FDA VRBPAC Meeting | Oct. 9, 2025

‘On October 8, 2025, the Committee will meet in open session to discuss and make recommendations on the following separate topics. Under Topic I, the Committee will discuss and make recommendations on the strain selection for the influenza virus vaccines for the 2026 Southern Hemisphere influenza season. Under Topic II, the Committee will discuss and make recommendations on advancing CBER’s allergen standardization program.’

Agenda (in Eastern Time):

• 8:30am — Opening Remarks: Call to Order and Welcome, Administrative Announcements, Roll Call, Introduction of Committee, Conflict of Interest Statement
• 8:50am — Open Public Hearing
• 8:55am — Introduction to VRBPAC Meeting Topics
• 9:05am — Introduction to Seasonal Influenza Vaccine Strain Selection Southern Hemisphere 2026
• 9:20am — CDC: Global Seasonal Influenza Virus Surveillance and Characterization
• 10:20am — Break
• 10:30am — Committee Discussion, Recommendations and Voting
• 11:30am — Break
• 12:00pm — Call to Order
• 12:05pm — OPH
• 12:10pm — Replacement of Radial Immunodiffusion (RID) Assays of Currently Standardized Extracts with ELISA or Aptamer-based Enzymatic Assays
• 12:55pm — Use of Tandem LC/MS/MS to Measure Potencies of Complex Extracts with Multiple "Major Allergens," Use of HDM Bodies and Fecal Pellets as Source Materials for HDM Extracts
• 1:45pm — Approaches to Allergen Standardization Related to Dust Mites
• 2:25pm — Industry Perspective from the Allergen Products Manufacturers' Association (APMA)
• 2:55pm — Break
• 3:05pm — Committee Discussion, Recommendations and Voting
• 5:05pm — Adjourn