GSK on Thursday announced positive pivotal phase III trial results for its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above, according to the company’s findings.
“GSK’s vaccine for respiratory syncytial virus proved strongly effective in a large Phase 3 trial, reducing cases of lower respiratory infection in people 60 years and older by 83% when compared to those given a placebo,” Biopharma Dive reported.
Although Pfizer and Johnson & Johnson are also testing RSV vaccine candidates, GSK managed to complete its trial first and collect the full data. Pfizer issued interim data from its trial, which showed their shot as 67% effective in treating lower-respiratory tract infections. Full analyses from both these companies are yet to be disclosed sometime later this year.
RSV and the lack of vaccine
RSV is a typical infectious virus that affects the lungs and respiratory airways.
It is one of the most prevalent infectious diseases for which an adult vaccine or particular therapy is not yet available.
Due to underlying disorders and the immune system’s deterioration with age, older persons are at significant risk for developing a serious illness.
In industrialized nations, RSV results in roughly 420,000 hospital admissions annually and 29,000 adult fatalities. Adults with underlying problems seek medical advice more frequently and are hospitalized more frequently than adults without these conditions.
“After decades of failure, vaccine researchers in recent years figured out how to direct the body’s immune system against a protein specific to RSV, prompting a race to develop the first preventive shot against a virus that causes hundreds of thousands of hospitalizations and tens of thousands of deaths,” Biopharma Dive explains.
According to GSK, the 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%.
“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, ” said Tony Wood, GSK Chief Scientific Officer.
The vaccine had a good safety profile and was well tolerated. The observed requested adverse effects were generally mild to moderate and temporary, with injection site pain, exhaustion, myalgia, and headache being the most prevalent.