The latest Pharmaceutical GSK study was the first to show significant efficacy for RSV in adults over 60 years of age.
June 14, 2022 | | Reading time: 4 min
Respiratory syncytial virus is the most common microbe that causes infections in the lungs and respiratory tract. Photo: Shutterstock.
GSK strives to bring its own vaccine against respiratory syncytial virus (RSV) to regulators for review later this year, after interim data showed that the vaccine was effective in a closely monitored late-stage study involving the elderly.
RSV is one of the leading reasons for pneumonia in children young and old, but the complex molecular structure of the virus and security concerns hampered efforts to develop a vaccine since the virus was first discovered in 1956.
“IN vaccine The GSK RSV OA candidate contains prefusion RSV F glycoprotein antigen (RSVPreF3) per recombinant subunit combined with GSK’s own adjuvant AS01, “the company said.” AS01 is used with several of the established GSK adjuvant vaccines. The combination of antigen plus adjuvant can help overcome the natural decline in immunity an age-related problem that contributes to the challenge of protecting children elderly of RSV disease.
RSV is one of the most common pathogenic viruses. Most cases are mild, but causes about 360,000 hospitalizations and more than 24,000 deaths worldwide each yearaccording to GSK.
Companies such as Pfizer, J&J, Sanofi, Moderna and AstraZeneca are also vying for approval of therapy or vaccine against RSV.
GSK’s latest experience is the first to show a statistically significant efficacy for RSV in adults over 60 years of agethe British drugmaker said on Friday of the ongoing study.
If approved, RSV vaccine is expected to generate billions for GSK, which is already the world’s largest producer of vaccines in salesbut is facing pressure from investor activists such as Elliott Management, who have called on the London-based company to support its drug portfolio.
RSV data are a critical impetus for GSK’s success in drug development as it prepares to separate its consumer healthcare business next month into a separate, publicly traded company called Haleon. After the split, GSK will focus solely on vaccines and prescription drugs.
GSK is also making an assessment whether the vaccine given to pregnant women can give immunity to unborn children.
In February, the company stopped enrolling and vaccinating in three RSV studies in pregnant women after initially stopping the studies, based on safety recommendations from an independent commission.
In the test with elderlyGSK said in a press release that no unexpected security issues were noted in the interim analysis.
Monthly treatment with Synagis from Swedish Orphan Biovitrum it is currently the only preventative therapy against RSV in high-risk infants.
On Friday, GSK did not disclose the degree of protection provided by vaccineexcept to say that vaccine offers “exceptional protection” for elderly of the serious consequences of RSV infection.
Instead, details will be presented in medical journals and at an upcoming scientific meeting.
Analysts at Jefferies predicted that vaccine for elderly could generate $ 2.5 billion in global peak sales in a note released last month.
Source consulted here.