Safety, efficacy, and immunogenicity of Flublok in the prevention of seasonal influenza in adults:

摘要: Flublok is the first recombinant hemagglutinin (HA) vaccine licensed by US Food and Drugs Administration for prevention of influenza in adults aged 18 older. The HA proteins produced insect cell culture using baculovirus expression system technology are exact analogues wild type circulating virus HAs. universal manufacturing process that has been successfully scaled to 21,000L contributes rapid delivery a substantial number doses. This review discusses immunogenicity, efficacy safety data from five pivotal clinical studies used support licensure trivalent years age older United States. trial demonstrate higher antigen content results improved immunogenicity. Data further suggest slightly lower local reactogenicity compared with standard inactivated vaccine, despite presence more (statistically significant). can include HAs designed mimic 'drift' viruses as predicting antigenic drift advances and, at minimum, could address late appearing viruses. implementation latter will require regulatory authorities.