The US Food and Drug Administration (FDA) has approved the world’s first vaccine against respiratory syncytial virus (RSV). RSV is a common respiratory illness that can be life-threatening, particularly for young children, the elderly, and people with underlying health conditions. The vaccine, named Arexvy by the manufacturer GSK, is a major breakthrough that could save many lives.
The vaccine requires approval from the US Centers for Disease Control and Prevention (CDC) before it can be made available to the public. However, officials have indicated that it may be available to individuals over the age of 60 within the next few months.
According to the CDC, RSV kills 100-300 children under the age of 5 in the US every year, as well as 6,000 to 10,000 adults over 65 annually. In addition, the virus causes between 60,000 to 120,000 hospital admissions. In severe cases, it can cause bronchiolitis, which includes a buildup of inflammation in the lungs and trouble breathing.
After over 60 years in development, the vaccine has become the first to receive approval worldwide for the prevention of RSV. In a study by GSK, the UK-based firm that developed the vaccine, published in February, the vaccine showed an efficacy of 82.6%. The vaccine also demonstrated mostly mild or moderate side effects that ended within two days, such as pain around the injection site or fatigue.
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening,” said Dr Peter Marks, who leads the Center for Biologics Evaluation and Research at the FDA.