Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory.

Slides:

Advertisements

Similar presentations

Candidate Vaccine Strains and Potency Reagents for Influenza Season

Advertisements

Duration of Serum Antibody Response to Seasonal Influenza Vaccines: Summary The level of antibody response made to seasonal influenza vaccines depends.

Influenza Vaccine Manufacturing

Candidate Vaccine Strains and Potency Reagents, Season Rajesh K. Gupta, Ph.D. Deputy Director, Division of Product Quality OVRR, CBER, FDA Prepared.

Vaccines and Related Biological Products Advisory Committee 18 February 2009 Topic 2: Considerations and Implications for adding two B Strains to the Seasonal.

INFORMATION FOR THE VACCINE AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA (Seasonal Influenza and Zoonotic Influenza) FEBRUARY 28, 2012.

Influenza-like Illness Visits & Influenza Labs as of December 10, 2012.

Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory.

Lisa Grohskopf, MD, MPH Medical Officer Influenza Division Centers for Disease Control and Prevention U.S. Influenza Surveillance National Center for Immunization.

Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory.

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

National Vaccine Advisory Committee November 29, 2005 Update on NIH H5N1 Vaccine Trials Linda C. Lambert Chief, Respiratory Diseases Branch Division of.

Influenza Vaccine Responses Roland A. Levandowski, M.D. Division of Viral Products Prepared for Vaccines and Related Biological Products Advisory Committee.

Influenza Vaccine Manufacturing Industry perspective for influenza vaccine supply VRBPAC, 27 February 2013 The FDA CBER requested this annual.

Influenza Timothy Wiemken, PhD MPH CIC Assistant Professor Division of Infectious Diseases University of Louisville

Influenza Virus Vaccine Strain Selection Vaccines and Related Biological Products Advisory Committee (2/27/2013) Jerry P. Weir, Ph.D., Director.

Influenza Virus Vaccine Strain Selection Vaccines and Related Biological Products Advisory Committee (2/28/2014) Jerry P. Weir, Ph.D., Director.

INFLUENZA VACCINE Group 1 Zainab Ashfaq Bushra Abbas Ahtasham Danish.

Influenza Vaccine Manufacturing Industry perspective for influenza vaccine supply VRBPAC, 28 February 2012 The FDA CBER requested this annual.

NS 2 Lipid Bilayer NA (Neuraminidase) HA (Hemagglutinin) M 2 (Ion channel) M 1 (Matrix protein) NP (Nucleocapsid) PB1, PB2, PA (Transcriptase complex)

INTRODUCTION TO INFLUENZA The (Ferret) Sneeze Heard Around The World: The Case Of The Bioengineered Bird Flu Case Study for AAC&U STIRS Project Jill M.

INFORMATION FOR THE VACCINE AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA FEBRUARY 22, 2010 Nancy J. Cox, Ph. D Director WHO COLLABORATING.

Influenza Virus Vaccine Strain Selection Vaccines and Related Biological Products Advisory Committee (2/25/2011) Jerry P. Weir, Ph.D., Director.

Martha Thompson, MPH Viral Isolation Team Leader Medical Virology Group Laboratory Services Section TX DSHS Influenza Surveillance Viral Isolation Laboratory.

Pandemic (H1N1) 2009 Influenza Vaccine Manufacturing Considerations Vaccines and Related Biological Products Advisory Committee (7/23/2009) Jerry P. Weir,

Use of Immunogenicity Data to Assess Vaccine Effectiveness Cara R. Fiore, Ph D Microbiologist, Master Reviewer Office of Vaccines Research and Review Center.

Influenza Vaccine Manufacturing Industry Perspective Tony Colegate Novartis Vaccines and Diagnostics Prepared by PhRMA Vaccine Technical Committee for.

VRBPAC 25 February 2011 Influenza Vaccine Manufacturing Industry Perspective for Vaccine Supply.

Influenza Update September 2015

Review and Discussion Time line courtesy of:

“FluBlØk: A Recombinant Hemagglutinin Protein Vaccine for Influenza” Manon Cox VRBPAC February 27, 2007 A Vaccine Company for the 21st Century “Making.

Update on Pandemic Vaccine Development 3 rd WHO WPRO/SEARO NIC Meeting August, 2009, Beijing Masato Tashiro, MD., PhD. Director, WHO Collaborating.

Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products Prepared for Vaccines and Related Biological Products Advisory Committee.

Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory.

Vaccines and Related Biological Products Advisory Committee Meeting July 23, 2009 Pandemic Influenza A (H1N1) Virology Update Nancy Cox, PhD Alexander.

1 Overview of the Division of Viral Products February 28, 2014 VRBPAC Discussion of the August 28, 2013 Site Visit for the Laboratory of Respiratory Viral.

Options for Influenza Vaccine Composition Summary of Data Options with Pros and Cons.

1 Licensure of Pandemic Influenza Vaccines: Demonstration of Effectiveness Vaccines and Related Biological Products Advisory Committee Meeting February.

Ian Barr WHO Collaborating Centre for Reference & Research on Influenza, Melbourne (Now finally re-located at VIDRL) Influenza surveillance in Australia,

INFLUENZA UPDATE DEBBYE ROSEN ADULT IMMUNIZATION COORDINATOR CONNECTICUT DEPARTMENT OF PUBLIC HEALTH

Update on Influenza Virus Surveillance Findings in 2008/09 Season in Northern Hemisphere Who Collaborating Center for Reference and Research on Influenza.

Influenza Virus Vaccine Composition Roland A. Levandowski, M.D. Division of Viral Products Prepared for Vaccines and Related Biological Products.

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER Regulatory Approaches & Activities To Support Licensure of Pandemic (H1N1) 2009 Vaccine.

Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory.

Samar Musmar,MD,FAAFP Vice Dean for Clinical Affairs An-Najah National University Faculty of Medicine Head, Medicine and Society Dep. Flu Vaccination in.

Influenza Activity and Virus Characterizations (Northern Hemisphere) 5thMeeting of NICs in the WPR and SEAR 7-10 June, 2011 Laos Takato Odagiri WHO Collaborating.

Influenza Branch VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA February 16-17, 2005, Bethesda, MD Nancy COX, Ph.D. WHO COLLABORATING.

Vaccines: A Molecular View

1 Influenza activity in the Southern Hemisphere Ian Barr WHO CC for Reference & Research on Influenza Melbourne The Melbourne WHO.

Influenza Virus Vaccine Strain Selection Vaccines and Related Biological Products Advisory Committee (2/22/2010) Jerry P. Weir, Ph.D., Director.

1 IMMUNE CORRELATES OF PROTECTION AGAINST INFLUENZA A VIRUSES IN SUPPORT OF PANDEMIC VACCINE DEVELOPMENT FDA/NIH/WHO Public Workshop, December 10-11, 2007.

Novartis Vaccines - Influenza A H1N1v vaccine development Theodore F Tsai MD MPH July 23, 2009 DHHS supported influenza cell culture vaccine production.

Lisa Grohskopf, MD, MPH U.S. Influenza Surveillance Season National Center for Immunization & Respiratory Diseases Influenza Division U.S. Food.

Influenza Vaccine Responses Roland A. Levandowski, M.D. Division of Viral Products Prepared for Vaccines and Related Biological Products Advisory Committee.

Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products Prepared for Vaccines and Related Biological Products Advisory Committee.

Options for Influenza Vaccine Composition Roland A. Levandowski, M.D. Division of Viral Products Prepared for Vaccines and Related Biological.

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

Microbiology discussion… Virus Vs Bacteria ID / Inspection Techniques.

INFORMATION FOR THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE, CEBR, FDA February 27-28, 2007 WHO COLLABORATING CENTER FOR SURVEILLANCE,

1 Influenza Vaccination 2016 Cluster: Communicable Disease, NDoH.

Vaccination Info. Journal of immunology Vaccination of HCWs was associated with reductions in total patient mortality from 17% to 10% (odds ratio [OR],

Marketing Authorisation & Yearly Licence of Influenza Vaccines - „Mock-up” & Pre-Pandemic Influenza Vaccines Zsuzsanna Pauliny MD

I Introduction to influenza

Influenza Virologic Surveillance and Vaccine Strain Selection Xiyan Xu MD Deputy Director WHO Collaborating Center for Surveillance, Epidemiology and Control.

The State of Communicable Diseases in Indiana

ACIP Recommendations Update for the U.S. Influenza Season

Copyright © 2014 American Medical Association. All rights reserved.

*all p< *all p< SAT0037

CD154 Expression Is Associated with Neutralizing Antibody Titer Levels Postinfluenza Vaccination in Stem Cell Transplant Patients and Healthy Adults

J. -H. Lin, S. -C. Chiu, J. -C. Cheng, H. -W. Chang, K. -L. Hsiao, Y

Presentation transcript:

Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory Committee 28 February 2012

Inactivated Vaccine Serology Studies l Recent A(H1N1)pdm09, A(H3N2) and B isolates were analyzed by using 5 panels of sera from adults, 5 panels from elderly and 2 panels from pediatric populations receiving seasonal trivalent inactivated vaccine ( formulation). l Sera were analyzed for the presence of antibodies to the HA antigens of recent virus isolates –Hemagglutination inhibition (HI) titers for recent isolates were compared to HI titer of the vaccine virus by HI assay –A subset of sera were tested by micro-neutralization assay 2

Serum panels used for studies: seasonal trivalent vaccine AUSTRALIAA/California/7/2009 (H1N1pdm09) (NYMC X-181) A/Victoria/210/2009 (H3N2) (NYMC X-187) B/Brisbane/60/2008 (Victoria lineage) CHINA EUROPE JAPAN USA ADULTS OLDER ADULTS CHILDREN (12-60 Mon)) ADULTS OLDER ADULTS ADULTS OLDER ADULTS ADULTS OLDER ADULTS CHILDREN (6-24 Mon) ADULTS OLDER ADULTS A/California/7/2009 (H1N1pdm09)-like A/Victoria/210/2009 (H3N2)-like B/Brisbane/60/2008 (Victoria lineage) A/California/7/2009 (H1N1pdm09) (NYMC X-181) A/Victoria/210/2009 (H3N2) (NYMC X-187) B/Brisbane/60/2008 (Victoria lineage) A/California/7/2009 (H1N1pdm09) (NYMC X-179A) A/Victoria/210/2009 (H3N2) (NYMC X-187) B/Brisbane/60/2008 (Victoria lineage)

Antigens for serology: A(H1N1)pdm09 VACCINE VIRUS A/California/7/2009-like REPRESENTATIVE CURRENT VIRUSES A/Cape Town/60/2011 A/Valparaiso/17275/2011 A/Wisconsin/26/2011 cell A/Perth/533/2011 A/St. Petersburg/100/2011 A/Argentina/656/2011 cell A/Florida/27/2011

HI ANTIBODY RESPONSES TO THE A(H1N1)pdm09 COMPONENT (% GMT)–Example: Older Adults Trial No. of Sera Virus strain pre- vacc GMT Post-vacc GMT Post-vacc GMT reduction (%) Older Adults EU 24A/California/7/ A/St. Petersburg/100/ A/Cape Town/60/ A/Valparaiso/ A/Aigentina/656/ Older Adults US 24A/California/7/ A/St. Petersburg/100/ A/Cape Town/60/ A/Valparaiso/ A/Aigentina/656/ Data from CBER

HI ANTIBODY RESPONSES TO THE A(H1N1)pdm09 COMPONENT – SUMMARY OF DATA FROM ALL LABORATORIES relative GMT

Antigens for serology: A(H3N2) VACCINE VIRUS A/Perth/16/2009-like REPRESENTATIVE CURRENT VIRUSES A/Victoria/361/2011 egg; group 3 A/Hunan-Yueyanglou/1320/2011cell; group 3 A/Hunan-Suxian/1319/2011cell; group 3 A/Utah/12/2011cell; group 3 A/Chiang Rai/277/2011cell; group 3 A/Kobe/241/2011cell; group 3 A/Bangladesh/5071/2011cell; group 3 A/South Australia/03/2011cell; group 3 A/Guangdong-Jinping/1334/2011cell; group 6 A/Brisbane/299/2011egg; group 6 A/Christchurch/28/2011 egg; group 6 A/Kentucky/5/2011cell; group 6 A/Victoria/362/2011egg; group 6

HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT –Example: Older Adults Trial No. of Sera Virus strain pre- vacc GM T Post-vacc GMT Post-vacc GMT reduction (%) Older Adults China 30A/Victoria/210/ A/Brisbane/299/ A/Christchurch/28/ A/Kentucky/5/ A/Victoria/361/ A/Victoria/362/ All viruses47 Older Adults Australia 20A/Victoria/210/ A/Brisbane/299/ A/Christchurch/28/ A/Kentucky/5/ A/Victoria/361/ A/Victoria/362/ All viruses52 Data from NIBSC

HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT – SUMMARY OF DATA FROM ALL LABORATORIES relative GMT

HI ANTIBODY RESPONSES TO THE A(H3N2) COMPONENT –GMT ratio plots Data from NIBSC

Antigens for serology: B VACCINE VIRUS B/Brisbane/60/2008 (Vic-lineage) REPRESENTATIVE CURRENT VIRUSES Vic-lineage B/Dominican Republic/5486/2011 B/Hong Kong/767/2011 B/Nevada/3/2011 B/Shanghai-Chongming/1458/2011 B/Chongqing-Yuzhong/1651/2011 B/Cameroon/11V-12080GVF1/2011 B/Tokyo/91107/2011 Yamagata-lineage B/Wisconsin/1/2010 B/Texas/6/2011 B/Jiangsu-Tianning/1470/2011

HI ANTIBODY RESPONSES TO THE B COMPONENT –Example: Younger Adults Data from CDC PopulationNAntigen Pre GMTPost GMT AUSTRALIA24B/BRISBANE/60/ B/NEVADA/03/ B/DOMINICAN REPUBLIC/5486/ B/CHONGQING-YUZHONG/1651/ B/WISCONSIN/1/ US24B/BRISBANE/60/ B/NEVADA/03/ B/DOMINICAN REPUBLIC/5486/ B/CHONGQING-YUZHONG/1651/ B/WISCONSIN/1/ JAPAN29B/BRISBANE/60/ B/NEVADA/03/ B/DOMINICAN REPUBLIC/5486/ B/CHONGQING-YUZHONG/1651/ B/WISCONSIN/1/

HI ANTIBODY RESPONSES TO THE B COMPONENT - SUMMARY OF DATA FROM ALL LABORATORIES relative GMT

Summary l H1N1pdm09 – Representative recent A(H1N1)pdm09 viruses were covered by vaccine containing A/California/7/2009 l H3N2 – Many representative recent (H3N2) viruses showed significant reductions in GMT when tested with sera from recipients of vaccine containing A/Perth/16/2009-like viruses l B – B/VICTORIA/2/87-lineage Representative recent viruses were well covered by current vaccine (B/Brisbane/60/2008) – B/YAMAGATA/16/88-lineage Representative recent viruses were less well covered by the latest vaccine (B/Florida/4/2006-like viruses, 2008/2009 influenza season)