Thirty-second Session of WHO South-East Asia
Advisory Committee on Health Research
Bangkok, Thailand
11-13 October 2011
SEA/ACHR/32/2.7
8 October 2011
Agenda Item 2.7
Review of the Regional Policy on Research
Aspect of Immunization
By Dr Monir Islam
1.
BACKGROUND
Global efforts to achieve MDG 4 have resulted in the reduction of under five
mortality from 11.9 million deaths in 1990 to 7.7 million deaths in 20101 with
immunization being a major contributor to this effort. The EPI programme was
established more than 30 years ago initially with 6 antigens BCG, Diphtheria
Pertussis and Tetanus (DTP), Polio and Measles. In 2000, new initiatives were
launched with the financial support of the Global Alliance for Vaccine &
Immunization (GAVI) to introduce Hepatitis B vaccine followed five years later
with the introduction of DTP containing combination vaccine with Hepatitis B
and Haemophilus Influenzae type b [Hib] vaccine altogether in a single jab.
Today, immunization against 8 childhood infections (tuberculosis, diphtheria,
tetanus pertussis, polio, measles, hepatitis B and hib) are preventing more than
2.5 million child deaths every year. According to WHO estimates, raising the
vaccination coverage with these vaccines to 90% would result in averting an
additional two million deaths a year3.
The South East Asia region includes major manufacturers of vaccines located
mostly in India and in Indonesia. These producers from both private and public
sectors play a significant role in ensuring vaccine availability in the region and on
a global scale. The WHO regional office for South East Asia has encouraged the
Member Countries to develop long term policies not only to maintain the current
level of vaccine production but also to stimulate research and development for
vaccines to prevent tropical diseases i.e.; Dengue, Japanese Encephalitis and
Malaria. In 2003, SEARO/IVD published the first regional vaccine policy for the
South East Asia region with the broad objective to provide a framework for
decision makers on issues related to vaccine research, production availability and
distribution.
Since 2003, the EPI programme in countries of the SEA region have undergone
many changes and transformed its character to a great extent. During this period,
new vaccines and new combinations of established vaccines have been
introduced. This change has been initiated subsequent to observations by the
immunization stakeholders at the global level that the uptake of vaccines which
were available in the developed countries was slow in the developing world . For
an example, Hepatitis B vaccine
had not been able to be used in developing
countries even 20 years after its extensive use in developed countries.
Recognizing the reasons for slow up take, the GAVI was created by immunization
stakeholders to support introducing Hepatitis B and Auto Disabled (AD) syringes
in developing countries. This eventually led to an increase in uptake of Hepatitis
B vaccine.
1
Riding on the success of the introduction of the Hepatitis B vaccine in developing
countries, the immunization stakeholders continued research on developing low cost new
vaccines and technologies and provided these research findings to the vaccine
manufacturers including in developing countries. Parallel to these developments,
countries were identified based on Gross National Income (GNI) for prioritization of
support. The measure of defining eligibility for support was aimed at increasing the
uptake of underutilized new vaccines in least affordable countries. In order to enhance
the country responsibility in vaccine procurement, subsequently a co-financing
mechanism was introduced. In addition to these interventions small groups were
identified in focussing on specific vaccines. As a result of these activities, low cost
vaccines such as live attenuated Japanese Encephalitis Vaccine SA-14-14-2
were
available for introduction in lower income countries.
Among other developments, new technologies have been introduced to improve injection
safety, the price of vaccines have overall decreased but new vaccines are available with
higher cost the epidemiology of vaccine preventable diseases has changed, expectations
of the community for vaccine safety have increased and intensified campaigns have been
conducted as a final push to achieve set eradication and elimination targets and the
Millennium Development Goals by 2015. The Table 1 summarizes major immunization
policy changes that occurred since 2003 in each of the 11 SEA countries.
Table 1: Major policy changes in the National Immunization Programme (NIP) in
South East Asia
Countries
New Vaccine and
under-utilised vaccine
Injection safety
policy
NRA status
Vaccine produced
locally that become
PQ
BANGLADE
SH
 Hep B introduced over
2003-2005,
 Pantavalent vaccine DPTHepB-Hib introduced in
2009
 Pneumococcal vaccine in
2012
 Combo vaccine DPT-Hep
B introduced in 2003
 Measles Rubella vaccine
introduced in 2006
 Pentavalent vaccine
introduced in 2009
 HPV vaccine introduced in
2010
 AD syringes
introduced for all
antigens in 2004
 NRA assessment
conducted in 2009
 Institutional
development plan to
build capacity
implemented
 No local production of
vaccine but has future
plans for local production
of vaccine
 AD syringes
introduced in 2003
 Not assessed
 No production
 JE vaccine introduced in
2006 in selected districts
 Introduction of Hep B
vaccine into 10 states in
2007 and expansion in
2011-12
 AD syringes
introduced in 2005
 NRA becomes
functional in 2008
 Partnership with NRA
in IC established for
Market Authroization
(Canada)
 3 new manufacturers
started production of PQ
vaccines
 8 new vaccines became
WHO PQ between 2003
and 2010
 Total of 8 manufacturers
are producing PQ
vaccines
BHUTAN
DPR KOREA
INDIA
2
SIA
implemented
Countries
New Vaccine and
under-utilised vaccine
INDONESIA
MALDIVES
DTP-Hep B/ DTP-Hep B-Hib
DTP-Hep B/ DTP-Hep B-Hib
in 2012
DTP-Hep B/ DTP-Hep B-Hib
in 2012
Hep B vaccine introduced in
2003
DTP-Hep B introduced in
2005
DTP-HepB-Hib introduced in
2009
JE vaccine introduced in 2006
in endemic districts
MYANMAR
NEPAL
SRI LANKA
THAILAND
TIMOR
LESTE
Hep B introduced in 2003
DTP-Hep B-Hib introduced in
2008
Transition to Live JE vaccine
from Inactivated JE vaccine in
2009
MMR replaces Measles and
MR in 2011
Injection safety
policy
NRA status
Vaccine produced
locally that become
PQ
SIA
implemented
Injection safety policy
developed, AD
syringes and safety
boxes introduced in
the EPI 2003
No vaccine production
First NID
conducted in
1996, TT
campaign
started in
2000, measles
campaign in
2004/05 and
JE campaign
in 2006
AD syringes introduced
in 2003
No local production
DTP-Hep B-Hib introduced in
2012
In 2005, the WHO and UNICEF jointly prepared a Global Immunization Vision
and Strategy 2006-2015 (GIVS) to meet the challenges in global immunization.
GIVS goal by 2010 or earlier is for countries to reach at least 90% national
vaccination coverage and at least 80% vaccination coverage in every district or
equivalent administrative unit. By 2015, the GIVS aims to sustain vaccination
coverage goal reached in 2010 and to reduce morbidity and mortality due to
vaccine preventable diseases by at least two thirds compared to 2000 levels. It
further aims gradual introduction of new vaccines to reach full scale availability
for all eligible population within 5 years of the introduction of these new
vaccines in national programmes, ensuring capacity for surveillance and
monitoring, strengthen health systems and assure financial sustainability4.
Introduction of new vaccines will also be an important contributor to achieving
Millennium Development Goal 4. The challenge to develop immunization policy
is to take advantages of achievements and to understand and utilize the
opportunities created by vaccine market forces that will drive vaccine prices to
affordable levels for developing countries.
In the last decade, the vaccine market has grown at an annual rate of 10% from
$2.9 bn to 6bn. This growth is forecast to continue. The market remains
characterized by strong value /volume skews. High income country demand
represents 82% of industry revenue but only 12% of volume (Mercier
Management consulting; Lessons Learned: New procurement Strategies for
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vaccines Final report to the GAVI Board). For the multinational targeting high
income country markets (USA, Western Europe and Japan), the profitability has
risen significantly driven by patented products. As a consequence, Reasearch and
Development (R&D) initiatives and investments have also risen significantly to
reach pharmaceutical industry levels.
In the low and middle income countries the paradigm is different. Vaccines used
to vaccinate children and adults in the national immunization programmes are
non-patented products.
The Developing Country Vaccine Manufacturers
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Network (DCVMN ), a non-profit public health driven alliance of vaccine
manufacturers which are located in developing countries, estimated that 2 out of
every 3 children born in the world get immunized with at least one vaccine come
from a manufacturer of the DCVMN. This further demonstrates the critical role
vaccine manufacturers in developing countries have taken to ensure the global
supply of most needed vaccines. However, these vaccines are sold at very low
prices yielding less profit than patented products and thus generating less
financial opportunity to invest in R&D. Out of the 28 members of the DCVMN,
10 are located in the SEA region including India, Indonesia and Thailand. India
has become a major vaccine producing country manufacturing more than 80% of
the total DTP group of vaccines produced by the DCVMN members.
Since 2000, R&D for vaccine in developing countries has received substantial
financial support from international funding sources and initiatives including the
International Finance Facility for Immunization (IFIM), Product development
partnerships with International Vaccine Initiative such as the Malaria Vaccine
Initiative, Advance Market commitment, etc. This assistance, critical to stimulate
regional vaccine research, was mainly focusing on clinical trials with products
developed by industrialized country manufacturers, transfer of technology and
bulk importation of non-patented vaccine products to develop production
capacity in developing countries. In the SEA region, 3 vaccine manufacturers,
namely, 1) Biopharma, Indonesia, 2) Serum Institute of India, India and, 3)
Biological Evans Limited, India, have benefited from a transfer of technology
from the National Vaccine Institute (NVI) in Netherlands for the production of
conjugate vaccine against Hib based on the Robbins conjugate technology. In
2009, these 3 manufacturers produced around 53 million doses of Hib containing
vaccine with SII manufacturing 72% of it (XXXX REFERENCE).
DCVMN membrs includes: 1) Bharat Immunologicals & Biologicals Corp’n India, 2) Bharat biotech Intl,
India, 3) Bio farma Indonesia, 4) Biological Evans Ld India, 5) BIRMEX Mexico, 6) China Natl Biotech
corp’n china, 7) CGEB Cuba, 8) Fiocruz/BioManguinhos Brazil, 9) Finlay Institute Cuba, 10) Hafkine BioPharmaceutical copr’n India, 11) India Immunologicals lts india, 12) Instituto Butantan Brazil, 13) Institute
Pasteur d’Iran Iran, 14) Institu Pasteur de Dakar Senegal, 15) Institut Pasteur de Tunis Tunisia, 16) Institute
of Virology of Belgrade Yugoslavia, 17) Queen Saovabba institute (QSMI) Thailand; 18) LG Life science
South Korea; 19) National Institute of Vaccine and Biologicals (IVAC) Vietnam; 20) Panacea Biotech Ltd
india; 21) Razi Institute for serums and Vaccine Iran; 22) serum Institute of India Ltd India; 23) Vabiotech,
National Institute of Hygiene and Epidemiology (NIHE) Vietnam, 24) VACSERA, Egypt; 25) Zhengzhou
Kangtai Pharmaceutical Co Ltd China; 26) Zydus Cadilla India; 27) The Biovac South Africa; 28) Xiamen
YST Biotec China
1
4
Table 2: Clinical trials conducted in the region.
Sr No.
Name of the Country
1.
India
2.
3.
3.
Indonesia
Sri Lanka
Thailand
Vaccine under
development
Stage of Development of most advance
candidate
a)Oral Cholera
vaccine
b) Rota Virus Vaccine
Clinical Trial
Clinical Trial
c) Anthrax Vaccine
Clinical Trial
d) Pneumococcal Vaccine
e) Meningococcal Vaccine
Pre-clinical
Clinical Trial
f) H1N1 Vaccine
Pre- Clinical
a) H1N1 Vaccine
a) JE SA 14-14-2
a) H1N1 Vaccine
b) HIV
c) Dengue and JE vaccine
Pre- Clinical
Immunogenecity and safety
Pre- Clinical
Clinical trial phase 1, 2 and 3 (prime-boost
MOPH/RTA/Mahidol/US)
Preclinical
Avian Influenza/allergy vaccine
Preclinical/bioequivalent study
The region has a large community of well qualified scientists especially in
vaccine producing countries with sophisticated laboratory facilities in some
countries. However, the lack of interest , incentives and support of governments
for R&D in producing countries, the challenges posed by Intellectual Property
Rights (IPR) , regulatory compliance, the limited coordination between research
institutes, manufacturers, National Regulatory Authorities and national
immunization programmes have hampered the development of novel vaccines
needed for the South East Asia region i.e.; Cholera, Japanese Encephalitis (JE),
Malaria, dengue, Diarrhoeal diseases, etc. There is a need to develop an
immunization policy for the SEA region that would foster Government leadership
for vaccine R&D, and stimulate greater synergy between research institutes and
universities, National Regulatory Authorities, manufacturers and national EPI
programmes to define vaccine research and development priorities.
A national policy on immunization will rationalize the decision making process, provide
a vision with priority interventions and estimate financial requirements in the short- and
medium-term perspectives. It would also send a clear signal to vaccine production units
within the country, within the region and globally to plan and coordinate production to
meet the global needs of vaccines. Rather than developing national policies from scratch,
it would be more beneficial to adapt a regional policy to the national needs. This will also
enable some degree of similarity of the national policies of different countries in the
region which share common characteristics with regard to the epidemiology of vaccine
preventable diseases and socio-economic considerations.
2. PURPOSE OF THE POLICY
The need for a regional vaccine policy was first articulated by the South-East
Asia Regional Advisory Committee for Health Research (ACHR) in April 1999.
A task force was formed and a policy document was developed covering the
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period 2003 to 20107. This policy document is for the five year period of 20102015.
This policy does not intend to cover all aspects of the service delivery of
immunization programmes or detailed guidelines on specific vaccines that are
included in other global and regional documents8. Rather, its primary purpose is
to provide a framework for decision-making on wide-ranging issues related to
research, production, availability, and distribution of vaccines and the
sustainability of the immunisation programmes in the countries of the region. The
ultimate aim of this document is to develop regional priorities for sustainable
vaccine initiatives and immunisation strategies that support the goals of national
immunization programmes of Member Countries. By providing direction for
vaccine initiatives and immunization strategies, the policy can serve as an
advocacy tool to increase government and donor commitment and to encourage
greater cooperation among countries.
In retrospect, SEA members states immunization programmes have achieved a
great deal since the first regional policy was introduced in terms of vaccine
safety, vaccine quality and its regulations, vaccine coverage and Supplementary
Immunization Activities for Polio eradication , measles mortality reduction and
Measles-Neonatal Tetanus elimination . This regional policy aims to take
advantages of the past lessons learnt and to move countries of the region towards
vaccine security with quality products alongside a greater visibility and
mobilization of the regional and country vaccine scientists’ communities and
governments to address needs of vaccine R&D to prevent tropical diseases.
CONTEXTS
3.1
Currently Used Routine EPI Vaccines
Routine vaccination is an effective, safe, and economical intervention that has
brought about dramatic improvements in reducing childhood morbidity and
mortality and overall in health. In the South-East Asia Region (SEAR) childhood
immunizations against polio, diphtheria, pertussis, tetanus, measles and
tuberculosis have been given since the 1970s and every child has a right to receive
these vaccines. In 2010, except for India, and Timor Leste, all other countries in
the region have over 80% coverage with DTP39.
Currently, member countries have different immunization schedules (refer Table
1). Nevertheless, during the last decade a number of new vaccines have been
introduced in all countries which have now become routine. These include
vaccines against Hepatitis B, Japanese Encephalitis (JE) and Haemophilus
influenzae type B.
Countries must have the capacity to forecast their vaccine supply needs and
procure and have necessary funding to meet these needs. Of the countries in the
SEA Region, India, Indonesia and to some extent Thailand produce substantial
quantities of routine vaccines. Other non vaccine producing countries purchase
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their vaccines either directly through WHO pre-qualified vaccine manufacturers
in the global market or through international group procurement systems such as
through UNICEF Supply Division or PAHO revolving funds.
3.2
Other Vaccines
Other vaccines may be either 1) currently available and under-utilised vaccines or 2) new
or potential vaccines.
A workshop9 held in 2009 to develop the regional vaccine priority framework for
introduction of new vaccines in the South East Asia Region prioritized vaccines
for consideration for introduction in the region, and categorized them into three
categories (short term, medium term and long term):
Rubella, Hib, conjugate pneumococcal,
1. Immediate priority vaccines
typhoid, seasonal influenza, rotavirus,
(for consideration for
cholera
introduction in the next 2-3
years)
Mumps, new and improved JE vaccines,
human papillomavirus (HPV), rabies,
Hepatitis A, meningococcal vaccine
(against meningococcus A)
HIV, IPV, Dengue, Hepatitis E,
Tuberculosis
2. Vaccines considering to be
introduced in the near future (
in 5-10 years)
3. Vaccines considering to be
introduced in the distant
future (for consideration for
introduction in 10 years)
Vaccines against hepatitis A, pneumococcal diseases, rotavirus diarrhoea and
human papiloma virus and a few others have been available for sometime, but
have not been used extensively in the public health programmes of most
developing countries for reasons primarily due to cost, unknown disease burden,
other priority health issues and lack of infrastructure including cold chain
facilities. However, a number of these vaccines, though poorly regulated and
controlled, are available in the private sector in all countries of the region.
There are other diseases such as malaria, dengue and tuberculosis prevalent in the
countries of the region that take a huge toll on productive lives for which no safe,
effective, and economical vaccine yet exist. HIV/AIDS has a wider global
prevalence, but still has a much deeper impact in developing countries. Due to
resource constraints and multiple competing health problems and lack of clear
health policies and strategies, drugs and even low-cost prevention measures are
less available in developing countries.
Most of the research and progress in developing new vaccines has taken place in
the industrialized countries10. Until recently, comparatively little effort has been
7
made to develop new vaccines for diseases that are priorities in the developing
countries. Further compounding this disparity is the reality that developing
countries have limited access to new technologies for vaccine development and
production. Consequently, developing countries primarily produce only the
“traditional” vaccines and limited work takes place to address the needs of the
third world. In response to these concerns, the Developing Countries Vaccine
Manufacturers’ Network was established in November 2000.
Strategies
recommended by this group to promote vaccine research and production in
developing countries should be considered in formulating a regional vaccine
policy 11.
Vaccine research in the SEA should focus on improving regional capacity for the
following: to carry out basic science research, conduct clinical trials, to transfer
research into viable products, to support immunization programme
implementation and evaluation, and to facilitate introduction of new research
techniques and methodologies. Clear policy statements will enable relevant
regional bodies (such as the Regional Committee and the Technical Consultative
Group on Immunizations) and Member Countries to establish a strong network of
resources and develop a research agenda based on local priorities.
3.3
Vaccine Quality
Since the last publication of the regional Vaccine Policy for the South East Asia
Region in September 2003, the vaccine regulatory context in South East Asia has
significantly improved among the eleven member states. The 3 vaccine
producing countries, namely, India, Indonesia and Thailand, now have a fully
functioning NRA in compliance with WHO set of criteria to regulate vaccine
safety, quality and efficacy. All countries including those that are procuring
vaccine directly or through UN procurement agencies have established
monitoring system for Adverse Events Following Immunization (AEFI). A
network of vaccine regulatory experts was expanded to include specialists from
industrialized countries and emerging countries in other WHO regions. This
network of regulatory specialists was instrumental to conduct WHO formal NRA
assessments with international teams of highly specialized technicians, to foster
innovative partnerships to implement Institutional Development Plans including
development of training material to facilitate in-countries training courses on
Vaccine Quality with WHO. A regional vaccine policy can set the goal and
strategy to further promote partnerships among vaccine regulatory institutions
and specialists, to harmonize and to standardize procedures allowing countries
with limited regulatory capacity to benefit from NRA with expertise to assess the
vaccine dossier. The regional vaccine policy provides the framework for a
country to establish fast track licensing procedures for vaccine and support
mechanisms for mutual recognition of regulatory pathways with NRA from
countries with assessed regulatory capacity. The regional vaccine policy should
encourage the integration and the standardization of WHO PQ procedures with
existing regional fora and task forces activities such as “the vaccine chapter” for
clinical evaluation of vaccines in the Association of South East Asian Nations
(ASEAN). Finally, the regional vaccine policy is in line with on-going policy to
decentralize WHO support to bring expertise closer to countries in need.
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3.4
Context of overall health policy
Implementation of any immunization programme must be put in the perspective
of ongoing public heath policy. Health sector reform is sweeping through many
countries in the world, including Bangladesh, Indonesia, Sri Lanka and Thailand
in the SEA Region. The opportunities and challenges presented by these reforms
need to be evaluated in the context of vaccine security, research and development,
and vaccine regulation.
The EPI programme has contributed in many ways in strengthening of health
systems and its acceptance by the community. In addition to providing
immunization services, the EPI programme has been used to complement other
programmes such as the vitamin A supplementation programme by providing an
opportunity for their initiation and implementation. The EPI programme has also
trained many health care workers in various aspects of programme management
and implementation. Some aspects of these training programmes are applicable to
other programmes as well and there are many lessons that could be learnt from
this experience. In short, it can be concluded that the EPI programme has helped
in strengthening the health system.
As much as the EPI programme has helped in strengthening the health system,
immunization programmes cannot function in isolation. Consequently, the
capacity to integrate with other programmes needs to be developed. A regional
immunization policy should provide broad guidance to countries on how to
address this challenge.
4. GUIDING PRINCIPLES
The regional immunization policy is based on five guiding principles that underscore the
tenets of immunization:
(1) Immunization is the most cost-effective public health interventions.
Hence every child in the target age group should have equal access to
immunization services regardless of its social determinants of health
(religion, caste, or economic status etc).
(2) Immunization is a public good. That is, immunization produces group
benefits far greater than the sum of individual benefits obtained by those
immunized. Therefore, governments should allocate sufficient funds in
ensuring adequate vaccines of assured quality for immunization
programmes .
(3) Immunization services are only one modality for health promotion and
disease prevention. Immunization services should complement other
methods of health promotion or disease prevention.
(4) Immunization services should complement and be integrated with other
health care services. This is best achieved through primary health care
approaches that provide the best opportunity to reduce inequities.
(5) The Region should strive for vaccine self-sufficiency for all countries.
This is broadly defined as:
9
Access to all nationally adopted vaccines either through procurement
from the global market or through domestic production overseen by a
competent national regulatory authority. Mechanisms to finance
vaccines should be developed in close collaboration with governments,
donor agencies, and vaccine manufacturers to ensure sustainability.
There are three important approaches which serve as the premises for
implementing the policy itself:
(6) Based on the primary principles of equity, sustainability, and regional
solidarity, the regional immunisation policy will complement and
support the development of a national immunisation policy in each
country.
(7) The process of policy development should be guided by technical experts
and related stakeholders in the field and it should be an interactive
process with Member Countries. Good practices and desirable standards
must be balanced with country needs and realities.
(8) Development of the current policy will be based on the best available
evidence/knowledge with the understanding that this is a dynamic
process incorporating multiple issues both directly and indirectly related
to immunization services. To take this into account, the Task Force
should periodically review the policy.
5.
POLICY OBJECTIVES
Within the broad purpose of providing a framework for decision-making, the
immunization policy has nine policy objectives:
(1) To ensure political and administrative commitment at the highest level
to ensure sustainable immunization services in member countries;
(2) To provide guidance to member countries to ensure an adequate, safe
and equitable immunization service;
(3) To provide guidance to member countries to improve and expand
existing immunization services;
(4) To provide criteria for countries to select new vaccines for National
Immunization Programmes;
(5) To provide a coordinated approach to establishing regional vaccine
needs, including evaluation of current vaccine production capacity and
suggested initiatives for determining the burden of vaccine preventable
diseases;
(6) To assist countries in assessing the options for attaining and sustaining
financial self-sufficiency for existing and expanded immunization
services;
(7) To provide support and direct global and bilateral inputs to the countries
in the Region, and facilitating public-private partnerships in vaccine
development and immunization services;
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(8) To provide guidance on establishing regional vaccine research and
development (R&D) priorities in the global context and to determine
steps necessary to strengthen regional R&D, production, and necessary
regulatory oversight capacity; and
(9) To broadly support the implementation of national immunization
programmes within the framework of the health systems based on
primary health care/PHC in member countries.
6. POLICY FRAMEWORK
6.1 Political and administrative commitment at the highest level to ensure
sustainable immunization services
In most countries in the region, the management of the EPI programme has been
done as a vertical programme with integration of services at the client level. The
management of, and the logistic support for, the EPI programme at the Central
level requires a high level of political and administrative commitment
6.2 Adequate, safe and equitable immunization services
In the region, the challenge for WHO remains providing guidance to member
countries to
ensure an adequate, safe and equitable immunization services.
Hence, this policy objective will be key for ensuring the accessibility, the
availability and the uninterrupted supply of quality vaccines that has been widely
accepted by the community in all countries.
6.3
Improve and expand existing immunization services
Seven member states (Bangladesh, Bhutan, DPR Korea, Maldives, Myanmar and
Sri Lanka) have already achieved >90% coverage for DTP3 at the national level.
Nepal and Indonesia have a DTP3 coverage > 80% at national level. India and
Timor Leste are the only countries in the region that have not achieved 80%
coverage of DTP3. However, there are wide differences in immunization
coverage across Member States as well as within countries between states,
provinces, districts or equivalent administrative areas. When countries reach
immunization coverage of 80%, the push to improve coverages beyond what has
already been achieved becomes difficult. At this stage, it is essential to assess
coverage at sub national / district or even local level to identify pockets of low
coverage and unimmunized children and take appropriate actions to improve
coverage and reach the unimmunized. As indicated by the District Level Health
Survey III (2007-08) in India, 90% of children who did not receive DTP3 resided
in 11 states (Uttar Pradesh, Bihar, Rajasthan, Madhya Pradesh, Maharasthra,
West Bengal, Assam, Jharkhand, Gujarat Andhra Pradesh, and chattsgarh). Out
of these states Maharasthra, West Bengal, Gujarat and Andhra Pradesh are
medium performing states with DTP3 coverage of at least 70%. This evidence
very clearly stress the need for providing guidance to member countries to
improve and expand existing immunization services.
There is evidence from Indonesia to suggest that the post financial crisis of the
late 1990s and the decentralization of immunization services have led to a decline
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in access and quality of immunization services in the country. However,
strenuous efforts have been undertaken to enhance coverage in Indonesia and as a
result the current, DTP3 coverage in Indonesia is > 80% at the national level. .
Based on existing knowledge and experience, interventional framework is being
suggested for six key determinants that has been identified for low routine
immunization coverage in the SEA Region.
1.
Improving access:




2.
Using social mobilization and advocacy campaigns to publicize time, date
and location of immunization services
Increasing opportunities for immunization by using community
information to design context specific delivery mechanisms to reach every
community
Increasing the range of settings in which immunization services are
provided
Reducing the opportunity costs for immunization (decreasing waiting
time/community pooling of transport services )
Ensuring resource availability & utilization:







3.
Mapping and addressing gaps in resource positions including finances,
infrastructure, human resources, vaccine supply and cold chain
Advocating governments for financing immunization as an investment
Developing financial sustainability plans
Adopting different mechanisms to support existing staff until new staff is
recruited
Ensuring availability of an adequate number of trained vaccinators
Advocating for filling vacancy positions and reducing the workload of
the overburdened staff
Introducing a coordination network of all field level staff who can be
mobilized for immunization activities
Strengthening immunization service delivery:




Improving utilization of available immunization services through
improvement of quality of service delivery,
Strengthening cold chain ( vaccine Supply chain) systems, effective vaccine
management ensuring assured quality of vaccines and other logistics
distributed timely to all levels of immunization programme
Strengthen collaboration and integration with other primary health care
services
Using maternal health delivery mechanisms to increase awareness and
establish early linkages for compliance to immunization schedules and
follow up on children who have missed vaccinations.
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4.
Information Use:


5.
Management of AEFI:




6.
Strengthening of AEFI surveillance
Investigation of serious AEFI cases
Implementation of a plan for effective management of AEFI and risk
communication.
Exploring ways to encourage parents to be partners in maintaining up to date
vaccination records and reporting AEFI. .
Enhancing managerial capacity:




6.4
Strengthen recording, reporting, improving data quality; analysis,
interpretation, use and exchange of data for programme planning at all levels
Sharing of data, using common platforms for monitoring and evaluation
Using Middle Level Managerial training modules to address training needs at
different levels and scaling up training of key managers.
Reorganizing monitoring and supervision systems to improve performance
Task based Standard Operating Procedures for Immunization service
providers and supervisors; incentives / rewards for teams achieving outlined
targets.
Introducing quarterly monitoring of
standard denominators.
immunization coverage at
all levels with
Introduction of new vaccines for National Immunization Programmes
The introduction of new vaccines in routine immunization programmes is a
lengthy and complex process. Ideally, vaccine development should be guided by
the extent of disease burden, but market forces often dictate other directions. On a
regional or global basis, the disease burden should determine research and
development priorities.
However, for the introduction of new vaccines the major criterion appears to be
the availability of a vaccine. Subsequent to the availability of the vaccine, disease
burden studies are carried out that may not necessarily reflect the relative burden
of disease in measurable terms such as the attributable fraction. When studies to
estimate the burden of disease of a specific disease are conducted singularly, it is
13
likely that exaggerated estimates are obtained unless the entire surveillance
process is enhanced to encompass all preventable infectious diseases.
Individual countries must use the same data as measured in the same way as other
diseases as one of the criteria to select which, if any, of available vaccines to add
to their routine EPI or offer through other mechanisms. This is important as there
is a tendency to target the assessment of the burden of disease of diseases for
which vaccines are available irrespective of the relative burden of disease. If
decisions are based solely on the absolute burden of disease, there is the
theoretical possibility of a member country not being able to finance a new
vaccine that is cost-effective, affordable and sustainable if found in the near future
(say in the short term of 2-5 years) due to commitment of the introduction of a
new vaccine that may not have been relatively that important.
Norms and standards for new vaccines are set by national authorities in vaccine
producing countries and, globally, by WHO Expert Committees. National
Regulatory Authorities (NRA), in both exporting and importing countries, are
responsible for ensuring the quality of all vaccines used to vaccinate populations.
Countries also have to determine whether to produce locally or procure globally
and how they will continue to finance vaccine purchases. Selected vaccines are
introduced in routine immunization programmes with appropriate safety
precautions. Ultimately, it is the role of the NRA to monitor quality and safety but
it has to rely on the NIP capacity to collect quality AEFI data.
6.5 Establishing regional vaccine needs including evaluation of current vaccine
production capacity
Forcasting regional vaccine needs is a priority for the region. This is grounded not
only on the enhancement of the forecasting capacity of the countries, but also in
new innovative cost saving manoeuvres such as pooel procurement of vaccines.
To determine the regional vaccine needs,, appraisal of the current vaccine
production capacity of the region is also important. This may be relevant for
production capacity of vaccines such as JE which is produced outside the
region. Hence, the policy framework promotes providing a coordinated approach
to establishing regional vaccine needs.
6.6 Assesing the options for attaining and sustaining financial self-sufficiency for
immunization services
Attainment and sustenance of self-sufficiency is important based on the fact that
all member states fund their immunization programmes through allocations of
national budgets or through donor funds. Various circumstances in different
countries in the region will stretch finaincail resources. Hence, the policy
framework suggests the assessment of options for financial self-sufficiency
6.7
Support and direct global and bi-lateral inputs to regional countries and facilitation
of public private partnerships
14
The South East Asian region is characterised by the need for global and bi-lateral input
for aspects ranging from vaccine manufacturing to new vaccines introduction. The same
is essential in terms of mobilizing public and private partnerships for vaccine
manufacturing, introduction of new vaccines and delivery of vaccines to end recipients in
the country level. Hence, the policy frame work requires supporting access to global
inputs and facilitating public private partnerships
6.8
Establishing regional vaccine resreach and development priorities
Given the availability of s a large scientific community especially in vaccine
producing countries with sophisticated laboratory facilities in some countries and
non-availability of a strong link with medical institutes, NRAs, manufacturers
and the national EPI programmes to define research priorities, policy framework
highlights the need for providing guidance on establishing regional vaccine
research and development priorities in the global context and to determine steps
necessary to strengthen regional R&D, production and necessary regulatory
oversight capacity.
6.9
Implementation of the National immunization Programmes within the
framework of the health system
The regional policy framework is advocates that the implementation of the National
Immunization Programme should be carried out within the framework of the health
system. The suggested approach should be the time tested Primary Health Care
approach.
As these policy objectives are health system related, to further improve immunization
coverage, strengthening health system is critical. The relationship between the
improvement of the immunization services and the health system may be depicted as
shown in Figure 1.
15
Figure 1. Relationship between immunization services and the health system
7.
POLICY ISSUES
Based on the framework of improving the management of existing immunization services
and introduction of new vaccines, specific regional goals, policy approaches and
activities to assist in meeting these goals have been identified.
7.1
Political and administrative commitment
7.1.1 Regional goal
To ensure maximum political and administrative commitment at the highest level to
sustain, strengthen and expand existing immunisation services.
7.1.2 Status
The regional growth of political, administrative commitment and patronage since the
introduction of the EPI programme is best exemplified by the procurement of vaccines by
16
all member countries with funds allocated from their country’s regular budget or donor
funds.
7.1.3 Issues
 Ensuring political and administrative commitment and support for a
country-wide programme such as the EPI.

Competing priorities in resource limited settings in member countries.

Requirement of much advocacy at the highest level for ensuring maximum
political and administrative commitment and support

Political and administrative support in vaccine producing countries to
enforce the vaccine regulatory system to ensure that vaccines domestically
produced and used are equivalent or of higher safety and quality standards
than those which are WHO PQ.
7.1.4 Policy approaches and activities
Most politicians and administrators are cognizant of the benefits of immunization
services and view immunization as an intervention that serves the people. In order to
maintain this commitment at the highest level in the midst of competing priorities, the
following policy approaches need to be identified as priorities:
7.2

advocacy at the highest level to be maintained and strengthened.

reviewing activities at regular intervals and sharing the findings with all
concerned to ensure EPI programme continue to be a national priority

sufficient financial allocations made for the strengthening and expansion
of immunization services.
Strengthening and expanding existing immunization services
7.2.1 Regional goal
To strengthen and expand existing immunization services to reduce inequities and to
provide better services ensuring safe and effective vaccines and immunization services in
an integrated health system.
7.2.2 Status
In the South-East Asia Region (SEAR), childhood immunizations against polio,
diphtheria, pertussis, tetanus, measles and tuberculosis have been included in the
immunization programmes since the 1970s and every child has a right to receive them.
Except for India, Indonesia, Nepal and Timor Leste, all other countries in the region have
over 90% coverage with DTP3.
During the last decade a number of new vaccines have been introduced in different
countries. These include vaccines against Hepatitis B (Hep B), Japanese Encephalitis (JE)
and Hemophilus influenzae type B (Hib).
17
7.2.3
Issues

Need for strengthening of the health system. to increase coverage over
and above levels achieved currently and to develop capacity for the
introduction of new vaccines

Challenge of providing immunization
populations and marginalised communities.
services
to
hard-to-reach
Policy approaches and activites
With regard to the schedule of routine immunization, the region recommends the
following policy approaches:
a.
to ensure an opportunity for children to receive the 4th dose of DTPw
before they reach 5 years of age,
b.
to ensure an opportunity for a dose of Td in the
immunization schedules to prevent diphtheria in adulthood, and
c.
to ensure the delivery of a 2nd dose of measles in the
respective immunization schedules either as a 2nd routine dose or
through routine immunization or periodic SIAs. The countries may
provide opportunities for either MR or MMR depending on the
epidemiology of rubella and mumps in the respective country
The issues pertinent to strengthening and expanding immunization services are
interrelated and overarching. Hence some of the policy approaches and activities are
addressed separately under separate headings below. Client perspectives are addressed in
section 7.7.
7.2.3.1
7.2.3.1.1
Access to safe and effective vaccines
Regional Goal
To ensure equitable access to immunization services and availability of
safe and effective vaccines to all children in all member states in the
region
7.2.3.1.2
Status
Currently, most of the SEA countries are using vaccines of assured quality
as per WHO definition. India is using a mix of vaccines from PQ sources
and from public sector domestic manufacturers that have not submitted
their products for WHO Pre-Qualification. All vaccines used in India for
the National Immunization Programme are domestically produced except
JE which is manufactured in China. Thailand also procures vaccines out of
the WHO list of PQ products but mostly from producers in Industrialized
Countries with functioning NRAs. In all SEA vaccine producing countries,
including India, Indonesia and Thailand, the NRAs were recently assessed;
after the implementation of the Institutional Development Plan all were
18
found functioning to regulate vaccine safety, quality and efficacy. All the
other countries use WHO PQ vaccines that are procured directly through
their national procurement agencies or through UNICEF. The priority for
countries that do not produce vaccines is to establish vaccine licensing
procedures that comply with fast track guidelines for registration of WHO
PQ vaccines (REFRENCE) and/or other harmonized and standardized
registration procedures agreed upon among member states. A country in
the region with a strong NRA could conduct part of the pre-clinical
assessment of the product dossier and its manufacturing process that is
required for a full vaccine licensure and be endorsed by countries with
limited regulatory capacity.
7.2.3.1.3

7.2.3.1.4
Issues/Challenges
Future challenge of overstretched capacities of countries to provide an
efficient regulatory framework to entry of more vaccine producers and
newer vaccines in the market

Hard-to-reach populations and marginalized communities where
immunization coverage is low as compared to national figures. for special
attention

Issues emerging from the lucrative immunization market offering a
plethora of vaccines not available in the public sector in all member
countries
o Using various schedules
o Mostly not being regulated and monitored properly
o Not reporting immunization coverage in routine returns compiled
by the public sector.
o Affecting the coverage reported by the public sector as more
clients would avail of private sector services and would not be
counted in the returns of the public sector.
Policy approaches and activities
.
Continuation with the current practice of pre-qualification and facilitating
a dialogue to ensure the availability of safe and effective vaccines between
countries in the region and, between countries and vaccine producers
o Assigning responsibility of regulation to the NRA of the country in
which the vaccine is produced and the NRA in the country in
which the vaccine is supplied.
o Providing assistance to enhance capacity of NRA
o
,
Removal of all potential barriers to immunization services
o Establishing an adequate number of vaccination centers to cover
all populations with proper infrastructure facilities
19
Increasing immunization coverage of hard-to reach marginalized
communities with low immunization coverage by strengthening the health
system, raising community awareness and promoting community
participation.
o Providing regular services including outreach sessions in “hard to
access areas”.
o Providing additional financial resources to improve infrastructure
and train additional human resources.
Operating immunization services within hours convenient for the access of
service users to increase immunization coverage
o Need to look at this aspect with a view to enhancing utilization of
immunization services by all member states.
Private Sector
Monitoring immunization services provided by the privates sector and
incorporating their statistics in national returns as a strategy for overall
programme monitoring to ensure that national goals are achieved.
o Using novel methods to coax the private sector to be partners in the
surveillance and reporting systems.
o Promulgation of legislation where the private sector will have to
account for all vaccines imported or purchased from local
manufacturers.
o Encouraging, the National Immunization Programme to offer the
vaccine free of charge to private practitioners, private clinics in
return that coverage data are provided to the NIP.
o Monitoring vaccines that are provided in the private sector by the
NRA that grants licenses to vaccines that may not be used in the
NIP.
o Establishing provisions in the vaccine licensing procedures to
make compulsory reporting of data as for a post-licensure clinical
trial (Phase IV) by The NRAs with the NIPs.
7.2.3.2
Vaccine management, logistics and cold chain infrastructure
7.2.3.2.1
Regional Goal
To establish
an un-interrupted effective delivery mechanism for and
maintain vaccines and supplies with suitable cold storage facilities and
management practices for the delivery of an effective immunization service
7.2.3.2.2
Status
The success of the EPI programme has been largely due to the
maintenance of the cold chain. Improvements in technology have
20
contributed tremendously to this effort. Member states have established a
good system for the maintenance of the cold chain as is evident from the
impact of the immunization programme.
In 2010, WHO IVB/EPI in Geneva compiled data on vaccine storage
capacity availability and requirements from 66 countries representing all
WHO regions. The finding shows that present vaccine storage capacity in
SEA member states is adequate. However, the storage requirement will
increase in a couple of years with the introduction of new vaccines.
7.2.3.2.3
Issues/Challenges


7.2.3.2.4
Requirement for upgrading and expansion of the cold chain in most
member states to increase coverage and introduce new vaccines. The
upgrading requires increased infrastructure in terms of physical space as
well as additional equipment.
Requirement for additional vaccine storage volume for introducing prefilled vaccine syringes and new vaccines in containers of less than 5 doses.
Pre-filled vaccine syringes may require up to 10 times more storage space.

Accurate forecasting of cold chain requirements where new vaccines are
to be introduced

Additional requirements will include infrastructure in terms of physical
space, necessary equipment, sites for proper storage facilities and plans
for development of these sites

Increased global demand for vaccine cold chain equipment that may
exceed the production capacity worldwide in next 5 years with the
introduction of New and under-utilized vaccines in many countries

Requirement of important recurrent equipment needs just to maintain the
existing cold chain infrastructure in large countries such as India and
Indonesia
Policy approaches and activities

Establishing optimal, overarching infra-structures including cold
storage facilities to provide immunization services for the successful
implementation of an effective immunization programme.

Upgrading and modernization and expansion of the existing clod chain
infrastructure system.
21

Updating of the inventory of existing cold chain infrastructure to
determine the extent of the resources needed for upgrading and
expansion

Commitment of the governments of member states , donor agencies,
other financing schemes such as co-financing and involvement of the
private sector for large scale funding required for expansion of the
cold chain facilities

Building on the WHO supported laboratory testing units established in
India and Singapore to promote regional production of cold chain
equipment suitable for vaccines. Tested and pre-qualified cold chain
equipment listings can be found on the WHO website
http://www.who.int/immunization_standards/vaccine_quality/pqs/en/

Strengthening and organization of health system for sustainable and,
continued supply of vaccines and other logistics
o Establishing well organized systems to procure, manage and
distribute vaccines and other logistics.

Oversight of vaccine safety and quality not only within vaccine
production facilities and during the lot release by NCL but also
throughout the distribution and storage phases in health facilities until
the vaccine is administered to the person by the National Regulatory
Authorities.

Prioritizing supporting activities to reinforce the regulatory role over
the storage and distribution of vaccines within the country in vaccine
producing countries and subsequent expansion to all countries of the
region.

Incorporating good management practices to effectively deliver
vaccines and supplies to the service delivery points in the grass root
levels.

Promoting co-ordination of immunization services with the private
sector to ensure an un-interrupted effective delivery mechanism for
vaccines and supplies with suitable storage facilities
7.2.3.3
VPD Surveillance
7.2.3.3.1
Regional Goal
To enhance VPD surveillance to assist immunization programmes in
achieving goals and targets
7.2.3.3.2
Status
22
Effective Vaccine Preventable Disease (VPD) surveillance is essential for
guiding immunization strategies, monitoring programme performance, and
allocating resources.
Since 2005, substantial progress has been made in accelerating and
integrating surveillance of VPDs with existing AFP surveillance systems
in the region. The polio eradication program in SEAR continues to be a
model for using data effectively to support AFP surveillance and control
polio and other vaccine-preventable diseases8. The polio Surveillance
Medical Officer (SMO) network in Bangladesh, India, Myanmar and
Nepal and the Surveillance Officer (SO) structure in provinces in
Indonesia have proven to be an essential component of effective AFP
surveillance for polio eradication.
The AFP surveillance performance indicators of most countries have
exceeded global and regional targets. Sub national indicators have been
used as benchmarks to identify areas of concern and to prioritize
surveillance reviews.
There is an effective system in place where member country surveillance
systems notify AFP cases to SEARO/IVD which, in turn, cross-notifies
countries within and outside the region in order to shorten response times.
Nepal, Bangladesh, Indonesia and Myanmar submit measles case-based
data2 on a monthly basis from their integrated VPD surveillance systems.
With the aim of obtaining information to determine the progress of
countries in achieving measles elimination, since 2009, the data collection
tools of SEAR were modified to capture information on suspected measles
cases, outbreaks and classification of outbreaks.
A comprehensive laboratory network supports field surveillance. The
SEAR laboratory network consists of 17 polio, 22 measles and 14 JE
laboratories supporting field surveillance. Laboratory data and field data
are merged electronically to give the final “picture” of the Vaccine
Preventable Diseases in the region.
7.2.3.3.3
Issues/Challenges


Expansion of case based surveillance especially for measles to ensure
that all indicators and targets towards elimination are achieved at
national and sub-national levels.
Requirement of greater government support for expansion of
surveillance networks
including case-based surveillance and
investigation of case
23


7.2.3.3.4
Varying quality of the annual data provided in WHO/UNICEF Joint
Reporting Form (JRF) and Annual EPI Reporting Form (AERF) by
country and inconsistency with the year-end surveillance data
provided through the aggregate monthly reporting system
Need for commencing surveillance of the diseases targeted by the
introduction of new and underutilized vaccines.
Policy approaches and activities:
.
Surveillance of VPDs before vaccine introduction

Demonstrating the disease burden to justify vaccine introduction,
identifying circulating strains of the organism and establishing a
system to measure vaccine impact when the vaccine is introduced.
o Currently, targeted syndromes are diarrhoeas and pneumonias
targeting Hib and pneumococcus, meningococcus, rotavirus
and typhoid organisms.
o In general, sentinel hospital based surveillance is being carried
out for some of these diseases among children less than five
years.

Where potential vaccines have been identified for introduction,
commencing surveillance of the respective diseases while
strengthening the overall surveillance system.
o This ensures that correct estimates of the attributable faction
are obtained for decision making.
o Concentrating only on the disease for which a potential vaccine
has been identified leads to erroneous exaggeration of the
disease burden
o Although starting such surveillance activities will be costly
initially, in the long term, it provides
benefits of the
investment for the introduction of a new vaccine that will far
outweigh the negative impacts in the short term.
Surveillance of VPDs after vaccine introduction

In line with the guiding principles of the Global Immunization Vision
and Strategy - GIVS (2006-2015)12 to pursue policies and strategies
based on evidence and best practices, the SEA Region is encouraging
Member States to ensure that, by 2015 or earlier, all countries will
have developed the capacity at all levels to conduct case-based
24
surveillance of vaccine-preventable diseases, supported by laboratory
confirmation where necessary.

Where this may not be possible for all VPDs, starting case-based
surveillance and investigation at least for diseases targeted for
elimination; and carrying out routine surveillance for all other diseases
at all levels.

prioritizing diseases for which case based surveillance systems should
be established by Member countries

Considering measles which is targeted for elimination as a priority

Strengthening of the existing system and its expansion of VPD
surveillance.
o Recruiting and providing adequate training to selected
personnel
o Considering funding of these activities a priority by both
governments and donor agencies.

Reviewing the discrepancies between the annual data provided by JRF
and AERF and the monthly surveillance data in detail.
o Periodic reviews at closer intervals such as quarterly intervals
to reconcile inconsistent data.
o The introduction of immunization registers maintained by
health care workers that record all immunizations given would
help in minimising data discrepancies.

Expansion and integration of the VPD surveillance laboratory network
with surveillance of other communicable diseases.
7.2.3.4
Adverse Events Following Immunization (AEFI) Surveillance,
causality assessment and management
7.2.3.4.1
Regional Goal
To eestablish and sustain effective systems for monitoring adverse events
following immunization, their management and communicating the
investigation results with all stakeholders
7.2.3.4.2
Status
As the incidence of vaccine-preventable diseases is reduced or even close
to elimination due to high routine immunization coverage, Supplementary
Immunization Activities (SIA), the use of vaccine of assured quality, and
the rate of adverse events associated with immunization become relatively
25
more apparent with better surveillance systems able to detect and report
AEFI which before were unnoticed. This conjunction of factors
consequently has led to increased public concerns about vaccine safety. In
the SEA region, MoHs had to temporally suspend immunization services
following clusters of deaths temporally associated with AEFI (e.g. with
the use of Measles vaccines in Myanmar in 2005-2006 and in India in
2008 and 2010, and with Rubella vaccine in Sri-Lanka in 2009). The
MoHs with the technical assistance of WHO, conducted causality
assessments and scientifically demonstrated that the quality of the vaccine
was not related to the causes of the deaths reported as AEFI.
AEFI surveillance is an important aspect of immunization services. While
all member countries have some sort of AEFI surveillance system in place,
there are wide variations in its practice, both between and within countries.
Where surveillance systems are in place, causality assessment is done
when serious events occur. Management of potential AEFI are done at the
peripheral level based on guidelines issued by the nationalprogrammes.
7.2.3.4.3
Issues/Challenges
 Improving AEFI surveillance and causal investigation with view to
improving immunization services as well as maintaining client
confidence in the programme.

Causality assessment and reassurance of the public to counter adverse
media reports following the occurrence of adverse events.

Non-allocation of funds by many MoHs to the national AEFI
committee to conduct vaccine post-licensure studies or to conduct
periodic meetings for causality assessment and providing feed back.
Though very well documented vaccine safety profiles which have
facilitated AEFI causality assessment are available for traditional EPI
vaccines, changing paradigm for the introduction of under-utilized
and new vaccines possessing regulatory challenges to the NRA in the
SEA countries
o Pentavalent vaccine is manufactured by four manufacturers in
four countries including 2 in the SEA region.
o The vaccine although licensed in all the producing countries, is
not used in the National Immunization Programm as it is
produced to supply developing countries mostly with no AEFI
system.
o Consequently very limited post-licensure safety data are
available constraining the comparison of AEFI rates among the
countries using the vaccine.

7.2.3.4.4
Policy approaches and activities
26

Establishing functional expert committees on monitoring AEFI in all
Member States-

Operationalizing mechanisms of adequate monitoring and timely
management of AEFI along with
establishing effective
communicating channels with all stakeholders.

Countries being open on this issue and sharing the information with
immunization stakeholders including WHO and national AEFI
committees to avoid crisis situations resulting from inaccurate and
adverse media reports based on false allegations of vaccine subquality.
o Keeping the media informed by EPI managers not only at the
time AEFI occurs but each time a major policy change occurs
such as the introduction of a new vaccine in the NIP, major
upgrading of the cold chain infrastructures, Supplementary
Immunization Activities, etc…

Including a secretariat and having a budget to fulfill their duties and
responsibilities by National AEFI committees.

Striving to raise funds in novel ways by member countries to support
AEFI surveillance including mobilization of the support of vaccine
industry, the AEFI surveillance role of which has been limited. Due
to perceived conflicts of interest, lack of credibility, and vaccination
promotion by public health institutions.

Ensuring that the role of the National Regulatory Authority and the
National Control Laboratory in overseeing the safety, quality and
efficacy of the vaccines is well understood especially in the countries
that do not produce vaccines.
o Establishing the role of the NRA/NCL from the moment the
vaccine specifications are developed and tenders are issued for
their procurement.
o Then checking compliance with specifications and release the
lot for use in the NIPs by NRAs.
o Contacting manufacturers to verify if similar incidents have
occurred in other countries where the vaccine was distributed
and also to conduct testing procedures when AEFI occurs
o Adopting WHO developed guidelines for fast track licensing
that include simple procedures to be undertaken by the NRA
when WHO pre-Qualified vaccines are delivered to countries13.
27

Providing WHO’s technical support to strengthen procedures
established by countries to respond to serous AEFI cases
by
empowering national AEFI committees and advocacy for greater
involvement of NRAs/NCLs in investigations.

Promoting the capacity of assessing the causality assessment between
an AEFI and a vaccine using a three-pronged strategy:
a.
To enhance regional networking of AEFI experts to share AEFI
data in order to document vaccine safety profiles especially for
vaccines that have recently been introduced and for which limited
data is available in the region.
To streamline and standardize procedures for field and laboratory
investigations. This includes completeness and timeliness of the
investigation.
To prepare a regional guideline by the WHO to utilize laboratory
investigations to verify causal hypothesis,
post mortem
investigations when they can be undertaken to verify a hypothesis
for the benefit of National AEFI committees
b.
c.

Ensuring access to vaccine regulatory experts from 10 different
member countries of the global PMS network, gain experience in
conducting AEFI investigation and causality assessment, develop and
field test models to establish a system for post-marketing safety
surveillance of vaccine.
o SEARO/IVD/VSQ strategy to strengthen surveillance of
vaccine safety is in line with WHO global strategy that
promotes cross-country cooperation and establishment of
networks
o Participation of member states in WHO established Global
Network for Post-marketing surveillance of newly PreQualified vaccines

Management of AEFIs and counseling of clients to boost public
confidence in immunization services.
o Developing proper guidelines for the management of AEFIs
and counseling services for the region having taking into
consideration the vaccines used in the region.
o Making this a part of all refresher training programs for all
categories of health care personnel involved in providing
immunization services.
7.2.3.5
7.2.3.5.1
Human resources
Regional Goal
28
To make available adequate trained and competent human resources with
necessary skills and facilities for their mobility to provide an effective and
quality immunization services
7.2.3.5.2
Status
For the EPI programme to be effective an adequate number of competent
personnel at all levels is required. Personnel should have the basic
prerequisites, core knowledge, specific skills and competencies to
accomplish the given task. However, inadequate human resource
availability is a problem in all member countries. Human resource
capacity is not adequate to cover all the target population. As a result of
inadequate human resources, the existing workforce is overburdened and it
will reflect in their performance of the duties.
7.2.3.5.3
Issues/Challenges



7.2.3.5.4
Lack of an adequate number of competent personnel to increase
immunization services to pockets of hard-to reach populations and
marginalized communities identified in member countries.
Lack of adequate human resources in clinic centers due to the poor
mobility of existing health workforce especially in hard to reach areas.
Ensuring the availability of a critical mass of competent personnel in
all member states with the need to improve current immunization
services in general and the possibility of introduction of new and
under-utilized vaccines in the short- and mid-term
Policy approaches and activities

Mapping existing health workforce required for maintaining equitable
immunization by countries
 Filling vacancies of the workforce in providing immunization
services based on the gaps detected
 Providing relevant facilities for mobility by the health workforce to
provide an equitably accessible, quality immunization service
o In many pockets of hard to reach populations, the lack of
mobility of the workforce further affects the access to
immunization services
 Providing training opportunities to enhance the skills of the
immunization workforce
o There is an abundance of literature and training materials that
have been developed by WHO and other agencies for public
use
29


7.2.3.6
7.2.3.6.1
o Currently training programmes at different levels are been
carried out in all member states.
o There is a need to train additional personnel to improve
existing immunization programmes as well as to cater to the
increased demand envisaged with the introduction of new
vaccines.
 Considering translation and modification of generic training material
to suit the demands of member countries without compromising the
essential knowledge, skills and competencies required by personnel
working in immunization programmes.
 Enhancement of basic training and in-service training
programmes for all categories of health care personnel at all
levels both in quality and quantity with attendance of a critical
mass.
. Considering a system of certification especially in places where sectors
other than the public sector are heavily involved in immunization services.
Where possible, this would have to be tailor made for individual member
states.
Considering appropriate attractive incentive schemes based on
performance to retain trained personnel to ensure that services of the
highest quality are delivered.
Good governance and management capacity
Regional Goal

7.2.3.6.2
To Invest in strengthening effective management of immunization
services with a view to promoting good governance, accountability
of quality services and effective decision making
Status
All programmes have to be managed efficiently to be effective.
Management of EPI programmes have to be done at different levels viz,
national, sub-national, field level etc. At each of these levels, the skills and
competencies required of managers vary. Although materials for training
of managers are available, training of managers are not carried out on a
regular basis in member states for different reasons.
Governance relates to decisions that define expectations, grant power, or
verify performance as a separate process or part of management process.
Governance remains an integral component in provision of immunization
services in terms of both the coverage and quality. All member states in
the region have governing mechanisms consolidated within their
Expanded Programs Of immunization. However, the governance types,
degree of execution and effectiveness of the governing methods are so
variable that they have been reflected in output indicators of immunization
programs. For example, all countries in the region tend to have areas with
30
low immunization coverage. Nevertheless, only seven countries in the
region have successful in reaching immunization coverage of over 90%.
The success of these countries lies in the fact that they have been able to
identify barriers leading to low immunization coverage and address them
proactively. Meanwhile the inability to address these issues proactively in
other countries has hampered the success in achieving the GIVS target of
over 90% coverage at national level. This has occurred against the
background of the availability of evidence on further improvability of
immunization coverage with a proactive approach and the continued
failure to demonstrate results indicate existing governance issues that
attribute to management failures in these countries
7.2.3.6.3
Issues/Challenges

Non consideration of qualifications and experience in appointment lower level
EPI managers though it is considered in appointing higher level managers.
o Sometimes, even at higher levels of management, experience in the EPI
programme itself may not be considered with deleterious effects on the
programme itself.

Inability of the managers to adequately conduct situational analysis, monitor
processes and take corrective actions.
Inaction in relation to coordinating and capitalizing on strengthening
immunization through health system strengthening mechanisms due to inadequate
managerial capacities
Ensuring that lower level managers of the EPI programme have the necessary
management skills to function efficiently to ensure an effective immunization
service.
Introducing and sustenance of good governance in immunization programs to
make effective decisions directed at improving access to immunization services,
creating demand in areas where the coverage is low, strengthening immunization
service delivery, information use and overall improvement in management
capacity.



7.2.3.6.4

Policy approaches and activities
Intensive focus of member countries on improving the overall management
process.
o commitment of member states to ensure managers at higher levels of the
EPI programme have the necessary technical knowledge and management
skills to manage immunization programmes efficiently
o Regular programmes not necessarily be specific to immunization services
for managers to improve their skills and competencies
o Training of lower levels managers done periodically especially at junior
levels where there is a regular turnover of personnel.
31




Requirement of the commitment of governments of member states and funding
agencies such as WHO to ensure adequate funding of these programmes that
would have ripple effects on the entire health system
Investment in training and supporting good managers to strengthen their
managerial skills for effective management of immunization services to provide
quality immunization service.
Promoting Middle Level Management (MLM) training to consolidate
management process through enhancing managerial skills in following areas
o partnering with the community, logistic management, ensuring vaccine
safety, annual planning for EPI related activities, ensuring proper
function of the disease surveillance system, conducting EPI coverage
surveys, engaged in supportive supervisions and monitoring the EPI
activities.
Supporting the mangers to
o be responsive and accountable for situations affecting immunization
services and adoptive in taking corrective actions.
o innovatively strategize for emerging new situations which may be
challenging for the sustainability of immunization services


Setting priorities and based on priority activities setting targets
Supervision and monitoring activities to appraise if these targets
have been reached
o Regular reviews of immunization services where good and bad
management practices are highlighted would help to relinquish bad
practices and adopt good practices that would ensure accountability and
quality of the immunization service in general.
o Improve performance through reorganizing monitoring and supervision
systems
o Establish Standard Operative Procedures (SOP) for streamlining the
purview of activities more efficiently
7.3
New Vaccines
7.3.1
Regional goal
To ensure that the introduction of new and under-utilized vaccines into
immunization programmes in the region are evidence based, affordable to
member countries, and done in an equitable manner without affecting the
effectiveness of existing programmes so that limited resources are used in a
manner that helps achieve optimum outcomes in terms of reduction of the disease
burden in the region.
7.3.2
Status
Vaccines not included in the EPI programme have been available for some time
and some of them are available in the private sector. A safe and effective
Hepatitis B vaccine has been available for many years now but SEAR has still
not completed its introduction. Except India, all countries in the region have
32
introduced the Hepatitis B vaccine within the last 10 years; in India, 25 of 35
states are still to introduce it. Sri Lanka introduced the pentavalent vaccine within
2 years of its introduction; currently 4 countries in the region have introduced the
pentavalent vaccine into their national immunization programmes. Bhutan has
successfully negotiated with donors and introduced the relatively expensive HPV
vaccine in its EPI in May 2010.
7.3.3

Issues
Complexity of the introduction of new vaccines especially when the country’s
immunization systems are weak and routine immunization coverage are low.
o Recommendation of one school of thought that countries that have not
been able to provide the six basic EPI antigens in hard to reach areas
should strengthen the immunization systems before introducing new
vaccines.
o Recommendation of the other school of thought that countries with weak
systems have a better chance of improving their performance when faced
with new challenges and, hence, introducing new vaccines will be a great
opportunity for them to strengthen their existing weak systems.
o The availability of new vaccines in the private sector

Consideration of following aspects in the introduction of new vaccines as an
important intervention to achieve MDG 4
o The demand, vaccine characteristics, system capacity and vaccine
financing based on sound evidence.
o Programmatic issues, vaccine strategies for general and specific
populations, legal and regulatory frameworks and ethical issues.

Issues related to graduation as a result of the improving
conditions of the countries of the region
socioeconomic
o Promotion of five more countries in the region to the low middle income
country group in 2011
o Only Bangladesh, DPRK, Myanmar India and Nepal as GAVI eligible
countries in the region.

7.3.4
A rational approach to deal with AEFIs and gain the confidence of the medical
profession and the public. with the introduction of new vaccines,
Policy approaches and activities
Criteria for introduction of new vaccines in the Region have been clearly spelt
out in the Regional Vaccine Policy for South East Asia12 and the Report of the
South East Asia Regional Vaccine Prioritization Workshop13. These criteria are
currently applicable. A checklist of criteria for introduction of new vaccines is
given below:
33
CHECKLIST OF CRITERIA FOR INTRODUCTION OF NEW VACCINE
A. Demand

Burden of disease:
Is the disease a public health problem? How does this burden
compare to that of other diseases?

Epidemiological features of disease: Is the disease epidemic or endemic? What is the
age distribution of cases? What is the phenotype of the infecting organism?

Community demand/acceptance: Does the population generally feel the need for
another vaccine?

Availability and effectiveness of alternative/complementary measures for disease
control: Is immunization the best strategy for ameliorating this disease?
B. Vaccine characteristics

Availability of the vaccine: Is there an adequate global supply of quality vaccine
available? Are the sources WHO pre-qualified?

Protective characteristics of the vaccine: What is the vaccine efficacy? How long does
immunity persist? What are the adverse events associated with the vaccine?

Implications on local production: Will a new, imported vaccine threaten local
production? Is it feasible to produce the vaccine locally?
C. System capacity

Strength of current EPI system to absorb a new vaccine: Is it logistically feasible to add
a new vaccine? How well is the current immunization programme working? What are
the programmatic implications (e.g. Will it require an additional visit?)

Available information on practical effectiveness of the vaccine: What is the realistic
performance in target populations?
D. Financing

Balance between costs and benefits: What are the direct and indirect costs of adding a
new vaccine? How will benefits be calculated? Will the introduction of the vaccine
increase the equity of health services?
Source:
WHO Regional
Vaccine Policy
for South-East
Newnecessary
Delhi 2003
 Sustainability
of financing:
How will
the vaccineAsia
andRegion,
any other
resources
(SEA-Vaccines-133)
(e.g. syringes) be funded in the long term?
34

Focusing on estimation of the disease burden, which is an important consideration
in the introduction of a new vaccine, relative to all diseases by improving the
surveillance system, in general, rather than targeting an improvement of
surveillance of a single disease entity.

Not disregarding other effective preventive measures with the introduction of a
new vaccine, although immunization may be the most cost effective strategy to
control the spread of a disease and its consequences.

Introduction of new vaccines is at the sole discretion of member states
considering factors such as the availability and production of the vaccine, and the
affordability and the capacity of the routine immunization programme to
accommodate the new vaccine.

Requirement of in- and inter-country meetings and plans to identify gaps for
delaying NUVIs including risk communication plans, country support teams to
ensure coordinated response from partners and strengthening AEFI surveillance
systems for the introduction of new vaccines into routine immunization
programmes.

Promoting phased introduction of new vaccines or targeting high risk groups as
suitable alternatives in countries with inadequate capacities for introducing a
new vaccine on a country wide basis.

Ensuring that only safe and effective vaccines are made available to populations
in member countries through enhancing and empowering the legal and regulatory
framework of member states as described in section 7.4.4 to counter challenges
posed by the availability of new vaccines in the private sector.

Stockpiling vaccines at the regional level, preferably by WHO, to be used in any
emergency such as pandemic situations.
7.4
Legal and regulatory framework of countries of the Region
7.4.1
Regional goal
To enhance and empower country level legal and regulatory frameworks to
ensure the access and availability of safe effective and quality vaccines to
populations in member countries of the Region under the purview of a fully
functioning, competent national regulatory authority (NRA) backed by an
appropriate national control laboratory (NCL) and research institutions .
7.4.2
Status
WHO included a fully functioning NRA as a pre-requisite to Pre-Qualify
vaccines in 2002. WHO recommended six functions for NRAs in vaccine
35
producing countries and assessment tools to evaluate the NRAs were developed
in consultation with experts from developing countries and industrialized
countries. In SEARO, vaccine producing countries were assessed and
institutional development plans including training on vaccine quality through the
Global Training Network were implemented and progress monitored through
periodic re-assessments of the NRA. In 2009, all the NRAs in the vaccine
producing countries of the SEA region were functional regulating vaccine safety,
quality and efficacy.
It is well recognized that the WHO pre-qualification procedures for vaccines and
the NRA capacity building programme were successful in building national
regulatory authority capacities in member states and assuring the availability of
quality vaccines in developing countries. In the SEA region, it has enabled
several countries to procure quality vaccines from other sources after cessation of
procurement through UN agencies. In the vaccine producing countries, the
enforcement of WHO recommended safety and quality standards for vaccines
through capacity building of local NRAs have enabled local manufacturers to
expand their market beyond the NIP, to invest to upscale production and to
access novel technologies for vaccine production through joint ventures with
manufacturers in developing and industrialized countries.
In the developing countries with limited NRA capacity, the WHO PQ mechanism
has enabled local manufacturers to submit their vaccines to an independent
review process. Once the product is WHO PQ, the vaccine manufacturers may
gain access to international markets through UN procurement agencies. This
regulated environment has significantly increased availability of vaccines of
assured quality in the region and globally, fostered a more competitive market,
contributed to reduced prices and provided better access to high quality vaccines
including pentavalent vaccines which, currently, are still relatively expensive but
have become more accessible for low and middle income countries.
7.4.3
Issues/challenges

Urgent need to strengthen the sustainability of national vaccine regulatory
systems at the regional level giving priority to WHO PQ vaccine producing
countries in the region, namely, India, Indonesia and Thailand with the increased
demand for under-utilized and novel vaccines, the increasing complexity of
vaccine formulation and the limited capacity of WHO to review and assess all
manufacturers applications to PQ vaccines.

Challenges to capacities of countries in the region to develop production plans
posed by the emerging pandemics and the need to rapidly upscale production of
seasonal and pandemic vaccines

The need to increase regional cooperation to develop and manufacture vaccines
and for early involvement of NRAs in the pre-licensure phase of vaccine
development to minimize delays in commercial production of the vaccine and its
introduction into the population when required
36
.
7.4.4 Policy approaches and activities

Overall policy of building sustainable regulatory systems with financial and
expertise capacity to regulate vaccines giving priority to vaccine producing
countries and countries procuring vaccines directly from the international market.
o Ensuring following line with the WHO strategy to decentralize expertise
to regions and countries.
o Anticipated transfer of some of the PQ activities to NRAs in regions and
country in a phased manner. by the WHO as NRAs have better capacity
to regulate vaccines currently
o Providing greater responsibility in the PQ process to NRAs as they gain
experience and maturity in regulating vaccine safety, quality and efficacy
o Developing SOPs to assess the acceptability of vaccine for procurement
through UN agencies.

Training through the WHO Global Learning Opportunity (GLO) or through incountry training workshops

The regional policy is to support initiatives that involve global and regional fora,
such as the Developing Country Vaccine Regulatory Network (DCVRN3), the
Developing Country Vaccine Manufacturers Network (DVCMN4) and the
Association of South East Asian Nations (ASEAN) Vaccine Chapter, to
harmonize and standardize vaccine regulatory requirements across the region

Establishment of a regional network of NRAs to assist countries which may not
be able to develop ideal NRAs leading to greater inter-country cooperation,
3
The DCVRN was established in 2004 with the mission to promote and support the strengthening of
regulatory capacities of NRAs of emerging and developing countries for evaluation of clinical trial
proposals (including preclinical data and product development processes) and clinical trial data through
expertise and exchange of relevant information. The member countries include the Republic of South
Africa, India, Indonesia, Thailand, South Korea, China, Russia, Cuba and Brazil. The DCVRN is a strong
coordinating network which has already met to address regulatory issues on HIV, Rotavirus, HPV (Nov
2005), Typhoid (May 2006) and regulatory monitoring of Clinical trials (Nov 2006). The regional policy is
to promote harmonized procedures for clinical trials and will continue to engage DCVRN in the discussions
and elaboration of CT procedures for the region.
4
The DCVMN is a network of emerging vaccine manufacturers in developing countries including the
Republic of South Africa, India, Indonesia, Thailand, South Korea, China, Russia, Cuba and Brazil. The
network goals are: to promote transfer of vaccine conjugation technology from the Netherlands Vaccine
Institute (NVI) to produce DTP containing vaccine including DTP-Hep B and DTP-Hep B and Hib
vaccines and, to foster the development of the members to attain WHO Pre-Qualification criteria, to
encourage continuation of research and development efforts to facilitate emerging vaccine needs in
developing countries. Members of this network are all in demand for WHO PQ status and for a strong NRA
in their country to enable them to export their vaccines. The DCVMN network represents a strong
advocacy partner to strengthen NRA capacity.
37
granting reciprocal recognition and assisting countries in introducing new
vaccines.
o Enabling licensing of vaccines based on evidence provided by other
NRAs.
o Elimination of the need to conduct fresh trials in the recipient country
7.5
Research and Development
7.5.1
Regional goal
To establish and implement a research and development plan to ensure safe and
effective immunization services including vaccines of assured quality for all
vaccine preventable diseases prevalent in the region.
7.5.2
Status
Research and development of vaccines and immunization services in the region
are minimal due to poor infrastructure and limited funding for such activities
given other pressing problems faced by countries of the region. Currently, the
region is dependent on vaccines that have originated in developed countries. With
bilateral and global agreements such as the TRIPS agreement, technology
transfer is restricted and new vaccines are costly that some countries could ill
afford to introduce them into their routine immunization programmes.
The National Vaccine Committee Office (NVCO) established in 2003 by Thailand is the
only country in the region that has a committee which actively promotes vaccine research
and development
7.5.3
Issues/challenges

Despite financial support from international funding and initiatives since 2000,
the focus of this assistance which is critical to stimulate regional vaccine
research, was mainly focusing on clinical trials of products being developed by
industrialized manufacturers and on transfer of technology or importing bulk to
develop production capacity in developing countries of existing non-patented
vaccine products.

Hampering of the development of novel vaccines needed for the South East Asia
by
o the lack of interest, incentives and support from governments in
producing countries,
o the challenges posed by Intellectual Property Rights (IPR) and regulatory
compliance,
o limited coordination with research institutes, manufacturers, National
Regulatory Authorities and national immunization programmes
38

7.5.4
Despite the availability of a large regional scientific community especially in
vaccine producing countries with sophisticated laboratory facilities in some
countries, non-existence of a strong link with medical institutes, NRAs,
manufacturers and the national EPI programmes to define research priorities.
Policy approaches and activities

Sustenance of the system established in SEA countries to register and monitor the
number of vaccine clinical trials conducted in WHO member states by the WHO
supported NRA capacity building programme. This enables the NRAs to regulate
safety, quality and efficacy of vaccine from seeds to the mass production of the
final product.

Requirement of Vaccine Research and Development for strong coordination
among the stakeholders especially, with new vaccine products becoming
increasingly sophisticated in their preparation, formulation and production
technology.
o Conducting a review of vaccine R&D and developing a road map to
bring vaccine research to the final product and mass production by all the
vaccine producing countries
o Establishing coordinating bodies that would ensure the synergy among
stakeholders including the NRAs, the medical research institutes, the
manufacturers and the national immunization programmes by . Member
state governments
o Inclusion of a secretariat and budget to conduct product research reviews,
establish Scientific Technical Advisory Groups (STAG) to review
progress and to advise on steps to further develop the product in the
coordinating body
o Empowering the coordinating body to develop a vaccine policy based on
the disease burden, status of research, financial feasibility, and R&D and
production capacity

Encouraging the establishment of vaccine research and development coordinating
bodies similar to NVCO in Thailand to coordinate reviews of country-specific
vaccine research projects through Scientific Technical Advisory Groups (STAG)
established in compliance with WHO agreement on conflict of interest and
confidentiality
o Reviewing outcomes of STAG, communication to the international
research community through publications and presentations at
international peer meetings.

Promoting the networking of in-country coordinating bodies with existing transregional networks like the Developing Country Vaccine Manufacturers Network
(DCVMN) and other networks of international experts on vaccine development
.
39
7.6
Financing Immunization Programmes
7.6.1
Regional goal
To ensure sustainability for immunization programmes in all member countries
through assured funding from either national or international resources.
7.6.2
Status
All member states fund their immunization programmes through allocations of
national budgets or through donor funds for country programmes. The highest
percentage of budgets of public/preventive health programmes is spent on
immunization services. Immunization services have also proved to be costeffective investments in controlling vaccine preventable diseases and reducing
childhood morbidity and mortality in the quest to achieve MDG 4.
7.6.3

Issues/challenges
Adequate funding for sustainability of all effective programmes.
o Additional investments in terms of infrastructure development such as the
cold chain and purchase of the vaccines which are usually more expansive
than the vaccines used in routine immunization programmes for the
introduction
o Long term commitment for sustenance of a new vaccine , once
introduced, for many decades

Serious funding issues regarding funding of immunization programmes arising as
a result of cessation of funding from agencies such as GAVI parallel to moving
or likelihood of moving of a few countries of the region ahead in the socioeconomic ladder as low middle income countries
7.6.4

Policy approaches and activities
Assurance of adequate funding by individual governments through dedicated
allocations from national budgets.
o Inclusion of costs of vaccines and all other aspects of immunization
services including the use of auto-disable syringes in allocations
o Allocations being a central function even in a decentralised system
o Development of an immunization policy for each country incorporating
sustained funding for the immunization programme
.

Encouragement of national governments to increase their spending on
immunization, in general, as a cost-effective intervention that is a primary
responsibility of the public sector.

Approaches which can help move in this direction include:
o Use of cost-effectiveness and public finance principles to allocate funding;
o Establishment of legal mandates for baseline funding (e.g. budget line
item for vaccines);
o Establishment of trust funds
40
o Use of immunization coverage and measures of programme performance
as indicators of public sector involvement;
o Taking steps to ensure efficient use of funds;
o Working with donors to determine strategic interventions so that external
support does not displace domestic investment (7)
o Policy-makers should determine their national plan for financing
immunization based on a mix of the four basic sources of finance for
immunization in any country:
 Domestic public (e.g. tax revenues or social health insurance)
 Domestic private (e.g. user fees)
 External public (e.g. bilateral development assistance)
 External private (e.g. the Vaccine Fund)
o Evaluation of the options based on the following criteria in choosing
optimum sources for financing by countries : Promote equity, achieves
efficiency, provides resources in an adequate, timely, and reliable manner,
engenders accountability, and encourages the highest level of selfsufficiency.
o Consideration for sustaining the administration of the vaccine over many
decades when a decision to introduce a new vaccine is taken
o Reliable budgetary projections for consideration in the short-, the
medium- and the long-term
o Novel mechanisms of funding such as using the pentavalent
vaccine instead of monovalent vaccines enabling a decrease in the
cost of immunization programmes and cost-saving to the country.
o Then channelling these funds for improving the existing
immunization services and/or purchase of other antigens.
o Local manufacture of vaccines and AD syringes to reduce costs. this may not be financially viable for small countries and is not
advisable unless other infrastructure such as a NRA and a NCL are
in place
o Facilitating the purchase of quality vaccines at cheaper rates especially if bulk
purchases of pre-Qualified vaccines are done and negotiating with countries on
pricing structures by the WHO
o WHO’s assistance to member countries in finding funding options for
immunization programmes and striving to convince GAVI and other donor
agencies to extend benefits to low middle income countries as well.
o Coordinating donor supply, pooling of resources and exploring possibility of pool
procurement are some other policy approaches that deserve attention in this
context
41
7.7
Client satisfaction and community participation
7.7.1
Regional goal
To attain the highest possible levels of client satisfaction and community
participation in immunization programmes in all countries of the region.
7.7.2
Status
Client satisfaction and acceptance has generally not been addressed in
immunization programmes which, in the past, have been supplier driven. High
vaccine coverages and low drop-out rates are an indirect indication of client
acceptance and satisfaction.
With advances in the education sector and improvement in literacy in the
countries of the region, expectations of clients have also increased. The ready
availability of information on the internet and ready access to it has compounded
the knowledge of the public.
7.7.3
Issues/challenges

The way communities view and respond to health services including
immunization services as a result of client expectations and access to information
are changing. Contrast to the past where immunization services were supply
driven, more demand driven nature of the health system and immunization
services today with the private sector playing a leading role in delivery of
immunization services are seen.

Considering client satisfaction as a prerequisite for community participation that
would eventually lead to wide immunization coverage and an effective
immunization campaign client satisfaction also needs to be addressed. The issues
such as counselling and prompt and effective management of AEFIs should be
effectively managed.

Neglecting accountability to clients especially with regard to the occurrence of
serious AEFIs and the fact that clients have the right to know the reasons for the
possible AEFI.
7.7.4 Policy approaches and activities

Acknowledging that client satisfaction is a key to a successful immunization
programme,

Strengthening ability of health care workers to communicate and interact
effectively with clients, providing counselling services in a people friendly
manner to gain the confidence of clients on immunization services.
Ensuring
consistency in the messages given when dealing with the public especially in
dealing with serious AEFIs that may be misreported by the press.
o Setting up a public relations unit for this purpose within the immunization
programme to deal with these issues and to keep the public well informed.
This service may also be used as a hot line to provide current information
on vaccines and the immunization programme.

Improving client satisfaction and community participation. This requires
enormous amounts of attitudinal changes from staff. Special programmes will
42
have to be conducted and measurable reward systems set in place to achieve these
changes. The concept of certification as a “people friendly facility” may be
considered to boost public confidence.
7.8
Strengthening Health Systems by Augmenting Immunization Services in
Primary Health Care Services
7.8.1
Regional goal
To strengthen health systems in member countries of the region by revitalising
primary health care through immunizations programmes
7.8.2
Status
Primary Health Care (PHC) that was adopted by all member countries with the
Alma Ata Declaration of 1978 is the main strategy in provision of public
health/preventive care services in the region. Immunization service is a principal
component of that strategy and has been a success story in the health sector. High
immunization coverages in all member countries indicate the accessibility to, and
acceptability of, the PHC approach by the community. During last decade, the
concept of the PHC approach has lost momentum, but there are attempts to revive
the concept.
7.8.3 Issues/Challenges
o Inability to disintegrate immunization services and PHC (see figure 1) from the
health system. The benefit of this is that improvements in the immunization
services improve the health system and vice versa.
o The need to revitalise the PHC system not only to strengthen the health system to
provide basic services to populations to reduce morbidity and mortality but also to
reduce health care budgets which are increasing exponentially for a variety of
reasons.
7.8.4
Policy approaches and activities

Utilizing all the overarching and inter-related policy approaches and activities to
achieve the goal for health for all.

Liaising with other sectors and tacit coercion by WHO to build a strong political
commitment and inspired leadership to revitalise PHC.

.Strengthening immunization services and increasing immunization coverage to
strengthen the PHC approach
 Making the health system popular by extending the immunization
services to cover hard-to-reach populations and marginalised
communities

Encouraging national governments to invest in primary health care to achieve
equity in health care.
1. Making PHC an integral part of the Health sector reforms process.
2. Increasing resources for PHC
43
3. Involving the private sector in such reforms so as enabling opening an
avenue for the regulation and monitoring private sector immunization
services
4. Training and re-training of staff at all levels and expansion of services to
improve immunization services and to strengthen the health system. This
in turn will increase patient satisfaction and lead to a demand driven health
system.
Timor Leste
Thailand
Sri Lanka
Nepal
Myanmar
Maldives
Indonesia
India
DPRK
Bhutan
Vaccine
BCG
OPV
DTP
DTP+Hep B
DTP+Hep B+Hib
Measles
MR
MMR
TT
Td
YF
Vit A
HPV
Hep B
DT
IPV
JE
Rubella
Bangladesh
Table 1. Vaccines used in Member Countries - 2009
   
      
   
      

 
 

 
 
 

 
 
      




 

    
 
   
  

  
 
 
 

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