Novavax, Inc. (NASDAQ:NVAX) has launched the Phase 3 study of the RSV F protein recombinant nanoparticle vaccine (RSV F Vaccine) designed for children. The drug is adminstred through maternal immunization. The company also offered an update on the nanoparticle influenza vaccine candidate with proprietary Matrix-M™ adjuvant (NanoFlu™).
The company has completed an analysis of its Phase 3 trial of the RSV F Vaccine for infants via maternal immunization using threshold criteria for a commercial product. The company has announced that it will be accelerating its enrollment to 2018. The company’s maternal immunization project is funded by an $89 million grant offered by Bill and Melinda Gates Foundation. It has been issued with the Fast Track designation by the U.S. Food and Drug Administration.
In a statement, the company’s President and CEO Stanley C. Erck said they have enrolled more than 3,000 patients and are hoping that the current rate of enrollment will lead to an analysis in 2018. He added that a primary endpoint from the trial is expected in early 2019. This, he added, will enable the company to submit a license application by the end of 2019.
In a statement, Greg Glenn, M.D., President, R&D said the information that was recently published offer an opportunity as well as challenge for the company’s NanoFlu Vaccine program. He added that the company has a unique opportunity to establish whether the company’s adjuvanted NanoFlu vaccine is able to address egg-adapted virus mismatch. He also added that they will be able to find out whether the vaccine-induced antibodies are in a position to neutralize circulating viruses which have antigenic drift in humans.
Respiratory syncytial virus (RSV) is one of the leading cause respiratory tract diseases and a major cause of severe lower respiratory tract diseases in children globally. RSV is one of the major causes of hospitalization in children. Although there is post-infection immunity, there are always repeat infections and prolonged susceptibility to RSV.