Seniors and people with weakened immune systems can get another booster dose of the bivalent COVID vaccine this spring, the U.S. Food and Drug Administration announced Tuesday. Seniors age 65 and older can get a booster at least four months following their first dose of the bivalent vaccine, which protects against both the original and Omicron strains of COVID, the FDA said. People with weakened immune systems can get a booster at least two months after their last vaccine dose, based on their doctor’s judgment, the agency added. “COVID-19 continues to be a very real risk for many people. We are therefore encouraging everyone to consider staying current with vaccination,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during a Tuesday morning media briefing. COVID continues to be linked to about 1,300 deaths each week, according to the U.S. Centers for Disease Control and prevention. The FDA announcement was part of an overall effort to simplify the COVID vaccine schedule for Americans, the agency said. In its Tuesday announcement, the FDA also rescinded its emergency use authorization for the original Moderna and Pfizer mRNA vaccines, which are credited with saving tens of millions of lives during the pandemic. Only the bivalent vaccines will be available going forward, the FDA said. Adults and children who’ve only gotten the original vaccine…  read on >  read on >

Most cases of type 2 diabetes can be linked to making poor food choices, a new study finds. Researchers from Tufts University in Boston linked poor diet to 14 million cases of type 2 diabetes — about 70% of new diagnoses globally — in 2018. The biggest impact came from insufficient intake of whole grains, too much refined rice and wheat, and overconsumption of processed meat. “Our study suggests poor carbohydrate quality is a leading driver of diet-attributable type 2 diabetes globally, and with important variation by nation and over time,” said study co-author Dr. Dariush Mozaffarian, a professor of nutrition and dean for policy at Tufts’ School of Nutrition Science and Policy. “These new findings reveal critical areas for national and global focus to improve nutrition and reduce devastating burdens of diabetes,” Mozaffarian said in a Tufts news release. In type 2 diabetes, the body’s cells are resistant to insulin, a hormone necessary to convert the food you eat into fuel for the body. The scientists looked at data from 1990 and 2018, using a research model of dietary intake in 184 countries that was developed at Tufts. All of the countries studied saw an increase in type 2 diabetes cases during that time frame. Poor diet is causing a larger proportion of total type 2 diabetes incidence in men versus women, in younger…  read on >  read on >

The Supreme Court of the United States on Friday acceded to a Biden Administration emergency application and paused parts of a recent federal ruling that had limited the availability of the abortion pill mifepristone. Justice Samuel Alito Jr. issued the interim stay, which would allow women access as usual to mifepristone up until midnight next Wednesday, the New York Times reported. Alito’s move to temporarily restore full availability is not thought to have any bearing on the Court’s final decision on the case — it merely preserves the status quo while giving the justices time to review lower court rulings. Justice Alito issued the order because he oversees the appeals court whose ruling is the focus of an appeal. He ordered the groups behind the challenge to the Food and Drug Administration’s approval of mifepristone to file their brief by Tuesday at noon, the Times said. On Wednesday, a federal appeals court partially overruled Judge Matthew Kacsmaryk’s ruling made in Texas last week, which said the U.S. Food and Drug Administration’s approval of mifepristone back in 2000 was invalid and the drug should not be used. However, the three-judge appeals court panel said mifepristone could remain available for now, but it blocked mailing the pill to patients, as well as other measures the federal government has taken recently to boost access to the medication. In…  read on >  read on >

A federal appeals court on Wednesday said the abortion pill mifepristone could remain available for now. But the court’s judges added some provisions to their ruling: A block on mailing the pill to patients as well as stays on other measures the federal government has taken recently to boost access to the medication. The three-member panel partially overruled Judge Matthew Kacsmaryk’s ruling in Texas last week, which said the U.S. Food and Drug Administration’s approval of mifepristone back in 2000 was invalid. Mifepristone is typically given as the first of two drugs used during a medication abortion. The U.S. Justice Department had filed its appeal of the Texas ruling on Monday. “If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity,” the appeal stated. In its preliminary ruling filed on Wednesday, the federal appeals court suggested a statute of limitations bars any legal challenge to the FDA’s approval of mifepristone. The court also seemed to consider the government’s view that removing a long-approved drug from the market would have “significant public consequences.” But it left in place parts of Kacsmaryk’s ruling that rolled back a loosening of restrictions on mifepristone by the FDA in recent years. That includes a 2016 move to allow the drug to be…  read on >  read on >

As people with HIV live longer they’re at risk of premature heart disease. But a new study finds statin drugs can cut the risk of serious heart problems by more than one-third. The U.S. National Institutes of Health trial found the cholesterol-lowering drugs so effective, in fact, that the study was stopped early. Taking the daily statin pitavastatin calcium lowered the risk of major heart events by 35% in this patient group, according to an interim analysis of data from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study. “The REPRIEVE study reflects the evolution of HIV science, and progress from focusing mostly on approaches to treat and control the virus to finding ways to improve the overall health of people living with HIV,” said Dr. Hugh Auchincloss, acting director of the National Institute of Allergy and Infectious Diseases (NIAID). “These new data suggest that a common cholesterol-lowering medicine could substantially improve cardiovascular outcomes in people with HIV,” he said in a news release from the NIH and the NIAID. As people with HIV live longer thanks to decades of medical research and advances, premature heart disease and other chronic conditions have emerged as leading causes of illness and death. Statins are known to prevent heart disease in those at risk in the general population. But researchers weren’t certain before the trial if…  read on >  read on >

(HealthDay News) – The U.S. Justice Department on Monday appealed a Texas court ruling that invalidates the U.S. Food and Drug Administration’s approval in 2020 of mifepristone, the first of two drugs taken during a medical abortion. The ruling by U.S. District Judge Matthew Kacsmaryk in Texas is “extraordinary and unprecedented,” the Justice Department said in its appeal. “If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity.” Pharmaceutical executives have also weighed in on the ruling, signing a letter on Monday warning about the impact if the Texas order was to take effect. “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” stated the letter, according to the Associated Press. While Kacsmaryk’s ruling said the order would not take effect for seven days, within 20 minutes of the order a federal judge in Washington state issued a ruling directing the FDA to make no changes that would restrict access to the drug in 17 states where Democrats had sued, the AP reported. The Justice Department has asked for clarification on that ruling. The Texas lawsuit was filed…  read on >  read on >