Novavax and the Mexican Social Security Institute Publish Results from H1N1 Influenza Vaccine Trial in Mexico

Novavax NVAX and Specialties Hospital of the National Medical Center, Mexico City, today announced the publication of safety and immunogenicity results from a clinical study of Novavax's A/H1N1 virus-like-particle pandemic influenza vaccine candidate in the journal Vaccine. The two-stage, Phase 2, randomized, double-blind, placebo-controlled study was conducted in Mexico during the 2009 pandemic to evaluate the safety and immunogenicity of one or two doses of a monovalent recombinant A/California/04/2009-like influenza VLP vaccine in 4,563 healthy adults, 18-64 years of age. The study data showed that hemagglutination-inhibiting antibody responses to the vaccine fulfilled the immunogenicity criteria that are required to be considered for accelerated approval of seasonal and pandemic influenza vaccines by the US FDA Center for Biologics Evaluation and Research. These criteria were met at all dose levels after a single injection, including the lowest dose of 5 micrograms. Single administrations of the VLP vaccine induced high levels of HAI titers in subjects without pre-existing detectable immunity to the pandemic strain. Overall, the data indicated that Novavax's H1N1 VLP vaccine was well-tolerated and immunogenic.