination https://t.co/VZrbo0NEfQ pic.twitter.com/whsBY5IZTD — U.S. FDA Recalls (@FDArecalls) May 2, 2025 Daily Mail reports: The recall covers shipments from April 23 to April 28 sold in Georgia, North Carolina and South Carolina....
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Sara Brenner, worked as a career employee at the FDA until she was recently promoted to the No. 2 position under the new FDA Commissioner. Marty Makary. Brenner has recently stated that she never took the COVID vaccine despite it being a requirement for federal employees.Brenner’s reasoning was that she was pregnant and concerned about the safety of the vaccine for both her and her child. Perhaps she arrived at that conclusion because she’s an expert on nanobiotechnology (although the picture she provided at the link is a curious choice), and therefore had serious and fully legitimate clinical reservations.The question...
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Welcome to the age of reason, my friends. In a bid to stop beta-testing vaccine variations on everyday citizens, the new Federal Drug Administration (FDA) leaders are rolling out rules that pharmaceutical companies need to actually prove the effectiveness of Covid boosters for people under 65 without co-morbidities using randomized clinical trials. For people over 65 and with co-morbidities, the FDA says that there's ample evidence they have a healthy immune response from the boosters. But for healthy young people, FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad wrote in the New England Journal of Medicine: We...
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The Food and Drug Administration announced Tuesday that it will limit access to Covid-19 vaccines going forward to people 65 years of age and older and others who are at high risk of becoming seriously ill if they are infected, and will require manufacturers to conduct clinical trials to show whether the vaccines are of benefit to healthy younger adults and children. After weeks of signaling a shift in thinking, the new leaders of the FDA and the agency’s division that regulates vaccines published a commentary in the New England Journal of Medicine laying out their plan for future use...
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Plasma assessment is not intended as a screening or stand-alone diagnostic test, agency saysThe FDA cleared the first blood-based in vitro diagnostic test for Alzheimer's disease, the agency announcedopens in a new tab or window Friday. The blood test, known as the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, can be used to detect amyloid plaques associated with Alzheimer's in people ages 55 and older who have signs and symptoms of the disease, the agency said. "Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined," FDA Commissioner Martin Makary, MD, MPH, said in a statement....
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HealthWatch Weight loss drugs have "no end game" amid lack of data on long-term use, former FDA commissioner warns healthwatch By Edited By May 13, 2025 / 1:03 PM EDT / CBS News Weight loss drugs have transformed how Americans lose weight, including former commissioner for the U.S. Food and Drug Administration Dr. David Kessler. But, Kessler warns there are unknowns about long-term use of the drugs and how to get people off them. "There is no end game," he said on "CBS Mornings Plus" Tuesday. "FDA allowed these medicines out without a long-term strategy." Kessler faced unexpected weight gain...
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CV NEWS FEED // Health and Human Services Secretary Robert F. Kennedy, Jr. said Wednesday that he has ordered a top-down review of the abortion drug mifepristone in light of “alarming” research showing the Food and Drug Administration (FDA)-approved pill does far more harm to women than previously reported. The latest research is “alarming,” Kennedy said during a hearing before the Senate Health, Education, Labor and Pensions Committee. “And clearly it indicates at the very least the [FDA] label should be changed.” “I’ve asked Marty Makary, who’s the director of the FDA, to do a complete review and to report...
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