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The U.S. Food and Drug Administration on Tuesday approved Pfizer’s RSV vaccine for adults ages 18 to 59 who are at high risk for lower respiratory tract illness from RSV.
In June, the U.S. CDC narrowed down its recommendations for the use of the RSV vaccine for older adults this year, not recommending its use for adults under 60.
The CDC currently recommends the use of the RSV vaccine for adults age 75 and older and adults ages 60 to 74 who are at high risk for severe RSV disease.
FDA approval is a necessary step, but the CDC also needs to recommend vaccination before it can begin inoculating that age group.
The approval of the Abrysvo vaccine for adults aged 18 to 59 was based on the results of a late-stage trial testing two doses of the vaccine in immunocompromised adults aged 18 and older.
Pfizer said the vaccine was well-tolerated and showed a safety profile consistent with other studies of the vaccine.
CDC advisers plan to discuss Pfizer’s data at a meeting later this week, but they do not plan to vote on whether to expand the recommendations.
Pfizer’s vaccine is currently approved for people over 60 and women in the middle of their third trimester to protect babies.
RSV usually causes cold-like symptoms, but it is also a leading cause of pneumonia in young children and older adults, resulting in 177,000 hospitalizations and 14,000 deaths in the United States each year.
