GSK shares positive data for AREXVY, its respiratory syncytial virus (RSV) older adult vaccine, indicating protection over two RSV seasons

GSK plc (LSE/NYSE: GSK) today announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy of a single dose of AREXVY (respiratory syncytial virus vaccine, adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older over multiple RSV seasons and after annual revaccination.

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Efficacy of a single dose over two seasons

The results show that one dose of the vaccine is efficacious against RSV-LRTD and severe LRTD over two full RSV seasons.

	Vaccine efficacy
Endpoint	Season one efficacy Primary endpoint: 6.7 months median follow up	Mid-season two efficacy* Descriptive secondary endpoint: 14 months median follow up	Cumulative efficacy over two seasons* Confirmatory secondary endpoint: 18 months median follow up
RSV-LRTD	82.6% 96.95% CI, 57.9–94.1 7 of 12,466 vs 40 of 12,494	77.3% 95% CI, 60.2-87.9 15 of 12,469 vs 85 of 12,498	67.2% 97.5% CI, 48.2–80.0 30 of 12,469 vs 139 of 12,498
Severe LRTD	94.1% 95% CI, 62.4–99.9 1 of 12,466 vs 17 of 12,494	84.6% 95% CI, 56.4-96.1 4 of 12,469 vs 33 of 12,498	78.8% 95% CI, 52.6–92.0 7 of 12,469 vs 48 of 12,498
*The vaccine efficacy is estimated using a Poisson model adjusted by age, region and season.

A similar pattern of vaccine efficacy over two seasons was also observed in adults with underlying comorbidities and in advancing age, reinforcing the impact the vaccine could have on those most at risk of the severe outcomes of RSV.