Biotech
Wednesday, October 25th, 2023 2:16 pm EDT
Key Points
- Promising Trial Results: GSK’s vaccine, Arexvy, demonstrated positive results in the late-stage clinical trial, indicating that it could be effective in protecting adults in the 50 to 59 age group from RSV. RSV is known to cause numerous hospitalizations and fatalities among older Americans.
- Comparable Immune Response: The trial revealed that a single dose of Arexvy elicited an immune response in adults aged 50 to 59 who are at an increased risk of RSV due to underlying medical conditions. Importantly, the immune response in this age group was not worse than that observed in adults aged 60 and above, suggesting the vaccine’s potential to provide protection across a broader age range.
- Regulatory Plans and Impact: GSK plans to present the final trial results at a medical conference and submit them for publication in a peer-reviewed journal. The company aims to become the first to submit data on this age group to regulatory authorities, such as the Food and Drug Administration (FDA), with expectations of a potential label expansion in 2024. This development could offer adults aged 50 to 59 the option of receiving an RSV vaccine for the first time. Pfizer is the only other company with an approved RSV vaccine, primarily for adults aged 60 and older. US health officials are relying on vaccines like those from GSK and Pfizer to address the RSV season, especially after a severe RSV outbreak last year when public health measures were relaxed during the COVID-19 pandemic.
GlaxoSmithKline (GSK) has reported promising results from a late-stage clinical trial for its respiratory syncytial virus (RSV) vaccine, Arexvy, in adults aged 50 to 59. The initial findings suggest that GSK’s vaccine may offer protection against RSV to a wider age group, potentially addressing a significant health concern in the older adult population. Arexvy is currently approved for use in the US, Europe, Japan, and other countries for individuals aged 60 and older. The trial revealed that a single dose of the vaccine induced an immune response in the 50 to 59 age group, which has an increased risk of RSV due to certain underlying health conditions. This immune response was found to be comparable to that observed in adults aged 60 and above. A previous late-stage trial demonstrated that Arexvy was nearly 83% effective at preventing lower respiratory tract diseases caused by RSV in the older age group. GSK plans to present the final results of the trial at an upcoming medical conference and will seek regulatory approval for expanding the vaccine’s label to include adults aged 50 to 59. Pfizer is currently the only other company with an approved RSV vaccine, primarily for adults aged 60 and older, as well as expectant mothers. US health officials are relying on vaccines from both Pfizer and GSK to help combat the RSV season. RSV and other respiratory viruses have started circulating again, albeit at lower rates than the previous year, and caused a severe season last year. RSV can lead to severe illness and death, particularly among older adults and young children.
For the full original article on CNBC, please click here: https://www.cnbc.com/2023/10/25/gsk-rsv-vaccine-shows-potential-to-protect-adults-50-to-59.html
