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Stage is set for a strong link
between Microbiology &
Epidemiology :
A few stories of success
New Vaccines to the NIP
Dr. P.R.Wijesinghe
Consultant Epidemiologist, Epidemiology Unit
Dr. Nihal Abeysinghe
WHO SEARO [TIP, New Vaccine Introduction],
former Chief Epidemiologist, Ministry of Health,
Sri Lanka
Present Success achieved by NIP
• Milestones in vaccine introduction & AEFI surveillance
•
•
•
•
•
•
•

Vaccination ordinance 1886- compulsory vaccination against small pox
BCG vaccination-1941
DPT vaccination -1961
Oral Polio vaccination -1962
Introduction of EPI – 1978
Universal Child Immunisation (UCI) status - 1989
Introduction of additional vaccines
–
–
–
–
–
–

Measles in 1984
JE in high risk districts 1989
Rubella in 1995
ATd & MR in 2001
Hepatitis B on phase basis in 2003
Hib vaccine in 2008

• AD syringes and sharp collection system-2003
• Establishment of an AEFI surveillance system in 1995
Epidemiologists’ dilemma
• Are we going to boast old glory and stay
put ?
• Are we able to introduce benefits of new
vaccines to the SL public especially
children ?
• If so, what are the constraints?
• How do we plan to overcome these
issues?
• What are the choices to be made?
Traditional role played by the WHO &
Unicef is still continuing
• WHO & UNICEFF Support

• Technical assistance & logistic support for EPI
• Efficient service delivery
• Infrastructure development
– (central & regional cold facilities etc)

• Vaccine and associated equipment procurement
• Vaccine delivery
– ( vaccine transport vehicles etc)

• Surveys

– ( EVMS,VMA, coverage )

• Capacity building
Entry of New Partners
• Global Alliance for Vaccines and Immunisation
(GAVI)
• radical improvement of access to vaccines
• strengthen immunization services in poor nations

• GAVI funded vaccines accelerated development
and introduction plans
– HIB initiative
– PneumoADIP
– Rota ADIP
• Partnerships, coordination, strategic alliance with WHO
Entry of New Partners
• Support for evidence based decision making
and appropriate choice of vaccines
• Establish value : BOD, protection through vaccination
• Communicate value : ensuring availability of research
data
• Deliver value :
– Availability of quality , affordable vaccines
– Delivery system
– Finance for sustenance
Entry of New Partners
• International Vaccine Institute (IVI)
• Centre of research, training and technical assistance for
vaccine needs in developing countries

• Program for Appropriate Health (PATH)
• Improvement of health by advancing technologies,
strengthening systems, and encouraging healthy behaviors .

• UNFPA
• Poverty reduction, ensuring every pregnancy is wanted,

every birth is safe, every young person is free of HIV/AIDS,
and every girl and woman is treated with dignity and
respect [ supporting HPV prevalence study].
Changes in the vaccine industry
• Advance Market Commitment
• Target Product Profiles
• Product complying with detailed specification
• Product containing ideal attributes

• Co-Financing & Ownership
• Sharing vaccine cost with the GAVI alliance

– a WIN WIN relationship
New GAVI option for 7 vaccines
•
•
•
•
•
•
•

JE
Meningococcal A
Rubella
Typhoid
Cholera
HPV
Rabies
Surveillance and Research
• Hib & Pneumo surveillance : in- country net
work ( SLPnSN)
– Hib burden study
– with microbiologists at the LRH, NIHS, CSTH,
NCTH, Karapitiya TH
– Adult surveillance at the NHSL- 2008 /09 ??

• Rota surveillance at the LRH
– with the virology department of the MRI

• Study assessing the safety and
immunogenicity of the live JEV SA 14-14-2
Surveillance and Research
• Active surveillance for prevalence/incidence of
dengue ( Pediatric Dengue Vaccine Initiative)
• Prevalence of carcinogenic Human Papiloma Virus
(HPV) infection and burden of cervical cancer
attributable to HPV ( UNFPA)
• Morbidity cost study of rotavirus diarrhoea
(with the virology Dept. MRI)
• Cost effectiveness of introducing Pneumococcal
vaccine to the EPI in Sri Lanka
(based on surveillance data from LRH & CSTH)
The stage is set
• Hib > JE SA 14-14-2 > Mumps > Pneumo
> Rota > HPV [risk groups]
Typhoid [risk areas & groups]
Hepatitis A [risk areas &groups]
Take it or Leave it
• Sustainability issues
• Rising vaccine and AD syringe cost with every new vaccine
• Ownership issue for NPI when co financing expires
• Ability to self sustain if GAVI eligibility is revised
– Least poor group, GNI >1000US $

• Need for cost minimization within the vaccine budget
–
–
–
–
–

Accountability & transparency
Minimizing vaccine wastage
Need for bulk procurement
Alternative vaccines
Promotion of the private sector participation in immunisation
Take it or leave it
• Issues related to safety
• Experience of safety issues related to Hib vaccine
• Complicated nature of causality determination
• Impact on the acceptance of the programme
• Need to Prevent and minimize AEFI
• Phased based introduction??
• Need of sound post marketing surveillance data
• Enhanced surveillance of AEFI following
introduction
Gratitude
•
•
•
•
•
•
•

All ministry officials
All Epidemiologists and the staff at the Epid Unit
All Directors /MCH and the staff at the FHB
All Clinicians & All Microbiologists
REE, MOO/MCH & other district health staff
MOOH, PHNSS, PHMM, PHII,
All other curative sector health staff

of current & yesteryears

for their contribution to the success of NIP
• The media friends who understand the
importance of strong NIP
Gratitude
Wonderful Sri Lankan parents
without whose support EPI would
have been an illusion
Shouldn’t we face all
challenges & get the
maximum benefits to our
motherland?

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Stage is set for a strong link between1[1]

  • 1. Stage is set for a strong link between Microbiology & Epidemiology : A few stories of success New Vaccines to the NIP Dr. P.R.Wijesinghe Consultant Epidemiologist, Epidemiology Unit Dr. Nihal Abeysinghe WHO SEARO [TIP, New Vaccine Introduction], former Chief Epidemiologist, Ministry of Health, Sri Lanka
  • 2. Present Success achieved by NIP • Milestones in vaccine introduction & AEFI surveillance • • • • • • • Vaccination ordinance 1886- compulsory vaccination against small pox BCG vaccination-1941 DPT vaccination -1961 Oral Polio vaccination -1962 Introduction of EPI – 1978 Universal Child Immunisation (UCI) status - 1989 Introduction of additional vaccines – – – – – – Measles in 1984 JE in high risk districts 1989 Rubella in 1995 ATd & MR in 2001 Hepatitis B on phase basis in 2003 Hib vaccine in 2008 • AD syringes and sharp collection system-2003 • Establishment of an AEFI surveillance system in 1995
  • 3. Epidemiologists’ dilemma • Are we going to boast old glory and stay put ? • Are we able to introduce benefits of new vaccines to the SL public especially children ? • If so, what are the constraints? • How do we plan to overcome these issues? • What are the choices to be made?
  • 4. Traditional role played by the WHO & Unicef is still continuing • WHO & UNICEFF Support • Technical assistance & logistic support for EPI • Efficient service delivery • Infrastructure development – (central & regional cold facilities etc) • Vaccine and associated equipment procurement • Vaccine delivery – ( vaccine transport vehicles etc) • Surveys – ( EVMS,VMA, coverage ) • Capacity building
  • 5. Entry of New Partners • Global Alliance for Vaccines and Immunisation (GAVI) • radical improvement of access to vaccines • strengthen immunization services in poor nations • GAVI funded vaccines accelerated development and introduction plans – HIB initiative – PneumoADIP – Rota ADIP • Partnerships, coordination, strategic alliance with WHO
  • 6. Entry of New Partners • Support for evidence based decision making and appropriate choice of vaccines • Establish value : BOD, protection through vaccination • Communicate value : ensuring availability of research data • Deliver value : – Availability of quality , affordable vaccines – Delivery system – Finance for sustenance
  • 7. Entry of New Partners • International Vaccine Institute (IVI) • Centre of research, training and technical assistance for vaccine needs in developing countries • Program for Appropriate Health (PATH) • Improvement of health by advancing technologies, strengthening systems, and encouraging healthy behaviors . • UNFPA • Poverty reduction, ensuring every pregnancy is wanted, every birth is safe, every young person is free of HIV/AIDS, and every girl and woman is treated with dignity and respect [ supporting HPV prevalence study].
  • 8. Changes in the vaccine industry • Advance Market Commitment • Target Product Profiles • Product complying with detailed specification • Product containing ideal attributes • Co-Financing & Ownership • Sharing vaccine cost with the GAVI alliance – a WIN WIN relationship
  • 9. New GAVI option for 7 vaccines • • • • • • • JE Meningococcal A Rubella Typhoid Cholera HPV Rabies
  • 10. Surveillance and Research • Hib & Pneumo surveillance : in- country net work ( SLPnSN) – Hib burden study – with microbiologists at the LRH, NIHS, CSTH, NCTH, Karapitiya TH – Adult surveillance at the NHSL- 2008 /09 ?? • Rota surveillance at the LRH – with the virology department of the MRI • Study assessing the safety and immunogenicity of the live JEV SA 14-14-2
  • 11. Surveillance and Research • Active surveillance for prevalence/incidence of dengue ( Pediatric Dengue Vaccine Initiative) • Prevalence of carcinogenic Human Papiloma Virus (HPV) infection and burden of cervical cancer attributable to HPV ( UNFPA) • Morbidity cost study of rotavirus diarrhoea (with the virology Dept. MRI) • Cost effectiveness of introducing Pneumococcal vaccine to the EPI in Sri Lanka (based on surveillance data from LRH & CSTH)
  • 12. The stage is set • Hib > JE SA 14-14-2 > Mumps > Pneumo > Rota > HPV [risk groups] Typhoid [risk areas & groups] Hepatitis A [risk areas &groups]
  • 13. Take it or Leave it • Sustainability issues • Rising vaccine and AD syringe cost with every new vaccine • Ownership issue for NPI when co financing expires • Ability to self sustain if GAVI eligibility is revised – Least poor group, GNI >1000US $ • Need for cost minimization within the vaccine budget – – – – – Accountability & transparency Minimizing vaccine wastage Need for bulk procurement Alternative vaccines Promotion of the private sector participation in immunisation
  • 14. Take it or leave it • Issues related to safety • Experience of safety issues related to Hib vaccine • Complicated nature of causality determination • Impact on the acceptance of the programme • Need to Prevent and minimize AEFI • Phased based introduction?? • Need of sound post marketing surveillance data • Enhanced surveillance of AEFI following introduction
  • 15. Gratitude • • • • • • • All ministry officials All Epidemiologists and the staff at the Epid Unit All Directors /MCH and the staff at the FHB All Clinicians & All Microbiologists REE, MOO/MCH & other district health staff MOOH, PHNSS, PHMM, PHII, All other curative sector health staff of current & yesteryears for their contribution to the success of NIP • The media friends who understand the importance of strong NIP
  • 16. Gratitude Wonderful Sri Lankan parents without whose support EPI would have been an illusion
  • 17. Shouldn’t we face all challenges & get the maximum benefits to our motherland?

Hinweis der Redaktion

  1. Sri Lankan EPI is one of the rare success stories at the global level Sri Lanka can boast of. Vaccination against small pox has been referred to in the vaccination ordinance in 1886. Since then new vaccines have been introduced. 3 years following the introduction of EPI by the WHO, Sri Lanka managed to introduce it in 1977. By 1989, SL achieved UCI status by having reached a coverage >80%. Several non traditional vaccines have been added since then. In 2006, AD syringes and safety boxes were introduced and in 90s , AEFI surveillance was introduced.
  2. In recent times Epidemiologists had a dilemma. There was a global shift towards ensuring availability of benefits of new vaccines in developing countries. Time was ripe for them to decide whether to go for this or bask in the old glory. Relative strengths were known. They had to look for constraints and meticulously plan for overcoming the former. As the richest country even cannot afford to purchase every vaccine in the basket, choices have to be made . Making this choice needed support of local and foreign partners including our microbiological colleagues.
  3. Traditionally, EPI was supported by the WHO & UNICEFF. This support included ………..However, if new vaccines to be added , this support was inadequate. Support of other focussed partners was also pivotal.
  4. The biggest impetus in vaccine support to poor countries was GAVI. GAVI was made of governments, WHO,UNICEF, other NGOO, research organisation and philanthropist support. It intended to radically improve access to vaccines including new vaccines and strengthen immunization services. GAVI has financed accelerated development and introduction plans . These organisations make partnerships, coordinates activities through strategic alliances through the WHO to improve child health and survival in the developing world
  5. For individual new vaccines, support was essential for making evidence based decisions and selection of appropriate choices. GAVI funded umbrella organisations have been instrumental in initiation of burden studies, surveillance, strengthening local capacity in research and surveillance and accelerating access to these vaccines..
  6. Organisations independent of GAVI but with strong links with it have come forward to fill the gaps. IVI provides support for rota virus surveillance strengthen dengue surveillance and reducing other VPD. PATH supports research related to JE , cost of immunization. Vaccine trials and ensures access to LJEV. Meanwhile, UNFPA has supported HPV prevalence study and burden of cervical cancer attributable to HPV
  7. Parallel to all these, there were changes in the vaccine industry. There were advanced market commitments , target product profiles and co financing mechanisms which were win win situations for both recipient countries and the industry
  8. There are new GAVI options for 7 vaccines
  9. Having understood the opportunities available, EU has planned several research and surveillance activities to clear the ground for implanting new vaccines to the EPI in years to come. In many of these exercises, an inseparable link has been forged with microbiologists as partners of the EU
  10. So the stage is set for new vaccines. We have arrayed them according to the priority order. Meanwhile, there are vaccine options available for high risk areas and groups for typhoid and hepatitis A in the country.
  11. So now it is a matter of Take it or leave it. We as managers need to think of sustainability after introduction. Ours is a self funded programme and GAVI eligibility will be revised making us vulnerable to be non eligible. In the context of rising cost of introducing vaccines, we need to think about strategies to cut down cost within the vaccine budget to accommodate new vaccines. Some strategies suggested in the cMYP is given here .
  12. Finally, experience of deaths among some Hib recipients suggest us how severely such an event can impact the program. It is further exagerated by the complicated nature of causality assessment. Thus we need to prevent and minimise AEFI.A prior knowledge of post marketing data may appear handy while enhanced surveillance after introduction may be very vital. Microbiologists have to play an important role in excluding coincidental infections in case of deaths.