FDA approves first-ever RSV vaccine, for use among older adults
BALTIMORE — The U.S. Food and Drug Administration announced Wednesday, the approval of Arexvy, the first Respiratory Syncytial Virus (RSV) vaccine cleared for use in the United States.
The FDA said the vaccine is approved for the prevention of RSV in individuals 60 years of age and older.
RSV is a highly contagious respiratory illness that is particularly dangerous for those with weakened immune systems and certain underlying health conditions. This places infants, young children, and elderly adults in the high risk category.
Cases of the virus spiked in Maryland last fall, filling hospitals, and causing concern for medical professionals.
"Today's 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," said Dr. Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research.
According to the FDA, the safety and effectiveness of the vaccine is "placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older," in which the participants were given a single dose.
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