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

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.
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.
Adriana Weinberg, MD University of Colorado Denver.
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. Surveillance Update Anthony Fiore, MD, MPH CAPT, USPHS Influenza Division National Center for Immunizations and Respiratory Disease Centers for Disease.
Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory.
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 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 Manufacturing Industry perspective for influenza vaccine supply VRBPAC, 28 February 2012 The FDA CBER requested this annual.
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,
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.
Influenza Branch Division of Viral and Rickettsial Diseases National Center for Infectious Diseases Centers for Disease Control and Prevention Atlanta,
Food and Drug Administration
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.
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE USPHS INFLUENZA VIRUS VACCINE STRAIN SELECTION
Antigenic Shift v. Drift in Avian and Mammalian Sino- Influenza Type A Viruses. By Charles Hauser, St. Edward’s University Mark Maloney, Spelman College.
Influenza Influenza Virus magnified 100,000X. What is Influenza? Virus; causes chills, fever, sore throat, fatigue.
Options for Influenza Vaccine Composition Summary of Data Options with Pros and Cons.
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (Q-Pan H5N1 Vaccine) Manufactured by GlaxoSmithKline Vaccines and Related Biological Products Advisory.
1 Approaches to Demonstrate Effectiveness of Vaccines for Prevention of Group B Meningococcal Disease Introduction Vaccines and Related Biological Products.
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 H1N1 Introduction. What is Influenza A H1N1?  Influenza virus  Family Orthomyxoviridae  2 important surface proteins  Haemagglutinin (H)
John R. LaMontagne Memorial Symposium on Pandemic Influenza Research April 4-5, 2005 Institute of Medicine Working Group Five: Immunology, Assay Standardization,
Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory.
Influenza A (H1N1) Vaccine Vaccines and Related Biological Products Advisory Committee Meeting, 23 July 2009 Raburn Mallory, M.D. Proprietary Vaccines.
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 Branch VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA February 16-17, 2005, Bethesda, MD Nancy COX, Ph.D. WHO COLLABORATING.
Update on Surveillance for Influenza Viruses with Pandemic Potential and Candidate Vaccine Viruses Nancy Cox, PhD CDC.
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 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.
DoD Global Influenza Surveillance Program Sentinel Site Surveillance at AFIOH Sequence Analysis And Vaccine Effectiveness Overview Luke T. Daum, PhD, Molecular.
STATUS OF CANDIDATE VACCINE STRAINS AND POTENCY REAGENTS Zhiping Ye, M.D., Ph.D. FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH.
INFORMATION FOR THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE, CEBR, FDA February 27-28, 2007 WHO COLLABORATING CENTER FOR SURVEILLANCE,
1 Vaccines and Related Biological Products Advisory Committee Meeting FluBlok ® : Influenza Vaccine, Recombinant Hemagglutinin Applicant: Protein Sciences.
Carol Friedman, D.O. Associate Director for Adult Immunization Immunization Services Division National Center for Immunization and Respiratory Diseases.
Marketing Authorisation & Yearly Licence of Influenza Vaccines - „Mock-up” & Pre-Pandemic Influenza Vaccines Zsuzsanna Pauliny MD
1 Immune Responses of Healthy Subjects to a Single Dose of Intramuscular Inactivated Influenza A/Vietnam/1203/2004 (H5N1) Vaccine After Priming With an.
Influenza Virologic Surveillance and Vaccine Strain Selection Xiyan Xu MD Deputy Director WHO Collaborating Center for Surveillance, Epidemiology and Control.
ACIP Recommendations Update for the U.S. Influenza Season
Copyright © 2014 American Medical Association. All rights reserved.
Invest. Ophthalmol. Vis. Sci ;50(11): doi: /iovs Figure Legend:
Recommended Timeline for Influenza Vaccinations
KEY CONCEPT Some viral diseases can be prevented with vaccines.
Planning for Pandemic Influenza
J. -H. Lin, S. -C. Chiu, J. -C. Cheng, H. -W. Chang, K. -L. Hsiao, Y
KEY CONCEPT Some viral diseases can be prevented with vaccines.
KEY CONCEPT Some viral diseases can be prevented with vaccines.
RTA-specific serum IgG antibody titers and TNA in mice immunized with RiVax or RVEc. RTA-specific serum IgG titers after the second (A) or third (B) immunizations.
Presentation transcript:

Influenza Vaccine Responses Roland A. Levandowski, M.D. Division of Viral Products Prepared for Vaccines and Related Biological Products Advisory Committee February 2005

1. ALAN HAMPSONADULTA/NEW CALEDONIA/20/99-LIKE (H1N1) WHO, AUSTRALIAELDERA/WYOMING/3/2003 (H3N2) B/BRISBANE/32/ JOHN WOOD, PH.DADULTA/NEW CALEDONIA/20/99 (H1N1) NIBSC, ENGLANDELDERA/WYOMING/3/2003 (H3N2) B/JIANGSU/10/ TAKATO ODIGARI, PH.D. ADULTA/NEW CALEDONIA/20/99-LIKE (H1N1) WHO, JAPANELDERA/WYOMING/3/2003 (H3N2) B/SHANGHAI/361/2003 Serum Panels for Serologies

4. STEFAN GRAVENSTEIN, M.D.ADULTA/NEW CALEDONIA/20/99 (H1N1) EASTERN VIRGINIA ELDERA/WYOMING/3/2003 (H3N2) MEDICAL SCHOOLCHILDB/JIANGSU/10/ WILLIAM KOCH, M.D.CHILDA/NEW CALEDONIA/20/99 (H1N1) VIRGINIA COMMONWEALTHA/WYOMING/3/2003 UNIVERSITYB/JIANGSU/10/2003

ANTIGENS FOR SEROLOGIES (H1) VACCINE STRAIN A/NEW CALEDONIA/20/99 (H1N1) REPRESENTATIVE CURRENT STRAINS A/BANGKOK/1544/2004 (H1N1) A/FLORIDA/4/2004 (H1N1) A/NETHERLANDS/128/2004 (H1N1) A/NEW CALEDONIA/9/2004 (H1N1) A/OKINAWA/42/2004 (H1N1) A/SAITAMA/78/2004 (H1N1) A/SINGAPORE/14/2004 (H1N1)

HI ANTIBODY RESPONSES TO THE H1 COMPONENT INFLUENZA VACCINE ADULT POPULATION (CBER)

HI ANTIBODY RESPONSES TO THE H1 COMPONENT INFLUENZA VACCINE ELDERLY POPULATION (NIBSC)

HI ANTIBODY RESPONSES TO THE H1 COMPONENT INFLUENZA VACCINE PEDIATRIC POPULATION (CDC AND CBER)

A/NEW CALEDONIA/20/99 VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION

ANTIGENS FOR SEROLOGIES (H3) VACCINE STRAIN A/WYOMING/3/2003 REPRESENTATIVE CURRENT STRAINS A/BANGKOK/1563/2004 A/CALIFORNIA/7/2004 A/OSAKA/36/2004 A/OSLO/8/2004 A/SHANTOU/1219/2004 A/SINGAPORE/36/2004 A/SINGAPORE/37/2004 A/TENNESSEE/6/2004 A/TOKYO/1035/2004 A/VICTORIA/523/2004

HI ANTIBODY RESPONSES TO THE H3 COMPONENT INFLUENZA VACCINE ADULT POPULATION ( CDC )

HI ANTIBODY RESPONSES TO THE H3 COMPONENT INFLUENZA VACCINE ELDERLY POPULATION (NIBSC)

HI ANTIBODY RESPONSES TO THE H3 COMPONENT INFLUENZA VACCINE PEDIATRIC POPULATION (CDC AND CBER)

A/WYOMING/3/2003 VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION

ANTIGENS FOR SEROLOGIES (B) VACCINE STRAIN B/BRISBANE/32/2002* B/JIANGSU/10/2003+ REPRESENTATIVE CURRENT STRAINS B/HAWAII/13/2004* B/PHITSANULOK/2053/2004* B/COLORADO/4/2004+ B/FLORIDA/7/2004+ B/FUJIAN/430/2004+ * = HONG KONG/330-LIKE B/LISBON/1/ = SHANGHAI/361-LIKE B/SHIZUOKA/2/2004+ B/SHIZUOKA/58/2004+ B/VICTORIA/501/2004+

HI ANTIBODY RESPONSES TO THE B COMPONENT INFLUENZA VACCINE ADULT POPULATION (CDC)

HI ANTIBODY RESPONSES TO THE B COMPONENT INFLUENZA VACCINE ELDERLY POPULATION (AUS)

HI ANTIBODY RESPONSES TO THE B COMPONENT INFLUENZA VACCINE PEDIATRIC POPULATION (CDC AND CBER)

B/SHANGHAI/361/2002-LIKE VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION

Influenza Vaccine Responses Summary Studies with sera collected after immunization with current vaccines show that: Representative influenza A (H1N1) viruses are well-inhibited A/California/7/2004 (H3N2)-like viruses are poorly inhibited compared to the vaccine strain B/Shanghai/361/2002-like viruses are reasonably well-inhibited but B/Hong Kong/330/2001-like viruses are less well inhibited than the vaccine strains