Korea GSK said on the 20th that its respiratory syncytial virus (RSV) vaccine Arexvy received approval from the Ministry of Food and Drug Safety to expand the target age (indication).
It was approved in Dec. last year for adults age 60 and older, and with this approval, the target group has been expanded to adults age 50 to 59 who have an increased risk of lower respiratory tract disease (RSV-LRTD) caused by RSV.
High-risk groups for RSV infection include ▲ people with chronic respiratory disease ▲ people with chronic cardiovascular disease ▲ people with end-stage kidney disease ▲ people with diabetes ▲ residents of nursing homes and long-term care facilities. This expansion of the target age is based on the results of a global phase 3 clinical trial that compared the immunogenicity and safety after Arexvy vaccination in adults age 50 to 59 with chronic diseases to those in adults age 60 and older.
RSV infection is an acute respiratory infectious disease classified as a legally designated level 4 infectious disease, like influenza and COVID-19. It spreads in Korea from Oct. to Mar., and its transmissibility is as high as influenza, so during the epidemic period, one infected person can infect about three people nearby. RSV infection can occur at all ages, but in high-risk groups such as older adults and people with underlying conditions, the risk of severe complications such as pneumonia is high, and in severe cases it can lead to hospitalization or death.
In fact, according to a study conducted in the United States, among adults age 50 and older, the hospitalization rate due to RSV infection was 2.7 times higher for those with one underlying condition and nine times higher for those with two or more, compared with those without underlying conditions.
Professor Cho Seong-yeon, an infectious disease specialist at Catholic University Seoul St. Mary's Hospital, said, "RSV infection can cause pneumonia in middle-aged and older adults with chronic diseases, and in severe cases it is a respiratory infectious disease that can lead to intensive care unit admission or death," adding, "This expansion of the vaccination age will be a turning point in reducing the disease burden among middle-aged and older adults who have had a gap in prevention." Cho advised, "Because the RSV vaccine can be administered at the same time as the inactivated seasonal influenza vaccine, it is worth considering receiving the two vaccines together when visiting a hospital."
Kwon Hyeon-ji, executive vice president overseeing the vaccines business at Korea GSK, said, "We will work closely with medical professionals so that not only older adults but also high-risk adults, such as those with underlying conditions who face a high risk of RSV infection, can receive timely prevention against RSV infection, and we will do our best to raise awareness of RSV infection and spread a prevention-centered health management culture."