1. STATUS OF CANDIDATE VACCINE STRAINS AND POTENCY REAGENTS Zhiping Ye, M.D., Ph.D. FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH February 16, 2005

2. Current VaccineReassortantGrowth A/New Caledonia/20/99 IVR-116 Mod/high Candidate Strains: No new antigenically divergent strains available INFLUENZA A (H1N1) VIRUSES

3. Current VaccineReassortantGrowth A/Wyoming/03/03 NYMC-X-147 High NYMC-X-149 IVR-134 Candidate Strains: A/Wellington/01/04* RESVIR-20Mod/High IVR-139 Mod/High NYMC-X-155Mod/High * Recommended for Southern hemisphere in the 2005 season INFLUENZA A (H3N2) VIRUSES

4. A/California/7/04-like Candidate Strains: Egg-isolate ResassortantGrowth in Eggs A/Singapore/37/04IVR-140Mod A/New York/55/04N/A Mod A/California/7/04N/ALow A/Wisconsin/19/04N/A Low A/New York/40/04N/A No/Low A/North Dakota /01/04N/A No/Low A/Washington/01/04 N/ANo/Low INFLUENZA A (H3N2) VIRUSES-Cont.

5. Laboratories Preparing A/California/7/04-like Candidates 1) Center for Biologics Evaluation and Research - US 2) Centers for Disease Control and Prevention - US 3) New York Medical College - US 4) National Institute for Biological Standards and Control - UK 5) CSL- Australia 6) National Institute Infectious Diseases - Japan INFLUENZA A (H3N2) VIRUSES-Cont.

6. Current vaccines: Growth (B/Shanghai/361/02-like =Yamagata lineage ) B/Shanghai/361/02Moderate B/Jilin/20/03Moderate B/Jiangsu/10/03 Moderate Candidate Strains: No new antigenically divergent strains currently under evaluation INFLUENZA B VIRUSES

7. Reagents Currently Available for Type A: H1N1: A/New Caledonia/20/99 H3N2: A/Wyoming/03/03 If new strains are chosen, reagents will be available in May at the earliest. POTENCY REAGENTS

8. Reagents Currently Available for Type B: B/Shanghai/361/02-like (Yamagata lineage): B/Jiangsu/10/03 B/Hong Kong/330/01-like (Victoria lineage): B/Hong Kong/330/01 B/Hong Kong/1434/02 B/Shandong/07/97 If new strains are chosen, reagents will be available in May at the earliest. POTENCY REAGENTS