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The U.S. Food and Drug Administration approved Tuesday PfizerThe RSV vaccine is used to prevent lower respiratory tract illness caused by RSV in adults 18 to 59 years of age who are at increased risk.
In June, the U.S. Centers for Disease Control and Prevention zoom out Respiratory syncytial virus vaccine is recommended for older adults this year, but has been postponed for adults under 60 years of age.
CDC currently recommends RSV vaccine for adults 75 years of age or older and for those 60-74 years of age who are at increased risk for severe RSV disease.
While FDA approval is a necessary step, the CDC also needs to recommend a vaccine before it can be appropriate for that age group.
The Abrysvo vaccine is approved for use in adults ages 18 to 59, based on results from a late-stage trial that tested two doses of the vaccine in immunocompromised adults 18 and older.
Pfizer said the vaccine was well tolerated and showed a safety profile consistent with other studies of the vaccine.
CDC advisers are expected to discuss Pfizer’s data at a meeting later this week but are not expected to vote on whether to expand the recommendation.
Pfizer’s vaccine is currently approved for use in people 60 and older and in women in their third trimester to protect their babies.
RSV often 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.
