Tuesday, June 18, 2024

Respiratory Syncytial Virus Vaccine Arexvy by GSK Granted FDA Approval for Expanded Age Range

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Respiratory syncytial virus (RSV) vaccine, adjuvanted, developed by GSK, has received approval from the U.S. Food and Drug Administration (FDA) for use in adults aged 50 through 59 years who are at an increased risk of RSV lower respiratory tract disease (LRTD). This expansion marks a significant step in combatting RSV among a population particularly vulnerable to its effects.

Adults in this age group are estimated to experience around 42,000 hospitalizations annually due to respiratory syncytial virus, with those having underlying medical conditions such as COPD, asthma, heart failure, and diabetes facing elevated risks of severe outcomes. The approval is based on positive findings from a phase III trial evaluating the vaccine’s immune response and safety profile in adults aged 50-59, including those with underlying medical conditions predisposing them to RSV-LRTD.

Advancing Respiratory Syncytial Virus Immunization: GSK’s Efforts for Adults 50-59 at Risk

Tony Wood, Chief Scientific Officer at GSK, emphasized the importance of extending RSV immunization benefits to adults aged 50-59 at increased risk, highlighting the serious consequences RSV can pose for those with underlying health conditions. Professor Ann R. Falsey from the University of Rochester School of Medicine echoed this sentiment, emphasizing the significance of age and health status in determining susceptibility to severe RSV illness. The vaccine’s regulatory approval is not limited to the US, as GSK has submitted applications for its use in adults aged 50-59 at increased risk in other regions like Europe and Japan.

GSK’s RSV vaccine contains recombinant respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant. The vaccine’s initial approval in May 2023 was for individuals aged 60 and older, and its expanded indication for adults aged 50-59 reflects the company’s ongoing commitment to addressing RSV across a broader age spectrum. Further clinical trials are underway to evaluate the vaccine’s safety and immunogenicity in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over, with data expected in the second half of 2024.

Respiratory Syncytial Virus

Expanding Respiratory Syncytial Virus Vaccine Use: GSK’s Clinical Trial Results for Adults 50-59

The phase III trial (NCT05590403) supporting the expanded age indication assessed the immune response and safety of GSK’s respiratory syncytial virus vaccine in participants aged 50 to 59, including those at increased risk for RSV-LRTD, compared to older adults aged 60 years and above. Results from the trial demonstrated non-inferiority in immune response and confirmed the vaccine’s safety profile. Common adverse events included pain, myalgia, fatigue, and headache, with the majority being transient and mild to moderate in intensity.

The approval of Arexvy for use in adults aged 50-59 at increased risk of RSV-LRTD underscores the importance of preventive measures against respiratory syncytial virus in vulnerable populations. With RSV causing significant morbidity and mortality among adults, especially those with underlying medical conditions, the availability of vaccines targeting this age group is a crucial step towards reducing the burden of RSV-related illness and improving public health outcomes.

 

Resource: GlaxoSmithKline , June 07, 2024

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