FDA Expands Approval of GSK’s RSV Vaccine to High-Risk Adults 50-59

GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, has received expanded approval from the Food and Drug Administration (FDA) to include adults between the ages of 50 and 59 who are at a higher risk of severe illness from the virus. This marks the first vaccine authorized by the FDA to protect this specific age group from RSV. Previously, the vaccine was approved for patients aged 60 and above, who are more vulnerable to severe cases of the virus.

RSV is a respiratory virus that causes thousands of hospitalizations and deaths among seniors each year. However, it can also lead to severe illness in adults aged 50 and older who have underlying chronic conditions such as asthma, diabetes, and congestive heart failure. According to data from the Centers for Disease Control and Prevention, approximately 13 million Americans in the 50 to 59 age group are at high risk of severe illness from RSV.

Phil Dormitzer, GSK’s head of vaccines research and development and infectious disease research, stated that the expanded approval is beneficial both in meeting the medical needs of this age group and providing simplicity to pharmacists who can administer a single vaccine to a wider population.

While GSK’s shot has gained FDA approval for adults aged 50 to 59, it still awaits recommendations from an advisory panel to the CDC, which will vote on the vaccine’s usage along with rival shots from Pfizer and Moderna.

This expanded approval by the FDA could help GSK maintain its dominance in the RSV market during the fall and winter seasons when the virus typically spreads more widely in the U.S. In 2022, GSK’s vaccine generated approximately £1.2 billion in sales, surpassing Pfizer’s vaccine revenue of about $890 million. GSK’s Chief Commercial Officer, Luke Miels, expressed confidence that Arexvy has the potential to bring in more than £3 billion in peak annual sales over time.

Dormitzer acknowledged the competition in the RSV market but noted that GSK had a successful last RSV season. He highlighted the strong efficacy of Arexvy in patients with underlying medical conditions. Clinical trials demonstrated that a single dose of the vaccine elicited an immune response in high-risk adults aged 50 to 59, which was comparable to those aged 60 and above. The vaccine was found to be approximately 83% effective at preventing lower respiratory tract disease caused by RSV and around 94% effective at preventing severe disease.

Safety data for adults aged 50 to 59 was consistent with data from older age groups, with side effects primarily being mild to moderate, including fatigue, headache, and muscle pain. GSK plans to evaluate the vaccine’s efficacy over three RSV seasons to determine if it can provide longer protection.

GSK is also conducting studies to expand the reach of Arexvy to other patient groups. Trial data is expected later in 2024 for two separate patient groups: individuals aged 18 to 59 who are at increased risk of severe RSV and adults with weakened immune systems. Additionally, GSK is seeking regulatory approval in Europe, Japan, and other regions to expand the vaccine’s usage to high-risk adults aged 50 to 59.

Overall, GSK’s Arexvy vaccine has received expanded FDA approval to include adults aged 50 to 59 at an increased risk of severe illness from RSV. The expansion not only addresses the medical needs of this age group but also provides convenience for healthcare providers. With its strong efficacy and safety profile, GSK aims to maintain its market dominance and continue expanding the vaccine’s usage in other patient groups and countries.