Posted by Michael Wonder on 28 Oct 2022
GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment
28 October 2022 - Application based on positive pivotal Phase 3 data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract disease in adults aged 60 years and above with a favourable safety profile.
GSK today announced that the EMA has validated the marketing authorisation application for its respiratory syncytial virus older adult vaccine candidate.
