INFLUENZA VACCINE SHORTAGES COULD BE MITIGATED BY APPLYING REGULATORY HARMONIZATION

Abstract

Seasonal and pandemic influenza vaccine shortages continue to occur despite regulatory agency recommendations and manufacturers' awareness. To achieve the public health goal of protecting the human population against seasonal influenza, vaccines will have to be produced more efficiently and with a broader target in order to manufacture sufficient quantities of a safe and efficacious product to meet increasing demands. To evaluate the current problem areas in the influenza vaccine industry, manufacturing malfunctions were researched and analyzed, guidance documents for the industry were highlighted, regulatory processes were researched and analyzed, and new and future influenza vaccine technologies were evaluated. In order to mitigate influenza vaccine shortages, manufacturing companies and regulatory agencies can work together to achieve regulatory harmonization as defined by the ideals of the International Conference on Harmonization (ICH). Harmonization of technical guidelines and requirements, refining duplicate testing procedures, newly developed technologies and dialogue between authorities, the influenza vaccine industry can successfully mitigate vaccine shortages.