Vaccines Production
Vaccines Production
2019
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AUTHOR IS THE HEAD, DEPARTMENT OF HEALTH ECONOMICS AT PIDE ISLAMABAD
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Contents
ACKNOWLEDGEMENT .............................................................................................................................. iv
LIST OF ACRONYMS .................................................................................................................................. v
ABSTRACT................................................................................................................................................. vi
INTRODUCTION .......................................................................................................................................... 1
METHODOLOGY ......................................................................................................................................... 2
DISCUSSION ................................................................................................................................................ 2
Vaccines Market Potentials .............................................................................................................................. 2
Vaccine Market in Pakistan ............................................................................................................................. 4
Routine EPI Vaccine & Requirements............................................................................................................... 5
Non- EPI Vaccines ......................................................................................................................................... 6
Wastage of Vaccines ....................................................................................................................................... 6
Public Sector Production Facilities ................................................................................................................... 6
FINDINGS AND WAY FORWARD ................................................................................................................ 7
1. Low Investment and Limited Production .................................................................................................... 7
2. Donor dependence ................................................................................................................................... 7
3. Human Capacity in Basic Sciences, Biotechnology, Vaccines & Biological .................................................... 7
4. Absence of Vaccine Policy ....................................................................................................................... 7
5. Inefficiencies in Drug Regulatory Authority (DRA) and Drug Testing Labs ................................................... 7
6. Incentives in Vaccines Manufacturing Sector .............................................................................................. 8
a) Tax Holiday ........................................................................................................................................ 8
7. Buy Back Agreement ............................................................................................................................... 8
8. Research & Development Cost Sharing ...................................................................................................... 9
9. Strategies for Local Purchase of Vaccines .................................................................................................. 9
a) Biological Production Division (NIH) .................................................................................................... 9
b) Private Sector .................................................................................................................................... 10
c) Human Resource Development. ........................................................................................................... 10
10. Training of Scientists and Researchers .................................................................................................. 11
11. Veterinary Vaccines ........................................................................................................................... 11
CONCLUSION ............................................................................................................................................ 12
REFERENCES ............................................................................................................................................ 13
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List of Tables
Tables Description Pages
Table 1: Vaccines and Industries Status 3
Table 2: EPI Performance 5
Table 3: Wastage of Resources 6
Table 4: Projects with Cost and Funds Allocation 9
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ACKNOWLEDGEMENT
All glories to Allah Almighty, the most beneficent, the most merciful, who gave me strength
and enabled to undertake and execute this research task. Countless salutations upon the Holy
Prophet Hazrat Muhammad (SAW), the city of knowledge for guiding mankind, the true path
of life.
The paper on the vaccine production in Pakistan was initiated on the advice of the Deputy
Chairperson of the Planning Commission as guidelines for indigenous production of vaccines
so, approach paper was written and circulated to the concerned stakeholders.
Actually senior colleagues participated to finalize this paper. Mr. Ahsan Iqbal (DCPC), Dr.
Naeem ul Zafar (Chief Economist Sindh and member social sector planning commission of
Pakistan), Mr. Ayub sheikh (Secretary Health), Mansoor (ED,NIH) and Dr. Asad Hafiz
provided the major guideline and support to accomplish this paper as a policy document. Ms
Hira, Ms Amina and Mr. Irfan worked hard on this paper. I am grateful to all the colleagues
for their support to finalize the policy paper.
Regards
Dr. Fazli Hakim Khattak
HOD, DOHE, PIDE
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LIST OF ACRONYMS
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Vaccines Production in Pakistan (VPIP)
ABSTRACT
The safe and efficacious vaccine is the most effective way to combat a disease specially a
deadly disease like rabies, tetanus, measles, meningitis, and hepatitis etc. No health interventions
are as simple, powerful and cost effective as vaccines and these prevent millions of deaths
globally. Vaccines have transformed public health throughout the world particularly for children
and global immunization program a powerful tools to control the burden of vaccine preventable
diseases. Access to quality vaccines at affordable cost represents a challenge to health systems
due to the few manufacturers, the limited capabilities of national regulatory authorities and under-
funded health systems, particularly in low and middle- income countries. A limited proportion of
vaccines used in routine and non-routine immunization programs is produced locally by four
main institutions in EMRO i.e. VACSERA (Egypt), Razi Institute (Iran), NIH (Pakistan) and
Tunis. There are 18 countries, produce 51 types of vaccines for their own consumption, however
a few of the country’s export and supply vaccines to other countries. It includes China, India,
Brazil, Cuba and Indonesia. There is a vast scope of vaccine due to growing population of
Pakistan. There are possibilities for Joint Venture in the area of vaccine production with China,
Iran, Egypt and Tunis, a preferently with China using the CPEC window for investment in the
country.
It is estimated that nearly 85% population of world is living in developing countries and only
15% population is living in developed countries. While developed countries contribute towards
82% of global vaccine sales and developing countries contribute only 18%. The growth of global
vaccine market from 2000 to 2013 is US$ 5 billion to US$ 24. It is estimated that this vaccine
market will rise to US$ 100 billion in 2025. In 2012 UNICEF purchased 50% of global volume
of vaccine does mainly EPI vaccines. The global vaccine leaders are GSK having 23% market
share, Sanofil Pasteur 17%, Pfizer 13%, Merck 12% and Novartis 10% market share while
remaining 25% is contributed by other vaccine manufacturers.
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INTRODUCTION
Global scenario
Currently 120 new vaccine products are in development phase and out of it 60 products are of
importance for developing countries. Recently, a vaccine for dengue fever is under registration process while
vaccine for zika virus is under clinical trials. Vaccine products against cancer, hepatitis C and HIV/AIDS are
under active research and development processes.
In Muslim region a limited proportion of vaccines used in routine and non- routine immunization
programs is produced by the VACSERA-Egypt, Razi institute-Iran, Biofarma -Indonesia, and pasteure
institutes-Tunis. China and India are also major vaccine producers and India is supplying vaccine products
like Measles and Polio to UNICEF. Biofarma- Indonesia is a WHO pre-qualified manufacturer and supplying
Measles vaccine to WHO.
Pakistan scenario
Vaccines can be produced in Pakistan either by shared manufacture, ready to fill material,
Concentrate or from raw material using seed bacteria and seed viruses (Basic Manufacture). It was noted
that US $ 600 million were to be spent on EPI and Polio during next 3-5 years. Therefore, it is a crucial
need to produce this paper as first step toward this sacred task.
Vaccines are important tools in disease prevention and their availability in good quality and of at
affordable cost represents a challenge for health systems. The two public health interventions, have had
the greatest impact on global health, are clean water and vaccines. However, it is profoundly tragic that
despite the availability of simple vaccines, almost 1.5 million children still die each year from vaccine
preventable diseases. New global changes and challenges, including increased competition, difficulties
in accessing cutting edge technology, reduction in the number of vaccine suppliers, limited market and
profit margins and decreased interest in vaccine production by the industrialized countries, are putting
additional strains on self- sufficiency initiatives.
Multinational manufacturers have traditionally supplied a large proportion of the vaccines to EPI,
which targets the killer diseases of childhood, are now diverting their business to more profitable
products. This move has created a void for EPI vaccines, which is being filled by manufacturers from
developing countries. Over 60% of all the BCG vaccine and over 80% of all measles vaccine produced
globally are manufactured in India and Indonesia. These factors have direct and great implication for
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the policy makers in Pakistan. The 2005 earthquake disaster and 2010 floods in Pakistan had exposed
our vulnerability to the critical availability of life saving Vaccines and Biological like anti tetanus serum.
METHODOLOGY
There is a little literature available on manufacturing of vaccines in Pakistan. Therefore,
comprehensive review of literature was undertaken the record of the National Health Services
Regulation and Coordination Division (NHSCR), considered NIH and the data available with GAVI
Headquarter. International and multilateral companies involved in the vaccines business were studied.
Work done by UNICEF, WHO, and Project history of EPI since 1978has been reviewed and provided
a firm base for this policy paper. This is a desk research correlated with the past 03 National Health
Policies i.e. 1990, 1997 and 2001being formally approved/ tabled before the cabinet in different regimes.
Work done by Prof. Atta ur Rehman (Ex. Chairman, HEC) and chairman of the vaccines committee
(2007) was value addition to accomplish this paper.
DISCUSSION
In Pakistan about 80% of the vaccines market is the public sector. Based on IMS data the
total size of the private vaccine market in Pakistan is estimated at Rs. 2 billion annually. This is a
small fraction of the annual market size of Rs. 140 billion (US 1.4 billion) for pharmaceuticals.
There is an estimated requirement of EPI vaccines of Rs. 28 billion for (2015-20), and Polio
Vaccine requirements are Rs. 30 billion for 03 years. The annual requirements of vaccines for EPI
is Rs 5.6 billion, and Rs 10 billion for polio in the public sector. Total annual intakes vaccines in
public and private sector is Rs 17.6 billion per annum. It is clear that concerted efforts are required
to start vaccines production locally as the market is quite sizeable.
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In the private sector, there are several multinationals such as Glaxo Smith Kline (GSK),
Aventis, Wyeth, Crucill and Novartis, supplying vaccines in the country. Only one national
company Amson Vaccines is doing some valued steps in vaccine manufacturing for TT and Hep
B vaccines. Following are a few vaccines and industries status in the country: -
Table 1: Vaccines and Industries Status
Vaccine Industry
Hepatitis B GSK, Aventis, Amson, Macter, Highnoon
Rabies Aventis, Chiron, Berna and Indian Immunological
Tetanus Amson, Berna and Aventis
Hib Aventis, GSK
Influenza Chiron, Aventis, Crucill and GSKB
Typhoid: Aventis, Berna & GSKB
Combination vaccines: GSK, Aventis
The most significant role in public health being carried out by NIH is prevention of vaccine
preventable diseases by production of quality vaccines and anti-sera as per WHO guidelines and
provides it to national immunization program, government hospitals dispensaries and to armed
forces. Production of vaccines is the only corporate function of NIH while rests of NIH functions
are non-corporate public health functions.
These units manufacture following 09 products by the way basic and shared manufacturing technology.
1. Measles vaccine
2. Tetanus Toxoid
3. Cell Culture rabies vaccine
4. Allergy vaccine
5. Typhoid vaccine
6. Typhoid & Cholera vaccine
7. Anti-snake venom serum (polyvalent)
8. Anti- snake venom serum (trivalent)
9. Anti- rabies serum (ARS)
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Vaccine Market in Pakistan
EPI is the largest user of vaccines in the public sector since 1978. It aims at protecting children
by immunizing them against 09 vaccines preventable diseases, childhood, tuberculosis,
poliomyelitis, diphtheria, pertussis, measles, tetanus and childbearing, and pregnant women
against tetanus.
Government of Pakistan through NHSR&C Division provides support to the program through
development program i.e. PC-I. The PC-I for the period 2010-2015 at a total cost of Rs. 27.00
billion. This ensures the commitment of the Federal Government for the provision of vaccines,
syringes, cold chain equipment, transport, printed material and launching of health education
and motivation campaigns. Another PC-I at a cost of Rs.38.00 billion was approved for a period
of 05 years 2015-2020. This huge investment is based on the policy direction provided in vision
2025 to meet the SDGs targets related to infant, children, and mothers’ mortalities
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Routine EPI Vaccine & Requirements
The EPI performance chart for (2015-2020) is given in the following table: -
Source: - EPI, PCI, Federal EPI Programme, 2015 (NHSR&C Division), Islamabad.
Total local cost of vaccines met through the PSDP is Rs, 3.12 billion (11.6 %) of the total cost,
whereas donors and development partners are providing vaccines of Rs. 14.2 billion therefore total cost
of vaccines is Rs,17.32 billion which is 64% of the total PC-1 cost. The vaccines imported and consumed
by the private sector is not corrected. Population of Pakistan is growing at 2.4 % per annum and
resources decreased for children & mother vaccines. The financial cost will further enhance that will
consume our foreign exchange resources in future.
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Non- EPI Vaccines
The following vaccines are used in Pakistan in the private sector. These are not included in any
government program: -
a. Tissue culture Rabies vaccine (major vaccine)
b. Anti-Snake Vaccine Serum (available but in limited supply)
c. Meningitis (meningococcal vaccine, special purpose for Hajj)
d. Influenza vaccine (seasonal vaccines, every year a short is required)
e. Varicella vaccine (Chickenpox, underutilized vaccine)
f. Vi-polysaccharide Typhoid Vaccine
g. Combo vaccines
h. Cholera-Typhoid vaccine (classic TAB, century old used in armed forces0
i. Gas Gangrene
j. Yellow fever (available from special outlets)
Wastage of Vaccines
Vaccines wastage factor is important to consider for avoiding the wastage of resources.
Following is the wastage chart by WHO for different vaccines: -
Table 3: Wastage of Resources
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FINDINGS AND WAY FORWARD
1. Low Investment and Limited Production
In order to make real progress both the public and private sectors must play their roles in
Pakistan. During the last 40 years, research and development leading to the improvement of the
existing vaccines and the development of the new vaccines has gradually shifted to the private
sector in the developed world. Many of the public vaccine producers in industrialized countries
being the source of know-how and technology transfers to developing world are being privatized
or function as viable public-private partnerships. Unlike the situation 40 years ago, most of new
vaccine research and development is undertaken by private sector companies and is funded either
by private venture capital and/or from profits on sales. Also, public university research becoming
increasingly linked to pre-existing intellectual property agreements with private companies.
2. Donor dependence
The GoP working with the donors have developed some Immunization Programmes where
there is guarantee of co-financing like the pentavalent with GAVI, is a good proposition in the
short run. The donor program is also fraught with the potential risk of interruption, due to the
rapidly changing geopolitical and security situation in the world.
a) Tax Holiday
Reduce the operating cost and keeping the final price of local vaccines in check, duties &
taxes need to be lowered. e.g. Tax holding for 10-15 years may be granted. In consultation of
Finance (FBR), Commerce, and Industry Divisions, the following incentives may be considered:-
profits, gains made out of the project should not be taxed during tax-holiday
period.
Zero rating of .W.H. Tax, Sales Tax, and Excise Duty on Import of PME
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8. Research & Development Cost Sharing
Research & Development is an investment in future; and biotech, of all fields, perhaps
needs it more today than ever before (Pakistan’s scenario). Local production of vaccines should
be complemented by an equally effective and intense effort in R&D. It will play a pivotal role in
future success and attaining self-sufficiency-level for the new product.
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b) Private Sector
This is one of the most important segments in Vaccines. Its economic impact is comparable to human
vaccines. This can revolutionize the social sector in Pakistan. It is a strong supporting agent for livestock
ultimately help the poor people in the rural areas.
Almost 95% of vaccines against large animals are produced locally in public sector institutes.
But Foot and Mouth diseases vaccines are imported. A few private entrepreneurs have started to produce
vaccines in limited quantity. About 2- Domestic Poultry is not fully vaccinated; however, all commercial
poultry farms are hundred percent vaccinated against the viral disease. The Breeders of flocks do not
use local vaccine to avoid vertical transmission of virus. It is estimated that poultry vaccines worth Rs.
1.2 billion are imported every year. There is urgent need to have Specific Pathogen Free Eggs production
facilities in the country for the production of better-quality vaccines. Biotechnological Interventions can
be very effectively used for production of better-quality vaccines for poultry diseases to capture ever-
increasing demands for all types of poultry vaccines.
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Vaccines for the infectious disease of dogs and cats are imported. The Veterinary Research
Institute (VRI) Lahore is producing Anti-Rabies vaccine for dogs in limited quantity but these are not
well accepted by the dog’s owners. They prefer to use imported vaccines for their pets/dogs etc. It is
estimated that every year 02 million doses of Rabies vaccine for dogs and cats are imported.
CONCLUSION
The needs for public health and new vaccines in Pakistan are enormous and increasing. Despite,
the mandate of the NIH to supply the vaccine needs of the country, the majority of public sector vaccine
requirements have been met through import of vaccines produced by multi-national suppliers. The NIH
has been providing a fraction of national requirements. Pakistan has fully advanced in the field of
technology, know how, and having well qualified and trained human resources. Indigenous vaccine
production can be started with the support of the available HRD and Technology, and gradually these
inputs can be refined for enhanced Production and export of vaccines to other countries of the regions.
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REFERENCES
1. Maj. Gen. (Rtd) Masood, Ex, ED, NIH, ‘The Vaccines Priority’ Islamabad, Oct., 2007.
2. Resource Persons, Dr. S.T.K. Naim COMSTECH, Dr. Hafiz, Ex. National EPI Manager,
Dr. Altaf Bosan, Focal Person ‘Bill gates’ Foundation in Pakistan, and Madam Anwari
Begum, Biological Division, NIH, Islamabad (Nov., 2015)
3. Veterinary Research Institute, Lahore, 2008
4. Prioritizing New Vaccines Introduction in Pakistan, World Bank, Sept., 2008, Islamabad
5. Janct Bumpas, ‘Study on Comparative Efficiencies in Vaccine Procurement Mechanisms,
World Bank, since 2008.
6. Paris Declaration on Aid Effectiveness, High Level Forum Paris France 2nd March, 2005.
7. Vaccines Procurement and self sufficiency in Developing Countries, Dianc Woodl,
Access Policy & Planning, WHO, 2000.
8. Vaccines and Biologicals, Lt. Gen (R) K.K. Karamat, Ex. Advisor (Health) Planning
Commission, 2009, Islamabad.
9. Public Sector Development Program (PSDP) June 2015, PDR, Islamabad.
10. The state of Routine Immunization, EPI Pakistan, Dr. Saqlain Gillani, NPM, NIH, Dec.,
2015, Islamabad.
11. Emergency polio Vaccination, ‘Interview with Dr. Safdar Rana, Chief Executive, Polio
Program, Dec., 2015, Islamabad.
12. Tender Evaluation Documentation, Ministry of Health (Devolved), Govt. of Pakistan,
2008, Islamabad.
13. Colin, Tayyeb, Viktor, Pakistan New Vaccines Decision Making. Vol. I. Cost Effectiveness
and Financial impact, May 4, 2010, Islamabad.
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