In a significant development, GlaxoSmithKline (GSK) announced promising results from a late-stage clinical trial for their vaccine, Arexvy, which exhibits the potential to protect adults aged 50 to 59 from respiratory syncytial virus (RSV). This news comes as a ray of hope in the fight against RSV, a disease responsible for thousands of hospitalizations and fatalities among older Americans each year. Currently approved for adults aged 60 and above in several countries, GSK’s Arexvy has demonstrated effectiveness in a broader age group, specifically among individuals aged 50 to 59.
One of the most significant findings in this clinical trial is that a single dose of GSK’s Arexvy has shown the ability to elicit a robust immune response in adults aged 50 to 59. These individuals are considered at increased risk of contracting RSV due to certain underlying medical conditions. The encouraging aspect is that the immune response observed in this age group is not worse than that seen in adults aged 60 and above.
In a previous late-stage trial conducted among adults aged 60 and above, GSK’s Arexvy exhibited an impressive 83% effectiveness rate in preventing lower respiratory tract disease caused by RSV. Furthermore, safety data in adults aged 50 to 59 was found to be consistent with the data collected from adults aged 60 and above, indicating that Arexvy maintains a reliable safety profile across these age groups.
GSK has laid out a comprehensive plan for the future of Arexvy. The company intends to present the final results from the trial at an upcoming medical conference and then submit these findings for publication in a peer-reviewed journal. Importantly, GSK aspires to be the first company to submit data on the effectiveness of the vaccine in adults aged 50 to 59 to regulatory bodies, including the Food and Drug Administration (FDA). They anticipate a decision on a potential label expansion for this age group in 2024, which is a significant step toward making the vaccine more widely available.
“We will submit these data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time,” said Tony Wood, GSK’s Chief Scientific Officer, underscoring the company’s commitment to advancing public health.
Currently, Pfizer is the only other company with an approved RSV vaccine on the market. However, Pfizer’s vaccine is limited to adults aged 60 and older and expectant mothers who can pass on protection to their fetuses. There has been no immediate response from Pfizer regarding their own data on adults aged 50 to 59.
U.S. health officials are closely monitoring the situation and looking to vaccines from companies like Pfizer and GSK to combat the RSV season. RSV, alongside other respiratory viruses such as the flu, is beginning to circulate, albeit at lower rates compared to the same period last year, as reported by the CDC. It is worth noting that last year witnessed an unusually severe RSV season, which overwhelmed hospitals due to an increase in cases among both children and older adults. Public adherence to Covid pandemic health measures had significantly contributed to the decline in RSV transmission before last year’s surge.
While RSV typically causes mild, cold-like symptoms in most individuals, it is essential to recognize its potential severity. Each year, RSV is responsible for the deaths of 6,000 to 10,000 seniors and a few hundred children younger than 5, according to data from the Centers for Disease Control and Prevention (CDC). These statistics underscore the significance of the development and potential expansion of vaccines like Arexvy and the role they can play in preventing RSV-related hospitalizations and fatalities.
(Source: Annika Kim Constantino | CNBC | Robert Hart | Forbes)
