FLUSECURE A consortium of European Health Institutes with vaccine development capabilities February 2006 August 2010

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Chastity Elliott
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Health Protection Agency (HPA) Statens Serum Institute (SSI) National

Public Health NIPH) Cantacuzino Institute (CI) National Centre for

1 FLUSECURE A consortium of European Health Institutes with vaccine development capabilities February 2006 August 2010 Partners Jan Hendriks jan.hendriks@rivm.nl October 2012 Luxembourg Netherlands Vaccine Institute (NVI) Health Protection Agency (HPA) Statens Serum Institute (SSI) National Institute of Public Health (KTL; later: THL) Norwegian Institute of Public Health NIPH) Cantacuzino Institute (CI) National Centre for Epidemiology (NCE) Slovenia National Institute of Public Health (IVZ) Robert Koch Institute (RKI) Institut Pasteur (IP) 1

Background EU- Influenza vaccinology landscape & policies DG-Sanco Health Threats Unit Health Security Smallpox; SARS, pandemic influenza EU Pandemic Influenza preparedness

2 Background EU- Influenza vaccinology landscape & policies DG-Sanco Health Threats Unit Health Security Smallpox; SARS, pandemic influenza EU Pandemic Influenza preparedness activities European Vaccine Manufacturers (EVM) proposals Concept of an European Public Private Partnership for pandemic influenza vaccines Flusecure: FastVac:

Background Towards Sufficiency of Pandemic Influenza Vaccines in the EU, April 2005 Recommendations for a public-private partnership (PPP) between public bodies

3 Background Towards Sufficiency of Pandemic Influenza Vaccines in the EU, April 2005 Recommendations for a public-private partnership (PPP) between public bodies and the vaccine industry to deliver influenza vaccine to the European Union population. Influenza/influenza_key03_en.pdf 3

4 EU Vaccinology Landscape 4

5 Approach Objective: Underpin the vaccine industry in preparing plans to manufacture influenza vaccine in an emergency Specific objectives: Make a library of reassortants plus reagents on a continuous basis that is readily available to industry Develop strategies to improve potency of vaccine Develop new tests to prove efficacy in humans Assist industry in setting up clinical trials 5

6 Subtype Strain Vaccine reference strain Sheep an2se rum Freeze- dried an2gen H5 viruses H5N1 (Clade 1) A/Hong Kong/213/2003 A/Vietnam/1194/2004 A/Cambodia/R /2007 NIBRG- 12 NIBRG- 14 NIBRG- 88 H5N1 (Clade 2.2.1) A/turkey/Turkey/1/2005 NIBRG- 23 H7 viruses H7N3 A/mallard/Netherlands/12/2000 NIBRG- 60 H7N1 A/mallard/Netherlands/12/2000 (7:1 reassortant) A/turkey/Italy/3889/99 (low path) NIBRG- 63 wt H7N2 A/New York/107/03 NIBRG- 109 H9 viruses H9N2 A/chicken/Hong Kong/G9/97 (G9 lineage) A/Hong Kong/1073/99 (G1 lineage) NIBRG- 91 wt H2 viruses H2N3 A/mallard/England/727/2006 NIBRG- 107 H2N2 A/Singapore/1/57 NIBRG

Library production: reagents Matched reagents for standardisation of vaccine production antigens antisera The FLUSECURE library and reagents are available upon request (contact flusecure@nvi-vaccin.

7 Library production: reagents Matched reagents for standardisation of vaccine production antigens antisera The FLUSECURE library and reagents are available upon request (contact or NIBSC). Antigen produced through collaboration between NIBSC & Cantacuzino Institute Antigen calibration in collaboration with WHO-recognised regulatory laboratories Antigen standards & antisera available from NIBSC 7

Centre, Budapest, Hungary Bekkestualegene, Baerum, Norway Norwegian Institute of Public Health

8 Clinical Study Centres Dept of Infectious Diseases, University Medical Centre (UMC), Ljubljana, Slovenia Julius Center, University Medical Center (UMC) Utrecht, The Netherlands State Health Centre, Budapest, Hungary Bekkestualegene, Baerum, Norway Norwegian Institute of Public Health (FHI), Oslo, Norway National Institute for Health and Welfare (THL), Study Clinics, Tampere, Finland 8

9 The H1N swine flu pandemic was in the project period 9

The H1N1 2009 swine flu pandemic was in the project period Fig.

10 The H1N swine flu pandemic was in the project period Fig. 1 Summary of the activities that occurred in 2009 from day 0 of the pandemic on 18 March 2009, when the first case of H1N1 virus was reported in Mexico, to November and December (months 8 and 9), when large quantities of the pandemic vaccine became available. R Rappuoli, P R Dormitzer Science 2012;336: Published by AAAS

11 Results (1/2) A network of 10 European public health institutions with vaccine development and manufacturing capabilities established. During the project, six different clinical study sites throughout Europe joined the consortium Extensive set of products, services and tools in relation to influenza pandemic preparedness. The appearance of the H1N1 pandemic in 2009 triggered a targeted response in the activities. A list of the output both prior to the pandemic, as well as resulting from the pandemic, is in the information package Various vaccine seed strains with corresponding reagents have become available. New technologies have been implemented to produce vaccine strains with improved growth characteristics. Two European institutes within the consortium have developed their own pandemic reference vaccines by reverse genetics technologies. Their newly developed technologies allowed the production of pandemic seed strains with improved growth characteristics, combined with a marked reduction in the time needed for the development of reassortant seed strains A study has been completed in which 14 different influenza adjuvant candidates have been compared with each other. The best performing influenza vaccine formulations have been further tested in three different animal model species 11

12 Results (2/2) Three different assays developed and validated as new correlates for protection for influenza vaccines. This enabled a significant broadening of the efficacy evaluation against influenza in combination with the standard serological assays Three different trial studies performed within the European network of clinical study sites. In response to the 2009 H1N1 pandemic, a cohort study protocol was developed for implementation into a pandemic H1N1 vaccine trial study within one of the participating member states Collective output of the project disseminated to European stakeholders (European Commission, national governments, international agencies and industry) through workshops, conferences, reports and scientific publications. 12

13 Conclusion & Follow up This EU network contribution of public institutes to shorten timeline of flu vaccine availibility as seen in 2005 was too optimistic, due to (a.o.): National changes in legal structure of various partners A conservative regulatory process The public pandemic influenza vaccine specific Flusecure consortium formed the basis for a further generic public vaccinology consortium action called FastVac, with the objective to develop a set of predictive rules to develop in a shorter time span vaccines against emerging cross border health threats. 13

14 Thank you for your attention 14

FLUSECURE Towards sufficiency of Pandemic Influenza vaccines in the EU TECHNICAL REPORT 2 (August 2006-February 2007)

1 FLUSECURE Towards sufficiency of Pandemic Influenza vaccines in the EU TECHNICAL REPORT 2 (August 2006-February 2007) 2 FLUSECURE Towards sufficiency of Pandemic Influenza vaccines in the EU Table of