The vaccine still needs approval from the US Centers for Disease Control and Prevention before it can be rolled out to the public.
Officials say the vaccine, named Arexvy by the manufacturer GSK, is a major breakthrough that will save many lives.
It could be available to people over 60 within months, officials say.
"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 Food and Drug Administration (FDA).
RSV is a respiratory illness that typically results in cold-like symptoms for adults, but can be dangerous for young children, the elderly, and those with underlying health conditions.
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Source: BBC News, 4 May 2023
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