FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

VRBPAC

Committee Discussion Questions

February 20, 2003

Session 1

1. What strains should be recommended for the antigenic composition of the 2003-2004 inactivated influenza virus vaccine based on:

1) the epidemiology and antigenic characteristics of influenza virus strains circulating in human populations,

2) the serologic responses to circulating influenza viruses of persons immunized with current influenza virus vaccines, and

3) the availability of suitable vaccine candidate strains?

FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

VRBPAC

Committee Discussion Questions

February 20, 2003

Session 2

2. Do you concur with the recommendations of the Site Visit Team?

If not why?