Understanding the Growing Importance of Immunization in India

Dr Pritu Dhalaria MBBS, DCM, MDDirector, Clinical Services, IAVI - International AIDS Vaccine Initiative

Vaccines Summit – 2015, Mumbai

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Immunization

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

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

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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%

Source - UNICEF

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Vaccine Developmen

t

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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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• 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

Recent Initiatives

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• 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

Recent Initiatives…

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• 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

Recent Initiatives…

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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

Challenges

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• 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

Future

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Introduction of New Vaccines

India

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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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Decision MakingNational 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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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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ChallengesLack 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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Other ChallengesCold 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 supplyHuman resources • Shortages in the trained work force at all levels • JSY helped increase in number of births - increase in immunization coverageSupply 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

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Lesson Learned

Introduction of JE Vaccine (SA 14 14 2)

in India

Case Study

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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 situationAction• 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

Decision to Act

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Decision Making• 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

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Background Work

Inputs into the decision to introduce

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Go AheadGoI - 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)

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Thank You!