After decades of scientific research, the first vaccine for respiratory syncytial virus (RSV), designed to protect older adults, has been approved by the United States.
Individuals aged 60 years and older can now use GSK’s vaccine, called Arexvy, to prevent lower respiratory tract disease (LRTD) resulting from RSV, following its approval Wednesday from the Food and Drug Administration.
Annually in the United States, RSV causes around 60,000 –120,000 hospitalizations and results in 6,000 –10,000 deaths among adults aged 65 years or older, according to the Centers for Disease Control and Prevention.
"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 Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release.
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The circulation of RSV is seasonal, with a usual start in the fall and a peak in the winter.
The approval came after the FDA conducted a study in which about 12,500 people received Arexvy and 12,500 got a placebo. According to the FDA, Arexvy reduced the risk of developing RSV-associated LRTD by 82.6% and severe RSV-associated LRTD by 94.1% in comparison to the placebo group.
The trial participants who received Arexvy reported injection site pain, fatigue, muscle pain, headaches, and joint stiffness and pain as the most common side effects.
The next step in vaccine approval involves the CDC, which must determine whether everyone over 60 should receive the vaccine or only those at high risk. The vaccine could be available for seniors as soon as this fall.
The decision by the FDA now licenses the shot as the first of many in the pipeline, as Pfizer’s comparable vaccine for adults is also under consideration by the FDA.
There’s currently no vaccine to prevent RSV infection in children.
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