Health Care — FDA approves first RSV shot for healthy kids

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View Online Health Care Health Care The Big Story  Game-changing RSV shot for kids nears finish line The Food and Drug Administration (FDA) on Monday announced the approval of the first injection designed to prevent RSV infections in healthy infants and toddlers. © National Institute of Allergy and Infectious Diseases, NIH via AP Beyfortus, developed by AstraZeneca and marketed by Sanofi, was cleared by the FDA for use in children up to the age of 24 months for preventing RSV infections. This is the first RSV drug for healthy children to be approved by regulators. Earlier this year, two RSV vaccines for seniors were approved by the FDA. The newly approved medication is a single-dose monoclonal antibody. It is not a vaccine but works in a similar way.   The drug was approved for use in newborns and infants born during or entering their first RSV season, as well as for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.  The shot will likely provide comfort to many parents following last year's surge, when small children unexposed to the virus were infected and hospitals scrambled to find room for all of them. While most people infected with RSV will experience some cold-like symptoms and recover with rest and care, infants and toddlers stand at a higher risk of developing respiratory diseases like pneumonia. An existing monoclonal antibody treatment is intended only for high-risk infants with heart or lung conditions, or high-risk preemies. The most that clinicians can usually do for healthy children admitted with severe RSV is supplemental oxygen or putting them on a ventilator. The drug will now be discussed and voted on by the Centers for Disease Control and Prevention's expert advisory panel on Aug. 3. The committee is likely to formalize its draft recommendations in February.    The companies plan to make Beyfortus available ahead of the upcoming 2023-2024 RSV season.   With the approval, Sanofi and AstraZeneca officially beat out a maternal RSV vaccine developed by Pfizer that's also under review. Welcome to The Hill's Health Care newsletter, we're Nathaniel Weixel and Joseph Choi — every week we follow the latest moves on how Washington impacts your health. Did someone forward you this newsletter? Subscribe here. Essential Reads  How policy will be impacting the health care sector this week and beyond: Iowa abortion ban temporarily blocked by state court Iowa’s new abortion ban was temporarily blocked from taking effect on Monday, restoring access to abortion in the state while the lawsuit moves forward. Polk County District Court Judge Joseph Seidlin ruled that a lawsuit by abortion providers is likely to succeed, and the temporary injunction will remain in place for the duration of the lawsuit. “The court will grant the temporary injunction requested here,” …  Full Story Alzheimer's is most prevalent in east, southeast, according to new research Alzheimer’s disease is most prevalent in the east and southeast, according to new research published Monday that seeks to map out the disease on a state and county level.  The prevalence of Alzeheimer’s in those regions is closely tied to demographics and age. Researchers are hoping that a better understanding of the geographic breakdown of the prevalence of the disease, however, can help officials make better decisions …  Full Story Eli Lilly expects FDA approval of its Alzheimer's drug this year A second drug that modestly slows the progression of Alzheimer's disease could be approved by the end of this year, manufacturer Eli Lilly said Monday. In a statement, Lilly said it applied to the Food and Drug Administration (FDA) for traditional approval last quarter and expects the agency to act by the end of the year.   Full Story On Our Radar  Upcoming news themes and events we're watching: A House Oversight subcommittee on Tuesday will discuss whether extending Medicaid to DACA recipients will exacerbate the border crisis  A House Energy & Commerce subcommittee hearing Tuesday will examine accelerated Medicare coverage for innovative drugs and devices   The Hill event Join The Hill in person: More than Memory Loss: Caring for those with Alzheimer's | National Press Club | July 18 at 8:30 a.m. ET   The Hill will bring together caregivers, patients, clinical experts and lawmakers to discuss the fight against Alzheimer's and breakthroughs in providing relief to those who suffer from agitation and aggression.   Speakers include: Rep. Vern Buchanan (R-Fla.), chair, Ways and Means Subcommittee on Health Rep. Linda Sánchez (D-Calif.), lead co-sponsor, CHANGE Act Sue Peschin, president & CEO, Alliance for Aging Research Jen Pettis, director of strategic alliances, The Gerontological Society of America Jackie Pinkowitz, co-founder, Dementia Action Alliance Chad Worz, executive director, American Society of Consultant Pharmacists Carrie Shaw, Alzheimer's caregiver Click here to RSVP In Other News  Branch out with a different read from The Hill: A heat wave in southern Europe generates health warnings for residents and tourists ROME (AP) — Italian health officials intensified heat warnings Monday as southern Europe began a brutally hot week with temperatures expected to top 40 degrees Celsius — or 104 degrees Fahrenheit — on a continent already sizzling under the sun and overburdened by tourists. Countries with borders on the Mediterranean Sea weren’t alone … Full Story Around the Nation  Local and state headlines on health care: Miami-Dade County has highest prevalence of people with Alzheimer's, dementia in the US, new research finds (NBC 6) 'We're truly not valued': In New Orleans, Black mothers are increasingly the victims of gun violence (The 19th News) Kentucky health care providers defend certificate of need (States Newsroom)   What We're Reading  Health news we've flagged from other outlets: They lost their legs. 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