Vaccines and Related Biological Products

Slides:

Advertisements

Similar presentations

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

Advertisements

0 HHS Influenza Vaccine Projects for NVAC Meeting June 7-8, 2005 By: Dr. Robin Robinson (HHS/OPHEP)

Licensing Pandemic Vaccines Novartis Vaccines Penny Heaton, MD, Global head clinical development clusters VRBPAC Washington DC, February 2012.

HHS Pandemic Influenza Vaccine Program VRBPAC Meeting Robin Robinson, Ph.D. Director, BARDA Deputy Assistant Secretary, ASPR November 14, 2012.

1 Proposed Pharmacovigilance Plan for H5N1 Influenza Virus Vaccine Patrick Caubel, MD, PhD Head of Pharmacovigilance North America February 27, 2007.

0 HHS Influenza Vaccine Projects for NVAC Meeting June 7, 2006 By: Dr. Robin Robinson Acting Assoc. Director ORDC/OPHEP/DHHS.

Avian and Pandemic Influenza Vaccine Development John Treanor Professor of Medicine University of Rochester Medical Center Rochester, NY.

Pre-2003 Pandemic Influenza Vaccine Goal & Strategy

Overview of the Division of Viral Products VRBPAC Presentation of the Site Visit Report for the Laboratories of Retrovirus Research, Immunoregulation,

Global Vaccines 202X : Access, Equity, Ethics Panel discussion: Pandemic Influenza Preparedness Framework for the sharing of Influenza Viruses and Access.

National Vaccine Advisory Committee June 7, 2005 Pandemic Influenza Vaccine Research and Development Linda C. Lambert Chief, Respiratory Diseases Branch.

0 HHS Influenza Vaccine Projects for NVAC Meeting November 29-30, 2005 By: Dr. Robin Robinson Sr. Project Officer ORDC/OPHEP/DHHS.

Adult Immunization 2010 Influenza Segment This material is in the public domain This information is valid as of May 25, 2010.

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 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.

Vaccines and Related Biological Products Advisory Committee Meeting

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

Vaccines and Related Biological Products Advisory Committee Presentation on Sanofi Pasteur’s H5N1 Vaccine Andrea N. James, M.D. Senior Medical Officer.

0 H1N1 Vaccines VRBPAC Meeting Robin Robinson, Ph.D. HHS/ASPR/BARDA Director July 23, 2009.

Influenza Vaccine Development

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.

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

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

Facility ID: Vaccination #: Healthcare Worker Demographics *HCW ID#: HCW Name, Last:First:Middle: *Gender:  F  M *Date of Birth: *Work Location: *Occupation:

Office of Public Health Preparedness and Response Division of Strategic National Stockpile Ben Erickson Public Health Analyst Inventory Management Tracking,

Food and Drug Administration

Texas Immunization Branch Influenza Update July 24 th, 2008.

A Potential Influenza Pandemic: Possible Macroeconomic Effects and Policy Issues Julie Somers Congressional Budget Office Prepared for the Ninth Annual.

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.

America Responds: An HHS 2009-H1N1 Retrospective to Advance All Hazards Preparedness Discussion with the National Vaccine Advisory Committee June 3, 2010.

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

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (Q-Pan H5N1 Vaccine) Manufactured by GlaxoSmithKline Vaccines and Related Biological Products Advisory.

National Vaccine Advisory Committee Report from the Chair Gus Birkhead, MD, MPH NVAC Chair February 3, 2010.

1 Approaches to Demonstrate Effectiveness of Vaccines for Prevention of Group B Meningococcal Disease Introduction Vaccines and Related Biological Products.

FDA/CBER Vaccines and Related biological Products Advisory Committee Meeting Discussion of Clinical Trials to Support use of Vaccines against the 2009.

1 Vaccines and Related Biologic Products Advisory Committee (VRBPAC) May 16, 2007 FluMist ® Influenza Virus Vaccine Live, Intranasal Safety and Effectiveness.

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.

VRBPAC Topic #2: Clinical Development of Influenza Vaccines for Pre-pandemic Use Joseph G. Toerner, MD, MPH VCTB/DVRPA/OVRR/CBER/FDA February 27, 2007.

Pathway to Licensure for Protective Antigen-based Anthrax Vaccines for a Post-exposure Prophylaxis Indication Using the Animal Rule.

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

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

Influenza A (H1N1) Vaccine Vaccines and Related Biological Products Advisory Committee Meeting, 23 July 2009 Raburn Mallory, M.D. Proprietary Vaccines.

Primary Immunogenicity Endpoints for New Infant Pneumococcal Conjugate Vaccines Vaccines and Related Biological Products Advisory Committee Meeting Lucia.

1 Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting Detection of Porcine circovirus (PCV) and PCV DNA Sequences in U.S. Licensed.

FDA’s Role in Facilitating the Availability of Influenza Vaccine Norman W. Baylor, Ph.D. Director, Office of Vaccines Research and Review CBER/FDA.

Office of Vaccines Research and Review

Seasonal and Pandemic Influenza Research Activities National Vaccine Advisory Committee Meeting September 27, 2006 Barbara L. Mulach, Ph.D. National Institute.

Developing a Vaccine to Protect Against Pandemic Influenza Public Statement by GlaxoSmithKline 27 February 2007.

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

1 H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004 (Clade 1) VRBPAC Presentation Kenneth P. Guito, MBA Strategic Project Office.

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.

Update from the Office of Vaccines Research and Review, CBER/FDA NVAC Meeting Washington, D.C. February 4-5, 2003.

Kenneth McCall, BSPharm, PharmD Associate Professor | UNE.

NVAC Influenza Working Group: Preliminary Report Charles Helms, M.D., Ph.D. June 1, 2004.

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 Considerations in the Pre- and Early Pandemic Use of Influenza Vaccine Jesse L. Goodman, MD, MPH Center for Biologics Evaluation and Research, VRBPAC,

*Facility ID:*Event #: *Patient ID:Social Security #: Secondary ID: Patient Name, Last: First: Middle: *Gender: F M Other *Date of Birth: Ethnicity (specify):Race.

1 Considerations for Licensure of Next Generation Smallpox Vaccines Timothy Nelle, PhD Team Leader, Division of Vaccines and Related Applications Office.

and John C. Victor, Ph.D., M.P.H.

ACIP Recommendations Update for the U.S. Influenza Season

Vaccines and Related Biological Products Advisory Committee Meeting

Case presentation of non-clinical and clinical development of vaccines

DSHS Adult Vaccine Program

Presentation transcript:

Licensure of Pandemic Influenza Vaccines: Demonstration of Effectiveness Vaccines and Related Biological Products Advisory Committee (2/29/2012) Marion F. Gruber, PhD, Acting Director Office of Vaccines Research and Review/CBER/FDA

Purpose of Today’s VRBPAC Discussion Review pathways to licensure of the influenza A (H1N1) 2009 vaccines and an influenza A (H5N1) vaccine Discuss approaches to the pre-licensure evaluation of effectiveness of adjuvanted pandemic influenza A virus subtype vaccines manufactured using the same process as the manufacturer’s U.S-licensed unadjuvanted seasonal influenza vaccine Discuss approaches to the pre-licensure evaluation of effectiveness of pandemic influenza A subtype vaccines manufactured using a process that is not U.S.-licensed

US licensed Seasonal & Pandemic Influenza Vaccines Seasonal Influenza Vaccines (Inactivated, intramuscular) Afluria (CSL) Agriflu (Novartis) Fluarix (GSK) FluLaval (IDB-GSK) Fluvirin (Novartis) Fluzone (Sanofi Pasteur) Seasonal Influenza Vaccine (Live attenuated, intranasal) FluMist (MedImmune) Monovalent pandemic Influenza vaccines H5N1 Influenza Virus Vaccine, (inactivated, i.m) Sanofi Pasteur) H1N1: Influenza A (H1N1) 2009 Monovalent Vaccines (inactivated, i.m) CSL IDB-GSK Novartis Sanofi Pasteur H1N1: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal (live attenuated, i.n) MedImmune

Pandemic Preparedness: Regulatory Considerations Development and timely availability of a vaccine matched to the pandemic influenza strain is a cornerstone of pandemic influenza prevention National regulatory authorities must be prepared to respond with regulatory pathways to expedite the availability of pandemic influenza vaccines In the event of a pandemic, prior licensure of “prototype” influenza vaccines will shorten the time to licensure of a vaccine against the pandemic strain

Pre-pandemic and Pandemic periods Pre-pandemic period Pandemic Pre-pandemic and Pandemic periods U.S. Licensed Seasonal influenza vaccine A, subtype: H1, H3 Licensure of “Prototype” pandemic vaccine: adjuvanted unadjuvanted Pandemic vaccine update: adjuvanted unadjuvanted strain change supplement A, subtype: H5 A, subtype: H7 A, subtype: H5 A, subtype: H7 A, subtype: H9... Licensure approach: Safety Immunogenicity Efficacy A, subtype: H9... Licensure approach: Safety Immunogenicity Annual update: Strain change supplement Effectiveness

Pandemic Preparedness: Regulatory Considerations (cont.) Influenza A (H1N1) 2009 vaccines and an influenza A (H5N1) vaccine Manufacturers utilized same egg based manufacturing process as their seasonal vaccines Clinical endpoint efficacy data accrued with a U.S.-licensed seasonal influenza vaccine has been used to infer effectiveness Approach discussed at previous VRBPAC meetings (e.g., February 2007 and July 2009) Pandemic influenza vaccines in clinical development Made by the same process as licensed seasonal vaccine except that the vaccine contains adjuvant Made by a process not US licensed (adjuvanted/nonadjuvanted)

Pandemic Preparedness: Regulatory Considerations (cont.) FDA is working with vaccine manufacturers interested in developing pandemic influenza vaccines to establish pathways to support effectiveness prior to licensure FDA will outline approaches to licensure that are specifically tailored to pandemic influenza vaccines for which it is not feasible for manufacturers to conduct clinical endpoint efficacy studies Scenarios outlined pertain to adjuvanted and unadjuvanted pandemic influenza vaccines for use in the event of a pandemic

Overview of Today’s Agenda BARDA perspective regarding pandemic influenza vaccine preparedness Dr. Robin Robinson, PhD FDA proposed approach to licensure of pandemic influenza vaccines Dr. Theresa Finn, PhD Manufacturer’s presentations on pandemic influenza vaccine development GSK, Kati Abraham Novartis, Penny Heaton, MD Committee discussion

Discussion items 1. To infer effectiveness of an adjuvanted pandemic influenza A subtype vaccine, please discuss the use of: a) clinical endpoint efficacy data accrued with a U.S.-licensed unadjuvanted seasonal vaccine made by the same manufacturer and process, and b) observational effectiveness data accrued during the H1N1 2009 pandemic for a non-U.S.-licensed adjuvanted monovalent vaccine made by the same manufacturer and process.

Discussion items 2. Please discuss approaches to infer effectiveness for pandemic influenza vaccines that are manufactured using a process not licensed in the U.S.: a) pandemic influenza vaccines dependent on an HA antibody response b) pandemic influenza vaccines with protective mechanisms that are not dependent on an HA antibody response