GSK plc said the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, supplemental) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals aged 60 and over.
This is the first RSV vaccine for older adults approved anywhere in the world.
It will be available to older adults before the 2023/24 RSV season, which usually kicks off near winter.
Last year, Beyfortus (nirsevimab) AstraZeneca and Sanofi were approved in the European Union (EU) for the prevention of RSV LRTD in newborns and infants during their first RSV season.
About RSV in adults
RSV is a common infectious virus that affects the lungs and respiratory tract. Older adults are at increased risk for severe disease due in part to age-related decline in immunity, and older adults with underlying conditions are even at greater risk for severe disease. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.
Each year, approximately 177,000 adults aged 65 and over are hospitalized in the US for RSV; an estimated 14,000 cases result in death. For adults aged 60 years and over, the data suggests an increased risk of severe RSV infection that can lead to hospitalization. Adults with underlying conditions are more likely to seek medical care and have higher hospitalization rates than adults without these conditions.
The focus is turning to access to the RSV vaccine
Tony Wood, GSK’s chief scientific officer, said: “Today marks a turning point in our efforts to reduce the significant burden of RSV. Arexvy is the first RSV vaccine approved for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible parents in the US can access the vaccine as quickly as possible and to advance regulatory reviews in other countries.”
John Kennedy, president of the American Medical Group Association (AMGA), added: “For decades, the AMGA and the healthcare community at large have been active in finding ways to improve adult immunization. As a result, we are pleased that we can now add a respiratory syncytial virus vaccine to provider options for patient care. With this vaccine, Americans over 60 years of age, and especially those with underlying health conditions such as COPD, asthma, or congestive heart failure, will get a vaccine to help protect against the potentially serious outcomes of RSV.”
US FDA approval is based on GSK’s critical AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial. In trials, the vaccine demonstrated a statistically significant and clinically significant overall efficacy of 82.6% against RSV-LRTD in adults aged 60 years and over, meeting the primary endpoint. In addition, efficacy was 94.6% in older adults with at least one underlying medical condition, such as certain endocrine cardiorespiratory and metabolic conditions.
The efficacy against severe RSV-LRTD, defined as episodes of LRTD associated with RSV that prevent normal daily activities, was 94.1%.
Vaccines are generally well tolerated with an acceptable safety profile. The most commonly observed side effects were injection site pain, fatigue, myalgias, headaches and arthralgias. These are generally mild to moderate and transient.
In June 2023, the Advisory Committee on Immunization Practices (ACIP) will make recommendations on the proper use of vaccines in the US
In April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending a vaccine for the prevention of LRTD caused by RSV in adults aged 60 years and over. A final European regulatory decision is anticipated in the coming months, while regulatory reviews are under way in Japan and several other countries.
About the Arexvy RSV vaccine
Recombinant respiratory syncytial virus vaccine, adjuvant, contains the recombinant prefusion subunit RSV F glycoprotein antigen (RSVPreF3) in combination with GSK’s proprietary AS01E adjuvant.
In the US, Arexvy is indicated for the prevention of RSV-LRTD in individuals aged 60 years and over. GSK’s RSV aged adult vaccine is not currently approved anywhere outside the US Proposed trade name remains subject to regulatory approval outside the US
A clinical trial aiming to expand the population that may benefit from RSV vaccination to adults aged 50 to 59 years, including participants with underlying comorbidities, has been fully recruited. Results are expected in 2023, together with additional results from the phase III AReSVi-006 efficacy trial and AReSVi-004 immunogenicity assay. This trial continues to evaluate the annual revaccination schedule and protection/immunogenicity for several seasons after a single dose of RSV vaccine. Results of two co-administration trials of additional influenza vaccines are also expected before the June 2023 meeting of the Advisory Committee on Immunization Practices (ACIP).
GSK’s AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.