GSK has announced that China’s Center for Drug Evaluation (CDE) has accepted its regulatory application for Arexvy, the company’s respiratory syncytial virus (RSV) vaccine, for review. The application seeks approval for the prevention of RSV-associated lower respiratory tract disease (LRTD) in adults aged 60 years and older.
If approved, Arexvy would become the first RSV vaccine available in China for this age group, addressing a significant unmet public health need. RSV is estimated to affect more than six million adults aged 60 and above in China each year, resulting in over 350,000 RSV-related hospitalisations annually.
The regulatory submission is supported by a comprehensive clinical data package, including positive findings from a Phase III trial conducted in China (NCT06551181). The study met all primary endpoints, demonstrating non-inferior immune responses to RSV-A and RSV-B strains compared with older adults vaccinated outside China, along with an acceptable safety profile. A regulatory decision is expected in 2027.
Arexvy is a recombinant, adjuvanted RSV vaccine that contains the RSV prefusion F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant system, designed to enhance immune response. As with all vaccines, immune protection may not be achieved in all individuals.
Globally, the vaccine has already received regulatory approvals in more than 65 countries for adults aged 60 years and older. It is also approved in over 60 countries, including the United States and Japan, for adults aged 50–59 years at increased risk due to underlying medical conditions. In the European Economic Area, it is approved for adults aged 18 years and above.
The Phase III China study enrolled approximately 2,600 participants, including adults vaccinated in China, vaccinated adults outside China, and a placebo group. The trial was conducted across 41 sites in seven countries and evaluated immunogenicity, safety, reactogenicity, and RSV-associated respiratory illness following a single vaccine dose.
RSV is a widespread respiratory virus that affects an estimated 64 million people globally each year. While often associated with paediatric illness, RSV poses a serious risk to older adults and those with chronic conditions such as COPD, asthma, and heart failure, frequently leading to pneumonia, hospitalisation, and increased mortality. Experts note that the true burden of RSV in adults is likely underestimated due to limited routine testing.
The acceptance of Arexvy for regulatory review marks a key step in expanding RSV prevention options for China’s ageing population and strengthening adult immunisation strategies against severe respiratory disease.
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