Global Vaccines 202X : Access, Equity, Ethics

1. Global Vaccines 202X : Access, Equity, Ethics Panel discussion: Pandemic Influenza Preparedness Framework for the sharing of Influenza Viruses and Access to Vaccines and other Benefits : Industry Perspective Dr. S.S. Jadhav Executive Director Serum Institute of India Ltd., Pune ssj@seruminstitute.com Philadelphia 2 – 4 May 2011

2. Global Health Threats: Pandemic Preparedness • A World Health Assembly Resolution (WHA 58.5, Agenda item 13.9): WHO Secretariat to seek solutions for reducing global shortage of influenza vaccines for both epidemics and pandemics – 23 May 2005. • WHO Global Pandemic Influenza Action Plan to Increase Vaccine Supply (GAP) – 2-3 May 2006, launched in November 2006.

3. Global Pandemic Influenza Action Plan to Increase Vaccine Supply (GAP 2006) Goal • Developing enough pandemic vaccine to immunize the world's population (6.7 billion people in 6- 9 months) Specific objectives "By increasing the supply of a pandemic vaccine and thereby reducing the gap between the potential vaccine demand and supply anticipated during an influenza pandemic.” - Increase use of seasonal vaccine to drive market & production capacity - Expand vaccine production capacity by building new production plants in both developing and industrialized countries. - Encourage further research and development

4. Conditions for Favorable In-House Manufacturing:Determinants in developing countries • Policy level - Sustained Market demand - Political Will and advocacy - Trained and well equipped National Regulatory authority • Operation level - Cost effective and scalable technology - Macro and Micro econmics - Skilled Human Resource - Capacity for meeting international regulatory requirements - Existing manufacturing capability/skills.

5. As on date, no demand for seasonal vaccine Even post 2009 H1NI pandemic, no policy on seasonal influenza vaccination. Difficult proposition for sustaining influenza manufacturing capacity. Unpredictable demands (supply contract generally of short duration). - Vaccine composition (change of virus may involve major process changes. No demand Investment ?? Conditions for Favorable In-House Manufacturing: Case study of India Large population Vaccine requirement for Indian subcontinent

6. Considerations for vaccine development: DC Perspective REPORTED INFLUENZA VACCINE TECHNOLOGIES • Attenuated influenza vaccine for immunization through nasal route • Inactivated vaccine containing whole virus/subunit virus preparations • Time tested technology • Large number of doses in a short duration • Small manufacturing setup • Low cost

7. WHO Global Action Plan for Pandemic Influenza (GAP) and DC manufacturers. • Year 2006: GAP intiative was planned . • Year 2006-2007: 5 DC manufacturers were approached for seasonal and H5N1 influenza vaccine production capacity building. Each member was expected to generate production capacity of 50 million doses/year. • Year 2008: Many grantees completed pre-clinical development of H5N1 and seasonal influenza vaccine. • Year 2008: Additional 6 DC manufacturers were shortlisted for capacity buidling. • April 2009: Pandemic threat of H1N1 was announced and these manufacturers were asked to be ready with H1N1 vaccine for global use. • July 2009/August 2009: Pandemic strains supplied by WHO to the manufacturers. • July 2010: Serum Institute of India licensed LAIV and injectable (inactivated) H1N1 vaccine for global use.

8. WHO Global Action Plan for Pandemic Influenza (GAP) and DC manufacturers. • This represent an leading example wherein pandemic threats led to capacity building. • New manufacturers have been established in developing countries, which brings hopes to more adequate production capacity and equitable access in case of a future pandemic. • By 2015, production capacity of more than 1 billion doses is expected by DC manufacturers.

9. Swine Flu Vaccination: India Story • Imported Vaccine not used by medical practitioners in worst hit state for unknown reasons. July 5 2010, Indian Express, Mumbai. • Union Government had placed an order with French drug maker Sanofi Pasteur for 1.5 million doses of H1N1 vaccine in December, mostly to be given to the high-risk group of medical practitioners. Not even 2,000 of the 34,300 French vaccines procured by Maharashtra at a cost of Rs 300 per dose have been administered. • Serum’s Intranasal HINI vaccine likely in a week. - The Times of India19 June 2010. • Serum Institute of India received the go-ahead from DCGI to market the country first intra-nasal indigenous H1N1 flu vaccine.

10. Challenges • Market demand, political will and national regulatory structures are important pre-requsities for domestic manufacturing capacities and rapid production responses. • Economies of scale generally necessary to achieve global competitiveness and rapid responses. • No assurance of offtake of production as on today. Therefore, difficult to sustain production capacity for future demand.

11. Global Expectations • Mechanisms for assuring guaranteed demand at sustainableprice from national and international agencies to keep production facility viable and to up-scale the production in minimum possible time in case of any future threats. • Better and improved advocacy of benefits of influenza vaccination globally. • Global R & D efforts to develop evidence based correlates for assuring efficacy and safety of influenza vaccines.

12. Thank You