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Indian Pediatr 2016;53: 567-568 |
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Healthcare Interventions and Vaccines
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K Vijay Raghavan
From the Department of Biotechnology, Ministry of
Science and Technology, New Delhi, India.
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R otavirus infections are ubiquitous. Where
vaccines have been widely introduced, there has been an extraordinary
positive impact on mortality and morbidity. There is much yet to be done
in India to ensure full introduction of rotavirus vaccination in the
national immunization program. There are many challenges in
implementation of a new vaccine for a large birth cohort and new
challenges will surely emerge, as with any effort on this scale. Our
collective experience will deal with existing and emerging issues, and
full deployment of the vaccine will save hundreds of thousands of lives
and will greatly improve the health of children. On the science and
technology front, the development and deployment of an indigenous
vaccine is exemplary, and raises confidence that more such efforts will
follow. The Indian vaccine industry, indeed all of India, should take
great pride in what it did in the manufacture of vaccines in general and
against rotavirus in particular. Two big cheers are due to India.
Yet, this is a time for introspection and
self-criticism. We need to ask ourselves if we could have gone ahead
faster and implemented faster. We also need to learn from the rotavirus
experience what we need to do for immunization programs in general, and
for specific vaccines as needed. While our vaccine and vaccination
challenges are complex, our programs can be broken down into components
in a pipeline. Each component can be analyzed and we can chart out where
and how we can do better. Reality is far more complex, dynamic and
unpredictable but such an approach and a constant self-appraisal can
help in strategic development and implementation.
We can divide the components in the pipeline into
research, the ‘valley of death’ that needs to be crossed to take vaccine
development into trials, manufacture, implementation and monitoring.
While a detailed analysis is needed, I outline aspects that need
attention, and try and point to realistic routes to address these
problems. In each of these components, we can analyze our strengths,
weaknesses and, very important, the efforts needed to address the
problem. These components and the current situation are broadly and
qualitatively summarized in Table I. A constant and
critical mapping of each cell in the table, for each vaccine candidate,
is needed. As a research funder, not directly involved in
deep-downstream implementation (a responsibility of central and state
health ministries), this dynamic mapping could be anchored by a
partnership of the Department of Biotechnology (DBT) and the Indian
Council of Medical Research (ICMR). Such a ‘landscaping’ unit,
organically connected with our reality is an effort which the DBT will
put in place. Indeed, some such structures are already in place;
learning from their successes and weaknesses, and coordination with them
can itself help develop a more effective aid to those who need to take
decisions and monitor performance.
TABLE I The Components in the Implementation Pipeline
Component |
Strengths |
Weaknesses |
How to address
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Research |
Terrific Cell and MolecularBiology community
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Disconnected with society
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DBT can, and is developing better incentives to connect. |
‘Valley of Death’ |
Many leads globally |
Disparate laboratories, uncertain funding, poor connect, little
investment in research and development from companies for
potential small volume markets. |
Create a nimble global research fund. |
Trials |
Quality clinical researchersand industry
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Foggy regulation. More trainingprograms needed as trial require-ments
scale-up. Investment in surveillance to establish sites
forefficacy trials. |
ICMR-DBT proactively clarify regulatory routes in
complex debates. This is happening,as also training programs and
some surveillanceefforts.
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Manufacture |
Excellent capacity |
Market complexities and resources keep costs high. Morevaccine
candidates needed. |
DBT-BIRAC should drive earlier steps morein partnership with
public and private biotech industry. Industry incentives from
regulators for ‘public good’ vaccines. |
Introduction
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NTAGI functional |
Needs to be more nimble, proactive, forward looking to broaden
scope. |
Formal steps for improving NTAGI function. |
Implementation
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Steady and well-organizedat each stage.Experiencewith large
birth cohorts and campaigns |
Coverage issues continue incertain regions.Costs and capacity
are a challenge when deciding on introduction. Shortage of
trained staff and resources are constraints on speedier national
implemen-tation.
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Better alignment between centre and states. New
strategies for implementation, which raise national and global
resources and train deliveryworkers to scale. S&T can help here.
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Monitoring
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Outstanding experience with polio |
Disease prevalence, surveillanceand impact of introduction
studies constrained due to costs and capacity |
New strategies for monitoring, which raise national and
global resources and linkprograms with independent monitors.
S&Tcan help here. |
DBT: Department of Biotechnology; ICMR: Indian Council of
Medical Research; NTAGI: National Technical Advisory Group on
Immunization; S&T: Science and Technology. |
This simplistic table (Table I)
suggests that we have bottlenecks at every stage in the pipeline. This
may lead us to the view that the pipe will have a poor flow rate or be
clogged. This would be wrong. There are ways to clean pipes by
addressing challenges, even as the pipeline continues to work as it
does. Our being more active in being aware, in an integrated manner, of
our strengths and weaknesses (columns 2 and 3), and using this awareness
to address solutions (column 4) is the only way to bring vaccines to the
Indian people. In this effort, the DBT has a special role. It is removed
enough to be able to think unhurriedly and objectively, and it is
connected enough to help develop and implement urgent solutions. The
model was developed with the end-to-end engagement with the indigenous
rotavirus vaccine. We have learned from the experience and need new
challenges.
Funding: None; Competing interest: None stated.
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