Lt. Gen. (Retd) Prof. Dr. K.A. Karamat1
Vaccine Security in Pakistan
Vaccine security, defined as the sustained and uninterrupted supply of
affordable, quality vaccines, has emerged as a pressing public health issue.
Shortages in the supply of vaccines have become so acute that immunization
programmes may be undermined. With declining availability, additional vaccine
shortages sometimes occur, often as a result of a spike in demand due to
campaigns such as those against Polio, maternal and neonatal Tetanus, and
Measles. Until recently, vaccines used in developing countries including Pakistan
were the same as those used in industrialized nations. When they were used in
all countries, abundant-production of the “basic” vaccines – DTP (Diphtheria,
Tetanus and Pertussis), Polio (OPV), Measles and BCG, – meant that they could
be obtained at low cost for children in poorer countries as manufacturers offered
them at marginal prices. In the 1990s, wealthier nations began using newer,
more expensive vaccines, and many manufacturers stopped producing the less
profitable ones used by most developing countries.
Vaccine production in countries such as Pakistan is recognized as a critical
factor in ensuring vaccine security. This has become increasingly important in
view of the current shifts in the production of traditional EPI vaccines which are
becoming increasingly difficult to acquire by national immunization programmes
of developing countries.
In addition to ensuring the availability of traditional
vaccines, Governments need to ensure that newer technologies will be
incorporated to allow production of new combination vaccines which will define
immunization programme needs in the coming decades.
The Era of Invention
1
Advisor (Health) Planning Commission
The closing years of the 19th century and the early years of the 20th century were
marked by the achievements of great vaccine scientists such as Jenner &
Pasteur. Since the introduction of vaccinia by Jenner 200 years ago
("vaccination" in its true sense), nine major diseases of man have been
controlled to a greater or lesser extent through the use of vaccines (Table 1&2).
Several other vaccines have been used in individuals at risk from diseases such
as rabies and plague, but have not been systematically applied on a global scale.
On the other hand, while BCG vaccine has been widely administered to
newborns in the developing world, administration of this vaccine alone is
insufficient in controlling the disease.
Table 1. The date of introduction of the first generation of vaccines for use in humans
1798
1885
1897
1923
1926
1927
1927
1935
Smallpox
Rabies
Plague
Diphtheria
Pertussis
Tuberculosis (BCG)
Tetanus
Yellow Fever
Table 2
Vaccines introduced after World War II
1955
1962
1964
1967
1970
1981
Injectable Polio Vaccine (IPV)
Oral Polio Vaccine (OPV)
Measles
Mumps
Rubella
Hepatitis B
2
Although these first generation vaccines were crude in some respects, they have
proved to be efficient, and continue to be the workhorses of global immunization
programmes. They have dramatically reduced the burden of death and disease
from these infections, and have given credibility to the entire preventive health
movement. During the 1920s, diphtheria and tetanus toxoids, whole-cell
pertussis vaccine and BCG were introduced. Thanks to the development of the
chorio-allantoic membrane for culturing viruses, a yellow fever vaccine was
available by 1935. After the Second World War, there followed an explosion of
technology, resulting in the emergence of other vaccines still in use today. These
included the killed and oral polio vaccines, the measles, mumps and rubella
vaccines and the Hepatitis B vaccine (Table 2).
Background and history of global vaccination strategies
The two public health interventions, which have had the greatest impact on
global health, are clean water and vaccines. Because of the pioneering work of
individuals such as Edward Jenner and Louis Pasteur, the world was introduced
to vaccines as potential public health interventions. Immunizations are widely
regarded
as
the
most
cost-effective
and
equitable
public
health
interventions, with benefits to all sections of society. However, it is profoundly
tragic that despite the availability of simple vaccines, almost two million children
still die each year from vaccine preventable diseases and many fall victim to
paralytic polio. The slow pace of global vaccine strategies, especially for common
preventable disorders, is a function of global inequities in health, poverty and
indeed dysfunction within health systems. Indeed the rapid developments in
vaccine technology and the introduction of new vaccines in the armamentarium
against childhood diseases threaten to increase the inequity between nations
and also within different socio-economic strata. If history is to serve any useful
purpose, it should help us find ways to promote widespread availability and
utilization of vaccines.
3
Early National Immunization Programmes 1900-1973
During this initial period, the use of available vaccines was largely confined to
industrialized countries. For instance, smallpox vaccine was offered to all age
groups, but only those at risk - health care workers and travelers - were specially
targeted. As a result, coverage was patchy and outbreaks continued to occur
throughout the world. When this happened, massive vaccination efforts were
mounted by health authorities, often very successfully, to contain the infection
through vaccination and isolation or quarantine of infected individuals or
suspected cases.
Other vaccines such as BCG were gradually introduced in the West, (Table 3) as
they became available. Better-off families who could afford vaccination benefited
most - the poor benefited the least. Because of low, irregular coverage,
communities continued to be devastated intermittently by outbreaks of these
vaccine-preventable diseases throughout the 1930s and 1940s. Following the
pioneering work of Jonas Salk an injectable form of killed polio vaccine (IPV)
became available in 1955. This resulted in widespread administration in schools
and clinics in industrialized countries across a broad age range resulting in a
marked drop in cases in these countries. In 1962, the oral polio vaccine (OPV)
replaced IPV and continues to be the vaccine of choice for eradication of the
virus. Despite initial low coverage, the vaccine showed itself capable of
dramatically reducing the number of polio cases when administered to a wide
age range over a short period of time.
In terms of strategy, the early programmes offered routine immunization through
regular maternal and child health services. While efforts were made to encourage
acceptance, no major effort was made to achieve total coverage. The implied
target was to raise coverage, but there was no disease reduction targets
specified nor an effort made to upscale these interventions.
4
The Eradication Era
The early years of the 19th century saw widespread but haphazard use of
Jenner's vaccine to control smallpox in humans. However, efforts at a systematic
application of smallpox vaccine were made in Mexico and Guatemala. The first
attempt to use it on a global scale began in 1956 when the World Health
Organization and others selected smallpox for global eradication. This was not
the first time disease eradication had been mooted. Already the scientific
community had considered the possibility of eradicating
bovine contagious
pleuro-pneumonia (a highly fatal disease of cattle), hookworm, yellow fever,
malaria and yaws. Now with a clear strategy and a highly effective, affordable
vaccine, it was possible to unite all countries in a mighty effort to rid themselves
of this disease and the tremendous annual cost it incurred. To meet this special
circumstance, very high population coverage with the smallpox vaccine was
used. Finally in the late 1960s, an additional strategy was developed whereby
cases
were
identified
through
intensive
surveillance
and
confined
("containment"), and possible contacts within a given radius were vaccinated.
The Global Expanded Programme on Immunization
Following the impressive success of the smallpox eradication programme, the
World Health Organization looked for other activities that could build on what had
already
been
achieved.
In
1974
the
Expanded
Programme
on
Immunization (EPI) was created. The term "Expanded" was coined because
most programmes until then had only used smallpox, BCG, diphtheria, tetanus
and pertussis (DTP) vaccines. EPI would include two new diseases. The six
diseases chosen were tuberculosis, diphtheria, neonatal tetanus, whooping
cough, poliomyelitis and measles. The selection of these diseases was made on
the basis of a high burden of disease and the availability of a well-tried vaccines
at an affordable price. "Expanded" also meant increased coverage - incredibly,
5
less than 5% of children in developing countries were being reached at that time
by immunization services.
Table 3
Vaccines used in national immunization programmes up to 1974
Smallpox
BCG
Diphtheria toxoid
Tetanus toxoid
Pertussis
IPV/OPV
Measles
Gradually, global coverage for the six vaccines rose (Fig.1), although success
was not uniform. Regions and countries with the greatest resources,
infrastructure and political will were able to raise coverage faster and higher and
in some instances these differences are remarkable. Many organizations such as
UNICEF and Rotary International became partners in the programme. Between
1974 and 1980, the programme developed training materials and disseminated
them widely. In those busy years, almost every country in the world adopted the
principle of a national immunization programme. (Many used and continue to use
the name "EPI" which has become a trademark). Hundreds of training courses in
dozens of languages were conducted resulting in huge mobilizations of human
resources. Personnel were trained in the management of the programme so that
every community was reached (at least in theory) by some form of immunization
service. The number of doses administered and the number of target diseases
occurring were recorded and reported.
Figure 1
Global coverage of EPI vaccines
6
Vaccine production in the Islamic World
There are currently 15 vaccine producers in 10 member countries. The capacity
of those producers varies greatly. In terms of quantity and numbers of produced
vaccines and sera, the capacities of member countries are illustrated in Table 4
detailed below:
Table 4
Vaccine manufacturers and production in the Islamic world
Country
Manufacturer
Bangladesh
IPH
Egypt
VACSERA
Vaccines
TT,
DPT, DT,
Measles, Polio
OPV, (Bulk),
7
% of
National Need
50% (TT),
100%
100%,
Export
No
No
Indonesia
PERUM
BIOPHARMA
Iran
Razi Institute
Pasteur Institute
Malaysia
Morocco
Pakistan
Senegal
Tunisia
Turkey
N.I.H
Pasteur Institute
Pasteur Institute
REFIK
SAYDAM
NYGIENE
CENTER
BCG,
5%,
TT,
100%,
DT
32.2%
DPT, DT,
100%
Measles, Polio,
TT
OPV, DPT,
100%
DT, Measles,
TT, BCG
No Data
Product Anti-Venoms only
Measles, TT
30%
Measles
NA
BCG
100%
BCG
100%
DTP
No
No.
No.
No.
No.
No.
As shown in the above table, there is a reasonable extent of self-sufficiency of a
limited number of vaccines in some member countries. Yet most member
countries rely on imported vaccines from non-member countries. In addition,
recent survey revealed that none of the OIC member countries has the capacity
to produce the vaccine against Hepatitis A and B, Haemophilus influenzae type B
(Hib) and measles, mumps and rubella. The above vaccines are considered very
important in the new modified children immunization programs and thus crucial
for member countries to start planning their production. Not withstanding the
above, the market potential for vaccines in the 54 countries of the Islamic world
with a combined population of 1.2 billion is considerable.
Pakistan is a member state within the Eastern Mediterranean Region of WHO
(EMRO). Within this region, several countries have established facilities for local
manufacture of EPI vaccines. These include Egypt, Iran, Jordan, Tunisia and
Pakistan.
Egypt:
8
In EGYPT the local vaccine producer is Egyptian Organization for Biological
Products and Vaccine (VACSERA), which is the public sector institution
responsible for satisfying all national vaccine requirements in the country either
by local production or through importation. VACSERA has supplied OPV through
bulk filling and finishing. It also produces DTP, TT and BCG. The organization
has seldom produced sufficient quantities of these vaccines to meet all national
needs. Vacsera has developed a joint venture with a multinational organization
Iran:
In IRAN, EPI vaccines are produced in two institutions, the Razi Institute and the
Pasture Institute, both located in Tehran. The Razi institute, although originally a
public sector organization, has recently been partially privatized. The Pasteur
Institute continues as a public sector organization. The Razi Institute produces
BCG. Thus while neither institute produces products at quantities necessary to
meet full national requirements, both together provide some portion of national
need for all of the 6 initial EPI immunogens.
Jordan:
The Jordan Vaccine Institute, which is public sector institution, has variously
produced components of the DTP platform, its primary products being TT and
DT. It has never been able to provide the full range of EPI vaccines.
Tunisia
The Pastuer Institute of TUNIS is the public sector organization in Tunisia, which
is responsible for the production and/or import of all vaccines needed for the
national EPI Programme. While the Institute initially produced only BCG, it now
has obtained the capability to produce measles vaccine in collaboration with Iran.
Pakistan
9
In Pakistan, the National Institute of Health (NIH) is the only public sector vaccine
producer, which over the years has been able to gradually expand its capacity for
this purpose. At one stage over a decade ago the NIH was able to meet the
indigenous EPI vaccine needs in several areas. The vaccine production units are
being gradually upgraded to meet the current Good Manufacturing Practices
(cGMP) of W.H.O and National Control Authority for Biologicals (NCAB) (Govt. of
Pakistan).
In addition, Non-EPI vaccines and sera namely TAB, mixed TAB-cholera, Anti
Rabies Vaccine and Anti snake venom Serum are also being produced through
“basic production” and “shared production” strategies.
The targets of the NIH vaccine production facilities are
1. To achieve self-sufficiency and self reliance in vaccine and sera
production by improving production facilities through up gradation,
capacity enhancement, manpower training/human resource development.
2. To provide the current menu of EPI vaccines i.e. Polio, Measles,
Diphtheria, Pertussis, Tetanus (DPT), BCG, and any new vaccines that
may be incorporated in the future EPI program.
3. Achieve and sustain Vaccine Production of at least 50% for DPT, T.T.
measles, polio and BCG vaccines among children under one year of age
and with 2 or more doses of tetanus toxoid among pregnant women.
10
4. To improve and enhance the existing production of non EPI vaccines/sera
such as Anti snake venom serum, anti rabies vaccine and Immunoglobulin
and TAB-cholera (mixed).
One of the most important developments related to the quality of vaccines and
sera was the establishment of National Control Authority for Biologicals (NCAB)
in the Ministry of Health during the year 2000. This authority is functional and is
now responsible for licensing, registration, lot release, GMP inspections etc of
NIH and private producers/importers of vaccines and anti sera in the country
Ensuring Vaccine security requires a number of measures:
●
Improved forecasting
Accurate forecasts are vital for manufacturers to produce sufficient quantities of
vaccine.
●
Multi-year funding
Long-term financing is needed because of the time needed to produce, and
especially to expand production, of vaccines.
●
Reduced vaccine wastage
High wastage rates were the norm when vaccines were both cheap and plentiful.
The introduction of new and more expensive vaccines combined with reduced
production means better management is needed to reduce wastage.
●
Expanding High-Quality Vaccine Production
11
Efforts are needed to attract and qualify more vaccine producers, both in
industrialized and developing countries, noting that several non WHO prequalified manufacturers do export their vaccines to a number of countries.
Vaccine Supply Barely Meets Demand
The vaccine market has doubled in value in the last decade, from $2.9 billion to
over $6 billion. Profitability in the vaccine market is increasingly associated with
enhanced vaccines, such as acellular pertussis and inactivated polio vaccine,
new proprietary vaccines, such as pneumococcal and meningococcal vaccines,
and adult vaccines, such as influenza.
Five years ago there were 7-8 manufacturers of basic vaccines whereas now
there are only 3-4 that are pre-qualified by WHO. Some companies have
preferred to focus on high profit vaccines. Mergers of some vaccine
manufacturers have contributed to the reduction in numbers of manufacturers.
Some have opted to completely close the vaccine segment of their businesses.
Most basic vaccines, except for oral polio vaccine, are now manufactured in
developing countries but to date only a few are pre-qualified by WHO.
Higher prices for current EPI vaccines plus the price of new vaccines being
introduced and rising operational costs are increasing the overall cost of
immunization. Funding for vaccines now and into the future is therefore an issue
where concerted action is needed by ministries of health and finance, as well as
among donors. GAVI and the Vaccine Fund have contributed significantly to
increase funding for vaccines, but the future rests with the countries and their
abilities to sustain funding for vaccines through their national budgets
supplemented by donors. Reduced production capacity globally means that
vaccine prices are increasing. Interestingly, Hepatitis B, which is common to both
industrialized and developing countries, is the only vaccine in abundant supply
and where tiered pricing is being successfully implemented and made affordable
for low income countries.
12
Given this environment, it is imperative that countries become more aware of
factors causing vaccine shortages at local, provincial and national levels, closely
monitor the situation and take corrective action when vaccine supply is insecure.
At the same time, countries must ensure that gaps in vaccine coverage are
significantly reduced and all children are reached with needed vaccines.
Approximately 33 million children still do not receive routine vaccination in their
first year of life, a tragedy which should not exist.
Vaccine Production Economics:
Choices made by vaccine buyers can significantly impact the cost of production
and pricing of the vaccines. In particular, the cost of vaccine varies which
depends on the supplier, the presentation and the timing of commitment to
purchase the new vaccines.
The cost of vaccine production varies significantly ranging from $0.05 per dose
up to $6-10 per dose. Five factors drive the variation in the production costs:
1.
Presentation: The number of doses per vial with single dose
presentations being significantly more costly than multi-dose
presentations.
2.
Scale of operations: High volume leads to lower costs.
3.
Supply policy for vaccine inputs: Whether raw material is
produced in-house or is purchased from another supplier.
4.
Supply base location: Whether production is located in a
country with high or low wage rates.
5.
Vaccine Production Characteristics: Amount of time, labour
intensity and testing regime required to produce a given
vaccine.
Pakistan requires vaccines worth approximately Rs.1100 million/year for routine
immunization of children. This does not include Hepatitis B which is currently
13
funded by GAVI for approximately US$ 6 million per year (EPI Islamabad.)
Furthermore with the shift towards combination of Hep B and DPT vaccine (from
2006) this price is expected to rise (from 2008) once GAVI support will not be
available.
Given this scenario and with the overwhelming state where surplus capacity does
not exist for basic vaccines, quality vaccine manufacturer countries are the
increasingly important source of vaccines. Production may not be limited entirely
for domestic use, e.g. India and Indonesia dominate more than 60% of the global
measles requirements.
Pakistan with its birth cohort of 4.5 million children annually needs to undertake
some serious steps towards the production of vaccines both in the public and
private sector. The public sector, severely limited at the moment must develop a
doable repertoire of basic EPI vaccines and undertake viable options with global
multinationals. Availability of funding for vaccine purchasing is a key driver to
manufacturer response. Given the quantum of requirements in Pakistan and the
government’s sustained support for routine immunization needs for the past
decade, is a strong signal for manufacturing facilities to be developed in
Pakistan.
MANUFACTURING AND SAFETY CRITERIA
The preparation of microbial vaccines demands the highest level of precautions.
Vigorous efforts are made by WHO to ensure that virus vaccines seed material
and production facilities in different countries conform to given standards.
However, there are countries who have become self- sufficient in their National
Vaccine needs prior to certification by WHO.
All commercial vaccine manufactures use well characterized stock vaccine
viruses. A seed virus technique is used whereby a large batch of vaccine virus is
frozen at –70 degrees C. The actual vaccine is produced by infecting cells with
virus that is only 2 passages removed from the seed. This procedure reduces the
14
opportunity for unwanted mutations to occur in the vaccine virus, which might
alter its virulence or antigen characteristics. The amount of infective virus in a
given live virus vaccine is quantified in cell cultures to ensure an adequate
infectivity titer. For inactivated or subunit vaccines, such as influenza or hepatitis
B, the amount of viral antigen is adjusted to around 10 µg protein per dose.
Needless to say, rigorous quality assurance checks, including tests of microbial
contamination are carried out from start to finish of the production process.
World Health Organization (WHO) Policy Regarding Vaccine Quality:
Vaccines are generally included in the legal definition of pharmaceutical
products, and thus would fall under the jurisdiction of Drug Regulatory Authority.
WHO has identified six essential control functions to be undertaken by an
effective vaccine regulatory system (NRA). These are:

A Published set of clear requirements for licensing (of products and
Manufacturers)

Surveillance of vaccine field performance (safety and efficacy).

System of lot release.

Use of laboratory when needed.

Regular inspections of manufacturers for GMP compliance.

Evaluation of clinical performance through authorized clinical
trials.
The degree of implementation of these functions varies according to the source
of the product. WHO has set in place procedures to ensure that appropriate
regulatory functions are being performed for products that are purchased by
agencies of the United Nations (such as WHO or UNICEF). Therefore, countries
receiving vaccines only through the United Nations have lesser responsibility in
terms of the essential control. As for countries that are sourcing their vaccines
15
through local production and direct procurement, greater responsibility is needed
for ensuring vaccine quality.

If the country is producing vaccines, the six essential control functions
should be performed (Table 5).

For countries which are importing vaccines, fewer functions need to be
ensured within the authority of the importing country. Nevertheless, the
importing country should ensure that the appropriate regulatory
activities are being carried out in the country of manufacture. The table
below indicates the functions recommended according to the source of
vaccine:
Table 5
Essential Control Functions of a National Control Authority
Vaccine
Licensing Surveillance Lot
Laboratory GMP
Clinical
source
release
access
inspections evaluation
UN agency 

Procure




Produce






EDUCATION AND HUMAN RESOURCE DEVELOPMENT FOR VACCINES
& BIOLOGICALS IN PAKISTAN
Pakistan is one of the Islamic states, which has the capacity to develop limited
numbers of essential vaccines needed to control the spread of Infectious
diseases. One of our major limitations has been the lack of trained manpower,
state of the art infrastructure and capacity for production of essential vaccines,
sera and diagnostic kits for preventable infectious diseases.
Capacity building in vaccine production to meet national demands and to reach
self sufficiency in vaccines and other R & D products to combat high incidence of
preventable infectious diseases should be our national priority. We cannot
depend any more on international donors in the current era of geopolitical
16
uncertainty. There is an urgent need to allocate funds for extensive training
programs of our junior and senior level scientists in the art of vaccine production.
There should be short and long term courses, inclusion of core courses on
vaccine, sera production and diagnostic techniques, Kits/reagents along with
related scientific curricula including Immunology, Medical Microbiology, Virology,
Tissue culture, and other related topics. This would help us to develop skilled
manpower needed for upgrading our infrastructures for national vaccine
production units in various provinces.
In order to make Pakistan self- sufficient in essential vaccines
and other
biological R&D products , the Higher Education Commission , MOST and
Ministry of Health should come forward with sufficient funds to initiate research
projects on related topics under the supervision of identified investigators in
Universities of Pakistan. Post-graduate students should be trained to work on
the following research problems / Ph.D. projects

Study the immunobiology of particular pathogens to identify the candidate
immunogens for better vaccines to prevent such infections.

Investigate the short comings in vaccines produced by old technologies to
justify the use of new methods for developing more effective and cheaper
vaccines.

To develop and study novel approach to address the immunopathological
questions related to vaccines.

Studies to identify advantages over technologies and uniqueness for
particular immunological problems. Such investigations are necessary to
understand the technicalities involved in developing a successful vaccine
production program.

Studies on Edible vaccine production against hepatitis virus in
banana/carrot.
17

Studies on Interferon interleukin action and the role of interleukins 8 on
resistance to antiviral therapy.
TRAINING OF SCIENTISTS IN INSTITUTES OF HIGHER EDUCATION:
Immuno-biologicals including vaccines have to be prepared according to set
criteria which are monitored by WHO in each country which has the capacity
for manufacturing such products. Before April 1999, there were no specific
guidelines or documented procedures for the regulation of vaccine production
in Pakistan. The WHO experts who visited Pakistan during 1997-1998 also
noted that there was a general lack of expertise for conducting the
appropriate regulatory functions recommended by WHO to ensure that
vaccines used in national immunization programs meet the required criteria.
In order to meet such requirements and standards for vaccine production, we
must:
1. Ensure active participation of
trained and qualified Immunologists ,
Pediatricians , Microbiologists , Biochemists, Quality Assurance Experts
, Veterinarians
and
other
Basic Scientists at all steps involved in
vaccine/ Biological Product Preparation as per WHO Criteria.
2. These experts should be involved in activities like GMP inspections,
clinical evaluation - Phase I, II and III trials, proper testing of local and
imported Biologicals.
3. Ensure
proper
surveillance
and
efficacy
studies,
detection
and
investigation of adverse events following immunization with locally
produced and imported vaccines, studies on impact of vaccination on
disease incidence by the expert scientists.
4. We must provide necessary equipment and training to our public health
workers involved in monitoring the spread of microbes and responding to
infectious disease outbreaks.
18
EFFORTS TO INCREASE OUR SKILLED MANPOWER BASE
Unfortunately, we are still short of properly qualified and trained individuals who
can shoulder the responsibility of
properly managing our Vaccine Production
Units to meet the growing demand of essential vaccines and other Biologicals.
Vaccine and Sera production requires specialized facilities for testing which can
be carried out in
properly equipped laboratories, by well qualified and
specifically trained technicians / post- graduate students / researchers under the
supervision of expert scientists. In order to achieve self sufficiency in Vaccine
production, we should initiate the following:
1. For an effective , economical and successful National Vaccine Production
Program , we must involve public and private sector institutions of higher
education and research , including Universities for providing training in all
aspects of vaccine production , seed virus testing , undertaking
vaccine
research projects related to conventional vaccines and development of new
vaccines using innovative biotechnologies.
2. Create training opportunities for young scholars from colleges and
universities, in all areas of infectious diseases,
immuno-diagnosis,
and
development
of
molecular epidemiology,
vaccines
as
well
as
immunotherapeutic agents. Post- graduate training programs in molecular
techniques, statistical and geographical tools will help us increase the number
of trained laboratory scientists. This in turn will help medical and public health
professionals to keep up with new tools, techniques and Vaccine issues.
3. Vaccine development and critical laboratory testing methods should be
included in the curriculum of postgraduate studies.
We must work with
Universities, Public Health Institutes, and Veterinary Colleges to update their
curricula to include courses on vaccine preventable diseases as well as
19
prevention and control of conventional and emerging diseases. Regular
training of staff involved at various stages of Vaccine production is very
important in enhancing the capability and efficiency of laboratories. They
should be regularly trained in product testing, GLP, Calibration and Validation
with newer technologies. We should make efforts to provide technically
qualified staff in order to boost the current vaccine production activity in
Pakistan.
4. Since our requirements for
Vaccines and Biologicals are increasing, we
urgently need to set up at least 3-4 new Vaccine and Sera Production Units.
We should provide training, proper courses, surveillance and efficacy studies,
in selected Public Sector Universities in all four provinces of Pakistan. Higher
Education Commission should allocate funds for Human Resource
Development for short-term trainings and Post Graduate Studies here and
abroad as well as for maintenance of such facilities in selected Universities.
Recommendations
Investments in education and research base for vaccine technology
It is envisaged that a technological base is critical for future research and
developments in the fields of vaccines and biologicals. This requires an
investment in strengthening the science base and training of a work force in key
areas such as microbiology, immunology and molecular biology. In addition,
biotechnology projects and training programs must focus on training individuals
for future research and development.
The following recommendations are being made for consideration by the Higher
Education Commission and MOST
1. Ensuring that these disciplines and related laboratories in public sector
universities receive adequate funding for staff and advanced equipment to
enable training and development in microbiology, immunology, cell and
molecular biology and biotechnology.
20
2. Creation of specific training and research support programs (scholarships
and grants) for leading public and private sector Universities in Pakistan in
the above disciplines.
3. It is strongly recommended that multi-disciplinary research projects related
to vaccine R&D be supported (e.g. antigen purification, immuno-biology
and animal vaccine research). These can be in the form of partnerships
between public and private sector universities or higher institutes of
learning as well as joint projects with the industry.
Production
1. The strong role of the only national public sector vaccine production facility
i.e. the NIH Vaccine Laboratories is recognized. This institution needs to
be strengthened and given the requisite resources and manpower in order
to meet the challenge of producing vaccines for public health needs. It is
recommended that the NIH consider keeping its focus on developing and
meeting the national needs for the three classic EPI vaccines i.e.
Measles
OPV
Tetanus Toxoid
2. It is also recommended that the NIH increases its capacity and manpower
in this field with appropriate support from the Government of Pakistan and
also develop appropriate partnerships with national and international
industry and academia.
3. Private Sector

National Industry must be encouraged to increase investments in
vaccine R&D especially in sectors where the public sector is not
currently developing vaccines or unable to meet the national
demands. These include Hepatitis B, typhoid vaccine, tissue culture
rabies vaccine etc.
21

Appropriate regulatory and support environment must be created to
protect national investments in this sector for Vaccines and
Biologicals. In the absence of such supportive environment it will be
difficult to attract investments in this area.
4. Active Public-Private partnerships in this field must be promoted. In view
of the importance of our National Vaccine Production Program and to
meet the future population needs, there must be increased funding for
vaccine development projects by the MOST and Ministry of Health.
Regulatory Framework and Quality Control/GMP assessment
recommendations
1. Vaccine and biologicals require specialized facilities for testing. It is,
therefore, recommended that universities and research organizations
should be involved in some critical testing to strengthen the NCA and NCL
in Pakistan.
2.
Strengthening of National Quality Control Lab for the execution of all the
six functions. There is an acute shortage of staff in NCL. It is
recommended that NCL should be equipped with more technical staff in
order to boost the current activity. Vaccine and biologicals requirements
are increasing day by day and in future role of NCA and NCL is becoming
more important to ensure the quality of these products.
3. Regular training of staff plays an important role in enhancing the capability and
efficiency of laboratory. It is recommended that staff should be regularly trained
in products testing, GLP, Calibration and Validation.
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