FDA-approved RSV vaccine is world's first

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Cold and flu season hit hard in the U.S. this past fall and winter, with crushing numbers of infections from respiratory viruses like flu and RSV, or respiratory syncytial virus, amid the ongoing threat of COVID-19. But doctors were left with little recourse for preventing or treating RSV, for which there has been no available vaccine – until now.

After six decades of drug companies and researchers making circuitous attempts at developing a successful vaccine against RSV, the Food and Drug Administration has approved the world’s first RSV vaccine, with a crowded field of other candidates trailing close behind it.

The vaccine, which is approved for adults ages 60 and up, must still undergo review by an expert advisory committee that makes recommendations to the Centers for Disease Control and Prevention, explains Annette Regan, an epidemiologist who specializes in vaccines and maternal health. Pending the CDC’s greenlighting of the vaccine, it could begin going into arms in a few months, well before the typical fall and winter spike in RSV infections.

In the meantime, Regan notes, the FDA will also be reviewing data on other RSV vaccine candidates, including a maternal vaccine aimed at protecting infants.

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Amanda Mascarelli

Senior Health and Medicine Editor

The long-awaited vaccine is a necessary tool in the fight against the most common respiratory viruses. angelp/iStock via Getty Images Plus

FDA’s approval of the world’s first vaccine against RSV will offer a new tool in an old fight – 4 questions answered

Annette Regan, University of San Francisco

The newly approved RSV vaccine could be rolled out by fall 2023, in time for the typical winter surge in RSV infections.

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