The U.S. Food And Drug Administration (FDA) said it has approved Arexvy— the first Respiratory Syncytial Virus (RSV) vaccine for use in the United States.
Arexvy, manufactured by GSK PLC (a UK pharmaceutical and biotech company), is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
A GSK plc study that was released in February found an 82.6 percent efficacy of the vaccine.
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RSV is a typical respiratory virus that typically causes minor, cold-like symptoms. RSV can be serious, especially for infants and elderly individuals, although majority of infected people recover within a week or two.
The director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. said “Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV.”
The Director noted that “Today’s (Wednesday) approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”
According to the US Centers for Disease Control and Prevention, respiratory illnesses cause an average of 100–300 deaths in children under the age of 5 each year, as well as 60,000–120,000 hospitalizations, 6,000–10,000 deaths, and 60,000–120,000 hospitalizations among adults 65 and over.
The vaccine was over six decades in the making and is the first to receive authorization to prevent RSV anywhere in the world.
According to the FDA, RSV is a highly contagious virus that infects the lungs and breathing airways in people of all ages.
It stated that RSV is seasonal, often starting in the fall and peaking in the winter. In older adults, RSV is a major cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs).
Side effects associated with the vaccine are said to be mostly mild or moderate and end within two days.
The most common symptoms are soreness around the injection area or fatigue.