Global Vaccines 202X : Access, Equity, Ethics

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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_at_seruminstitute.c
om
Philadelphia 2 4 May 2011
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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.

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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

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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.

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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.

Large population
Vaccine requirement for Indian
subcontinent
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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

• Time tested technology

• Large number of doses in a short duration
• Small manufacturing setup
• Low cost

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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.

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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.

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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.
• Serums 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.

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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.

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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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Thank You