US Approves First Vaccine for RSV, Shots to Protect Older Adults


Key Highlights :

1. The US has approved the first vaccine for RSV, shots to protect older adults against a respiratory virus that’s most notorious for attacking babies but endangers their grandparents, too.
2. The move sets the stage for adults 60 and older to get vaccinated this fall — but first, the Centers for Disease Control and Prevention must decide if every senior really needs RSV protection or only those considered at high risk from the respiratory syncytial virus.
3. CDC’s advisers will debate that question in June.




     The US Food and Drug Administration (FDA) has made history by approving the first vaccine for RSV, a respiratory virus that is most notorious for attacking babies but also endangers older adults. The approval of GSK's shot, called Arexvy, sets the stage for adults 60 and older to get vaccinated this fall, after the Centers for Disease Control and Prevention (CDC) decides if every senior needs RSV protection or only those considered at high risk from the respiratory syncytial virus.

     RSV is a cold-like nuisance for most people but it can be life-threatening for the very young, the elderly and people with certain high-risk health problems. It can impede babies’ breathing by inflaming their tiny airways, or creep deep into seniors’ lungs to cause pneumonia. In the US, about 58,000 children younger than five are hospitalised for RSV each year and several hundred die. Among older adults, as many as 177,000 are hospitalised with RSV and up to 14,000 die annually.

     After decades of failure in the quest for an RSV vaccine, doctors are anxious to finally have something to offer — especially after a virus surge that strained hospitals last year. The FDA is also considering competitor Pfizer’s similar vaccine for older adults, and Pfizer is seeking approval to vaccinate pregnant women, so their babies are born with some of mum’s protection. There isn't a vaccine for kids yet but high-risk infants often get monthly doses of a protective drug during RSV season — and European regulators recently approved the first one-dose option. The FDA also is considering whether to approve Sanofi and AstraZeneca's one-shot medicine.

     GSK’s new vaccine for older adults trains the immune system to recognise a protein on RSV’s surface, and contains an ingredient called an adjuvant to further rev up that immune reaction. In an international study of about 25,000 people 60 and older, one dose of the vaccine was nearly 83 per cent effective at preventing RSV lung infections, and reduced the risk of severe infections by 94 per cent. To see how long protection lasts, GSK is tracking study participants for three years, comparing some who get just one vaccination during that time and others given a yearly booster. Shot reactions were typical of vaccinations, such as muscle pain and fatigue.

     If the CDC ultimately recommends the vaccination for some or even all seniors, it will add another shot for the fall along with their yearly flu vaccine – and maybe another COVID-19 booster. Educating the population about the importance of this virus and the need for vaccination is key to its success.

     The approval of the first vaccine for RSV marks a major milestone in the fight against this virus, and provides hope for those most vulnerable to its effects. With multiple potential RSV solutions coming out after years of really nothing, there is a light at the end of the tunnel.



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