This will save many.
The U.S. Food and Drug Administration (FDA) announced its historic approval on Friday for the use of a respiratory syncytial virus (RSV) vaccine in individuals aged 50 to 59 who are at heightened risk for the illness. This marks the first time such approval has been granted for this age group.
GSK’s Arexvy vaccine, along with vaccines from Pfizer and Moderna, has already received approval for use in adults aged 60 and older, reflecting the increased risk of RSV disease with age. Arexvy, specifically, has now secured authorization for individuals aged 50 to 59 with specific health risk factors.
In a statement released on Friday, GSK highlighted the significant burden of RSV, citing a systematic review estimating 42,000 hospitalizations annually in adults aged 50 to 64 in the U.S. The company emphasized that adults with underlying medical conditions such as chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes face elevated risks of severe consequences from RSV infection, including pneumonia, hospitalization, or death.
The U.S. Centers for Disease Control and Prevention (CDC) is expected to convene in June and October to consider endorsing the use of Arexvy in individuals aged 50 to 59, potentially facilitating insurance coverage.
Additionally, Pfizer and Moderna are conducting trials to evaluate their RSV vaccines for use in younger patients, expanding the scope of protection against this respiratory virus.
GSK reported that Arexvy demonstrated a safety profile consistent with that observed in older individuals, with less than 10% of recipients in their 50s experiencing any adverse reactions, primarily injection site pain, fatigue, muscle ache, and headache.
Regarding rare neurological complications, such as Guillain-Barré syndrome (GBS), associated with RSV vaccination, GSK assured that their latest trial data did not reveal concerning trends among the 50-to-59 age group. Dr. Phil Dormitzer, senior vice president and global head of vaccines research and development at GSK, emphasized that ongoing research will inform decisions regarding the spacing of RSV booster shots for older adults.
Looking ahead, trials assessing the efficacy of Arexvy in 18- to 49-year-olds are anticipated to commence in the latter half of the year, as GSK continues its efforts to broaden RSV vaccine coverage across age groups.
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