The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting from annual strain selection. The timeline for development of a seasonal influenza vaccine starts with a meeting by an FDA advisory committee in March1 to decide which strains to include in the next season’s vaccine which in turn must be produced, released, and distributed to pharmacies, clinics, and physician offices in as little as 6 months. The limited time span from strain selection to distribution requires most vaccine producers to rely on outsourcing partners to ensure timely production and supply.
