Seasonal Vaccine Manufacturing

By Elizabeth Joseph

The production of seasonal vaccines, particularly those for influenza, poses unique challenges for manufacturers due to the strict time constraints associated with annual strain selection. The development timeline for a seasonal influenza vaccine begins each March with a meeting of an FDA advisory committee, which determines the strains to be included in the upcoming season's vaccine. Following this decision, manufacturers must produce, release, and distribute the vaccine to pharmacies, clinics, and physician offices within a tight timeframe of as little as six months.

This limited period between strain selection and distribution often forces vaccine producers to depend heavily on outsourcing partners to meet production and supply deadlines effectively. As a result, the seasonal influenza vaccine market is anticipated to exceed $4 billion USD by the end of 2022. Given this substantial market growth, it is reasonable to predict that as the demand for seasonal influenza vaccines increases, so too will the need for contract manufacturing organizations (CMOs) to facilitate efficient and timely production.