Candidate Vaccine Strains and Potency Reagents for 2014-15 Influenza SeasonCandidate Vaccine Strains and Potency Reagents for 2014-15 Influenza Season

Division of Biological Standards & Quality Control Laboratory of Biochemistry, Virology & Immunochemistry

OCBQ, CBER, FDA

Manju Joshi

Prepared forVaccines and Related Biological Products

Advisory Committee28 February 2014

Influenza A (H1N1)

• Current Vaccine Strain (2013–14 Season) : A/California/7/2009 (H1N1)pdm09-like virus– Reassortants X179A; X181and NIB-74

• WHO Recommended Strain for 2014–15: an A/California/7/2009 (H1N1)pdm09-like virus– No change from 2013–14 Strain

CBER Authorized Reagents for H1N1

• CBER Reference Antigen – For Egg Derived

• X-179A CBER Reference Antigen (Lot 69) (low inventory).• X-179A CBER New Reference Antigen (Lot 76: under calibration)*• X-181 CBER Reference Antigen (Lot H1-Ag-1107)• X-181 Reference Antigen from TGA* • NIB-74: Reference Antigen from NIBSC*

– For Cell Derived • A/Brisbane/10/2010 (Cell Derived): Reference Antigen from

NIBSC

• CBER Antibodies • New lots: H1-Ab-1304 and H1-Ab-1305*(CBER approval of these reagents: case by case basis)

Influenza A (H3N2)

• Current Vaccine Strain (2013–14 Season) : A (H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011 – A/Texas/50/2012 (reassortants X-223 and X-223 A)

• WHO Recommended Strain for 2014–15: A/Texas/50/2012 (H3N2)-like virus– same as 2013-14 recommendation

CBER Authorized Reagents for H3N2

• CBER Reference Antigen – For Egg Derived

• X-223A CBER Reference Antigen (Lot 75)• X-223 CBER Reference Antigen (Lot H3-Ag-1308)• X-223 Reference Antigen: From NIBSC and NIID*

*(CBER approval of these reagents: case by case basis)

– For Cell Derived • X-223A CBER Reference Antigen (Lot H3-Ag-1312)

• CBER Antibodies • New lots: H3-Ab-1314, H3-Ab-1318 and H3-Ab-1319

Influenza B

• Current Vaccine Strain (2013–14 Season): Yamagata lineage-B/Massachusetts/2/2012-like Virus

– B/Massachusetts/2/2012 (Wt and Reassortant BX-51B)

• WHO Recommended Strain for 2014–15: Yamagata lineage-B/Massachusetts/2/2012-like Virus

– No change from 2013–14 Strain

CBER Authorized Reagents for B-strain (Yamagata Lineage)

• CBER Reference Antigen – For Egg Derived

• Wild Type CBER Reference Antigen (Lot 74)• BX-51B CBER Reference Antigen (Lots B(y)-Ag-1309 & B(y)-Ag-

1311)• BX-51B-Reference Antigen: From NIBSC and TGA*

*(CBER approval of these reagents: case by case basis)

– For Cell Derived • Wild Type CBER Reference Antigen (Lot B(y)-Ag-1313)

• CBER Antibodies • New lots: B(y)-Ab-1315; B(y)-Ab-1316; B(y)-Ab-1321 & B(y)-Ab-

1323

Influenza B for Quadrivalent Formulations (2nd B-Strain)

• WHO Recommended Second B Strain (2013-14 Season): Victoria lineage-B/Brisbane/60/2008-like Viruses.

• WHO Recommended Second B Strain for 2014-15: Victoria-lineage-B/Brisbane/60/2008-like Viruses– No Change from 2013-14 Season

CBER Authorized Reagents for 2nd B-strain (Victoria Lineage)

• CBER Reference Antigen • CBER Reference Antigen (Lot 68): previously used however inventory has

been depleted• CBER New Reference Antigen (Lot 77: under calibration)*

• CBER Antibodies • Lot B-Ab-1108 (previously used).• New Lots: B-Ab-1215 & B-Ab-1216 will be made available

• Use of Reference Antigen• Use of mixture of Reference Antigens for testing of both B Strains in

Quadrivalent Vaccine.• Correction Factors with use of specific Reference Antigens are

not recommended

(CBER authorized the use of Antibody Reagents from NIBSC and TGA under special circumstances to gain specificity in quadrivalent testing. Consult with CBER)

Challenges in Production of SRID Reagents

• Challenges due to selection of multiple reassortant/strains and production of vaccine in different platforms.

• Homologous Reference Antigen is optimal and preferred; Heterologous Antibodies may be acceptable.

• If it is not feasible to prepare and calibrate a homologous reagent in the short time frame heterologous reagents may be an option.

• Performance of heterologous reagents for use in combination with a particular product need to be evaluated.

• The performance of heterologous reagents need to be verified and authorized by CBER.

• CBER will work to re-calibrate a heterologous reference antigen if necessary.

CBER Influenza Potency Reagents Summary ….1

• CBER authorized reagents should be used to test potency of vaccines marketed in the US.

• Authorized reagents are either produced by CBER or adopted by CBER for use.

• CBER collaborates with other ERLs in calibration of adopted reagents.

• CBER will verify availability and acceptable performance of compatible authorized reagents.

• The use of reference antigen and reference antiserum (as a calibrated pair) from same source is desirable to avoid discrepancies.

CBER Influenza Potency ReagentsSummary….2

• Use of same reagents for Monovalent, Trivalent/ Quadrivalent formulations (and follow-up stability studies) for a particular lot is desirable.

• To confirm Identity of B-strains in Quadrivalent Vaccine: Mono-specific or minimally cross reactive antibodies either developed by CBER or Authorized by CBER are recommended (consult with CBER to receive appropriate Lot)

• CBER will make every effort to assure timely availability of reagents appropriate for selected vaccine strains.

• The reagent lots (sp. antisera) may change from those provided last year. Please communicate with CBER and let us know if you have any problem with reagents.

Thank You