The FDA Approves First mRNA-Based Flu Vaccine for Adults 50 and Older The U.S. Food and Drug Administration (FDA) has approved the nation’s first mRNA-based flu vaccine, mFlusiva, for use in individuals aged 50 and older. Developed by Moderna, this marks a significant shift in influenza prevention, leveraging the same mRNA technology used in many COVID-19 vaccines. The approval comes after years of regulatory hurdles, including initial rejections by the FDA and political challenges during the Trump administration, which had cut funding for mRNA vaccine research. The vaccine’s development faced a complex path to approval. Initially, the FDA declined Moderna’s application, citing concerns about the study’s design. However, the agency’s independent vaccine advisory panel unanimously recommended approval in June 2024, stating the vaccine’s benefits outweigh its risks. After further negotiations, the FDA agreed to a dual approval pathway: standard approval for adults aged 50–64 and accelerated approval for those 65 and older. This decision followed criticism that Moderna’s original trial did not meet the FDA’s standards for comparing the mRNA vaccine to the enhanced dose recommended for older adults. The mRNA flu vaccine operates differently from traditional flu shots. While conventional vaccines use inactivated or weakened viral components to stimulate immunity, mRNA vaccines deliver genetic instructions to cells, prompting them to produce viral proteins that trigger an immune response. This method allows for faster production and adaptability to emerging viral strains.#fda #johns_hopkins #moderna #mflusiva #center_for_infectious_disease_research_and_policy
New guidelines offer new approach for managing high cholesterol Doctors now recommend that patients get a lipoprotein(a) test along with other screenings to manage high cholesterol, according to updated guidelines released by the American Heart Association and the American College of Cardiology. The guidelines emphasize more aggressive prevention strategies and earlier treatment, including a one-time lipoprotein(a) test for all adults. This genetic marker is linked to an increased risk of heart attacks, strokes, and other cardiovascular conditions. The guidelines aim to improve tools doctors use to assess cardiovascular risk, which remains the leading cause of death for men and women in the United States. Dr. Roger Blumenthal, a cardiologist at Johns Hopkins and chair of the guideline writing committee, noted that 80% or more of cardiovascular disease is preventable. Elevated LDL cholesterol, often called "bad" cholesterol, plays a major role in this risk. However, relying solely on LDL levels may not be sufficient. Blumenthal highlighted that measuring additional biomarkers can provide a more complete picture of a patient’s risk and help determine whether cholesterol-lowering therapy should begin earlier. The lipoprotein(a) test is a simple blood test that is widely available and increasingly offered by primary care physicians as part of preventive care. Since lipoprotein(a) is genetically determined and stable over time, it typically needs to be tested only once, ideally early in adulthood. Elevated levels indicate an inherited risk for cardiovascular disease. The guidelines also promote the use of coronary calcium scoring, a noninvasive scan that measures calcified plaque in arteries.#american_heart_association #american_college_of_cardiology #johns_hopkins #cleveland_clinic #circulation
