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 Philadelphia 2 – 4 May 2011

Global Health Threats: Pandemic Preparedness o 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 o WHO Global Pandemic Influenza Action Plan to Increase Vaccine Supply (GAP) – 2-3 May 2006, launched in November 2006.

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

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.

Conditions for Favorable In-House Manufacturing: Case study of India 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 ?? Large population Vaccine requirement for Indian subcontinent

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

WHO Global Action Plan for Pandemic Influenza (GAP) and DC manufacturers. Year 2006: GAP intiative was planned. Year : 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.

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.

Swine Flu Vaccination: India Story - Imported Vaccine not used by medical practitioners in worst hit state for unknown reasons. July , 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 India 19 June Serum Institute of India received the go-ahead from DCGI to market the country first intra- nasal indigenous H1N1 flu vaccine.

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.

Global Expectations Mechanisms for assuring guaranteed demand at sustainable price 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.

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