Novavax, Inc. (NASDAQ:NVAX) Phase 2 report indicated remarkable clinical profile of RSV F vaccine. In 2014, the company commenced Phase 2 study assessing efficacy of RSV F vaccine plus aluminum as phosphate salt in subject group of pregnant women. The investigational vaccine was given in the third trimester of the pregnancy.
Safety is considered as of utmost significance in maternal immunization. Novavax’s drug showed only mild to moderate and interim injection site pain, else it didn’t have any other grave side effect on the subjects. Moreover, RSV F drug did not show any adverse event pertinent to infant safety. The Phase II study validated that healthy amount of antibodies were moved to the infant in a transplacental way. Further, the study also validated that the antibodies can protect newborns for at least 90 days.
Novavax is assessing efficacy of gently immunizing infants with RSV F for dealing with RSV infection, together with hypoxemia for at least initial 90 days of life, in Phase III study, Prepare. It marks a group sequential study that will be go on for four years.
So, it will enable company to capture data depending on actual events that occur across numerous RSV seasons. After giving the drug in pregnancy (during 28 to 36 weeks), the company will follow the subjects for imminent nine months. The study design comprises observing the infant for one year.
Last year, Novavax performed testing under Phase III study, Prepare, at USA, South Africa, Chile, New Zealand and Australia. To capture results across the different climates and geographies, in 2017, the company intends to add new sites at Italy, Spain, Philippines and Argentina.
Involving over 8,600 pregnant subjects worldwide, Prepare, has been advancing at a steady rate without being affected or derailed by any noted safety event. The DSMB has not recommended any modifications or changes to the study based on interim data assessment.