GSK’s older adult respiratory syncytial virus (RSV) vaccine candidate shows 94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6

[Mary Wilson]

For media and investors only

Issued: London UK

Data to be presented at IDWeek 2022 showed overall vaccine efficacy against RSV-lower respiratory tract disease (LRTD) in adults aged 60 years and above, with a favourable safety profile

• Consistent high vaccine efficacy observed against LRTD in severe disease (94.1%), adults aged 70-79 years (93.8%) and in adults with underlying comorbidities (94.6%)
• High vaccine efficacy is consistent across RSV A and B strains

GSK plc (LSE/NYSE: GSK) today announced positive pivotal phase III trial results for its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above to be presented at IDWeek 2022. The vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs. 40 of 12,494) against RSV lower respiratory tract disease (RSV-LRTD), meeting the trial’s primary endpoint.

Consistent high vaccine efficacy was also observed across a range of pre-specified secondary endpoints, highlighting the impact the vaccine candidate could have on the populations most at risk of the severe outcomes of RSV. Efficacy against severe RSV-LRTD, defined as LRTD with at least two lower respiratory signs or assessed as severe by the investigator and confirmed by the external adjudication committee, was 94.1% (95% CI, 62.4–99.9, 1 of 12,466 vs. 17 of 12,494). In participants with pre-existing comorbidities, such as underlying cardiorespiratory and endocrinometabolic conditions, vaccine efficacy was 94.6% (95% CI, 65.9–99.9, 1 of 4,937 vs. 18 of 4,861), with 93.8% (95% CI, 60.2-99.9, 1 of 4,487 vs. 16 of 4,487) efficacy observed in adults aged 70-79 years. ...

https://www.gsk.com/en-gb/media/pre...atory-syncytial-virus-rsv-vaccine-candidate/#