GSK Korea's RSV vaccine expands indication to benefit high-risk people in their 50s

GSK Korea's RSV vaccine, Arexvy, has expanded its indication to include high-risk individuals aged 50 to 59.

High-risk groups for RSV infection include people with chronic respiratory disease, chronic cardiovascular disease, end-stage renal disease, and diabetes, as well as those living in nursing homes and long-term care facilities.

GSK Korea said Wednesday that it has received approval from the Ministry of Food and Drug Safety (MFDS) to expand the indication for adults at increased risk of RSV-related lower respiratory tract disease (RSV-LRTD).

The indication expansion is based on the results of a global phase 3 clinical trial comparing the immunogenicity and safety of Arexvy vaccination in adults aged 50-59 with chronic diseases who are at higher risk of developing RSV-LRTD with those aged 60 and older.

Arexvy previously demonstrated an 82.6 per cent efficacy in preventing RSV-LRTD in clinical studies targeting adults aged 60 and older. It also showed a 94.6 percent efficacy in preventing RSV-LRTD in adults aged 60 and older with one or more comorbidities.

Non-inferiority in immunogenicity and a similar safety profile, demonstrating the vaccine’s effectiveness and tolerability, were confirmed in adults aged 50-59 with chronic conditions compared with adults aged 60 and older.

A study conducted in the United States showed that the hospitalization rate due to RSV infection in adults aged 50 and older was 2.7 times higher in those with one underlying condition compared to those without any, and nine times higher in those with two or more underlying conditions.

The risk of exacerbation of underlying conditions also increases with RSV infection. Among patients aged 50 and older hospitalized for RSV infection, the risk of COPD exacerbation was about 2.8 times higher, the risk of asthma exacerbation was 6.5 times higher, and the risk of hospitalization due to heart failure was 3.1 times higher compared to the general patient population.

Since there is no specific treatment for RSV infection in adults beyond symptom management, vaccination becomes a crucial tool to prevent severe complications and hospitalizations.

“RSV infection can cause pneumonia in middle-aged or older adults with chronic conditions and, in severe cases, may result in ICU admission or death,” said Professor Cho Sung-yeon of the Department of Internal Medicine at the Catholic University of Korea Seoul St. Mary's Hospital. “Expanding the vaccination age group is a significant turning point for reducing disease burden among these adults, who previously faced a prevention gap.”

Professor Cho added that, with evidence confirming a similar immune response and safety profile to those of adults aged 60 and older, the vaccine is expected to provide meaningful protection against RSV for high-risk adults aged 50 to 59, helping prevent serious outcomes in this group.

Cho advised, “With early winter and rising RSV hospitalizations, now is the time for RSV vaccination. The RSV vaccine can be given with the inactivated flu vaccine, so consider both during your hospital visit.”

The expansion of Arexvy's vaccination age group follows approvals in major countries, including the U.S. and Europe. The U.S. CDC recommends RSV vaccination for all adults aged 50 to 74 in high-risk groups and for all adults aged 75 and older. The RSV vaccine is recommended as a single dose.