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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...

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...

(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...

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...

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....

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...

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...

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...

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....

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...

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...

The U.S. Food and Drug Administration is taking action to remove ingestible fluoride prescription drugs for children off the market. In a press release, the FDA said products that are swallowed offer significant risk to infants and toddlers, unlike toothpaste with fluoride or fluoride rinses. The FDA also said the ingestion of fluoride products comes with risks like problems with the early development of the gut microbiome in childhood, thyroid disorders, weight gain, and decreased IQ. The federal agency provided links to several studies that point to worrying effects in children, especially in regard to their IQ. A meta-analysis of...

Karen Kingston is a biotech analyst and former Pfizer employee who is back with some grotesque news about what the US government knew about the CV19 bioweapon vax. They knew it was not safe at all, and the FDA also knew Pfizer committed fraud to get the CV19 injections approved. Kingston says, “This is the government’s words exactly: ‘The FDA was aware of the protocol violations.’ So, the FDA was aware of the fraud that was reported . . . before it granted emergency use authorization (EUA) for its vaccine. They were aware of the fraud. Second, the government said...

Washington — The Trump administration on Monday urged a federal district court to dismiss a lawsuit challenging the Food and Drug Administration's actions expanding access to the widely used abortion pill mifepristone. Justice Department lawyers wrote in a filing with the U.S. district court in Amarillo, Texas, that the three states pursuing the lawsuit — Missouri, Idaho and Kansas — should not be able to do so in that court. The administration is pursuing a request initially made by the Biden administration last year in the closely watched challenge to mifepristone, a drug used to terminate an early pregnancy, that...

New study reveals an adverse event rate 22 times higher than the FDA-approved drug label reports. (Washington, DC): In a first-of-its-kind study, “The Abortion Pill Harms Women”, the Ethics and Public Policy Center (EPPC) reveals that serious adverse events from mifepristone are approximately 22 times more frequent than the Food and Drug Administration (FDA) currently recognizes. The study shows that, following a mifepristone abortion, 10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious or life-threatening adverse event. That is, over one in ten patients experience at least one serious adverse event. The study, authored by Jamie Bryan Hall,...

While the abortion pill is touted as “safe and effective,” shocking new data suggests complications are 22 times higher than previously reported. A study from the Ethics and Public Policy Center released on Monday found that 10.93 percent of women who had mifepristone abortions — the first drug used in a two-drug medication abortion regimen — experienced severe complications including sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following the abortion. This percentage is significantly higher than the less than 0.5 percent in clinical trials reported on the FDA-approved drug label. The study is the “largest-known study...

The Food and Drug Administration and the US Department of Health and Human Services have announced a ban on all petroleum-based synthetic food dyes beginning in 2026. Robert F. Kennedy has warned for years that America’s food supply has been compromised with chemicals that have aided in causing America to be the sickest nation in the developed world. The FDA is taking the following actions: Establishing a national standard and timeline for the food industry to transition from petrochemical-based dyes to natural alternatives. Initiating the process to revoke authorization for two synthetic food colorings—Citrus Red No. 2 and Orange B—within...

The U.S. Food and Drug Administration (FDA) has suspended its quality control program for testing fluid milk and other dairy products, citing reduced capacity in its food safety and nutrition division. This decision follows the termination and departure of 20,000 employees from the Department of Health and Human Services (HHS), part of a broader federal workforce reduction initiative. ​ Reuters reported, effective April 21, the U.S. Food and Drug Administration has suspended its quality testing program for Grade A milk and other dairy products, citing massive staffing losses tied to federal budget cuts. While the move may seem bureaucratic, it...

U.S. Food and Drug Administration (FDA) Commissioner Martin Makary announced a new policy directive limiting employees of companies the agency regulates, such as pharmaceutical companies, from serving as official members of FDA advisory committees. “While the FDA should be partnering with industry to ensure a user-friendly review process, the scientific evaluation of new products should be independent,” Makary said. “Industry employees are welcome to attend FDA advisory committee meetings, along with the rest of the American public, but having industry employees serve as official members of FDA advisory committee members represents a cozy relationship that is concerning to many Americans,”...

Sustained research funding is essential to progressI don't usually talk about my cancer diagnosis. But as a physician-scientist who survived leukemia at 18 years old and now cares for people facing their own cancer diagnoses, I feel compelled to share my story -- because it speaks directly to what's at stake in medicine today. The clinical trial that saved my life wouldn't have existed without robust investment in biomedical research. And as debates over federal research funding continue, I think about whether future patients will have access to the same life-saving opportunities I did. It was the summer of 2007....