Arexvy Demonstrates Sustained Protection From Respiratory Syncytial Virus in Adults Over 60 Years of Age for Three Seasons

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Results from the Phase III AReSVi-006 clinical trial found that GSK’s Arexvy provided sustained protection over three full respiratory syncytial virus (RSV) seasons in adults aged 60 years and older. According to the company, full data were presented earlier this week at the CHEST 2024 Annual Meeting, organized by the American College of Chest Physicians. GSK stated that these results indicate that Arexvy could significantly reduce the risk of severe respiratory outcomes, hospitalizations, and mortality in older adults.¹

“We are excited by these new data, which show that a single dose of Arexvy could help protect millions of older adults at risk of RSV disease over three seasons to benefit public health. This is the only RSV vaccine with efficacy and safety data available through three full seasons. We will continue to provide data on longer term follow-up to help recommending bodies determine future revaccination schedules,” said Tony Wood, chief scientific officer, GSK, in a press release.

AReSVi-006 was an international, placebo-controlled trial that consisted of 24,966 participants over 60 years of age. All participants were randomly assigned in a 1:1 ratio to receive one dose of Arexvy or a placebo. The primary endpoint of the study was to show vaccine efficacy of one dose of Arexvy against RSV-related lower respiratory tract disease (LRTD), confirmed by reverse-transcriptase polymerase chain reaction during one RSV season.²

Results found that after a single dose of Arexvy, patients experienced a cumulative efficacy of 62.9% against LRTD caused by RSV and 67.4% against severe RSV-LRTD. By the third season, efficacy was 48.0% against RSV-LRTD. Arexvy also demonstrated efficacy against a number of RSV subtypes, in adults between the ages of 70 and 79 years, and patients with underlying medical conditions.¹

A majority of adverse events (AEs) in the study were reported to be mild-to-moderate in severity. A total of 49 vaccine recipients and 58 placebo recipients died, mostly due to cardiac disorders, according to the study investigators. Overall, the safety profile of the vaccine was found to be acceptable.²

“Our results indicate that the RSVPreF3 OA vaccine provided protection across the clinical spectrum of RSV disease, from mild upper respiratory tract infection to severe lower respiratory tract disease. Older adults, particularly those with coexisting conditions, are at increased risk for severe RSV disease and could benefit from an effective vaccine,” said the authors of the study.

According to the Centers for Disease Control and Prevention, an estimated 2.1 million children under five years of age require outpatient visits annually due to RSV. Additionally, RSV leads to anywhere from 58,000–80,000 hospitalizations in this age group annually. In adults over the age of 60 years, that number increases to anywhere from 100,000–160,000 hospitalizations.³

According to the National Institute of Allergy and Infectious Diseases, RSV is the most common cause of bronchiolitis in children under the age of one year. Further, RSV is estimated to cause approximately 14,000 annual deaths in adults over 65 years of age in the United States annually. Globally, the virus effects around 64 million people and accounts for around 160,000 deaths each year.⁴ Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV can exacerbate multiple conditions, including chronic obstructive pulmonary disease, asthma, and chronic heart failure, and can lead to severe outcomes, such as pneumonia, hospitalization, and death.

GSK stated that revaccination may be needed over time to maintain protection, and ongoing data will guide future immunization schedules.¹

References

1. GSK presents positive data for Arexvy, its respiratory syncytial virus (RSV) vaccine, indicating protection over three RSV seasons. GSK. October 8, 2024. Accessed October 10, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-presents-positive-data-for-arexvy-its-rsv-vaccine-indicating-protection-over-three-rsv-seasons/

2. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. The New England Journal of Medicine. February 15, 2023. Accessed October 10, 2024. https://www.nejm.org/doi/full/10.1056/NEJMoa2209604

3. Surveillance of RSV. CDC. Accessed October 10, 2024. https://www.cdc.gov/rsv/php/surveillance/index.html

4. Respiratory Syncytial Virus (RSV) NIH. Accessed October 10, 2024.