GSK Halts Late-Stage RSV Vaccine Trial In Pregnant Women

GlaxoSmithKline plc 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 SNY and AstraZeneca plc AZN.
• In September, Pfizer Inc 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.