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Arexvy, the First RSV Vaccine for Older Adults, Granted Approval by HSA

Thursday, May 16, 2024

Arexvy, the world's first respiratory syncytial virus (RSV) vaccine, has recently gained approval from the Health Sciences Authority (HSA) of Singapore for immunizing individuals aged 60 years and above against lower respiratory tract disease (LRTD) caused by RSV. This groundbreaking achievement underscores GSK's commitment to safeguarding the health of older adults in Singapore by providing protection against a range of infectious diseases.

Raakhi Sippy, Vice President & General Manager of GSK Singapore, expressed satisfaction in introducing this vaccine to over one million older adults in Singapore, highlighting the extensive research and development efforts involved. With a growing portfolio of adult vaccines, GSK aims to promote disease prevention and support healthier aging among Singapore's population.

In 2019, RSV infections resulted in significant morbidity and mortality among individuals aged 60 and above globally, with millions of cases leading to hospitalizations and fatalities. Studies conducted in Singapore have revealed a considerable prevalence of RSV infections among older adults, emphasizing the need for preventive measures.

RSV is a contagious virus primarily affecting the respiratory system and often presenting symptoms similar to other respiratory infections. However, the impact of RSV can be particularly severe among individuals aged 60 and above, especially those with underlying medical conditions, leading to increased hospitalization rates and mortality.

Clinical trial data from the AReSVi-006 Phase III trial demonstrated Arexvy's efficacy in preventing RSV-induced LRTD among older adults, with particularly promising results in those with underlying medical conditions.

Dr. Stephanie Cinthu Stephen Ambrose, Country Medical Director at GSK Singapore, stressed the importance of protecting older adults from RSV infections, especially given Singapore's aging population trends. As the population ages, prioritizing preventive measures against infectious diseases like RSV becomes increasingly crucial to maintaining the health and well-being of older adults.

Arexvy, GSK's RSV vaccine for older adults, combines a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) with GSK's proprietary AS01E adjuvant. Approved in multiple countries, including Europe, Japan, the UK, Canada, and Australia, Arexvy has shown promise in preventing RSV-LRTD in individuals aged 60 and above.

The AReSVi-006 trial, conducted across 17 countries, aimed to demonstrate the efficacy of a single dose of GSK's RSV vaccine in individuals aged 60 and above, further validating its effectiveness in this vulnerable population.



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