A Gaithersburg biotechnology company is beginning a research which the FDA can examine when determining whether to approve its influenza vaccine.
Novavax Inc. announced it began a phase 3 clinical trial of NanoFlu, its seasonal influenza vaccine candidate, in adults 65 and older. The research will look at the ability of the vaccine, when used with its Matrix-M immunological agent, to promote an immune response, and at the vaccine’s safety.
The study will enroll roughly 2,650 healthy older adults across 19 sites. Participants will receive either NanoFlu or an already licensed vaccine, both of which will be made to protect against the influenza strains recommended for the 2019-2020 Northern hemisphere influenza season.
Novavax expects data from the study to be available in the first quarter of 2020. The company plans to use it to support a biologics license application. If the study finds that NanoFlu is safe and provides a meaningful therapeutic benefit over existing treatments, NovaVax may ask the FDA for accelerated approval.