The U.S. Food and Drug Administration (FDA) has officially approved Pfizer’s RSV vaccine, Abrysvo, for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 18 to 59 who are at increased risk. This pivotal approval comes as a significant advancement in public health, particularly for those vulnerable to severe illness from RSV.
While the FDA’s decision marks a critical milestone, the Centers for Disease Control and Prevention (CDC) must also recommend the vaccine for this age group before it becomes widely available. Recently, the CDC has focused its guidance on older adults, recommending RSV vaccinations for those aged 75 and older and for adults aged 60-74 who face heightened risk for severe disease.
Pfizer’s approval is founded on promising data from a late-stage trial that evaluated the safety and efficacy of two vaccine doses in immunocompromised adults aged 18 and older. The results indicated that the vaccine is well-tolerated, maintaining a safety profile consistent with previous studies.
The CDC’s advisory committee is set to review Pfizer’s data later this week, though no immediate vote is expected on expanding vaccination recommendations to younger adults. Currently, the vaccine is approved for individuals aged 60 and older, as well as pregnant women during their third trimester to provide protection for their newborns.
RSV typically manifests as cold-like symptoms but can escalate into severe respiratory issues, particularly in vulnerable populations. Each year, RSV is responsible for approximately 177,000 hospitalizations and 14,000 deaths in the United States, underscoring the urgent need for effective preventive measures.
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