Published in:
01-08-2013 | Adis Drug Evaluation
Recombinant Trivalent Influenza Vaccine (Flublok®): A Review of Its Use in the Prevention of Seasonal Influenza in Adults
Author:
Lily P. H. Yang
Published in:
Drugs
|
Issue 12/2013
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Abstract
Flublok® is a trivalent influenza vaccine manufactured using the baculovirus-insect cell system, which has a number of differences compared with the traditional embryonated chicken egg system. Flublok® is the first vaccine containing recombinant protein to be approved for the prevention of seasonal influenza, and is indicated in the USA in adults aged 18–49 years. In a large, placebo-controlled, phase III trial in individuals aged 18–49 years, Flublok® met the US FDA requirements for immunogenicity, effectiveness and safety, despite a high incidence of antigenic mismatch between confirmed cases of influenza and the vaccine component strains. Flublok® was also compared with Fluzone® in two noninferiority trials in older adults aged 50–64 or ≥65 years; although noninferiority was shown for a number of endpoints in these trials, Flublok® is not currently approved in these age groups. Flublok® is a useful and generally well-tolerated vaccination option for the prevention of seasonal influenza in adults aged 18–49 years, including those with egg allergy.