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1 Licensure of Pandemic Influenza Vaccines: Demonstration of Effectiveness Vaccines and Related Biological Products Advisory Committee (2/29/2012) Marion.

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Presentation on theme: "1 Licensure of Pandemic Influenza Vaccines: Demonstration of Effectiveness Vaccines and Related Biological Products Advisory Committee (2/29/2012) Marion."— Presentation transcript:

1 1 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

2 2 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

3 3 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

4 4 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

5 5 Pre-pandemic and Pandemic periods U.S. Licensed Seasonal influenza vaccine A, subtype: H1, H3 Pre-pandemic periodPandemic  strain change  supplement Licensure approach:  Safety  Immunogenicity  Efficacy A, subtype: H5 A, subtype: H7 A, subtype: H9... Licensure of “Prototype” pandemic vaccine:  adjuvanted  unadjuvanted Pandemic vaccine update:  adjuvanted  unadjuvanted A, subtype: H5 A, subtype: H7 A, subtype: H9... Licensure approach:  Safety  Immunogenicity Annual update:  Strain change supplement  Effectiveness

6 6 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)

7 7 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

8 8 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

9 9 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.

10 10 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


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