Novavax reports positive DSMB analysis of Phase III for RSV vaccine

Novavax Inc. (NASDAQ:NVAX) presented results from an "informational analysis" of the Phase III Prepare trial of its RSV F vaccine to prevent respiratory syncytial virus (RSV) in infants via maternal immunization. Data were presented at the J.P. Morgan Healthcare Conference in San Francisco.

The company said a DSMB analysis of the trial’s primary endpoint showed a vaccine efficacy at day 90 of 45-100%, beating the target threshold of 40%. The endpoint measured the presence of medically significant RSV lower respiratory tract infection in term infants in the 1,307-patient per protocol (PP) population. Novavax expects interim data from the trial as early as 4Q18 and plans to submit a BLA to FDA as early as 4Q19...