On Wednesday, the U.S. Food and Drug Administration announced the approval of the first respiratory syncytial virus (RSV) vaccine for use in the United States. Arexvy, manufactured by GlaxoSmithKline Biologicals, is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
RSV is a highly contagious virus that affects the lungs and breathing passages and can cause life-threatening pneumonia and bronchiolitis in older adults. According to the U.S. Centers for Disease Control and Prevention, RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older each year in the U.S.
The safety and effectiveness of Arexvy is based on the FDA’s analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older. Among the participants who received Arexvy, the vaccine significantly reduced the risk of developing RSV-associated lower respiratory tract disease by 82.6% and reduced the risk of developing severe RSV-associated lower respiratory tract disease by 94.1%.
However, in two other studies, some participants who received Arexvy developed rare types of inflammation affecting the brain and spinal cord or a rare disorder in which the body’s immune system damages nerve cells causing muscle weakness and sometimes paralysis. The FDA is requiring the company to conduct a postmarketing study to assess the signals of serious risks and is committed to assessing atrial fibrillation in the postmarketing study.
Despite the potential risks, the FDA is calling Arexvy’s approval an important public health achievement that reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States. Arexvy’s approval comes with Priority Review designation, indicating the significant impact the vaccine can have on public health. The FDA’s approval of Arexvy serves as a significant step towards combating the spread of RSV and protecting the health of older adults.
News Source : U.S. Food and Drug Administration