The Food and Drug Administration has granted Fast Track designation to NanoFlu (Novavax) for seasonal influenza vaccination in adults ≥65 years.
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine; it uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. The vaccine is adjuvanted with Matrix-M, which according to the Company, stimulates “high-quality and durable” antibody responses.
Findings from a phase 2 trial comparing NanoFlu to Fluzone High-Dose found that individuals administered NanoFlu had significantly superior hemagglutination inhibition (HAI) antibody responses against wild-type A(H3N2) viruses (45% increase against vaccine-homologous virus, A/Singapore (P <.001); 22% increase against a historic drifted virus, A/Switzerland (P =.014); 42% increase against a forward drifted virus, A/Wisconsin (P <.001)). A phase 3 trial comparing NanoFlu to the quadrivalent formulation of Fluzone in 2650 individuals is ongoing. Top-line results are expected by the end of the first quarter of 2020.
“We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We look forward to working closely with the FDA through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations.”
For more information visit Novavax.com.