STATUS OF CANDIDATE VACCINE STRAINS AND POTENCY REAGENTS

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STATUS OF CANDIDATE VACCINE STRAINS AND POTENCY
REAGENTS

• Zhiping Ye, M.D., Ph.D.
• Food And Drug Administration
• Center For Biologics Evaluation And Research

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INFLUENZA A (H1N1) STRAIN

• Current vaccine Reassortant
  Growth
• A/New Caledonia/20/99 IVR-116 Mod/high
• Candidate strain
• No new antigenically divergent strains

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INFLUENZA A (H3N2) STRAIN

• Current vaccine Reassortant Growth
• A/Moscow/10/99-like
• -A/Panama/2007/99 Resvir-17 Mod/high
• Candidate strain
• No new antigenically divergent strains.

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INFLUENZA B STRAINS

• Current vaccine strains Growth
• B/Sichuan/379/99-like
• -B/Johannesburg/5/99 Low
• -B/Victoria/504/2000 Moderate
• -B/Guangdong/120/2000 Moderate
• B/Yamagata/16/88 hemagglutinin lineage

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INFLUENZA B STRAINS-(Cont)

• Candidate strains
• B/Yamagata/16/88-like
• B/Shizuoka/15/2001 Low/Moderate
• B/Sichuan/317/2001 Moderate
• B/Beijing/243/97-like
• B/Hong Kong/330/2001 Low
• B/Hawaii/22/2001 Low
• B/Shangdong/07/97 Moderate
• Previously used for vaccines in Asia 1999-2000

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POTENCY REAGENTS

• Reagents Currently Available for Type A
• H1N1 -A/New Caledonia/20/99
• H3N2 -A/Panama/2007/99
• Candidate Strains
• If new strains are chosen, reagents will be
  available in May at the earliest.

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POTENCY REAGENTS-(Cont)

• Reagents Currently Available for Type B
• B/Yamagata/16/88-like
• -B/Victoria/504/2000
• -B/Guangdong/120/2000
• -B/Johannesburg/5/99
• B/Beijing/243/97-like
• -B/Shangdong/07/97
• Antiserum CBER/ antigen NIBSC
• Antiserum/antigen NIBSC

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POTENCY REAGENTS-(Cont)

• Candidate Strains
• If new strains are chosen, reagents will be
  available in May at the earliest.