The Food and Drug Administration has expanded the approval of GlaxoSmithKline’s respiratory syncytial virus (RSV) vaccine, Arexvy, to adults aged 50 to 59 who are at increased risk of severe illness from the virus. This makes Arexvy the first vaccine cleared by the FDA to protect this specific age group from RSV. The vaccine was originally approved for individuals aged 60 and above, who are more susceptible to severe cases of the virus. RSV can cause serious illness in adults 50 and up, especially those with underlying chronic conditions such as asthma, diabetes, and heart failure.
According to data from the Centers for Disease Control and Prevention, RSV leads to thousands of hospitalizations and deaths among seniors each year. About 13 million Americans aged 50 to 59 fall into a high-risk category for severe illness from RSV. Phil Dormitzer, GSK’s head of vaccines research and development, emphasized the significance of the expanded approval as it helps meet the medical needs of this age group and provides a single vaccine option for pharmacists to administer to a wider population, simplifying the process.
While the approval has been granted by the FDA, an advisory panel to the CDC will vote later in June on recommendations for GSK’s vaccine, along with competing shots from Pfizer and a newly approved jab from Moderna. The expanded approval could benefit GSK in maintaining its dominance in the RSV market during the upcoming fall and winter seasons when the virus typically spreads more widely in the U.S. GSK’s Arexvy generated significant sales last year and the company is aiming for peak annual sales exceeding £3 billion in the future.
GSK’s shot demonstrated strong efficacy in high-risk adults aged 50 to 59 with underlying medical conditions in a late-stage trial. The results showed that a single dose elicited an immune response comparable to that observed in older age groups. Arexvy was found to be nearly 83% effective in preventing lower respiratory tract disease caused by RSV and around 94% effective in preventing severe illness in older adults. Safety data in the 50 to 59 age group was consistent with that of older adults, with mostly mild to moderate side effects including fatigue, headache, and muscle pain.
The company plans to continue monitoring the vaccine’s efficacy over multiple RSV seasons to assess the duration of protection it offers. Ongoing trials are being conducted to evaluate Arexvy’s effectiveness in other patient groups including those aged 18 to 59 at high risk of severe RSV and adults with weakened immune systems. GSK is also seeking approvals in other countries, as regulatory agencies in Europe, Japan, and other regions are reviewing the application to expand the vaccine’s approval to high-risk adults aged 50 to 59.
With ongoing development and expansion efforts, GSK aims to further establish Arexvy as a key player in the fight against RSV. The company continues to invest in research and development to broaden the vaccine’s reach and effectiveness in various patient populations. As they pursue regulatory approvals in additional countries and gather more data on the vaccine’s performance, GSK remains committed to advancing the fight against RSV and protecting vulnerable individuals from severe illness caused by the virus.
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