Novavax unveils positive results for seasonal flu vaccine
“Titers of antibodies that inhibit hemagglutination by the influenza virus -- called hemagglutination-inhibiting or HAI antibodies -- remain the best-accepted correlates of the protection provided by influenza vaccines,” Louis F. Fries III, M.D., chief medical officer at Novavax, said. “We were very pleased to see that our seasonal influenza vaccine candidate elicited increases in HAI titers for all four viral strains that would allow our vaccine to fulfill CBER’s criteria for accelerated approval. Novavax has made a concerted effort to improve the antigens in our seasonal influenza vaccine. In particular, for the two viral strains (out of the four) for which we had sought immunogenic improvement, we showed robust HAI titer responses, approximately 50 percent greater than those in our prior phase two trial. Further, we measured neuraminidase-inhibiting (NAI) antibody responses against seasonal influenza viruses for the first time, and were able to detect significant NAI antibody responses to all four influenza strains, including strong responses against the B virus strains.”
The vaccine, called Seasonal Influenza VLP, showed no vaccine-related serious adverse events. It was well tolerated among the trial subjects.
“These positive topline data from the phase two trial of our Seasonal Influenza vaccine candidate represent an important achievement in this program,” Novavax President and CEO Stanley C. Erck said. “We look forward to a complete review of these data with our partner BARDA to determine next steps in the development of this product. Our collaboration with BARDA also includes the development of our novel H7N9 Influenza vaccine candidate in combination with Matrix-M. We expect the next steps in our collaboration will be the initiation of a phase two clinical trial of the H7N9 vaccine candidate in the adult population in the first quarter of 2016.”