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Report on “Consultative Meeting on Japanese Encephalitis (JE) Prevention and Control” February 12, 2009 Organized by: Institute of Epidemiology, Disease Control & Research (IEDCR) Supported by: World Health Organization (WHO)

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Page 1: Report on “Consultative Meeting on Japanese Encephalitis (JE) Prevention and …vaccineresources.org/files/Report_JE_Mtg_Mar2009.pdf · 2017-11-28 · Report on “Consultative

Report on “Consultative Meeting on Japanese Encephalitis (JE)

Prevention and Control”

February 12, 2009

Organized by: Institute of Epidemiology, Disease Control & Research (IEDCR)

Supported by: World Health Organization (WHO)

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Chairperson: Prof. Mahmudur Rahman PhD, Director, IEDCR Facilitators: Dr. Be-Nazir Ahmed, Principal Scientific Officer, IEDCR Dr. Shahana Sultana, Principal Scientific Officer, IEDCR Dr. Yasmin Jahan, Senior Scientific Officer, IEDCR Dr. ASM Mainul Hasan, National Professional Officer (Surveillance), WHO Dr. ASM Alamgir, Virologist, IEDCR Dr. Zahirul Islam, Medical Officer, IEDCR Contributing organizations: DGHS IEDCR IPH National Drug Administration PATH WHO ICDDRB UNICEF Report Composition & Layout Dr. Yasmin Jahan, IEDCR Consultation & Guidance Prof. Shah Monir Hossain, Director General of Health Services, DGHS Prof. Mahmudur Rahman PhD, Director, IEDCR Dr. Serguei Diorditsa, MO-IVD, WHO, Bangladesh Venue: Conference room # 301, IEDCR, Mohakhali, Dhaka Organized by: Institute of Epidemiology Disease Control & Research Supported by: World Health Organization

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Table of contents

Page no

Schedule 3 Background

4

Objectives

5

Session 1: Inaugural session

6

Session 2: Technical session

9

Recommendations

21

Annexes: Annex 1: List of Members of the Consultative Meeting 22-23 Annex 2: Presentation on Overview on JE Surveillance in Bangladesh

24-27

Annex 3: Presentation on A novel low cost method to estimate the incidence of Japanese encephalitis in three districts in Bangladesh

28-29

Annex 4: Presentation on Long-Term Neurologic and Functional Outcomes of Japanese Encephalitis Human JE Viral Infection

30-32

Annex 5: Presentation on Cost of illness of Japanese encephalitis in Bangladesh

33-35

Annex 6: Presentation on JE Disease Burden & Surveillance Network in SEAR

36-38

Annex 7: Presentation on Technical information and update on safety and immunogenicity of available JE vaccines

39-43

Annex 8: Presentation on Progress in Japanese Encephalitis Vaccine introduction in SEAR countries

44-47

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Consultative Meeting on Japanese Encephalitis (JE) Prevention and Control

Venue: Institute of Epidemiology, Disease Control and Research

(IEDCR), Mohakhali, Dhaka Date: 12 February 2009 Collaborating Institutes: IEDCR, WHO, ICDDRB, PATH

Schedule

Period Topic Facilitator

09:00 09:30 Registration IEDCR A: OPENING SESSION Overview on JE Surveillance in Bangladesh

Prof. Mahmudur Rahman PhD Director, IEDCR

Speech by Representative, PATH

Dr Asheena Khalakdina PhD Epidemiologist, PATH

Speech of Special Guests Dr. Serguei Diorditsa, MO-IVD, WHO, Bangladesh

09:30 10:30

Speech of Chief Guest Prof. Shah Monir Hossain, Director General, DGHS

10:30 11:00 TEA BREAK B: TECHNICAL SESSION 11:00 11:30 Burden of JE: Incidence , Long

term neurological deficits, Cost

Emily Gurley, Deputy Head, Programme on Infectious Diseases & Vaccine Sciences ICDDR,B

11:30 11:45 Regional situation of JE Dr. Serguei Diorditsa,WHO 11:45 12:10 Technical information and

update on safety and immunogenicity of available JE vaccines

Dr. Mansour Yaïch, PATH

12:10 12:30 Progress in Japanese Encephalitis Vaccine introduction in SEAR countries

Dr Asheena Khalakdina PATH

12:30 01:10 Discussion session 01:10 01:15 Remarks and Closing of

technical session by Chairperson

Prof. Mahmudur Rahman, PhD Director, IEDCR

01.15 LUNCH

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Report on “Consultative Meeting on Japanese Encephalitis (JE)

Prevention and Control”

Background Japanese encephalitis (JE) is the leading cause of viral neurological disease and disability in Asia. The disease can cause irreversible neurological damage. The severity of long-term disabilities, and large number of cases, make JE the most important cause of viral encephalitis in the world. Globally the annual incidence of JE disease is 30,000–50,000 cases and 10,000 deaths reported annually to WHO that could be a gross under- estimation. Case fatality rate for JE is 25-35% and about 40% survivors develop permanent neurological and psychiatric sequel. Countries affected by JE include Bangladesh and its neighboring countries like India, Pakistan, Myanmar, Bhutan, Nepal, Sri Lanka, Thailand and other countries also show the burden. The first outbreak of JE in Bangladesh was reported in Tangail forest area of Bangladesh in 1977. During the period 2003-2005 International Centre for Diarrhoeal Disease Research (ICDDR,B) did surveillance at 4 hospitals in Bangladesh and in that surveillance every fourth patients of acute encephalitis was tested with cerebrospinal fluid (CSF) and 20 (4%) JE cases identified. IEDCR with the collaboration with WHO, Institute of Public Health (IPH), ICDDRB, CDC started Acute-Meningo Encephalitis Surveillance (AMES) since September 2007 at 3 sentinel medical college hospitals (Rajshahi, Chittagong and Khulna). A total of 622 samples of Meningo-Encephalitis cases collected and tested till August 2008 and out of which 36 (6%) found positive for JE IgM. Naogaon district reported the highest number of JE cases (22%). Once a person gets sick with JE, there is no treatment that can be used to cure the patient. Human vaccination is the only method that has proven effective in control of JE disease. Other methods, such as mosquito control and pig control, have been used but with little success. Thailand, for example, for many years attempted to control mosquitoes and to respond to outbreaks, but it was not until JE vaccine was introduced into the country that the incidence of JE fell dramatically. Examples of countries with successful JE control programs are Japan and South Korea. Before the 1950s, these countries experienced JE outbreaks, but incidence rates have remained stable for more than 2 decades. The incidence of JE also declined in China, SriLanka and India as a result of large-scale vaccination programs implemented.

Currently available JE vaccines are relatively safe and effective. Other major issues with the mouse brain derived vaccines are the supply, production and cost. Also, adverse events are a concern. Effective delivery of the vaccines to poor, rural communities therefore remains a formidable challenge, and compliance and delivery costs have to be considered.

Some districts of Bangladesh have been identified as endemic for JE. For the prevention and control of JE necessary measures need to be taken early and this consultative meeting has been organized as a former step for planning.

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Objectives of the Consultative meeting

• To get an overview of the national and regional situation of Japanese Encephalitis

• To improve understanding on role of partner organizations in JE prevention and control

• To share updated information and experience on JE prevention and control between partner organizations

• To strengthen coordination between partner organizations for JE prevention and control

• To understand the efficacy and safety of JE vaccine currently available • To identify necessary steps for JE prevention and control in Bangladesh by

members

Members of the consultative meeting: Around 35 members attended the meeting. The members were Government officials from Directorate General of Health Services, Institute of Public Health, National Drug Administration, EPI and IEDCR and also from International Organizations ; PATH, WHO, ICDDRB, UNICEF (Annex-1).

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Session 1: Inaugural session Prof. Shah Monir Hossain, Director General of Health Services, DGHS inaugurated the consultative meeting as Chief guest. Prof. Mahmudur Rahman Director, IEDCR was the Chairperson and provided the welcome address in the inaugural session. In addition he presented the “Overview of JE Surveillance in Bangladesh” (Annex 2).

The Chairperson described the AMES surveillance mechanism, the activities ongoing and also the data of the surveillance. AAccuuttee MMeenniinnggoo--EEnncceepphhaalliittiiss SSuurrvveeiillllaannccee ((AAMMEESS)) started from September 2007 in Bangladesh. The 3 sentinel sites for surveillance are Rajshahi, Chittagong and Khulna Medical College Hospital. The objectives of this surveillance are to include Meningo-encephalitis in the current vaccine preventable disease surveillance activity in Bangladesh, to strengthen national capacity in the detection of important causes of meningo-encephalitis and to estimate the incidence of meningo-encephalitis in Bangladesh. Collaborating Institutes for AMES IEDCR: Leading the AMES surveillance, Institute of Public Health (IPH), Chittagong, Rajshahi and Khulna Medical College Hospitals- (Medicine & Pediatrics departments), WHO, ICDDR,B, and CDC,USA. 1 CSF and 2 serum samples are collected from AME cases for testing JE and Nipah. Latex agglutination test and Gram staining with CSF done to identify common pathogens for Bacterial meningitis. AMES data analyzed from October 2007 to August 2008. A total of 632 meningo-encephalitis cases were enrolled in this surveillance during this period. Patients were reported from 35 districts. Mean age of the patients was 20 years, 395 patients (62%) were male.

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Total confirmed JE cases were 36 (6%). Naogaon district reported the highest number of JE cases (11 cases) shown in table 1. Among bacterial causes 23 cases found positive for S pneumoniae, 5 for H influenzae, 5 for N meningitides and 3 for Streptococcus group B. The Chairperson added major achievement reached through this surveillance the capacity of Government facilities has been built enormously which is admirable and includes – orientation workshop for local resources on AMES, training of study physicians and laboratory technologist on data collection, sample collection, processing, transportation and laboratory personnel on JE, Nipah Latex agglutination technique.

Table.1 distribution of JE positive cases by district

District 2007 2008 Total

Chittagong 4 4 Chuadanga 2 1 3 Cox’s bazar 2 2 Feni 2 2 4 Gopalganj 1 1 2 Jessore 1 1 Jhenaidah 1 1 2 Joypurhat 1 1 Khulna 2 2 Kushtia 1 1 Narail 1 1 Natore 2 1 3 Naogaon 7 4 11 C’ Nawabganj 2 2 Pabna 1 1 Rajshahi 6 4 10 Rangamati 2 2 Shatkhira 1 1

Total 28 25 53

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Prof. Mahmudur Rahman put emphasis on upcoming challenges for JE surveillance they are;

Continuation of surveillance Funding Strengthening collaboration between partners TOR of the partners Establish proper linkage between IEDCR & CDC for technical support Expansion of other sentinel sites

After the presentation of the Chairperson, the special guest Dr. Serguei Diorditsa, MO-IVD, WHO delivered his speech. Later Dr Asheena Khalakdina, Epidemiologist, PATH, as a special guest delivered her speech. Prof. Shah Monir Hossain, Director General of Health Services provided his valuable speech as Chief guest. He thanked all the participating organizations and extended special thanks to Prof. Mahmudur Rahman, Director IEDCR for the ongoing surveillance activities which is crucial for future planning. He admired the capacity of IEDCR for continuing the surveillance. He requested the members that the recommendations of the consultative meeting should be sent to him and he will provide full support for its implementation.

The DG noted that the burden of JE was significant at 6% according to the surveillance project which only covered a small sample. He noted that it might be an even bigger threat to public health in future outbreaks. He recommended that immunization programme for JE should be developed. Surveillance is a tool for planners but control is most important which means EPI programme is also very important. He suggested that Bangladesh’s own capacity must be developed for sustainability and a proposal developed on the basis of performance.

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Session 2: Technical session There were six power point presentations in the technical session. After each presentation members asked questions and each presenter responded accordingly. The first presentation offered by ICDDRB and it was titled “Burden of JE: Incidence, Long term neurological deficits and Cost”. That presentation had three component and those were from recent innovative research findings presented by three researchers of ICDDRB. Emily Gurley, Deputy Head, Programme on Infectious Diseases and Vaccine Sciences, ICDDR,B introduced the researchers of the study and they presented their study findings respectively.

The 1st presentation was “A novel low cost method to estimate the incidence of Japanese encephalitis in three districts of Bangladesh” (Annex 3) and offered by the researcher Mr. Repon C. Paul of ICDDRB. The objective of the study was to estimate the population based JE incidence. He mentioned that hospital surveillance underestimates the total burden of disease and therefore cathment assessment is cost effective to measure the incidence of disease which is the core indicator for introducing vaccine for controlling “vaccine preventable disease”. Total population of hospital catchment districts is 6.1 million. The methodology used for this study was by correcting the hospital based JE incidence by the proportion of persons with symptoms of meningo-encephalitis in the hospital catchment area who seek care at surveillance hospitals. The statistical formula was “Incidence of JE” = n / N * D * P. where n =JE cases from hospital catchment area; N = Hospital catchment population; D= Duration of surveillance; P= Proportion of meningo-encephalitis cases in hospital catchment area admitted study hospital. Mr. Repon Paul described the innovative technique for data collection. Instead of house-to-house survey, they utilized broader community awareness of serious events to identify cases.

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Moreover, they approached all health care providers, educational institutions, and groups in local market and asked community people in village for gathering cases in their neighborhood. The team visited the households of suspect cases as per case definition. The study found 267 suspect meningo-encephalitis cases (0.85 per 1000 population) within last 1 year. Out of 267 cases 29 (11%) cases sought care at Rajshahi Medical College Hospital. Proportion of cases in the hospital catchment area admitted to study hospital is P = 29/267= 0.109. 17 cases identified JE positive from the 3 hospital catchment districts. He pointed out that a minority of patients (11%) with symptoms of acute meningo-encephalitis seek care at surveillance hospital. The estimated incidence of JE (2.9 per 100,000 population) is high in the study area and the study they conducted proved to be a low cost method to collect incidence information. He ended his presentation with some recommendations, they are; a) demonstration project of JE vaccine in the catchment area of Rajshahi Medical College Hospital b) cost analysis of Japanese encephalitis illness and c) understanding the burden of JE infection in reservoir and vector e.g.,Pigs, Herons and Mosquito.

The 2nd presentation delivered by Dr. Jahangir Hossain, ICDDR,B. It was titled “Long-Term Neurologic and Functional Outcomes of Japanese Encephalitis” (Annex -4). He started with saying that a little information is known about long-term outcomes of JE and those are from anecdotal case reports which are not necessarily representative. He emphasized that long-term outcomes represent substantial “burden” for Individual, for family/caregiver and could be societal. In this study 25 JE infected survivors were enrolled from 4 sites and from June 2003-July 2005. Median interval between acute illness and follow-up was 30 months (range, 10-35 months). The assessment of cases based on neurological examination, functional status, electroencephalography (EEG), brain magnetic resonance imaging (MRI) and electromyography (EMG) in patients with limb weakness.

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The findings of the study found nine (9) cases with significant Neurological deficit. They are as follows.

Neurological deficit Number Severe spasticity 3 Weakness of limbs 3 Limb weakness with atrophy and loss of reflex consistent with poliomyelitis

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Severe dystonia 2 Parkinsonism 1 Hemiplegia 1 Bowel and bladder incontinence 1 Cognitive deficit 4 Aggressive behaviours 1

A JE infected survivor with Neurological deficit The abnormal neuroimaging observed among six (6) JE infected survivors. Out of six observation 4 showed bilateral thalamic, basal ganglia lesions which is “classic” for JE and 2 showed Confluent subcortical signal abnormalities but no thalamic, basal ganglia involvement. 15 (71%) of the cases showed persistent subjective symptoms, 6 with objective neurologic deficits, 9 without objective neurologic deficits. He concluded that most of them had subjective functional impairment (table 2) which interferes with normal daily activities of the cases.

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Table 2. JEV: Subjective Functional Impairment

Symptom Total Persistence

N % N %

Fatigue 21 100 15 71

Mood Problems / Depression

14 66 12 85

Memory Problems 15 71 11 73

Concentration Problems

15 71 11 73

Headaches 11 52 6 54

Balance problems / “unsteadiness”

10 47 9 90

He added that toll for JE infection on individual and family/caregivers were also significant. Median period of absence from school was 1 year, 5 of them unable to attend school at follow-up. 7 of 9 patients with neurologic sequelae–unable to care for selves moreover constant attention required from caregivers. At the end Dr. Jahangir Hossain summarized the JE outcomes from the study findings, they are; - long-term persistence of neurologic sequelae following JE - limb weakness including poliomyelitis - “atypical” MRI findings-absence of thalamic involvement - burden of post-JE impairment substantial among survivors, their family & societal The 3rd presentation from ICDDRB was “Cost of illness of Japanese encephalitis in Bangladesh”(Annex-5). Nadia Ishrat Alamgir presented the study findings. The objective was to determine the economic burden incurred by a patient and family due to Japanese encephalitis. The study conducted from April 2008 to February 2009. A total of 86 confirmed JE patients were enrolled in this study. The cost was measured by different approaches. The “Direct cost” - multiplying the cost with the appropriate number and the “Indirect cost” - days of productivity loss & absenteeism from school. The mean cost for hospitalized patients was US$ 95 (±SD 40.33) and mean hospital duration eight days. The mean productivity loss for patient and caregiver was US$ 3.5. Nineteen families (54%) spent more than half of their total monthly expenditure. For long-term sequelae median expenditure for management was US$ 346 (range US$ 95 to US$ 4446), mean productivity loss for patients US$ 177 (±SD 125.8), 10% drop out from school, 20% absenteeism for an average of 1.5 years. She added that the coping mechanism for this cost were 7% from household savings, 90% by borrowing money, 26% by mortgaging and 19% by selling household assets. Families from lower socio-economic status (SES) were 5 times more likely to borrow money than the families from higher SES (p<.001).

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She concluded that the study demonstrated substantial costs for treatment where majority (76%) had catastrophic expenditure. She recommended for an effective vaccination in high prevalence areas and also for an economic evaluation to assess the cost benefit of the ‘Live attenuated (SA14-14-2) vaccine’.

The 4th presentation was delivered by Dr. Serguei Diorditsa, MO-IVD, WHO, Bangladesh. It was named “JE Disease Burden & Surveillance Network in SEAR”(Annex -6). He outlined the importance of JE as 50000 cases and 10000 deaths reported annually to WHO. He added there is 25-30% case-fatality, 30-50% survivors have significant sequelae, 1 in 250-500 manifest clinical disease, JE occurs in epidemics and most importantly there is no specific antiviral treatment for this disease. JE is endemic in the Asia-Pacific Region. He showed the figure of JJEE CCaasseess && DDeeaatthhss,, 11998855--22000088 iinn SSrrii LLaannkkaa ((FFiigguurree 11)) aanndd hhooww ssuubbsseeqquueennttllyy tthhaatt ffiigguurree ddrrooppppeedd aafftteerr iinnttrroodduucciinngg JJEE vvaacccciinnee..

Figure 1 : JJEE CCaasseess && DDeeaatthhss,, 11998855--22000088 iinn SSrrii LLaannkkaa

0

100

200

300

400

500

600

700

800 Introduction of JE immunization on phase

13858687888990919293949596979899 0 1 2 3 4 5 6 7

Cases

Deaths

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Dr. Serguei described the catastrophe of JE epidemic in India which occurred in 2005. In that epidemic 6,594 JE cases and 1,665 deaths occurred in 10 states. 6,011 cases and 1,472 deaths in Uttar Pradesh. There were similar outbreaks in the adjoining districts of Bihar and in Nepal’s Terai region which demanded for saving lives. To handle the devastated situation political crises arose. He showed the JE surveillance (2004-2006) findings of Nepal during which 4652 encephatlitis patients were evaluated. During the surveillance period 69% specimen from Acute Encephalitis Surveillance (AES) patients had collected. 32% of the specimen confirmed JE. Where 92% cases were from Terai region; 65% from just four western-most districts. 48% cases were less than 15 years old. Dr. Serguei highlighted the issues in defining burden of JE. The issues are;

• Limited surveillance: Disease is under-recognized in many countries • Unreliable or inaccurate data

- Non use of common surveillance standards - Limited or unreliable laboratory confirmation

• Competing priorities with other vaccine preventable diseases • Impact of long-term disability is not measured • Limited advocacy and lack of awareness

He emphasized that Surveillance is ESSENTIAL for policy level decision-making

• To quantify national and sub-national burden of disease

• To characterize the epidemiology, especially geographical areas and populations at high risk, for strategically targeting control efforts

• To establish baseline incidence of disease in order to monitor impact of an immunization or control program

He also shared the information on progress in surveillance and laboratory work. They are; • WHO JE surveillance standards available • WHO lab network established in SEARO and it is under development in WPRO • WHO laboratory manual developed and field tested • Studies undertaken on comparison of diagnostic kits for CSF and serum • Simple, standardized tool developed to measure long-term disability • Guide countries in introduction of JE vaccine • Guide the planning of mass campaigns and EPI with JE surveillance for JE and AEFI Dr. Serguei at the end of his presentation mentioned Pilot projects for integrated surveillance for acute meningitis and encephalitis are now ongoing in Cambodia, China, and Bangladesh. Standardized case definition to capture overlapping clinical syndromes of meningitis and encephalitis is essential. In addition to laboratory testing for JE laboratory testing for other vaccine preventable pathogens e.g., Hib, S. pneumo, N. meningitides is recommended. It is important to note that JE vaccine is one of four new vaccines included in recent GAVI Portfolio Recommendations. The partners and some potential partners working on JE are Bill & Melinda Gates Foundation, GAVI ALLIANCE, WHO, PATH, AFRIMS, unicef, JICA, Centre for Tropical Medicine, IVI, University of Liverpool, USAID, Mahidol University.

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The 5th presentation was offered by Dr Mansour Yaïch, PATH titled ‘Technical information and update on safety and immunogenicity of available JE vaccines”(Annex-7). He stated the recent and future studies of live, attenuated SA 14-14-2 vaccine. He started with the data of Epidemic potential of JE. There is evidence of large outbreaks in parts of China, South-East Russian Federation, South and SE Asia (outbreaks can reach >100 cases per 100,000). High endemic areas include Thailand and Viet Nam, but disease is year round in tropical climates. Vector control measures have limited effect. He mentioned there are all together 5 JE vaccines developed so far (table 3). The first Mouse brain-derived JE vaccine is the inactivated JE vaccine (JE-VAX) which is used in routine immunization in Japan, Korea, Taiwan, India, and Thailand. Minimum 3-4 doses needed in infants for “long-term” protection (4-5 years, max) and that is expensive (e.g., $3-4/dose in Sri Lanka, imported; $2-4/dose in Thailand, domestic production). He described with comparison the landscape of current JE vaccine which is shown below.

Table 3. Landscape of current JE vaccines

Company Technology Licensed* Min. Doses in Primary Series

WHO Prequalification

Biken Inactivated Mouse Brain

YES 3 N/A

Chengdu Institute of Biological Products (CDIBP)

Live, attenuated SA 14-14-2

YES 1 2011

Intercell/ Biological E/ Novartis

Ixiaro™ Inactivated cell-based SA 14-14-2

Yes (2009) 2 2011-12

Biken Inactivated cell-based Nakayama

NO (2008) 3

Intended for Japanese market but may seed prequal by 2012

Acambis/ SanofiPasteur

ChimeriVax™-JE Live, attenuated SA 14-14-2

NO (2009) 1 or 2 2011-12

. He demonstrated the Vaccine characteristics; In animals there is clearly no neurovirulence Genetic stability is demonstrated Master seed virus and the cell line are not contaminated by any virus Establishment of SPF colony and cell line Thermo stable up to 18 months between 2-8°C (>5.4 log pfu) Highly potent after reconstitution for at least 6 hours (actual data shows>14 h) at 37°C

(fully consistent with WHO policy)

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He also showed the protective rates of live and killed vaccines against different JEV strains and vaccine SA14-14-2 found to have more protective roles than inactivated vaccine. He showed the study findings of a recent a case-control study in children conducted in Nepal where long-term effectiveness of a single dose of SA 14-14-2 vaccine against JE had been observed. Effectiveness 12-15 months after vaccination was 98.5% (95% CI, 90.1 to 99.2). Effectiveness five years after one dose showed 96.2%. He concluded that one dose for infants and children 9 months to 15 years of age for a minimum of 5 years’ protection following initial and catch-up campaigns. In the JE/Measles vaccines co-administration study done in 600 subjects, aged from 9-11 months, were randomized into three groups:

• Group 1 received first dose of JE vaccine alone (and measles one month after). 100% protection after 30 days 95% after 365 days

• Group 2 received JE and measles vaccines together. 100% protection after 30 days 95.1%% after 365 days

• Group 3 received measles vaccine alone (and JE vaccine one month after as a benefit). 100% protection after 30 days 95.7%% after 365 days

Conclusions

• One-month and one-year post-vaccination, measles seroprotection rates were high after receipt of MV with or without JE vaccine.

• One month anti-measles GMC for the co-administered group was lower than that for the MV-alone group, but one-year anti-measles GMCs in both groups were similar.

• WHO’s Global Advisory Committee on Vaccine Safety concluded the short-term safety profile of live JE vaccine given with measles vaccine was acceptable.

• Follow-up study will examine the possible long-term impact on protection, if any.

• Providing the two vaccines together could eliminate the need for an additional clinic visit.

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Primary objective of NIV (Pune, India) viremia study was to determine levels of viremia between days 1-8 and day 15 following a single dose of SA 14-14-2 JE vaccine in adults and the secondary objective was to determine neutralizing antibody response at 30 days, 6 months, and one year. All viremia results were negative from Day 0-Day 8 and at Day 15

• CDIBP (Chengdu Institute of Biological Products) Facility Construction: New production facility will ensure a sufficient, sustainable, and affordable SA 14-14-2 vaccine supply to meet growing regional demand.

• Training to build capacity on compliance with international standards for current Good Manufacturing Practices.

• Continued technical assistance from PATH will confirm that equipment, installation, and production meet WHO prequalification manufacturing standards.

• Facility online and producing vaccine by 2011. He summarized

• Data show that the SA 14-14-2 JE vaccine is safe and efficacious with one dose. • Preliminary data show that SA 14-14-2 booster is effective following administration of

inactivated mouse brain vaccine • SA-14-14-2 vaccine is safe to administer to 9-month-old children • The short-term safety profile of co-administration of JE and measles vaccine is

acceptable The 6th presentation made by Dr Asheena Khalakdina, Epidemiologist PATH on “Progress in Japanese Encephalitis Vaccine introduction in SEAR countries”(Annex-8). She mentioned PATH JE project is for 5-years, which will end in October 2009, funded by the Bill & Melinda Gates Foundation (BMGF). Initially the project focused on data for decision-making (surveillance, dissemination, advocacy) but later shift to activities for vaccine introduction. The vision of JE project is to eliminate clinical JE and avoid the unnecessary death and disability caused by this disease. The project strategy is to routinely vaccinate all the at-risk population with a safe, efficacious and affordable vaccine. PATH support country level disease control and decision making when countries understand their disease burden and decide that JE is a priority and they need an available, affordable vaccine, they need increased support from international public health partners and they need the advice and experience of other countries that have excelled in JE control. She said for effective control of JE mass JE vaccination campaigns followed by routine immunization through EPI programs is required as JE transmission in children and adults is vector-borne with animal reservoir; therefore vaccination confers no herd-immunity. In addition she showed the JE vaccination data of Thailand and the incidence of JE case dropped after JE vaccination introduced in 1995 in endemic regions only and later introduced countrywide in 2000 (Figure 2).

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Figure 2 Impact of JE Vaccination in Thailand, 1971-2006

Impact of JE Vaccination in Thailand, 1971-2006

Source: Bureau of Epidemiology and Division of Arbovirus, MOPH Thailand

JE vaccination (endemic)

JE vaccination (countrywide)

EncephalitisEncephalitis

Estimated JE

0

1

2

3

4

5

6

1970 1975 1980 1985 1990 1995 2000 2005

Incid

ence, c

ases p

er 100,0

00

booster

JE vaccine licensed in Thailand

-Vertical program*-><--Integrated program*->-----EPI RI program----->

*surveillance, health education, vector control

She highlighted WHO position on JE vaccines (Weekly Epidemiological Record 2006. 91:325-340). WHO recommends “With increasing availability of effacious, safe and affordable vaccines, JE immunization should be integrated into the EPI programmes in all areas where JE constitutes a public health problem. The most effective immunization strategy in JE endemic settings is one time catch-up campaigns followed by incorporation of the JE vaccine into the routine immunization programme. This approach has greater public health impact than either strategy separately”. Dr Khalakdina also focused on status of JE vaccination programs in endemic countries which is shown in Figure 3. Figure 3. Status of JE vaccination programs in endemic countries

Status of JE vaccination programs in endemic countries

Comprehensive* Expanding None China

Japan

South Korea

Taiwan

Thailand

India

Nepal

Sri Lanka

Malaysia

Vietnam

Bangladesh

Bhutan

Brunei

Cambodia

Indonesia

Laos

Myanmar

North Korea

Philippines

Timor Leste

*Used in EPI or annual campaigns on a national or broad regional basis

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She added that India has taken a five-year strategy to reach high-risk districts and the target population is 100 million by 2010 where single dose of SA14-14-2 JE vaccine is given to children 1 to15 years of age and this campaign will be followed by routine immunization. In Sri Lanka JE Vaccine was introduced following a large outbreak and has been used in country since 1988 for 1-10 years age group. Out of 26, 18 districts were covered and there JE is no longer a public health problem. Decision now made to introduce SA 14-14-2 [5 dose vials] in mass campaign style in 2009 and planning to incorporate it in the National EPI schedule covering all 26 districts and all children reaching 1 year of age. If a single dose can give a longer immunity, the adult population may be considered with a single dose that could further bring down JE transmission in the country. Nepal is highly endemic for JE and there 3.8 million vaccinated with SA 14-14-2 in campaigns since 2006. China has also undertaken decision-making on vaccine introduction with this vaccine. Three control counties and three intervention counties were selected to make a transition from the use of inactivated JE vaccine to the live attenuated vaccine. There baseline and post intervention KAP and coverage surveys had been conducted and also cost analysis and economic evaluation of transition to live SA 14-14-2 vaccine has been conducted. She summarized the major accomplishments in JE control which are; • Initiated or strengthened lab-based JE surveillance in endemic areas • Generated vaccine-related data to aid with decision-making • Vaccine safety/efficacy

- Vaccine stability - Cost-effectiveness

• Manufacturer has public sector pricing to enable access in poor countries • JE vaccination campaigns in India and Nepal reached >45 million to date • JE is one of four new vaccines selected for GAVI investment.

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Recommendations After thorough discussion held in the consultative meeting between contributing partners all recognized JE as a public health problem of Bangladesh and opined that necessary measures should be taken for its prevention and control. In addition following recommendations were made by the distinguished members. 1. Policy makers (Ministry/DG) should be convened on this issue 2. For estimating JE burden nationwide

Scaling up JE surveillance (Should have complete picture of JE in BD) Expansion of the sentinel surveillance sites specially border areas More discussion and dissemination sessions with JE burden occurred locally involving

planners, academicians, and others. Partners from sentinel surveillance sites should be involved. National EPI should take into consideration of the JE surveillance findings.

Collaboration and partnership- can contribute in the surveillance Include EPI in the surveillance as a partner Rangpur Medical College should be included as a sentinel site for surveillance and should plan

to include more places Identify the area mostly affected with JE. Budget for surveillance should be increased Encephalitis cases to be included in the web based district surveillance as a Priority

Communicable Disease (PCD) 3. Need for further research on

How frequently people get infection with JE Sero-prevalence among pigs to be conducted by ICDDRB JE incidence catchments survey in different sites (ICDDRB is planning to do it in Rangpur

district soon) Longitudinal follow up of a cohort –on limited scale

4. For the introduction of vaccine Principle of vaccination should be cleared : Who will be given/How many times There should be sufficient data regarding the safety of the vaccine Simultaneous running of vaccination and clinical trial is preferred Availability of vaccine and regulatory mechanism should be there There should be plan for purchasing vaccine in near future and for introducing it.

5. Inter-country discussion to be held for Cross border issues Whether our neighboring countries are vaccinating bordering areas

6. Plan for Control There should be a plan for JE control to be developed combining GoB, NGO, international

organizations, development and private partners Identify the gaps existing and ways to meet those gaps Awareness raising activities followed by vaccination in endemic areas

The chairperson thanked the JE team of IEDCR and resource persons for experience sharing, providing an overview of JE activities ongoing nationally, regionally and globally. He emphasized all those presentations enhanced the knowledge of relevant personnel working for JE prevention and control. He also thanked all the participants who shared in-depth information and provided useful recommendations and made the discussion session more effective. He believes that the question and answer session explored the opportunity to have better understanding about JE prevention and way forward for future collaboration. The chairperson appreciated the members for their active participation and support to make the consultative meeting successful.

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Annex 1 List of Participants Attendance Sheet

Sl # Name Designation Signature

1. Prof. Shah Monir Hossain Director General, DGHS √

2. Prof. Hosne Ara Tahmin ADG (Admin), DGHS √

3. Prof. Moazzem Hossain Line Director, CDC, DGHS

4. Dr. Abu Jahangir Alam Director (PHC), DGHS √

5. Dr. Md. Akhter Hossain Miya Director Hospital, DGHS √

6. Dr. AKF Mozibur Rahman

Deputy Director, EPI& Surv PM, CH& LCC

7. Dr. Bazlur Rahman Deputy Director (Incharge), Planning, DGHS

8. Prof. Mahmudur Rahman Director, IEDCR √

9. Dr. Nurul Haq Chowdhury Chief Scientific Officer, IEDCR √

10. Dr. Nur Har Begum Chief Scientific Officer, IEDCR √

11. Dr. Mustafizur Rahman Chief Scientific Officer, IEDCR √

12. Dr. Mainuddin Ahmed Chowdhury

Chief Scientific Officer, IEDCR √

13.Dr, Benazir Ahmed Principal Scientific Officer, IEDCR √

14.Dr. Sultana Shahana Senior Sceintific Officer, IEDCR √

15.Dr. Yasmin Jahan

Senior Sceintific Officer, IEDCR √

16.Dr. Kh Mahbuba Jamil

Senior Sceintific Officer, IEDCR √

17.Dr. ASM Alamgeer Virologist, IEDCR √

18.Dr. Md. Zahirul Islam Medical Officer, IEDCR √

19.Dr. Madan Gopal Datta

Deputy Director & Head - Microbiology Dept, IPH

20.Dr. Anwarul Haque Chowdhury Virologist, IPH √

21.A A Salim Barami

Assistant Director, Directorate of Drug Administration

22.Dr Asheena Khalakdina Epidemiologist, PATH √

23.Dr. Mansour Yaich PATH √

24.Dr. Serguei Diorditsa MO-IVD, WHO √

25.Dr. ASM Mainul Hasan NPO (Surveillance), WHO √

26.Mr. Sharifuzzaman Data Manager, WHO √

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Sl # Name Designation Signature

27.Emily Gurley

Emily Gurley, Deputy Head, Programme on Infectious Diseases & Vaccine Sciences ICDDR,B

28.Dr. Jahangir Hossain Associate Scientist, ICDDRB √

29.Repon C Paul Research Investigator, ICDDRB √

30.Nadia Ishrat Alamgir Research Fellow, ICDDRB √

31.Dr. Salahuddin Khan Research Investigator, ICDDRB √

32.Dr. Jucy Merina Adhikari Immunization Officer, UNICEF √