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Pilot introduction of Vi Polysaccharide Typhoid Vaccine through School-Based and Tourism Sector Vaccination Programs in the Kathmandu Valley, Nepal Summary Report on Lalitpur and Bhaktapur Districts School-Based Vaccination Ministry of Health and Population, Government of Nepal MITRA Samaj International Vaccine Institute

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Page 1: Viva school based vaccination

Pilot introduction of Vi Polysaccharide Typhoid Vaccine

through School-Based and

Tourism Sector Vaccination Programs

in the Kathmandu Valley, Nepal

Summary Report onLalitpur and Bhaktapur Districts School-Based Vaccination

Ministry of Health and Population, Government of Nepal

MITRA Samaj

International Vaccine Institute

Page 2: Viva school based vaccination

1Rationale for the Typhoid Vaccination Program Typhoid fever is a disease caused by the bacterium Salmonella enterica serotype Typhi (S. Typhi) and is spread by the fecal-oral route through contaminated food or water. It continues to be a serious public health problem in many developing countries. The disease, which disproportionately affects children, is characterized by persistent fever, abdominal pain, and malaise, and often causes prolonged illness of one month or more. In about 10-15% of cases, it leads to serious complications, including hypotensive shock, perforation of the gut, and gastrointestinal hemorrhage. Even as a conservative estimate, the number of typhoid-related deaths each year in this estimate is comparable to that of cervical cancer caused by HPV and is greater than that of Japanese encephalitis and meningococcal meningitis – diseases that are top priorities for disease control in the global health community.

In addition to the continued high incidence of typhoid fever in many areas, rapidly rising rates of antibiotic resistant strains of S. Typhi have further worsened the impact of this disease, increasing the difficulty and cost of treatment and threatening to increase case fatality from the currently estimated 1-4% to pre-antibiotic era rates of 10-20%.

Prevention measures should include improvements in water and sanitation systems, but given the huge investment these improvements require, they are far-off goals. Thus, a vaccine against typhoid is a crucial interim preventive measure. The World Health Organization (WHO) in 2000 and 2007 recommended immunization of high-risk groups. In the region, WHO South East Asia Regional Office (SEARO) recommended the prior i t izat ion of typhoid vaccines for “ immediate” implementation at a 2009 WHO SEARO meeting. Further, the National Committee on Immunization Practices (NCIP) of Nepal recommended in 2010 to consider the use of typhoid vaccines to control the disease.

• Background Typhoid, considered a “disease of the neighborhoods,” has been

in existence since antiquity, with references found in ancient Chinese texts dating back to 100 AD. Although this disease has been controlled in much of the industrialized world, it continues to affect people of many developing countries including Nepal, where it is endemic. Nepal is prone to outbreaks, with cases of typhoid fever recorded every year. In 2010, there were large outbreaks in May (173 cases) and June (650 cases) registered in the Western Regional Health Directorate of Pokhara, and in 2011, outbreaks were recorded in various locales in the Kathmandu Valley, which has been infamously named “the enteric fever capital of the world” due to many cases occurring in the general population as well as among tourists.

• Pilot Typhoid Vaccination Program The goal of the Typhoid Vaccination Program in Nepal was to

accelerate the introduction of the typhoid Vi polysaccharide vaccine in high-risk areas of the country. To meet this goal, a pilot typhoid vaccination program was carried out in two sectors – schools and the tourism industry.

The school-based vaccination program addressed the critical need of students to be protected from typhoid fever given that children and youth have the highest rates of typhoid and face a huge burden of the disease. The vaccination program for workers in the tourism industry was conducted to prevent typhoid fever in the tourism industry and among tourists, as well as to provide a funding source for the school-based program. By charging tourism sector employees or employers a nominal fee, money was collected and deposited in a revolving fund to subsidize the no-cost vaccination program for the students. Figure 1 shows the system of vaccine procurement and the distribution of the vaccine for the pilot project.

This program is a good example of a public-private partnership wherein the government took the lead in implementing the vaccination program in collaboration with a local non-governmental organization (MITRA Samaj); an international organization (International Vaccine Institute, or IVI), which provided technical assistance and funding; and a for-profit vaccine manufacturer (Sanofi Pasteur), which donated 148,600 doses of the Vi polysaccharide vaccine.

Figure 1 Model of the Vi Typhoid Vaccination Program

Vaccine producer

Purchase

User fee

Vaccines

Vaccination Vaccination

VaccinesNGO

District Govt.

SchoolsTourism Sector

Dr. Shyam Upreti (standing), Director of Child Health Division, addressing the District Immunization Coordination Committee about vaccination strategy.

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2• Vaccination The school-based vaccination program was conducted in two of

three districts of Kathmandu Valley: Lalitpur and Bhaktapur. Each of these districts was divided into municipality (urban area) and Village Development Committees (VDCs) (rural area). In Lalitpur Sub-Municipality City schools (LSMC), school children in classes 1 to 10 were vaccinated, whereas in VDC, Lalitpur, it was students in nursery to class 12. The vaccination program began on August 2011 in LSMC schools and was completed in September 2011. It was conducted in schools in the VDCs from November 2011 to January 2012.

Students in the Bhaktapur municipalities (Bhaktapur and Thimi) and Village Development Committees were vaccinated from nursery to class 12. Vaccination in this district was conducted from December 2011 through January 2012.

This project was designed and executed as a public health vaccination introduction project. Because it was the first time the typhoid vaccine was to be delivered through schools, a consent form was used in the Lalitpur District to ensure that parents were adequately informed about the program.

In the Lalitpur District, the typhoid vaccine introduction program was formally inaugurated jointly by the Minister of Peace and Reconstruction and the State Minister of Health and Population on August 19, 2011 at Madan Smarak Higher Secondary School in Pulchowk, Lalitpur District, with attendance from Members of Parliament, the Director of the Child Health Division, WHO/IDP and IVI representatives, and representatives of international and national organizations, as well as media personnel. In Bhaktapur, the program was formally inaugurated on December 1, 2011 by the Bhaktapur District Local Development Officer with district representatives from the Local Development Office, the District Education Office, the District Public Health Office, political parties, and key district organizations.

1. Advocacy and Endorsement Lalitpur District National-level advocacy for the school-based vaccination was

carried out along with advocacy for the tourism vaccination project. Government of Nepal approvals and support were provided for the vaccinations in both sectors.

• Health officials of the Ministry of Health and Population, Health Services Division, Child Health Division, the Nepal Health Research Council and the National Health, Education, Information and Communication Center gave their approval and support for the vaccination, the IEC (information, education, and communication) materials, and the evaluative research for the project;

• The Lalitpur District Public Health Office, the District Education Office, the District Immunization Coordination Committee, and Private and Public School Association (PABSON) approved the project and agreed to support the vaccination; the Nepal Pediatric Society also gave its endorsement for the project.

Bhaktapur District Government approval for the Bhaktapur District vaccination project

was provided by the Director of the Child Health Division of the Ministry of Health and Population. The project also conducted a series of advocacy meetings with government and non-government stakeholders in November 2011 to inform them of the typhoid vaccination program, and to gain their endorsement and support for implementation of the program.

• Initial advocacy meetings were held with the District Immunization Coordination Committee;

Rationale for Vaccination of School-Age ChildrenResearch on typhoid fever in South Asia has shown that children and youths have the highest rates of typhoid fever and suffer its most severe consequences. The government of Nepal has utilized schools as a platform for immunizing children before and has demonstrated that it is an effective approach for achieving widespread coverage among this age group. Thus, vaccinating the students who are at greatest risk for the disease is critical for controlling the disease burden of typhoid fever in affected communities.

Training session for the vaccination teams at LSMC.

Cold boxes for transporting and storing the vaccines.

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3 • Advocacy and information meetings were held with the Local Development Official, the District Public Official, political parties, parents and teachers associations (PABSON, N/PABSON, ISASN), and with municipality officials.

2. Social Mobilization Activities a. Training Training was provided for the social mobilization teams on

typhoid fever, the typhoid vaccination program, communication skills, and the delivery of social mobilization materials and messages. An orientation session was also organized for the call center attendant to be able to record incoming queries and provide initial responses.

b. Formative Research Formative research was conducted to assess perceptions,

attitudes, and interest in typhoid fever and use of the Vi vaccine against the disease for parents, teachers, and local health care providers. It also assessed credible and common sources of information and media used by the target communities. This information was used to inform the design and planning of social mobilization and communication materials and activities. The study was conducted from December 2010 to January 2011.

This study involved qualitative data collection in 9 focus group discussions (FGD) and 10 in-depth interviews (IDIs). Trained teams were mobilized to collect and analyze the data. This data was used to guide the development of social mobilization and IEC material and messages through consultative meetings by the staff of MITRA Samaj.

The findings of the formative research indicated that: • There is a need to clarify the symptoms of typhoid fever; • There was awareness of risks for the disease, but also

misconceptions regarding its causes; • While many thought there were effective preventive measures

(e.g. safe water, clean food), they also thought they faced risky situations;

• While everyone thought the vaccine would be beneficial, they needed confirmation that it is not a trial, as well as information on its side effects and duration of protection;

• Teachers, medical personnel, and local government admini-strators were considered credible sources of information;

• Radio and TV stations and print material (e.g. posters) were identified as common sources of information.

Based on these and other outcomes of this study, IEC material (brochures, posters, flyers, and banners), radio jingles, TV announcements, and a DVD were developed and pre-tested. Additionally, a series of orientation meetings were carried out with community stakeholders when requested by school staff.

c. IEC material distribution and social mobilization Lalitpur District In LSMC, the social mobilization included three phased visits by

project staff.

Visit 1 Provision of information on typhoid and the vaccination through brochures, posters, and banners provided to the head teachers for distribution to parents or placement within the school premises. A short film DVD was provided to the school to show students and teachers.

Visit 2 Consent forms and flyers were delivered for parents and a second banner was provided to the schools on the details of the vaccination program. An orientation session was conducted if requested.

Visit 3 Collection of the consent forms

Continued on page 4

Students in Bhaktapur District waiting to receive the typhoid vaccine.

A vaccinator from the District Public Health Office of Lalitpur preparing for vaccination.

Students wait to receive the typhoid vaccine during the pilot school-based typhoid vaccination program in Lalitpur District.

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4 In the VDCs, the social mobilization activities were completed in only two visits because of the remote location of many of the VDCs. In the first visit, information was provided on typhoid fever and the vaccination program through brochures, posters, banners, and a DVD, and the consent forms were also distributed at this time. In the second visit, social mobilization teams collected the consent forms and distributed the second banner and flyers.

Radio jingles and TV commercials were broadcast a week prior to the start of the vaccination. A media sensitization workshop was also organized for journalists at this time.

Bhaktapur District It was decided not to conduct an informed consent process

in the Bhaktapur District school-based vaccination since it is standard government public health practice not to do so. This then provided an opportunity to assess whether the consent form limited participation in the vaccination. Two visits were planned in the 16 VDCs, the Thimi municipality, and Bhaktapur municipality. The purpose of these visits was to get a list of students from the teachers as well as to provide the IEC materials.

d. Social Mobilization Monitoring To assess the effectiveness of social mobilization, interviews

were conducted with 27 head teachers and three parents from 54 randomly selected schools. Head teachers found the delivery and content of the IEC materials appropriate, helpful, and informative. Of the schools in both sectors, 10% did not receive the IEC print information which was later provided to them. In the LSMC and the VDCs, about three-quarters of the parents had received information about typhoid fever, with two-thirds of them aware of the symptoms and risk of the disease in the LSMC, and in the VDC communities, under half of those interviewed were aware of these disease factors. Over 90% of parents in the municipality had received the brochure, with only three-quarters reporting having received it in the VDC communities.

3. Vaccination campaign a. Strategy Development Standard operating guidelines were developed for the

vaccination activities. There were 18 vaccination teams in the LSMC and VDC health posts. Each team comprised two vaccinators and a social mobilization member. Physicians regularly visited each vaccination site with medicines and an AEFI kit to observe and respond to any adverse reactions.

b. Training Training was provided for vaccinators hired from the District

Public Health Offices of Lalitpur and Bhaktapur, public health clinics, and health posts on the nature of typhoid fever, the Vi vaccine, safe injection practices, AEFI management, maintenance of the cold chain, waste disposal, and the vaccination program logistics.

c. Vaccination Coverage Lalitpur District Only students who had completed informed consent forms were

allowed to be vaccinated. Students with fever were considered ineligible for receiving the vaccine. In the LSMC, 57,203 consent forms were delivered and approximately 70% of forms were returned. In contrast, in the VDC, 64,150 consent forms were delivered and more than 90% were returned. In both sectors, 70% of the consent forms returned agreed to the vaccination. Since there were a number of reasons for consent forms not being returned (e.g. students not bringing them home or

Continued from page 3

Table 1: Coverage in LSMC Vaccination

The following table shows the summary of the vaccination campaign in 180 schools of the LSMC. Out of 55,461 students, 35,554 were vaccinated (64% of the students). Also, 2,423 teachers and social mobilization and public health staff were vaccinated.

SN VariablesPublic Private Total

# % # % # %

1 Total number of eligible schools targeted for vaccination in LSMC

32 18% 148 82% 180 100%

2 Total number of students in total targeted schools 8,467 46,994 55,461

3 Total number of students vaccinated in schools reached for vaccination

5,266 62% 30,288 64% 35,554 64%

4 Total number of teachers/THP/ DPHO/CDO vaccinated 2,423

Table 2: Coverage in Lalitpur VDC Vaccination

The following table shows the vaccination coverage in the VDC schools. Out of 66,583 students, 42,211 were vaccinated at a coverage rate of 63% of eligible students. Also, 2,462 teachers and health post staff elected to receive the vaccine.

Table 3: Coverage in the Bhaktapur District Vaccination

The following table shows the summary of the vaccination campaign in Bhaktapur District. A total of 58,857 students were vaccinated for a coverage rate of 84%. In addition, a total of 4,211 adults were vaccinated.

SN VariablesPublic Private Total

# % # % # %

1 Total number of schools targeted for Vaccination in Lalitpur VDC

175 55% 143 45% 318 100%

2 Total number of students in total targeted schools 27,853 38,730 66,583

3 Total number of students vaccinated in schools reached for vaccination

18,396 66% 23,815 61% 42,211 63%

4 Total number of teachers/staff vaccinated 2,462

SN VariablesPublic Private Total

# % # % # %

1 Number of schools that participated in the vaccination 142 42% 195 58% 337 100%

2 Number of students in schools participating in the vaccination 18,556 51,581 70,137

3 Number of students vaccinated 16,009 86% 42,848 83% 58,857 84%

4 Number of teachers/staff vaccinated 4,211

Page 6: Viva school based vaccination

Highlights:• School-based vaccination was shown to be safe and feasible in Lalitpur and Bhaktapur Districts.

• Local leadership (e.g. District Public Health Office, Municipality) was the key driver for success of the program and continued effort is needed to sustain the program.

• Collaboration with school administration was essential in conducting vaccination at school with minimal disruption to the school curriculum.

• Typhoid is a known disease, but preventive measures are less known. School health curriculum should include emphasis on hand washing and basic sanitary measures.

5returning them, a lack of attention to them), for the schools with the largest rates of consent forms not returned (25% or above), another set of forms were sent to the schools and requests were made to teachers to provide them to students who had not returned them.

Bhaktapur District The vaccination in Bhaktapur District followed the same

operating procedures and vaccination strategy as in Lalitpur District, except that the vaccination team included four members: one supervisor and two vaccinators from the Bhaktapur District Public Health Office, and one helper. Two doctors were mobilized to manage possible adverse events during the vaccinations in the schools. A total of 58,857 students were vaccinated for a coverage rate of 84%. In addition, a total of 4,211 adults were vaccinated.

d. AEFI preparation and Results Each vaccination team included a medical doctor who was

responsible for observing the vaccinees for at least 15-30 minutes after vaccination for the detection and management of immediate serious adverse events. Each vaccination site had an AEFI kit, and a hospital was identified in case of serious reactions. All vaccination staff were trained in AEFI management. Every vaccinee was given contact numbers of MITRA Samaj call center and the District Public Health Officer so that they could call to report any problems following the vaccination. During the vaccination campaign, a total of 118 (0.335) AEFI cases were reported in the LSMC schools, and 37 (0.07%) in the VDC schools. In Bhaktapur, out of the 58,857 school children vaccinated, 68 (0.1%) AEFI cases were reported. A majority of these cases were minor reactions such as pain at the injection side, fever, headache, and vomiting. There were no hospitalizations following any vaccinations.

A call center was set up at MITRA Samaj that monitored concerns of parents and school staff regarding typhoid fever and the vaccination. A total of 17 calls were received including requests for information on typhoid fever, the details of the vaccination, eligibility requirements, and the vaccine’s safety and side effects. Once the vaccination was underway there were six calls about possible AEFIs.

The Vi-based Vaccines for Asia (VIVA) Initiative is part of the Typhoid Program of the International Vaccine Institute. The VIVA Initiative aims to reduce mortality and morbidity due to typhoid fever in developing countries through acceleration of the adoption of Vi polysaccharide vaccines, and the development, testing, and licensure of affordable next-generation Vi-conjugate vaccines. For more information, please visit: http://viva.ivi.int.

About the Vi-based Vaccines for Asia (VIVA) Initiative:

ConclusionThe vaccination programs in Lalitpur and Bhaktapur Districts demonstrated the feasibility of delivering a typhoid vaccination through a school-based program. There were benefits to requiring an informed consent process in Lalitpur District, such as ensuring adequate information dissemination to parents and institutional freedom from liability. However, the higher vaccination coverage in Bhaktapur District where a signed consent form was not required, compared with the coverage in Lalitpur District, suggests that the consent requirement may have limited vaccination coverage in Lalitpur schools. Nevertheless, overall, a school-based vaccination conducted by district health departments in collaboration with the district education office and local school administrations provides a feasible and efficient means of protecting those most vulnerable to typhoid fever.