Options for Influenza Vaccine Composition 2005-2006

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Options for Influenza Vaccine Composition
2005-2006

• Roland A. Levandowski, M.D.
• Division of Viral Products

Prepared for Vaccines and Related Biological
Products Advisory Committee 16-17 February 2005
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Options for Influenza A H1N1
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H1N1 Option 1 Retain A/New Caledonia/20/99
PRO MOST RECENT H1 VIRUSES ARE A/NEW
CALEDONIA/20/99-LIKE BY ANTIGENIC
CHARACTERIZATION OF THE HEMAGLUTININ   CURRENT
VACCINES APPEAR TO BE WELL MATCHED TO HA OF
CURRENT STRAINS   MANUFACTURING IS WORKED OUT
AND YIELD IS PREDICTABLE     CON RELATIVELY FEW
RECENT STRAINS FOR ANALYSIS
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H1N1 Option 2 Use a More Recent H1N1 Virus
PRO A MORE RECENT STRAIN MIGHT PROVIDE A CLOSER
MATCH WITH THE HEMAGGLUTININ AND NEURAMINIDASE
OF CONTEMPORARY STRAINS     CON A NEW STRAIN IS
NOT LIKELY TO PROVIDE SUPERIOR IMMUNOGENICITY OR
EFFICACY COMPARED TO CURRENT VACCINE
STRAIN   MANUFACTURING ISSUES FOR NEW STRAINS
HAVE NOT BEEN INVESTIGATED
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H1N1 Option 3 Defer Recommendation
PRO ADDITIONAL ANALYSIS OF CONTEMPORARY STRAINS
MIGHT IDENTIFY A CLOSER MATCH FOR THE
HEMAGGLUTININ AND NEURAMINIDASE OF NEXT YEARS
VACCINE     CON LITTLE NEW INFORMATION APPEARS
FORTHCOMING SINCE H1 VIRUSES ARE CAUSING
RELATIVELY LITTLE DISEASE
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Options for Influenza A H3N2
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H3N2 Option 1 Retain A/Wyoming/03/2003
PRO MANUFACTURING IS WORKED OUT AND YIELD IS
PREDICTABLE CON THE HA OF MOST H3N2 VIRUSES ARE
ANTIGENICALLY DISTINGUISHABLE FROM THE CURRENT
VACCINE STRAIN SEROLOGICAL RESULTS WITH
CURRENT VACCINES INDICATE THAT THE MAJORITY OF
STRAINS ARE POORLY INHIBITED BY ANTISERA FROM
PEOPLE IMMUNIZED WITH THE CURRENT VACCINES
CONTAINING A/WYOMING/03/2003 H3N2 INFLUENZA
VIRUSES ARE OFTEN RESPONSIBLE FOR SIGNIFICANT
MORBIDITY AND MORTALITY
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H3N2 Option 2 Use a More Recent H3N2 Virus
PRO A MORE RECENT STRAIN IS LIKELY TO PROVIDE A
CLOSER MATCH WITH CONTEMPORARY STRAINS
SEROLOGICAL RESULTS WITH CURRENT VACCINES
INDICATES THAT THE MAJORITY OF STRAINS ARE
POORLY INHIBITED BY ANTISERA FROM VACCINES
CONTAINING A/WYOMING/03/2003 H3N2 INFLUENZA
VIRUSES OFTEN CAUSE SIGNIFICANT MORBIDITY AND
MORTALITY CON HIGH GROWTH REASSORTANTS FOR
A/CALIFORNIA/7/2004-LIKE VIRUSES ARE NOT
AVAILABLE, AND YIELD POTENTIAL IS UNDEFINED AT
PRESENT
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H3N2 Option 3 Defer Recommendation
PRO A MORE RECENT STRAIN IS LIKELY TO PROVIDE A
CLOSER MATCH WITH THE HEMAGGLUTININ AND
NEURAMINIDASE OF CONTEMPORARY STRAINS H3N2
INFLUENZA VIRUSES OFTEN CAUSE SIGNIFICANT
MORBIDITY AND MORTALITY CON A GREAT DEAL OF
DATA IS ALREADY AVAILABLE ABOUT H3N2 VIRUSES
CURRENTLY CIRCULATING. THESE DATA ARE NOT
EXPECTED TO BE SIGNIFICANTLY ENHANCED BY IN THE
NEXT FEW WEEKS
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Options for Influenza B
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B Option 1 Retain B/Shanghai/361/2002-like
Viruses
PRO MANUFACTURING IS WELL DEFINED AND
PREDICTABLE THE PREDOMINANT STRAINS ARE IN
THE SAME HA LINEAGE AND HAVE BEEN FOUND IN MANY
PARTS OF THE WORLD   CON INFLUENZA B VIRUSES
NOT IN THE VACCINE HA LINEAGE HAVE INCREASED IN
FREQUENCY AND ARE NOT WELL INHIBITED BY
POST- INFECTION AND POST-IMMUNIZATION ANTISERA,
IN PARTICULAR SERA FROM IMMUNOGLICALLY NAÏVE
YOUNG CHILDREN
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B Option 2 Use a More Recent B Virus
PRO VACCINES MIGHT PROVIDE BETTER COVERAGE FOR
INFLUENZA B VIRUSES   CON A NEW STRAIN MAY NOT
PROVIDE SUPERIOR IMMUNOGENICITY AND EFFICACY
COMPARED TO CURRENT VACCINE STRAIN IT IS NOT
CLEAR THAT THE NON-VACCINE STRAINS WILL INCREASE
IN FREQUENCY AND ARE NOT FOUND IN ALL AREAS OF
THE WORLD NEW INFLUENZA B STRAINS MAY CAUSE
DIFFICULTIES IN MANUFACTURING
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B Option 3 Defer Recommendation
PRO A MORE RECENT STRAIN MIGHT PROVIDE A CLOSER
MATCH WITH THE HEMAGGLUTININ AND NEURAMINIDASE
OF CONTEMPORARY STRAINS   CON A NEW STRAIN MAY
NOT PROVIDE SUPERIOR IMMUNOGENICITY AND EFFICACY
COMPARED TO CURRENT VACCINE STRAIN ADDITIONAL
SIGNIFICANT INFORMATION IS NOT LIKELY TO BE
FORTHCOMING
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Question for Committee Recommendation

• What strains should be recommended for the
  antigenic composition of the 2005-2006 influenza
  virus vaccine?
• Based on
• Epidemiology and antigenic characteristics
• Serologic Responses
• Availability of candidate strains