Burst CME: Regulatory Approval Pathways for Influenza Vaccines

Target Audience
This educational activity is directed toward geriatricians, primary care physicians, infectious disease physicians, internal medicine physicians, nurse practitioners, physician assistants, and nurses who manage older patients at risk for influenza.

Program Overview
This Burst CME: Regulatory Approval Pathways for Influenza Vaccines is an interview-based program in which an expert discusses the regulatory pathways for approval of influenza vaccines by the FDA. Licensure from the FDA of seasonal inactivated influenza vaccines may be sought through the submission of an application by means of either a traditional or accelerated pathway. To meet approval criteria with the traditional pathway, a manufacturer must demonstrate vaccine effectiveness against influenza in a randomized controlled trial that evaluates influenza illness as a primary end point. In contrast, the accelerated approval pathway for seasonal influenza vaccines may be preferred when a shortage of influenza vaccines exists in the US market. Accelerated approvals are based on adequate and well-controlled clinical trials establishing that a biologic product has an effect on a surrogate end point (eg, immunogenicity). Knowledge of the approval pathways for influenza vaccines helps clinicians to select vaccines and counsel their patients regarding vaccination against influenza.

Learning Objectives
Upon completion of this activity, participants should be better able to:
Define regulatory approval pathways for the licensure of influenza vaccines in the United States