Arexvy shows potential to protect a wider group of adults at higher risk of getting RSV

GSK announces new preliminary data on it Arexvya reformed vaccine professed against respiratory syncytial virus (RSV) in adults aged 18 to 49 years at increased risk for RSV-LRTD infection due to certain underlying medical conditions and in immunocompromised adults. These data demonstrate the potential of the vaccine to help protect a wider group of adults at risk from the potentially serious effects of RSV.. In the United States alone, the number of adults aged 18 to 49 with at least one risk factor who may be exposed to RSV infection may exceed 21 million.

The vaccine is currently approved for use in adults aged 60 and over in more than 50 countries.and in adults aged 50 to 59 years at increased risk in several countries, including the United States and Europe. RSV vaccines are not currently recommended for adults under 60 years of age at increased risk for the disease, despite the burden of the disease in this population.

Tony Woodchief scientific officer at GSK, that “these promising data add to the evidence supporting GSK’s RSV vaccine and may help extend protection to more adults at risk of RSV infection.” ” At the same time, he insisted that “they also provide valuable information about the potential impact of a second dose on specific populations.” “We are committed to working with health and regulatory authorities to help adults who are most at risk of RSV infection to benefit from vaccination,” he said.

In a Phase IIIb trial (NCT063894872), A single dose of the vaccine elicited strong immune responses in adults aged 18 to 49 at increased risk for RSV-LRTD due to certain underlying medical conditions. The immune response was not inferior to that seen in adults aged 60 years and older, meeting the trial’s co-primary endpoints. Meanwhile, in a Phase IIb trial (NCT059219033), one dose of the vaccine showed a strong immune response in adults older than 18 years who were vaccinated as a result of a kidney or lung transplant, while a second received dose responses similar to those of healthy adults over 50 years of age who received a single dose. These immune responses were consistent for RSV-A and RSV-B subtypes in all groups (those who received one or two doses). This data will be presented today at the Committee meeting

In both studies, safety and reactogenicity data were consistent with results from the Phase III program that supported the vaccine’s initial approval.. Pain was the most common local adverse event, and fatigue, myalgia, arthralgia, and headache were the most common systemic adverse events, most of which were transient and mild in intensity. RSV is a common and contagious virus that can cause severe respiratory illness and affects approximately 64 million people of all ages worldwide each year. Immunocompromised people and those with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes, are at a higher risk of serious side effects from RSV infection than those the absence of these conditions includes an increased risk of mortality.

The final results of these tests will be presented at upcoming medical conferences and will be submitted for publication in specialized journals.. Final data will also be presented to the US Food and Drug Administration (FDA) and other regulatory agencies to support possible label updates.

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