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Licensure of Pandemic Influenza Vaccines: Demonstration of Effectiveness

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.

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Licensure of Pandemic Influenza Vaccines: Demonstration of Effectiveness

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

  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. 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. 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. 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. 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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