J&J Pulls Plug On Large Late-Stage RSV Vax Study; GSK, Pfizer Shots Under FDA Review
- After reviewing its portfolio to prioritize and assessing the respiratory syncytial virus (RSV) vaccine landscape, Janssen, a unit of Johnson & Johnson , will exit its investigational RSV adult vaccine program and discontinue its Phase 3 EVERGREEN study.
- The Phase 3 study estimated to enroll over 27,000 participants.
- Pfizer Inc and GSK plc have their RSV vaccine candidates under FDA review, with a decision expected in May to use their shots in adults 65 and older.
- Pfizer also expects the FDA to decide by August whether the shot can be used in infants and pregnant women.
- The RSV vaccine market is estimated to be over $5 billion and could exceed $10 billion by 2030, Reuters reported, citing analysts.
- Data from a Phase 2b CYPRESS trial showed that the vaccine generated 80% protection against lower respiratory infections in older adults. By then, it had already initiated the large Phase 3 trial.
- The investigational RSV adult vaccine also demonstrated an efficacy of 70% against any symptomatic RSV-associated acute respiratory infection.
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