GSK rolls out RSV vaccine Arexvy in Korea, targeting older adult market

GSK is preparing to introduce its respiratory syncytial virus (RSV) vaccine, Arexvy, to the Korean market by the end of May. In anticipation of the rollout, the company held a media roundtable on Wednesday in Seoul to highlight the vaccine’s clinical value and discuss strategies for protecting high-risk adults from RSV-related illness.

Arexvy, the world’s first approved RSV vaccine for older adults, received marketing authorization from the Ministry of Food and Drug Safety in December 2024. It is indicated for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and above.

Globally, GSK has already established a strong market presence with Arexvy, following its U.S. FDA approval in May 2023. The vaccine recorded global sales of approximately 1 trillion won ($704 million) last year, and GSK now seeks to replicate that success in Korea as awareness grows around the serious health risks RSV poses to aging populations.

The Korean approval was based on two pivotal phase 3 trials -- AReSVi-006 and AReSVi-004 --which showed Arexvy reduced the risk of RSV-LRTD by 82.6 percent and severe RSV-LRTD by 94.1 percent. Efficacy against RSV-A and RSV-B subtypes reached 84.6 percent and 80.9 percent, respectively.

“RSV is frequently underdiagnosed and underestimated, despite its high disease burden among older adults,” Professor Moon Ji-yong of the Department of Pulmonary and Allergy at Konkuk University Medical Center said during the press conference. “In one Korean retrospective study, 56.8 percent of patients over 65 who were hospitalized with RSV developed pneumonia, and 10.6 percent died.”

Professor Lee Jae-gap of the Department of Infectious Diseases at Hallym University Gangnam Sacred Heart Hospital emphasized the vaccine’s importance for individuals with chronic conditions.

“Among adults aged 60 and older with at least one comorbidity, Arexvy showed a 94.6 percent efficacy rate,” Professor Lee said. “Given that 84 percent of Koreans over 65 have chronic illnesses, this is particularly relevant.”

Lee also cited real-world U.S. data from the 2023–2024 RSV season, which showed Arexvy reduced RSV-related hospitalizations by 83 percent and emergency room visits by 77 percent.

Based on these findings, the U.S. Advisory Committee on Immunization Practices (ACIP) now recommends RSV vaccination for all adults aged 75 and older, and for high-risk individuals aged 60 to 74.

Despite its promise, Arexvy is not yet included in Korea’s National Immunization Program (NIP) and will initially be available as a non-reimbursed vaccine.

Experts noted that disease burden studies and cost-effectiveness analyses in Korea will be necessary to support any future public coverage. Local immunization guidelines are expected later this year.

To boost awareness, GSK Korea plans to launch a national campaign, including television advertisements.

“RSV is still unfamiliar to many patients and healthcare providers despite its serious consequences,” GSK Korea Vaccine Business Unit Head Kwon Hyun-ji said. “As Korea enters a super-aged society, we will collaborate with medical professionals and policymakers to improve vaccine access and awareness.”