The U.S. Food and Drug Administration (FDA) has delayed the full approval of Novavax’s COVID-19 vaccine.  The decision had been expected by April 1, but the agency now says it needs more information before moving forward. The Novavax shot is already available under emergency use. But full FDA approval would allow the vaccine to be used more widely and could offer more reassurance to people looking for options besides the existing mRNA vaccines, CNN reported. The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, according to KFF Health News, are also pressing regulators to revoke federal approval for mRNA-based COVID shots, which President Donald Trump has touted as a key first- term achievement.  Novavax uses protein-based technology, a more traditional method than the mRNA vaccines from Pfizer and Moderna.  “As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License Application] is ready for approval,” Novavax said in a statement, adding that its application “included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19.” “We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.,” Novavax added. The delay comes as the FDA is undergoing leadership changes.…  read on >  read on >

Cancer survivors can reduce their ongoing risk of death by sticking to diet and exercise guidelines recommended by the American Cancer Society, a new study suggests. Non-smoking survivors of obesity-related cancers had an overall lower risk of death if they adopted the ACS lifestyle recommendations following their treatment, according to findings published April 3 in the Journal of the National Cancer Institute. They also had a lower risk of dying either from heart-related diseases or a subsequent bout with cancer, results show. “A cancer diagnosis often motivates people to think about how they can live healthier lives,” lead investigator Ying Wang, senior principal scientist of epidemiology research at the American Cancer Society, said in a news release. “Many survivors want to know what lifestyle changes they can make to improve their chances of living longer.” The ACS updated its nutrition and physical activity guidelines in 2022. The new recommendations emphasize maintaining healthy weight, exercising regularly, eating healthy and limiting alcohol intake. To test the effectiveness of these recommendations, researchers analyzed the lifestyle habits of more than 3,700 participants in a long-term study of cancer risk that began in 1992. The study focused on survivors of obesity-related cancers “due to the significant role of lifestyle factors in their development and prognosis,” researchers wrote. These included stomach, colon, liver, gallbladder, pancreatic, breast, uterine, kidney, thyroid, nervous system…  read on >  read on >

The U.S. Food and Drug Administration’s (FDA) top tobacco regulator, Brian King, has been placed on leave as part of a large wave of cuts across federal health agencies.  King, who led the FDA’s tobacco control efforts, told his staff Tuesday that he was removed with “a heavy heart and profound disappointment.” “If you make it virtually impossible to create and draft policy, then you are eviscerating the role of the center,” Mitch Zeller, the FDA’s former tobacco chief, said in an interview with The Associated Press. “From a public health perspective it makes absolutely no sense.” King joined the FDA in 2022 and became a target of vaping industry criticism for ordering thousands of flavored e-cigarettes off the market. During his tenure, teen vaping dropped to its lowest level in 10 years. His removal follows the recent resignation of vaccine chief Dr. Peter Marks, who said he could no longer support the Trump administration’s promotion of vaccine misinformation. The FDA has seen a major leadership turnover in recent months. Top officials overseeing drugs, food, vaccines and medical devices have either resigned or retired. In an online post, former FDA Commissioner Robert Califf said “history will see this as a huge mistake,” The Associated Press reported. “The FDA as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep…  read on >  read on >

Lower levels of “bad” LDL cholesterol could mean a lower risk of dementia and Alzheimer’s disease, a new study says. People with low-density lipoprotein (LDL) cholesterol levels lower than 70 mg/dl had a 26% lower risk of dementia and 28% lower risk of Alzheimer’s, compared to people with LDL levels above 130 mg/dl, researchers reported April 1 in the Journal of Neurology, Neurosurgery & Psychiatry. Statins taken to lower cholesterol also appeared to confer additional protection against dementia and Alzheimer’s. “These findings emphasize the importance of achieving specific LDL cholesterol thresholds for dementia prevention,” concluded the research team led by Dr. Yerim Kim, an assistant professor of neurology with the Hallym University College of Medicine in Seoul, South Korea. “Furthermore, it suggests a potential synergistic benefit of statin use within this optimal range,” researchers added. Current LDL cholesterol guidelines call for lower than 100 mg/dl in healthy people, and 70 mg/dl or lower in people with a history of heart attack or stroke, according to the American Heart Association (AHA). Those guidelines are based on a clear link between “bad” cholesterol levels and heart risk, but there’s been conflicting evidence regarding the association between LDL cholesterol and brain health, researchers said in background notes. Early studies suggested that lowering LDL cholesterol through statin use might cause some cognitive impairment, but later data has shown that low…  read on >  read on >

Microplastics appear to be contributing to chronic diseases in shoreline areas of the United States, a new study suggests. High blood pressure, diabetes and stroke rates are higher in coastal or lakefront areas with greater concentrations of microplastics in the environment, researchers reported at a meeting of the American College of Cardiology (ACC). The results also suggested a dose relationship, where higher concentrations of microplastics pollution are associated with more chronic disease, researchers said. “This study provides initial evidence that microplastics exposure has an impact on cardiovascular health, especially chronic, noncommunicable conditions like high blood pressure, diabetes and stroke,” lead investigator Sai Rahul Ponnana, a research data scientist at Case Western Reserve School of Medicine in Cleveland, said in a news release. Microplastics are tiny plastic particles as small as 1 nanometer; by comparison, a strand of human hair is about 80,000 nanometers wide. These particles are released as larger pieces of plastic break down, and can come from food and beverage packaging, consumer products and building materials, researchers said in background notes. People can be exposed to microplastics in the water they drink, the food they eat and the air they breathe. For this study, researchers linked U.S. Centers for Disease Control and Prevention (CDC) data on chronic illness rates with federal data on microplastics concentrations in the sediment along coastal and lakeshore areas…  read on >  read on >

Fasting every other day can prompt more weight loss than simply cutting calories, a new clinical trial shows. People who undertook 4:3 intermittent fasting lost just under 8% of their body weight within a year, compared to a 5% loss among people who cut their daily calories by about a third, researchers reported March 31 in the Annals of Internal Medicine. In 4:3 intermittent fasting, people restrict their calorie intake by 80% three days a week, alternating between days with no dietary restrictions at all. “Long-term adherence to daily calorie restriction is challenging for many people,” wrote the research team co-led by Danielle Ostendorf, an assistant professor of kinesiology, recreation and sport studies at the University of Tennessee Knoxville. “Our results suggest that 4:3 [intermittent] is an alternative dietary weight loss strategy that may produce modestly superior weight loss compared with [daily calorie restriction] at 12 months, when provided in the context of a high-intensity, comprehensive behavioral weight loss program,” the team concluded. For this trial, researchers assigned 84 overweight and obese people to this type of fasting, and another 81 folks to cut their calories by 34%. Both groups were asked to get in 300 minutes of moderate-intensity exercise a week, double the amount recommended by U.S. physical activity guidelines. They also received support from a weight-loss program led by a registered dietitian. After…  read on >  read on >