GlaxoSmithKline plc (NYSE:GSK) has paused a late-stage trial of its respiratory syncytial virus (RSV) vaccine candidate in pregnant women based on safety recommendations from an independent committee.
- GSK did not explain why it paused the phase 3 GRACE trial and two other studies.
- The Company said that halt doesn't apply to its AReSVi 006 phase 3 trial of the jab in older adults aged 60 years and above, which is due to read out in the next few months.
- "This decision was made following a recommendation from the independent data monitoring committee based on an observation from a routine safety assessment," said the Company, adding it will provide a further update "in due course."
- Yesterday, the European Medicines Agency accepted the marketing application for nirsevimab under an accelerated assessment procedure. Nirsevimab is a long-acting antibody designed to protect all infants against the respiratory syncytial virus, developed by Sanofi SA (NASDAQ:SNY) and AstraZeneca plc (NASDAQ:AZN).
- In September, Pfizer Inc (NYSE:PFE) initiated a Phase 3 trial evaluating its RSV vaccine candidate in adults ages 60 years or older.
- Price Action: AZN shares are up 0.42% at $43.50 during the premarket session on the last check Friday.
