After years of strenuous research and development the FDA finally approved Arexvy; the first vaccine against respiratory syncytial virus (RSV). Adults 60 years or older may now receive a single dose of the vaccine after consulting with their physician, as recommended by the US Centers for Disease Control and Prevention’s (CDC’s) immunization advisory committee. Arexvy will be administered for active immunization against lower respiratory tract disease (LRTD) associated with RSV. Individuals at highest risk for developing RSV are those who live in nursing or long-term care facilities, have underlying health conditions such as heart disease, lung disease or weakened immune systems. The recent approval of the drug is an important public health achievement to prevent a life-threatening disease and impact lives across the globe.
According to the CDC, RSV is a highly contagious virus responsible for approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older. RSV circulation is seasonal, typically starting early fall and peaking during the winter. The virus causes infection within the lungs and breathing passages which may furthermore cause life-threatening complications such as pneumonia or bronchiolitis (inflammation in the airways)
The safety and efficacy data were conducted from an ongoing, placebo-controlled, randomized clinical study conducted within the U.S and internationally in 25,000 older adults (aged 60 years or older). To assess the duration of effectiveness and the safety of repeat vaccination, the participants remained in the study throughout three full RSV seasons. The results of the phase-3 study show that the vaccine significantly reduced the risk of developing RSV associated LRTD by approximately 83% and reduced the risk of developing severe RSV-associated LRTD by about 94% when compared with the placebo group.
Arexvy was generally well tolerated in the trial participants, and the most common side effects were those similar to other vaccines such as injection site reactions, pain or fatigue, Though there were no evidence of alarming safety concerns, ten participants reported atrial-fibrillation and in two other studies, two participants developed ADEM when receiving Arexvy concomitantly with a FDA-approved influenza vaccine. In the other study, one participant developed Guillain-Barré syndrome. Because of these rare outcomes in 3 participants, Arexvy manufacturer GlaxoSmithKline Pharmaceuticals will conduct a post-marketing study to assess atrial fibrillation, Guillain-Barré and acute disseminated encephalomyelitis.
It was paramount that a vaccine was created to provide an opportunity to protect older adults against severe illness during these seasons. Although there were rare unanticipated outcomes, post-marketing studies will be conducted, and overall results were promising and definitely a step towards the right direction of drug manufacturing, research and development.
Article: https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine Picture: https://jamanetwork-com.lp.hscl.ufl.edu/journals/jama/fullarticle/2805297?resultClick=1