Vaccine Summit 2015- Mumbai

1. Understanding the Growing Importance
of Immunization in India
Dr Pritu Dhalaria MBBS, DCM, MD
Director, Clinical Services, IAVI - International AIDS Vaccine Initiative
Vaccines Summit – 2015, Mumbai

2. Immunization
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3. Role of Vaccines
• Pivotal role - Improving child health and survival
• Cost-effective solution - Health and Development
• Avoid recurring sickness, death and unnecessary
social and economic costs to society
• Many vaccines provide “herd immunity,”
protection even to unimmunized

4. India – History of Immunization
• The EPI was launched in India in 1978
• In 1985, the name was changed to the Universal Immunization Program (UIP
• Program was included in the reproductive and child health program (RCH) in
1997
• Brought under the National Rural Health Mission (NRHM) in 2005 / now NHM
– Targeting a birth cohort of 27 million each year
• India has one of the largest immunization systems in the world
– Carried out through the public system and by private practitioners
– The latter serving about 25% of the population
• The central government takes most of the decisions related to vaccine
introduction
– Responsible for procuring all the vaccines used in the country
– State governments execute the immunization program
• The States have some freedom to choose additional vaccines depending of the
available finances, sometimes prompting decisions to introduce the vaccine at a
national level

5. Immunization – Protecting India’s Future
• Country’s child mortality rates have declined by over 58% since 1990
• Vaccines in India
– Have successfully eliminated smallpox and polio from India
– Brought measles to an all-time low
– Reduced tetanus by an estimated 95% over the past three decades
• India declared neonatal tetanus free - WHO
• The current full coverage for six basic vaccines is 53.5 (DLHS 3)
– The remaining children belong to the most vulnerable section of the population
• Nationwide coverage of the third dose of the diphtheria-tetanus-pertussis
(DTP) vaccine increased to an estimated 72% in 2012 from 60% in 2000
• Bihar - Increased DTP3 coverage from 54% in 2007-08 (DLHS 3) to over 80% in
2012-13 (Annual Health Survey)
• Since 1980, diphtheria cases have declined by 94%
• Pertussis vaccination has helped reduce the burden of disease by 86%
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Source - UNICEF

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7. Vaccine
Development
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8. India - History
• Public-sector manufacturing started in the late 1960s
• India emerged as major supplier after EPI program launched –
Private & Public
• Current industry capable of producing all kind of vaccines
– Attractive investment environment
– Effective and innovative governmental support
– International partnerships
– Growing in-country technical work force
• New vaccine are available and administered in the private sector
• India has been slow in introducing new vaccines in public sector
– Hepatitis B, JE, Hib and second dose of measles vaccines added recently
– India continues to contribute significantly to global child mortality figures
• Opportunity for introduction of new and underutilized vaccines
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9. • Institutional Initiatives
– New institutions, clusters and consortia were established to carry out basic
and multidisciplinary applied research
– THSTI houses the translation-related activities for rotavirus, TB and JE
vaccines and is now on HIV vaccines, in collaboration with IAVI
– CDSA in partnership with ICMR, NIH & BMGF provides cost effective, high-
quality preclinical and clinical product development support services
– Hilleman Laboratories in partnership with Merck Sharp & Dohme and
Wellcome Trust support to improve thermostability of vaccines
– Vaccine Grand Challenge Program, ICGEB-EMORY Vaccine Center and the
Malaria Vaccine Development Program are also accelerating vaccine R&D
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Recent Initiatives

10. • Funding Initiative
– DBT initiated new funding mechanisms to support small
business innovation Research Initiative
– GoI funding for H1N1
– Biotechnology Ignition Grant was launched to support
innovation in affordable health care products
(http://www.birac.nic.in/desc_new.php?id=83 )
– Biotechnology Industry Partnership Program funds product
development with industry
• International Initiative
– DBT bilateral programs with United States (US), Norway, France,
Australia, African countries and Finland to support key vaccine
development
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Recent Initiatives…

11. • Private sector-driven initiatives to enhance manufacturing
– A new ecosystem that encourages partnerships and new market forces have
strengthened vaccine manufacturing in the country
• International partnerships for indigenous manufacture of
vaccines
– India has benefited tremendously from innovative international partnerships
due to its strong scientific base and manufacturing capabilities
– Rotavirus and the cholera (high burden in India) evoked interest from funding
agencies, academia and industry in investing
• Regulations pertaining to vaccine development and
manufacture
– China eligible for prequalification of their products, following the WHO
decision in 2011 – JE Vaccine SA 14 14 2 already prequalified
– Indicating increased competition in this market
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Recent Initiatives…

12. Policy changes affecting manufacturing capacity
– Indian vaccine manufacturers did not engage in vaccine R&D themselves
– Do not take up indigenously developed concepts but rather relied heavily on
mature technologies licensed from outside the country
– The new patent situation increased the need for home-grown innovations
– Changes in foreign direct investment policies (100% foreign direct
investment) under the category of “industrial parks” motivated global giants
to invest in Indian
– Indian vaccine manufacturers receiving WHO prequalification for their
products
• Academicians, industry and policymakers tend to work in vertical
“silos,”
– Minimal horizontal connections
– Building connections will help ensure the necessary synergy among
stakeholders
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Challenges

13. • Highly promising vaccine candidates - HIV, hepatitis E and malaria
– Difficulty proceeding to the commercial level due to lack of participation by partners
• Top-down, focused programs for vaccine development
– Flexibility to engage with diverse stakeholders could be more productive
• Multidisciplinary, multi-stakeholder approach
– With frequent opportunities for dialog among the stakeholders
– Support a common platform to discuss
– Overcome barriers of intellectual property rights, infrastructure and a skilled work force
• Availability of funding
– Collaborations as mentioned in previous slide
• Institutions with mechanisms for health policy analysis
– Synthesizing evidence and catalyzing communication among stakeholders to accelerate
indigenous vaccine development and commercialization
• A mentor network
– People experienced in vaccine R&D from industry and academia would provide additional
impetus
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Future

14. Introduction of New
Vaccines
India
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15. Introduction of New Vaccines
• HBV vaccine - Initially introduced in 10 states, was extended to the entire country
beginning in 2011
• JE vaccine has been gradually introduced since 2006- 183 districts - 19 states covered
• Introduction of the second dose of measles vaccine and JE Vaccine in RI
• Local production capacity to produce combination vaccine, the cost is likely to spiral
down as demand increases, as was the case with HBV vaccine
• Current status of new vaccine introduction
– Prime Minister announced introduction of 4 new vaccine on 3rd July 2014
– Pentavalent vaccine
• Introduction - pan India
• Priority states to introduce by December 2015
– Rotavirus vaccine – not introduced – maybe by next year’s 1st quarter
– IPV – to be introduced by November 2015 in a phased manner till March 2016
– Adult JE Vaccine – No timeline as of now
– MR – in the pipeline - no timeline decided
• India has been slow to introduce new vaccines in its UIP
• Supplemental immunization activities put a strain on the insufficient work force and
resources
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16. Decision Making
National Technical Advisory Group for Immunization (NTAGI)
• India was among the first countries in the developing world to establish a
National Technical Advisory Group for Immunization (NTAGI)
– Advises and supports the government in taking informed and evidence-based
decisions regarding strengthening the UIP
– Including new vaccines in the program
• Challenges
– Funding, documenting the epidemiology of diseases
– Coordinating efforts of government and stakeholders
– NTAGI may have members with competing agendas, direct conflict of interest
• Compulsory declaration and management of conflict of interests
• Transparent mechanism for induction of new members
• Recommendations of the NTAGI into strong policies, and strengthening
implementation as well as the monitoring and evaluation arm, will have an
enormous impact on the introduction of newer vaccines.
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17. Financing
• Growing GDP, more resources available for health care
• Amount allocated remains much below expected level
• Country has been utilizing major portion on budget for polio
• Even if government investment in health care reaches the
predicted 3% of GDP mark by 2020, a separate allocation for
immunization is desirable
• A sustainable financing plan for the introduction of new vaccines
and allowing the private sector to play a significant role along
with the public sector
• GAVI support
– Current support is for HSS, Pentavalent and IPV till 2020
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18. Challenges
Lack of locally generated evidence
• Traditionally, Central Bureau of Health Intelligence carries out VPD
surveillance
• Integrated Disease Surveillance Project (IDSP), a World Bank-funded project,
was initiated in 2004
– Both systems have shortfalls and provide fragmented data
• New vaccines, Hib and the pneumococcal conjugate vaccine, need
continuous surveillance over a long period in order to identify changes in
occurrence of the diseases and serotype distribution.
Opportunity
• WHO- NPSP is now supporting the national immunization program with VPD
surveillance, particularly for measles
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19. Other Challenges
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Cold chain
• There are several new vaccines waiting for entry into the UIP program
• Increased pressure on the cold chain
• Good use of storage facilities (e.g., multi-dose packaging of vaccines and
innovative power back-up systems) is needed
• Capacity of the cold chain will be a major challenge, especially in remote areas
with limited power supply
Human resources
• Shortages in the trained work force at all levels
• JSY helped increase in number of births - increase in immunization coverage
Supply chain
• Lack of oversight and coordination led to problems regarding the supply chain
and regular availability of vaccines at outreach sites
• Accurate and timely forecasting of the demand for vaccines is a major
bottleneck in the timely manufacture and delivery

20. Lesson Learned
Introduction of
JE Vaccine
(SA 14 14 2)
in India
Case Study
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21. 2005 Outbreak
• 6,594 JE cases/1,665 deaths in 10 states
• 6,011 cases/1,472 deaths in Uttar Pradesh
• Similar outbreak in the adjoining districts of Bihar and in Nepal’s Terai region
• Demand for saving lives
• Political crises to handle the situation
Action
• The decision to act was a clear mandate from demand
• The resulting decision to act and subsequently introduce vaccine was made
through a culmination of multiple activities and influences over several years
• JE control is under the NVBDC program which approached the problem
through vector control and sporadic endemic, village focused often
incomplete vaccination campaigns which were ineffective in JE control
• The immunization program is managed through the National Immunization
Program which didn’t follow JE as a vaccine preventable condition
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Decision to Act

22. Decision Making
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• The process of decision making at the national
level was a complex and evolving process
• Involves multiple decisions and cannot be
defined as a single point.
The key decision points in introducing a new
vaccine in the Indian process can be defined
in three major steps
• Decision to act
• Decision to introduce
• Decision to sustain the program

23. Background Work
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Inputs into the decision to introduce

24. Go Ahead
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GoI - Decision to Introduce
• Introduction of JE vaccination
as a component of the
National EPI
• Vaccine (current): Live
attenuated SA14-14-2 JE
vaccine manufactured in
Chengdu institute of
Biological products, China
• Strategy: One time campaign
targeting all children between
1-15 years followed by
introducing the vaccine in the
routine EPI targeting children
1 to 2 years of age (WHO-
recommended strategy)

25. Thank You!
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