The Food and Drug Administration has reversed its decision on Moderna's flu vaccine and has agreed to review it for possible approval, Moderna announced on Wednesday. From a report: Last week, the agency rejected Moderna's application for review of a new flu vaccine, saying the company's research design was flawed. But in subsequent discussions the company said that the agency had relented and agreed to begin a review. Moderna said it split its application for the flu vaccine based on age, seeking a traditional approval for people 50 to 64 years old, and accelerated approval for those 65 and older. The company also said it agreed to conduct an additional study among those 65 and older once the vaccine reached the market. Moderna said on Wednesday that the F.D.A. set a deadline of August to decide whether to approve the vaccine. If it is authorized, it would be available for those older adults in the flu season that begins later this year. The vaccine uses messenger RNA technology, which Health Secretary Robert F. Kennedy Jr. has repeatedly criticized as unsafe and ineffective. The mRNA approach, which instructs the body to produce a fragment of a virus that sets off an immune response, was widely successful in Covid vaccines and is considered generally safe by public health experts and scientists.

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In a small double-blind clinical trial, a single intravenous dose of DMT produced rapid and clinically meaningful reductions in symptoms of major depressive disorder within a week, with effects lasting up to three months in some patients. "Unlike psilocybin and lysergic acid diethylamide ( LSD), whose effects can last for hours, intravenous DMT has a half-life of around five minutes," notes ScienceAlert. "Its psychedelic effects are correspondingly brief, potentially making it more practical to administer in clinical settings." From the report: "A single dose of DMT with psychotherapeutic support produced a rapid, significant reduction in depressive symptoms, sustained up to three months," writes a team led by neuroscientists David Erritzoe and Tommaso Barba of Imperial College London. [...] They recruited 34 participants with major depression and divided them into two groups of 17 for a double-blind, placebo-controlled trial. In the first stage of the trial, one group received an intravenous dose of DMT, while the other received an active placebo. Neither the researchers nor the participants were informed which participants received the DMT. The doses took around 10 minutes to administer, and a therapist sat with each participant to ensure comfort and safety while the psychedelic effects were active, remaining silent throughout the treatment. The treatment was generally well tolerated. Most side effects were mild to moderate, and included nausea, temporary anxiety, and pain at the injection site. No serious adverse events related to the treatment were reported, although brief increases in heart rate and blood pressure were observed immediately after dosing. In the second, open-label stage, two weeks after the first dose, all participants were given the opportunity to receive a dose of DMT. Participants were assessed before and at intervals after each dose using the Montgomery-Asberg Depression Rating Scale. Just a week after the first dose, participants who had received DMT had improved scores compared to the placebo group, and improvements were sustained during follow-up assessments. Two weeks after the first dose, the participants who received DMT scored about seven points lower, on average, than those who received a placebo. On this commonly used clinical scale, a drop of that size is generally considered a meaningful reduction in symptom severity. There was no significant difference between patients who received one or two doses of DMT, suggesting a single dose may be sufficient. These effects persisted for up to three months, and some patients remained in remission for at least six months following the treatment. The findings have been published in Nature Medicine.

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Longtime Slashdot reader walterbyrd shares a report from ABC News: In a study of nearly 28 million older Americans, long-term exposure to fine particle air pollution raised the risk of Alzheimer's disease. That link held even after researchers accounted for common conditions like high blood pressure, stroke and depression. Fine particle air pollution, known as PM2.5, consists of tiny particles in the air that come from car exhaust, power plants, wildfires, and burning fuels, according to the American Lung Association. They are small enough to travel deep into the lungs and even reach the bloodstream. The research, conducted at Emory University and published in PLOS Medicine, tracked health data over nearly two decades to explore whether air pollution harms the brain indirectly by causing high blood pressure or heart disease, which, in turn, leads to dementia. However, these "middleman" conditions accounted for less than 5% of the connection between pollution and Alzheimer's, the research found. The researchers say this suggests that over 95% of the Alzheimer's risk comes from the direct impact of breathing in dirty air, likely through inflammation or damage to brain cells. "The relationship between PM2.5 and AD [Alzheimer's disease] has been shown to be pretty much linear," said Kyle Steenland, a professor in the departments of environmental health and epidemiology at the Rollins School of Public Health at Emory University, and senior author of the study. "The reason this is particularly important is that PM2.5 is known to be associated with high blood pressure, stroke and depression -- all of which are associated with AD. So, from a prevention standpoint, simply treating these diseases will not get rid of the problem. We have to address exposure to PM2.5."

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