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Oct 8, 2025

Oct 8, 2025

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FDA VRBPAC Meeting | Oct. 9, 2025

*The opinions expressed by the hosts and guests in this show are not necessarily the views of Children’s Health Defense.

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Resources

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Briefing Document- FDA- Topic II: Advancing CBER's Allergen Extract Standardization Program

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Briefing Document- Global Links

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Draft Agenda

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Draft Roster

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Final Agenda

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Presentation- Approaches to Allergen Standardization Related to Dust Mites: FDA Guest Speaker

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Presentation- Global Seasonal Influenza Virus Surveillance and Characterization: CDC Speaker

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Presentation- Industry Perspective from the Allergen Products Manufacturers’ Association: APMA Organizational Speaker

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Presentation- Influenza Virus Vaccine Strain Selection– 2026 Southern Hemisphere Formula

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Presentation- Introduction

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Presentation- Part I: Enzyme-linked monoclonal antibody and aptamer-based assays

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Presentation- Part II: Standardizing and advancing complex allergen extracts with tandem mass spectrometry

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Voting Questions- Session 1

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Voting Questions- Session 2

Vaccines and Related Biological Products Advisory Committee October 9, 2025 Meeting Waivers for Conflicts of Interest

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‘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

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