WHO Technology Transfer Initiative: supporting grantees through the next phase

Transcription

1 7th Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers WHO Technology Transfer Initiative: supporting grantees through the next phase G. Torelli, WHO, 5 March 0

2 WHAT HAS HAPPENED SINCE THE LAST MEETING in 0 SI PANDEMIC VACCINES APPROVED Green Flu S Vacina Influenza NASOVAC Nasovac-S FLUBIO Enzavac CANTGRIP FLU VAC Green Flu S+ TWO PANDEMIC VACCINES PREUALIFIED TWO SEASONAL VACCINES APPROVED THREE MORE being completed PRODUCTION FACILITIES LAIV H5N Ph II - immunogenic PRE- and CLINICAL STUDIES

3 WHAT HAS HAPPENED SINCE THE LAST MEETING in 0 0 assessments Desk review (reports, presentations, publications) Assessment visits (9 sites Oct-Dec 0) Assessment process: Advance uestionnaire Site visit with expert teams uestionnaire covering: Overall plans National plans Current vaccines prod Staffing and structure Production (process) Filling Facility A/C SOPs Training needs National regulatory process Product approval requirements Marketing/business details Budgetary needs Rsk analysis

4 WHAT HAS HAPPENED SINCE THE LAST MEETING in 0 -year workplans developed jointly with manufacturers, based on the 0 assessments New -year Cooperative Agreement with BARDA Collaboration with OGA-CDC new grants issued Workshop on Enhancing Communication around Influenza Vaccination (June 0, Atlanta) Initiated work on conditions for sustainability

5 06 TARGETS Company / Country Vaccine Late stage** Licensed*** BCHT China Seasonal LAIV Biofarma - Indonesia Seasonal Adjuvanted Pandemic [] Biovac South Africa Seasonal* Adjuvanted pandemic* Birmex Mexico Seasonal* Adjuvanted pandemic* Butantan Brazil Adjuvanted pandemic Cantacuzino - Romania Seasonal Adjuvanted pandemic GPO - Thailand Pandemic LAIV (H5) Seasonal LAIV/IIV IVAC - Viet Nam Pandemic (whole virion) Seasonal (split) SII - India Seasonal LAIV (egg) P? Seasonal LAIV Tissue Culture Torlak - Serbia Seasonal (split) Pandemic (whole virion) 7 Fill-finish; ** includes vaccines in late stage clinical trials or regulatory dossier submitted; *** For pandemic vaccines outside of a pandemic, licensure = mock dossiers or other tentative approval; 5

6 06 TARGETS Total pandemic production capacity at least 600 million Table of maximum current and predicted pandemic capacity by 06. Company Current Predicted* Note Birmex 0 0** Based on 5ug monovalent dose Butantan 0 0 Based on adjuvanted7.5ug dose vaccine Cantacuzino 9 6 Base on improved yields and adjuvanted 7.5ug dose Torlak 0 6 Biovac 0 ** Based on target 8M seasonal supply. SII 0 50** Based on submission TC LAIV and planned scale-up. GPO.5 0** LAIV IVAC 0 ** Biofarma 0. 6 Based on facility completion and adjuvant approval BCHT 0 90** Based on strain-change approval Green Cross Has adjuvant technology, approved adjuvanted vaccine. Total * to make estimations of predicted capacity we count vaccines that are licensed and also those that are in late stage development; ** unless company has dose sparing technology approved or submitted for approval, we assume a dose of 5ug HA or a 0 7 PFU LAIV as experienced with HN, enabling a conversion factor of over the maximum annual seasonal capacity. 6

7 H7N9 grants for H7N9 development BUTANTAN, Inactivated to SII and IEM, LAIV to Bio Farma From Virology Down Under and Dr. Ian M Mackay other manufacturers working on H7N9 (IVAC, BCHT) Barriers: Reagents a very long wait Ferret studies: costs, lab, availability of animals WHO CONDUCTING COORDINATED FERRET STUDIES 7

8 Meeting our targets A lot of progress has been made >00 million pandemic vaccine capacity already. A lot still needs to be made 0-06 To bring candidates to approval, and To add another 00 million doses pandemic capacity Challenges Approval pathways for both seasonal and pandemic Sustainability 8

9 Animal studies Activity Preclinical testing Preclinical study Challenge in ferrets Non-clinical mice study Toxicology & ferret studies. Preclinical immunogenicity Preclinical toxicology Repeated dose toxicity Developmental toxicity Immunogenicity study Single dose toxicity Immunogenicity Preclin immunogenicity (mouse) Toxicology (rat) Toxicology (mouse/rat) Ferret challenge (conducted by WHO) Preclinical immunogenicity Preclinical toxicology Immunogenicity (mice) Toxicology (rat) Ferret challenge A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x 9

10 Clinical Trials Activity I II I II I II I/III I Prime-Boost I /II I/III I/III I/III I A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D x x x x x x x x x x x x x x x x x x 0

11 Support to manufacturers WHO technical support will continue Technical advice, Visits by TAG and consultants, Interactions with MoH In collaboration with PATH Particular focus on support for preclinical and clinical development Study Protocol Templates being developed Workshop for manufacturers and NRAs the design, conduct and regulatory review of non-clinical and clinical studies in support of initial vaccine approval, annual strain change, process modification, and prequalification (tentatively end June/early July)

12 Maintaining the gains Sustainability of the capacity that you are establishing needs to be addressed. The HHS/WHO Workshop Series has allowed the stakeholders to comprehensively examine the different factors and drivers involved. You will hear tomorrow how the knowledge that was gained will be used to move this agenda forward.