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Merck Seeks FDA Review to Extend Enflonsia for a Second RSV Season

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The FDA will review Enflonsia’s ability to protect high-risk children under age 2 during a second RSV season. If approved, children with chronic lung disease, congenital heart disease, or qualifying preterm birth risk factors could receive a second dose. The supplemental application is backed by SMART phase 3 results, and Enflonsia was initially approved in the U.S. in June 2025 and in the EU in April 2026, with 276 eligible children dosed in the second season.

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