Novavax updates on Phase 3 trial of RSV F vaccine and Phase 1/2 trial of NanoFlu
Novavax, Inc announced the Phase 3 trial of its RSV F protein recombinant nanoparticle vaccine for infants via maternal immunization will continue. Novavax also provided an update on its nanoparticle influenza vaccine candidate with proprietary Matrix-M adjuvant. "Novavax has completed an informational analysis of our Phase 3 trial of the RSV F Vaccine for infants via maternal immunization using threshold criteria for a commercial product. As a result, we are accelerating our Phase 3 trial enrollment into 2018. Our maternal immunization program is supported by an $89 million grant from the Bill and Melinda Gates Foundation and has also been granted Fast Track designation by the U.S. Food and Drug Administration," said Stanley C. Erck, President and CEO. "We have enrolled over 3,000 volunteers to date and anticipate that the current pace of enrollment would trigger an interim analysis in mid-2018, with an expected Phase 3 primary endpoint readout in early 2019. This timing would allow us to submit a biologics license application by the end of 2019." Regarding NanoFlu vaccine, the company states: "The wild-type viruses necessary to assess immunogenicity of the vaccines to circulating strains have been difficult to obtain, grow and maintain genetic stability. Therefore, a complete Phase 1/2 data package expected in February 2018."