Shares of influenza vaccine maker Novavax looking a lot healthier, shooting up 10 percent Wednesday on word that the Food and Drug Administration opted to fast track its recombinant quadrivalent flu vaccine, NanoFlu, for adults aged 65 years and older.
Fast-track status, according to the agency, is a “process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.” The goal, it explains, is to get important new drugs to patients sooner.
From 2019 to this point in 2020, the Centers for Disease Control and Prevention estimates up to 14 million people were infected with the flu, resulting in up to 150,000 hospitalizations and 12,000 deaths. The CDC also reports flu costs in the United States, including hospitalizations and outpatient visits, reach more than $10 billion each year.
NanoFlu is currently the subject of an ongoing Phase 3 clinical trial intended to test its efficacy compared to earlier strains of the vaccination. Data from that trial are expected to be published toward the end of the first quarter of 2020, according to the FDA.
The agency’s decision to fast track the drug “reflects the urgent unmet medical need for a more effective vaccine against influenza, particularly in the older adult population which often experiences serious and sometimes life-threatening complications of the disease.”
NanoFlu "will offer an improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness,” Novavax Chief Executive Officer Stanley C. Erck said in a press statement. “We look forward to working with the FDA … accelerating access to this vaccine for the most vulnerable populations.”
Despite Wednesday's climb, the stock is down 89 percent compared to last year, largely due to the company's vaccine for respiratory syncytial virus failing a pivotal trial.