PremiumGSK plc today announced positive pivotal phase III trial results for its respiratory syncytial virus (RSV) vaccine for adults aged 60 years and above to be presented at IDWeek 2022.
GSK plc today announced positive pivotal phase III trial results for its respiratory syncytial virus (RSV) vaccine for adults aged 60 years and above to be presented at IDWeek 2022.
As per GSK statement, the vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6 percent against RSV lower respiratory tract disease (RSV-LRTD), meeting the trial’s primary endpoint.
The vaccine against respiratory syncytial virus, or RSV, protected volunteers against a disease that causes hundreds of thousands of hospitalizations in older adults each year in a key trial.
GSK said regulatory submissions based on the phase III data are anticipated in the second half of 2022.
“This phase III efficacy trial is part of a comprehensive RSV evidence-generation programme conducted by GSK. It will continue to evaluate an annual revaccination schedule and longer-term protection over multiple seasons following one dose of the RSV vaccine candidate," it said.
The findings mark a turning point in the hunt for an RSV vaccine, a goal that has eluded scientists for decades. Other drugmakers including Pfizer Inc. and Johnson & Johnson are also pursuing shots against the virus, a potential multibillion-dollar market opportunity.
“These are truly exceptional results given that today RSV remains one of the major infectious diseases without a vaccine, despite over 60 years of research. We believe that with the high vaccine efficacy demonstrated in this pivotal trial, our vaccine candidate has the potential to help reduce the significant global burden of RSV-associated disease in older adults, including those at the greatest risk of severe outcomes due to their age or underlying comorbidities," Tony Wood, GSK’s chief scientific officer, said in a statement.
What is respiratory syncytial virus (RSV)?
RSV is a common contagious virus affecting the lungs and breathing passages. It is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment available for adults. Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death. RSV causes over 420,000 hospitalisations each year and 29,000 deaths in adults in industrialised countries. Adults with underlying conditions are more likely to seek medical advice and have higher hospitalisation rates than adults without these conditions
(With inputs from Bloomberg)