Options for Influenza Vaccine Composition 2004-2005

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Options for Influenza Vaccine Composition
2004-2005

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

Prepared for Vaccines and Related Biological
Products Advisory Committee 18-19 February 2004
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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/Panama/2007/99
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 INDICATES THAT THE MAJORITY OF
STRAINS ARE NOT WELL INHIBITED BY ANTISERA FROM
PEOPLE IMMUNIZED WITH THE CURRENT VACCINES
CONTAINING A/PANAMA/2007/99 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 MIGHT PROVIDE A CLOSER
MATCH WITH THE HEMAGGLUTININ AND NEURAMINIDASE
OF CONTEMPORARY STRAINS HIGH GROWTH
REASSORTANTS FOR A/FUJIAN/411/2002- LIKE VIRUSES
ARE AVAILABLE FOR MANUFACTURING AND APPEAR TO
GIVE MODERATE TO HIGH YIELD H3N2 INFLUENZA
VIRUSES OFTEN RESPONSIBLE FOR SIGNIFICANT
MORBIDITY AND MORTALITY CON A NEW STRAIN MAY
NOT PROVIDE SUPERIOR IMMUNOGENICITY OR EFFICACY
COMPARED TO CURRENT VACCINE STRAIN
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H3N2 Option 3 Defer Recommendation
PRO A MORE RECENT STRAIN MIGHT PROVIDE A CLOSER
MATCH WITH THE HEMAGGLUTININ AND NEURAMINIDASE
OF CONTEMPORARY STRAINS H3N2 INFLUENZA VIRUSES
OFTEN RESPONSIBLE FOR SIGNIFICANT MORBIDITY AND
MORTALITY CON A GREAT DEAL OF DATA IS ALREADY
AVAILABLE ABOUT H3N2 VIRUSES CURRENTLY
CIRCULATING DUE TO THE EARLY INFLUENZA SEASON.
THESE DATA ARE NOT EXPECTED TO BE SIGNIFICANTLY
ENHANCED BY ADDITIONAL DATA EXPECTED IN THE NEXT
FEW WEEKS A NEW STRAIN MAY NOT PROVIDE SUPERIOR
IMMUNOGENICITY AND EFFICACY COMPARED TO CURRENT
VACCINE STRAIN
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Options for Influenza B
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B Option 1 Retain B/Hong Kong/330/01-like
Viruses
PRO MANUFACTURING IS WELL DEFINED AND
PREDICTABLE   CON THE PREDOMINANT STRAINS ARE
NOT IN THE SAME HA LINEAGE AND HAVE BEEN FOUND
IN RECENT MONTHS IN MANY PARTS OF THE WORLD
INFLUENZA B VIRUSES NOT IN THE VACCINE HA
LINEAGE, ARE NOT WELL INHIBITED BY
POST- INFECTION AND POST-IMMUNIZATION ANTISERA,
AND IN PARTICULAR SERA FROM IMMUNOGLICALLY
NAÏVE YOUNG CHILDREN DO NOT INHIBIT THESE
VIRUSES WELL
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B Option 2 Use a More Recent B Virus
PRO VACCINES MIGHT PROVIDE BETTER COVERAGE FOR
CURRENT INFLUENZA B VIRUSES SEVERAL CANDIDATE
STRAINS HAVE BEEN IDENTIFIED AND ARE BEING
EXAMINED FOR SUITABILITY BY MANUFACTURERS
  CON A NEW STRAIN MAY NOT PROVIDE SUPERIOR
IMMUNOGENICITY AND EFFICACY COMPARED TO CURRENT
VACCINE STRAIN NEW INFLUENZA B STRAINS MAY
CAUSE DIFFICULTIES IN MANUFACTURING
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B Option 3 Defer Recommendation
PRO WOULD ALSO PROVIDE MORE TIME TO EVALUATE
CANDIDATE VACCINE STRAINS 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
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Question for Committee Recommendation

• What strains should be recommended for the
  antigenic composition of the 2004-2005 influenza
  virus vaccine?
• Based on
• Epidemiology and antigenic characteristics
• Serologic Responses
• Availability of candidate strains