FDA CDC News
FDA Approves First RSV Vaccine, Arexvy, for Individuals 60 and Older
FDA approves first RSV vaccine, Arexvy, for those 60+ reducing risk of severe LRTD by 94.1%.
The FDA has approved the first respiratory syncytial virus (RSV) vaccine, Arexvy, for individuals 60 years of age and older.
RSV is a highly contagious virus that can cause severe lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis. Arexvy significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.
The most commonly reported side effects were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain.
The FDA is requiring the company to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and acute disseminated encephalomyelitis (ADEM).
