First-Ever Vaccine to Prevent RSV In Older Adults Wins FDA Approval

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Madeline Monroe/iStock/CDC via AP

Federal regulators gave the green light to the first-ever vaccine to prevent the respiratory disease RSV on Wednesday, a major breakthrough that’s been decades in the making.

The Food and Drug Administration (FDA) approved Arexvy, a shot developed by pharmaceutical giant GlaxoSmithKline (GSK) to prevent lower respiratory tract disease caused by RSV in adults aged 60 and older.

The development marks a significant turning point in the fight to protect vulnerable individuals against RSV, and other shots are close behind.

A vaccine that was developed by Pfizer and aimed at the same demographic is expected to be approved by the end of the month.

FDA is also considering Pfizer’s maternal RSV vaccine, intended to be given to pregnant individuals to help protect against RSV in infants.

RSV circulation is seasonal, typically starting during the fall and peaking in the winter. The vaccine is expected to be available before the start of next RSV season.

In healthy adults and older children, RSV typically causes mild, cold-like symptoms that go away with moderate rest and self care.

But older adults, including those with underlying medical conditions such as diabetes and chronic heart and lung disease, are at increased risk of severe RSV illness and drive the majority of RSV hospitalizations.

RSV causes between 60,000 and 160,000 hospitalizations annually for adults older than 65 in the U.S. and 6,000 to 13,000 deaths, according to federal statistics.

“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,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

A Centers for Disease Control and Prevention advisory panel will meet in June to make recommendations on the appropriate use of the vaccine in the U.S.

Results from a large clinical trial of nearly 25,000 participants showed a shot of GSK’s vaccine given before RSV season was shown to be about 83 percent effective in preventing lower respiratory tract disease in people aged 60 and over, and it was 94 percent effective in preventing severe disease.

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