REPUBLIC OF RWANDA

MINISTRY OF HEALTH

Annex A: Rwanda IPV introduction plan

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Table of contents

Executive summary of the introduction plan............................................................................3

1. Justification for introduction of IPV and national decision-making process...........................5

2. Overview of IPV...................................................................................................................5

2.1 Vaccine preference...............................................................................................................5

3. Introduction and implementation considerations.................................................................7

3.1 Policy development.............................................................................................................7

3.2 National coordination mechanism to ensure the successful introduction...........................9

3.3 Affordability and financial sustainability..............................................................................9

3.4 Overview of cold chain capacity at district, regional and central levels.............................11

3.5 Waste management and injection safety Waste management.........................................13

3.6 Health worker training and supervision.............................................................................13

3.7 Risks and challenges...........................................................................................................14

4. Situational analysis of the immunization programme.........................................................15

4.1 General context of the country..........................................................................................15

4.2 Geographical, economic, policy, cultural, gender and social barriers to immunization.....17

4.3 Findings from recent programme reviews..........................................................................19

4.4 Stock management............................................................................................................20

5. Monitoring and evaluation.............................................................................................21

5.1 Updating of monitoring tools.............................................................................................21

5.2 Adverse Event Following Immunisation (AEFI) monitoring and reporting.........................21

6. Advocacy, communication, and social mobilization........................................................22

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Executive summary of the introduction plan

Following the May 2012 World Health Assembly meeting which declared the completion of polio eradication to be a programmatic emergency, a polio eradication end game Strategic plan 2013-2018 was developed. In the plan a comprehensive approach for completing polio eradication including the elimination of all polio disease both wild and vaccine-related, is outlined.

To eliminate the risks associated with OPV use, the plan calls for a phased withdrawal of OPV beginning with removal of the type 2 component of OPV, which is responsible for over 95% of cVDPVsand 40% of VAPP through a switch from trivalent OPV (tOPV) to bivalent OPV (bOPV), containing only types 1 and 3 in 2016.

In the end game plan all countries using OPV in their routine immunization should introduce at least one dose of IPV in routine immunization by the end of 2015 prior to the tOPV to bOPV switch.

Introducing at least one dose of IPV will ensure that a substantial proportion of the population is protected against type-2 polio after OPV2 withdrawal and will also boost the immune response to OPV type 1 and 3 that are currently responsible for all wild polio cases.

Although the last polio case in Rwanda was in 1993, Rwanda appreciates the efforts the world and the country in particular have put in to maintain a high level of immunization against polio and joins this global initiative to eradicate and contain all polio disease, both wild and vaccine related through provision of potent vaccines to all children, continued surveillance activities, and prioritizing systems strengthening with focus on human resource, the health infrastructure and reinforcing community linkages for immunization services.

Rwanda plans to introduce the IPV vaccine in August 2015 into routine immunization targeting the 0-11 months and prefers that the introduction is done country wide/nationally.

Rwanda prefers the 10 dose as this has minimal space requirement on the cold chain. Even with a high wastage rate its use is cost effective due to the low cost per dose.

The vaccine will be administered to infants reporting for immunization at 14 weeks of age together with Penta3/DPT3, OPV3, Rotavirus Vaccine3 and PCV13 third dose. That age was chosen because immunogenicity to IPV is highest after 14 weeks. Administration of IPV vaccine to infants who have been given OPV will also boost the immune response of those children to OPV 1 and 3 with more infants ending up protected against the remaining types of wild polio viruses.

Introduction of IPV has financial implications. The whole process of IPV introduction in Rwanda will cost US Dollars 678,524 This figure takes into account National and district activities that will include Coordination meetings, Advocacy and social mobilization, Training, vaccine delivery, support supervision and monitoring. GAVI has pledged to provide US$ 330,000 as a Vaccine

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Introduction Grant and procurement of IPV vaccines up to 2024. Thereafter Rwanda will finance as may be required.

Annex C shows the sequence of activities as they are lined up prior to and after the actual IPV introduction in August 2015.

Pre-implementation activities will include advocacy, communication and social mobilization; review and printing of EPI data collection and reporting tools; training of health workers and immunizers and strengthening monitoring and support supervision.

Other preparatory activities will include Central and district coordination and feedback meetings with EPI stakeholders andcold chain maintenance and repairs as recommended by the 2013 cold chain assessment. The Government of Rwanda has started implementing the recommendations from the 2013 Cold Chain Equipment assessment.The upgrade of storage capacity at all levels is planned to start2014 and will be completed before IPV introduction in August 2015.

Rwanda has adequate experience and capacity in introducing new vaccines as demonstrated by successful introduction of DTP-HepB-Hib in 2002, PCV13 in 2009, HPV 2011, Rota vaccines in 2012 and measles rubella in 2013.The country has strong government commitment and a very good network of immunization partners both at national and sub-national levels. All health facilities in Rwanda that also provide immunization services in an integrated manner are manned by qualified health workers. Supportive supervision/In-service trainingson effective vaccine managementhave been conducted regularly and at least two health workers per health facilityhave benefited from such capacity building activities.IPV introduction will be preceded by health workers training in all aspects of IPV introduction and routine immunization. The vaccine will be integrated into the currentroutine immunization vaccines and supplies distribution system.

Based on the past vaccine introductions Rwanda does not foresee any major challenges and risks. However strong committeeswill be in place to develop mechanisms that will ensure early detection and immediate corrective measures are instituted. Prior to IPV introduction, Rwanda in collaboration with UNICEF has planned to conduct IPV acceptability study which will help as a baseline and a guide to social mobilization activities.

This document covers the following areas:

1. Justification for introduction of IPV and national decision-making process

2. Overview of IPV

3. Introduction and implementation considerations

4. Situational analysis of the immunisationprogramme

5. Monitoring and evaluation

6. Advocacy, communication, and social mobilisation

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1. Justification for introduction of IPV and national decision-making processRwanda is a signatory of the 66th World Health Assembly that endorsed the polio end game strategy in which Objective two highlights the importance of introduction of at least 1 dose of IPV into the routine immunization programs before the end of 2015 prior to the tOpV –bOPV switch. Rwanda therefore joins this global initiative to eradicate and contain all polio disease, both wild and vaccine related through provision of potent vaccines to all the infants.On receipt of official communications about the polio end game, Rwanda VDPD/EPI technical working group reviewed several relevant reference documents and later shared this development with Senior Leadership in the Ministry of Health.The Ministry of Health adopted the declaration and through advocacy sought the support from colleagues in the Ministry of Finance and health partners.

After exhaustively discussing with EPI stakeholders who included WHO, UNICEF, and many others; it was agreed in the ICC meeting chaired by the Honorable Minister of Health on 13 th

May 2014 that a GAVI IPV introduction plan be developed for funding and support.

Rwanda has introduced five new vaccines since 2002: Pentavalent in 2002, PCV in 2009, HPV in 2011 and Rota vaccine in 2012 and finally a measles-rubella vaccine in 2013. With that experience, Rwanda has the technical capacity, sufficient cold chain capacity and a good surveillance system to introduce IPV in its routine immunization.

2. Overview of IPV

2.1 Vaccine preferenceRwanda prefers the 10 dose vial as its first preference. See table B1. This preference is based on the fact that the 10 dose vial is fairly priced and requires less space in terms of storage though it may have a higher wastage rate. The higher wastage rate is countered by the low cost and lesser storage space requirements.

Table B1. IPV vaccine preferences and estimated date of introduction

Preferred IPV vaccine Month and year of first vaccination

Preferred second presentation

Preferred third presentation

10 Dose Vial August 2015 5 Dose vial 1 Dose Vial

For more information on vaccine presentations, please consult the UNICEF Product Menu: http://www.unicef.org/supply/index_66260.html. A list of final product presentations will be available after the UNICEF tender has concluded (by March 2014) and will depend upon WHO pre-qualification processes.

More information on current WHO pre-qualified IPV vaccines can be found at: http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/index.html .

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a. Country licensure status

EPI vaccines are procured by government through UNICEF. Although the National Regulatory Authority exists it does not handle UNICEF procured vaccines. No delays by this agency are therefore anticipated during IPV introduction.

b. Target population and vaccine supply

The table below presents the target populations of children to receive a single dose of IPV together with Penta3/DPT3 per year from August 2015 to 2018

Year 2015 2016 2017 2018

IPV Target Population

140,279 343,733 350,803 357,822

The new IPV vaccine will be introduced into the Rwanda national routine immunization program in August 2015. The country uses surviving infants for forecasting for all antigens, apart from BCG and TT. The estimated number of surviving infants in 2015 is 336,669, the target population for IPV will be all surviving infants and since the introduction will be in August; the surviving infantsof 5 months from August toDecember 2015 will be targeted during the introduction year.

Immunogenicity to IPV is best after 14 weeks of age. One dose of IPV will be administered to all children reporting at an immunization session at 14 weeks together with DPT3/Penta3 and OPV3. Those who report for DPT3 after 14 weeks will also receive their single IPV dose but there will be no vaccination catch-up for IPV. The injection will be administered intramuscularly on the same side and next to PCV but 2.0cm apart.

Rwanda procures and receives traditional vaccines through UNICEF on the basis of annual forecast estimates. The Pentavalent, PCV, rotavirus vaccines and HPV vaccines are co-financed between Government and GAVI Alliance.

The new IPV vaccine will also follow the existing vaccine procurement mechanism through UNICEF.

Vaccines are supplied to the national Program twice a year. Districts collect their EPI supplies including vaccines from the Central level once a month (Pulling system). In case of emergency and during Supplemental immunization campaigns, central level distributes the needed amount of vaccines to the identified health districts using the MoH (VPDD’s) refrigerated truck. Health centres, using the same requisition system, collect vaccines from the district hospital cold stores using Health centre's motorbikes. IPV vaccines distribution will also follow the same system of supply and distribution.

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3. Introduction and implementation considerations

3.1 Policy developmentAs already stated immunizations in Rwanda are fully integrated in the health system. IPV will be added to the National Infectious Diseases Policy just like any other new vaccines that have been introduced in routine immunization. Similarly the country cMYP will also be reviewed to include IPV.IPV will be administered as a single dose to infants coming for routine immunization at 14 weeks together with Pentavalent3, OPV3, PCV13 3 and Rotavirus Vaccine as shown in table 1 belowSince Pentavalent is administered on the left thigh and PCV on the right, IPV will be the last to be administered on the right thigh 2.0cm away from the PCV injection site.

Table 01: National VPDD immunization schedule Currently Available Vaccines

Vaccine Total doses Age and interval

BCG 1 Birth

OPV 4 Birth, 6, 10, 14 weeks

DTP or DTP-HepB-Hib 3 6, 10, 14 weeks

Pneumococcal Conjugate Vaccine 3 6, 10, 14 weeks

IPV 1 14 weeks

Rotavirus vaccine1 3 6, 10, 14 weeks

Measles-rubella (MR vaccine) 1 9 months

Measles vaccine2 1 15 months

TT (pregnant women) 2 During pregnancy

HPV3 3 3 doses of HPV for each cohort of girls 9-14 yrs old

Immunization activities in Rwanda are part of the minimum health package of interventions which are integrated within a health facility unit. The EPI program has developed some strategies to reach the highest target population and include: integration of immunization services at fixed health centres, revitalization of outreach services and a combination of several

1Rotavirus vaccine is given in 3 doses, the first dose no later than 15 weeks of age and the last dose by 32 weeks of age2 Second dose of measles vaccine will be introduced in 2013: MR vaccine at 9 month and measles vaccine alone at 12 months of age 3Human papilloma virus vaccine (HPV) will usea school based vaccination campaign approach

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RED approaches to reach the unreached in health catchment’s areas especially in the hard to reach areas.

More than 90% of Rwandan children are immunized at the fixed immunization sites4. The outreach strategy has been revitalized in most of health facilities, using financial support from Government and GAVI Alliance. The RED approach was introduced in all health districtsin the country in 2005.

Other health interventions that will go along IPV on its introduction into routine immunization include,Growth Monitoring for under five children and ITN distribution for malaria control. ITN distribution was introduced to go along immunizations in 2007.

The following tables and graphs show the trends of immunization indicators in the country.

Administrative vaccination coverage dataFigure 01: Routine immunization coverage data by antigen, Rwanda, 2010-2013

BCG DPT-HepB-Hib1 DPT-HepB-Hib3 Measles20

30

40

50

60

70

80

90

100

11099 99 97 95

99102

9993

99103 103 103

99102 100 98

Routine Immunization coverage 2010-2013

2010201120122013

The figure above shows that Rwanda has been meeting its immunization coverage targets

4National Immunization Coverage Survey, conducted in 2007

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3.2 National coordination mechanism to ensure the successful introductionThe IPV introduction activities begin with the development IPV introduction plan and end with PIE 6-12 months after launching. Other activities depicted in Annex C include advocacy and social mobilization activities that will be enhanced; development of mobilization materials, review and reproduction of data EPI tools, development of training guides and materials followed by training of health workers involved immunizations. Health workers will also be trained in interpersonal communication to enable them talk well about IPV which will be administered to an infant as a 3rd injection on the same visit day. Supportive supervision and monitoring will be initially more frequent and special attention will be paid to vaccine management, waste management and AEFI surveillance.

Since 1996, the EPI program has had a functioning Interagency Coordinating Committee (ICC). The committee consists of senior officials from the Ministry of Health, representatives from different funding partners (WHO, UNICEF, USAID, etc.), Civil society organization, Representative of Mayors, Private sector federation representatives, Representative of the community, Professional bodies (Representative of Medical Council, Representative of Peadiactrician association), Academicians, Religious and Cultural bodies, and technocrats from different ministries, and other partners.The Minister of Health is the Chairman and WHO is the Co-Chair of the committee. See attached minutes

The ICC is the overall committee that oversees and coordinates all inputs and resources for EPI program including introduction of new vaccines. The ICC is active and, above all, plays technical and advocacy roles in support of the program. The ICC meetings are regularly held on a quarterly basis and their proceedings are approved through formal written minutes.

During the meeting that approved introduction of IPV it was agreed that a strong committee be set up to handle advocacy and social mobilization.At District level there is District Health Management Team (DHMT) which comprises technical staff at district level and work under supervision of Vice-Mayor in charge of social affairs. This team oversees the entire health activities including immunization activities at district level and the team will contribute a lot towards IPV introduction in areas of coordination, monitoring and supervision, advocacy and social mobilization. The EPI/VPDD works in close collaboration with other divisions of RBC and directorates of the Ministry of Health, as well as with districts Hospitals. The program also maintains partnerships with different ministries, seeking their engagement in social mobilization, especially for national or local vaccination campaigns. At the community level, the program supports a network of community volunteers called “Community Health Workers”, whose assistance is increasingly relied upon, particularly in the areas of community sensitization and reduction of immunization drop-outs.

3.3 Affordability and financial sustainabilityThe activities included in the budget are: preparatory planning meetings, production of revised EPI data tools and materials, training at national and lower levels, cold chain maintenance and procurement of spare parts, supervision and monitoring tools review and production, social mobilization and communication, transportation and distribution of vaccines and supplies, implementation, surveillance, waste management and post introduction evaluation activities.

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Cost estimates are derived from working figures obtained from predetermined official government rates.Rwanda has one of the strongest immunization programs in Africa. Rwandan national EPI is financed by the Government and its partners (GAVI, WHO, UNICEF, USAID). The Government already pays for all the traditional vaccines and co-finances the new and under used vaccines.

The table below shows the baseline indicators related to immunization specific costs

Table 2.

Expenditure by category

Expenditure Year 2013 Source of funding

Country GAVI UNICEF WHO MERCK USAID 0

Traditional Vaccines* 745,496 745,496 0 0 0 0 0 0

New and underused Vaccines**

16,442,208 594,00014,045,808

0 01,802,400

0 0

Injection supplies (both AD syringes and syringes other than ADs)

1,304,902 141,189 1,163,713 0 0 0 0 0

Cold Chain equipment

418,169 306,000 0 112,169 0 0 0 0

Personnel 542,010 256,781 285,229 0 0 0 0 0

Other routine recurrent costs

1,304,241 727,547 0 0 576,694 0 0 0

Other Capital Costs 818,922 459,128 299,500 60,294 0 0 0 0

Campaigns costs 3,983,180 655,900 3,279,500 47,780 0 0 0 0

N/A 0 0 0 0 0 0 0

Total Expenditures for Immunisation

25,559,128

Total Government Health

3,886,041

19,073,750

220,243 576,6941,802,400

0 0

The table above is showing that GoR is slowly taking the lead of immunization program by providing routine cost and financing 100% of all traditional vaccines.

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For IPV, there is no co-financing requirement at the beginning, however with time the Government of Rwanda will consider funding of IPV just like it is doing for the underused vaccines.

3.4 Overview of cold chain capacity at district, regional and central levelsFunctional and sufficient cold chain system is the backbone of a successful immunization programme . The cold chain system has and must continue to be considered whenever a new vaccine is being introduced to the program.

The Rwandan EPI supply chain system comprises of the National vaccine store, the district hospitals store, the health centers store and health posts

Following the successful introduction of 4new vaccines in the last 5years, the need for cold chain capacity has progressively increased. In the process Rwanda has found itself with a cold chain storage gap of 43,238 liters. This has prompted several interventions by government in the procurement of cold chain equipment to meet the increasing challenge over the years.

The government of Rwanda is in the process of upgrading the cold chain capacities as per the recommendations of the Cold Chain assessment of 2013.

With the support of development partners plans to upgrade the cold storage are as follows:

1. Unicef is processing the procurement and installation of 1 cold room at the national level which is expected in September 2014. (40m3 equivalent to 9,524 liters)

2. Through HSS one cold room(40m3 equivalent to 9,524 liters) will be procured and installed at the central level by September. 2015

3.The Ministry of Health will advocate and make a follow up with WHO on the Global Rapid Response Fund for cold chain support based on the established cold chain analysis gap for Rwanda as it is one of the eligible countries for this support. (144m3 equivalent to about 30,000 liters)

4. The government of Rwanda has committed to procure cold chain equipment and spare parts throughannual government budgets to maintain cold chain equipment throughout the country

5.There are plans to change the vial size of penta from the current 1 dose vial to 10 dose vials and the number of doses per child for Rotaand HPV be reduced from 3 to 2 doses to reduce on cold storage needs from 2015.

As recommended also, spares required for repairs of non-functional repairable units have been procured and repairsare ongoing. Regular scheduled cold chain maintenance plans have been developed and are being implemented. The government has engaged the Medical Maintenance

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Table 3: Cold chain capacity need assessment (for positive storage)National vaccine

store 2013 2014 2015 2016 2017 2018

ATotal net cold-chain capacity required for a storage period

Capacity needed 39,224 litr 74,681 litr 77,508 litr 77,688 litr 81,552 litr 83,680 litr

BExisting net positive cold chain capacity (litres)

Capacity currently available

43,238 litr 43,238 litr 43,238 litr 43,238 litr 43,238 litr 43,238 litr

C Net additional positive capacity installed

Additional capacityexpected

0 litr 0 litr 38,095 litr 0 litr 0 litr 0 litr

D Total net positive cold-chain capacity available

Total capacity to be available

43,238 litr 43,238 litr 81,333 litr 81,333 litr 81,333 litr 81,333 litr

E Gap in litres A-D 4,014 litr- 31,443 litr 3,825 litr- 3,645 litr- 219 litr 2,346 litr

centre (MMC) to carry out regular maintenance for all equipment at the national level whereas at district and lower levels, biomedical technicians were trained for preventive maintenance of cold chain equipment and spare parts are provided as needed. Some of the missing spare parts are in procurement process.

The Rwandan VaccinationProgramis currently giving 9 vaccineformulations, with the introduction of IPV,the formulations will be 10.

The introduction of IPV in 2015 will require cold space of 1,200 liters and its arrival will find when the above mentioned expansion plans have been completed.

The table below depicts the cold chain status after the planned expansions at National level at the arrival of IPV

The government of Rwanda will upgrade to fill the gaps identified at the district vaccine stores

Before the introduction of IPV, cold storage capacity upgrade will be required at National and District levels

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3.5 Waste management and injection safety Waste managementRwanda has a National Policy on injection safety, transmission of nosocomial infections and healthcare waste management.

High temperature incineration is among the best waste management option available, followed by other less desirable options. All hospitals have incinerators and most health centers have burners. The health facilities that do not have burners use incinerators in neighboring hospitals.A few Aid posts are still using the burn and bury method,

The waste from the introduction of IPV will largely follow the existing waste treatment systems.

3.6 Health worker training and supervision

In Rwanda there is at least 1 nurse/ 1200 population this translates into 36 infants to be immunized by 1 nurse per year, from this figures we can conclude that there is adequacy of trained human resources to introduce IPV across all sectors of the immunization programme. Prior to actual training, the IPV training materials (training manual/ field guide), and knowledge assessment tools) will be developed. Rwanda will adapt the already existing WHO modules for IPV introduction after reviewing and adjusting them to the Rwandan situation. The training materials will include important topics like age, Schedule, techniques, AEFI, interpersonal communication and cold chain maintenance.

Training will be conducted in a cascade manner beginning at the National/Central level and spreading down up to the health facility level.

At the national level, training will last for 2 days and the trainees will be drawn from the national level- MOH and VPDD and partners. Lower trainings will take 3 days.

The national trainerswill then traintrainees drawn from the districts – the district immunization supervisors and health centre managers or immunization officers at the HC level.

These cadres of staff will later go back to their HC to train two health workers per HC.

The training will also be extended to non-immunization staff (e.g., medical officer or Nurse in charge) at the HC level because of their important role of overseeing health services at that level.

Monitoring and supervision are two activities which when properly and regularly carried out can have tremendous positive impact on any program. Supportive supervision is an opportunity for on job training and correcting mistakes without being accusatory while monitoring allows one to see what progress or otherwise the program is experiencing with a view to commending and/or correcting.

Prior to IPV introduction frequent supervisory activities will be conducted every two weeks from the Central to the district and district to the health centers to ensure that the planned activities

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are going on as scheduled at all levels. The planned activities to be monitored will include social mobilization, vaccine and supplies distribution, cold chain maintenance, trainings, distribution of new EPI data tools to every immunization site

3.7 Risks and challengesIPV is administered as an injection. This may be viewed by health workers as an additional task since they will now be administering 3 injections (Penta, PCV and IPV). Some health workers and community members may worry about the multiple injections the infants will receive when IPV is added to routine immunization. Health workers and the community will therefore need to be reassured about the benefits of the added IPV injection and to be assured that it would be harmless to the children. For that matter Rwanda would like to conduct an acceptability study and the findings from this study will inform the type of interventions to undertake in advocacy and communication. From past introductions of new vaccines, Rwanda anticipates no risks to IPV introduction in the country.

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4. Situational analysis of the immunization programme

4.1 General context of the countryRwanda is situated in central Africa, south of the Equator, between 1°4’ and 2°51’ latitude South and 28°53’ longitude East. It has a surface area of 26,338 square kilometers and borders with Uganda in the North, Burundi to the South, the Democratic Republic of Congo to the west and Tanzania to the East. Rwanda is land-locked and is country located 1200 km from the Indian Ocean and 2000 km from the Atlantic Ocean. Its topography is mountainous and the average altitude is 1700 meters.

Administratively, Rwanda is divided into four provinces, the city of Kigali, 30 districts, and has 547 health units. Each district is divided into sectors which are further subdivided into cells and imidugudu (Village). The smallest administrative unit is the cell.

The Fourth Rwanda Population and Housing Census (RPHC4_2012) established that the population of Rwanda is 10,515,973 residents, of which 52% are women and 48% men. Since the 2002 Census, the population has increased by 2.4 million, which represents an average annual growth rate of 2.6%. Thus, population growth has recovered its long-term rate following the decline in the 1990s, which were marked by the war and the genocide.During this period (i.e. 1991–2002), annual growth fell to 1.2%.

The population density in 2012 was 415 inhabitants per square kilometer. The population of Rwanda is young, with one in two persons being under 19 years old. People aged 65 and above account for only 3% of the resident population. This has consequences in that the demographic dependency ratio, measuring the number of potential dependent persons per 100 persons of productive age, is 93 at national level. In other words, in Rwanda every 100 persons of an economically active age are theoretically expected to be responsible for 93 persons of inactive age. Urban areas have more young adults than rural ones, and thus the dependency ratio is only 67 compared to 100 in rural areas. 42% of the population living in rural areas is under 15 compared to only 35% in urban areas. On the contrary, urban areas attract more young adults, presumably for studies or work: 34% of the urban population is aged between 20 and 34, compared to 24% of the population in rural areas. The mean age of the population of Rwanda is 22.7 years. The mean age of females is higher than that of males (23.5 vs. 21.9)

Health services in Rwanda are provided at different levels of the health care system. The levels include: at community level (community health, health posts (HP), at Sector level health centres (HC), at district level district hospitals (DH) and National level referral hospitals).The providers include Public/Government, religious, Private-for-Profit and NGO. All levels have administrative structures (Boards / Committees) and implementing agencies that manage, implement and monitor the services offered. All the health service providers in a District are under the overall supervision of the Vice-Mayor in charge of Social Affairs in the district.

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The District Health Unit (DHU) is responsible for planning, monitoring, supervision of implementing agencies, intersectoral collaboration and coordination with Development Partners operating in the district (through the Joint Action Development Forum (JADF). The DHU is composed of two technical staff members (Planning and M&E) and reports to the office responsible for Social Affairs or to the District Council where applicable.

Rwanda has 4 referral hospitals, 42 district hospitals and 501 health centers.

EPI activities are fully integrated into the routine health services as part of the minimum package of health interventions within each health facility.

The Rwanda EPI program that was created in 1978 has three main functions:

a) To provide routine vaccination

b) To conduct supplemental immunization activities and

c) To carryout surveillance for target diseases

These three functions are in line with the EPI goal of contributing to improved well-being of the Rwandan people through reduction of child morbidity and mortality due to vaccine-preventable diseases.

As already stated above, EPI activities are fully integrated in the health facilities and as a result of that integration more than 90% of Rwandan infants are immunized at fixed sites. Outreach immunization services have been revitalized to reach the remaining unimmunized with support from Government and GAVI.

Rwanda has a strong immunization program and enjoys great and highest political will, financial commitment and support from the government and development partners. Immunizations are free of charge all over the country.

The Rwanda National EPI program also known as Vaccine Program Unit is made up of a small team of 8 technical staff. The technical staffs include: EPI Coordinator and Head of the VPDD, one (1) Epidemiologist, one (1) Data Manager & Monitoring Officer, two (2) VPD Surveillance Officers, one (1) Director of immunization Unit working with a Cold Chain / vaccine storage Officer and a Storage Management / Vaccine procurement Officer, one (1) “International vaccination” Officer dealing with yellow fever vaccination for travellers. The supportive team is comprised of one Accountant, one administrative assistant, one driver and 2 Messengers.

The organizational chart for the division is shown in the figure 1below:

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The new structure of vaccine program is composed of 12 technical staff plus 1 cold chain preventive Maintenance and one cashier/ receptionist. Currently 8 staff is available and remaining positions will be filled before IPV introduction.

4.2 Geographical, economic, policy, cultural, gender and social barriers to immunizationThe table below shows Rwanda’s vaccine coverage for 2012 and 2013. The figures above 100% could be due to influx of refugees from a neighboring country, children for neighboring countries utilizing the Rwanda services or issues to do with population figures. The latter problem has been sorted out by the 2012 population census whose results were released in April 2014

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Table B2. Trends in national vaccine coverage

Trends of national vaccine coverage (percentage)

Vaccine Vaccine Used

Target population

(number by age and sex,

if availalbe)

Coverage reported (JRF)

Most recent year (2013)

Previous year (2012)

BCG [Type text] [338183] [99] % [99] %

OPV 3 [Type text] [322079] [100] % [101] %

DTP 1 / Penta 1 [Type text] [322079] [102] % [101.9] %

DTP 3 / Penta 3 [Type text] [322079] [100] % [101] %

HPV 1 [Type text] [131881] [Type text] % [98.9] %

HPV 3 [Type text] [131881] [Type text] % [98] %

Measles 1 [Type text] [322079] [99] % [102] %

Measles 2 [Type text] [322079] [Type text] % [Type text] %

PCV 1 [Type text] [322079] [102] % [101.9] %

PCV 3 [Type text] [322079] [100] % [101] %

Rota 1 [Type text] [322079] [102] % [101.9] %

Rota 2 or 3 [Type text] [322079] [100] % [101] %

Rwanda is a hilly country and this poses a geographical barrier to Health service delivery including routine immunization.However Rwanda has put in place systems to mitigate the effect of this barrier and they include at least one Health center in each sector, health post at cell levels (still few but there is a plan to increase the number of Health Posts) and 3 Community Health Workers in each village who are very well motivated and play a big role in immunization because they register all available children in village and they perform door to door visits to check on the immunization status of children. On monthly basis Community Health workers help to monitor under five children growth and the same card is used for vaccination, so it is very easy to trace the unvaccinated child. Immunization in Rwanda has become like a culture, we no longer have a problem of immunization coverage what we are dealing with today is the Quality of delivered services such as data quality issue, cold chain equipment maintenance,etc. Using the RED approach to reach hard to reach areas, every health center has a plan of outreach services where immunization services take the lead and the CHWs serve as a link between the community and health facility. Every month at health center, health officials meet with CHWs to discuss the achievement and take action for improvement of health services including immunization. IPV will also benefit from the existing system and will be integrated with other routine vaccines and will be included in health facilities plan.

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4.3 Findings from recent programme reviewsThe Vaccine program in Rwanda is blessed to have immunization partners who are ready to address immunization issues, high political commitment and community awareness of vaccine preventable diseases.Rwanda Vaccine program has got so many competencies/strengths; among many we can mention the availability of sufficientmotivated and knowledgeable manpower at central and peripheral levels and infrastructure accessibility. However, Rwanda vaccine program is trying to address the issues founds through different reviews conducted recently; these are Rotavirus vaccine Post Introduction Evaluation(PIE 2013), Immunization coverage survey (2013), Cold Chain Equipment Assessment (2013)and Effective Vaccine Management (2014). Rwanda is solving issues which can compromise the IPV introduction.

The common issues found during the reviews are:

1. Cold Chain: - Storage capacity is low- Irregular cold chain maintenance to health facilities- Lack of training in Basic preventive Maintenance at Health centers level-

2. Social Mobilization:- Use of social mobilization tools - Lack of documentation of social mobilization activities conducted at district and facility level

3. Training and Supervision:- Irregular supervision from District Hospitals to Health centers- Turn over of the health sector staff - Curriculum of health schools which not containing the vaccination skills

4. Routine immunization:- Use of data

To overcome the above issues Rwanda vaccine program has integrated them in different plans and there is an implementation plan for different recommendations and suggested solutions. The biggest issue which has come up is the cold chain capacity gap of 160 m3 that the country requires to address before IPV introduction. Rwanda is eligible for support from rapid response funds based on global cold chain gap analysis. The remaining will be covered by one 40 m3 committed by UNICEF and the other remaining gaps will be addressed by the planned cold rooms to be bought through Rwanda –Gavi HSS. Rwanda Ministry of Health will vigorously follow up the commitment promised by immunization partnersbefore IPV introduction. To address the needs of additional storage capacity at District level Rwanda is buying additional 76 refrigerators and the storage capacity at District level will be upgraded before the introduction of IPV.

The introduction of IPV will be an opportunity to train technicians from health centers on basic preventive maintenance of cold chain equipment.The procurement of cold chain spare parts has been already considered in 2014-2015 MoH plan of actions.

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For social mobilization and communication we have found that the social mobilization materials like posters and leaflets are not used very often by beneficiaries, findings from ICS conducted in 2013 have shown that people do not pay much attention to posters and leaflets, we have founds that many people get the information from CHWs, Radio spots and community leaders. So for IPV introduction these channels will be used for mobilizing the community.

The remaining issues highlighted in different reviews are related to administrative issue. To address these issues , Vaccine program Unit will hold meetings with health officials in districts and the problems found in line with training, supervision and routine immunization service delivery will be discussed and recommendations from the meetingswill be implemented and monitored before the introduction of IPV.

4.4 Stock management Currently, all vaccines are procured by the Government through UNICEF channel on the basis of annual forecast estimates. IPV supplies will be procured through the same system

Rwanda receives vaccines twice a year per antigen. Once every month, district hospitals using their own vehicles, come to the central level and collect vaccines upon their request and get the required amount. Health centres, using the same requisition system, collect vaccines from the district hospital cold stores using Health centre's motorbikes.

Vaccines are kept at the WHO recommended storage conditions in each level. There is an effective vaccine distribution system between each level which involves use of cold boxes and vaccine carriers.

At the Central level stock management is both electronic and manual however;at district levelthe stock management is still manual.The cold chain at central level has just been relocated to the present site Gikondo sector in Kicukiro district and the automatic continuous temperature recorders are yet to be installed. By the time of IPV introduction the automatic continuous temperature recorders will be in place.Temperatures are monitored manually, twice a day including weekends and holidays at central, district and health facility levels.

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5. Monitoring and evaluation

5.1 Updating of monitoring toolsThe Ministry of Health will review. update and print new monitoring tools (recording and reporting formats, including tally sheets, registers, immunization cards, wall charts, computerized database, others) with a view to include IPV vaccine. The forms will aggregate data by sex.

5.2 Adverse Event Following Immunisation (AEFI) monitoring and reporting

The Ministry of health has got a task force in charge of pharmacy including a unit in charge of pharmacovigilance and pharmacovigilance policy is used to monitor all issues related to medicines and vaccines. At District Hospital level there is pharmaco-therapeutic committee which is composed of medical doctor, nurse, and pharmacist and data manager. These committees are dedicated to oversee the proper use of all medicines and vaccines at district level, monitoring of side effects as well as AEFIs in the district. The committee has to investigate all severe cases while minor cases are handled by nurses in health centers. Severe cases are referred to district hospitals for proper management.

EPI/Vaccine program regards AEFI surveillance as a very important activity in routine immunization and for that reason guidelines and kits have been developedin collaboration with the phamacovigilance task force and distributed to health facilities following training of health workers. AEFI surveillance has to be strengthenedprior and after introduction of new vaccines in our routine immunization to counter rumors in the community that often follow introduction.

At central level the AEFI committee which is composed by multidisciplinary health officials is in place.

There is a reporting system of AEFI cases including 0 reporting from health facilities to central level and the district can easily monitor the AEFI cases and can react accordingly. When there is a serious AEFI case, the AEFI committee meets to analyse the situation and go to field to investigate the case. The AEFIs which can occur due to IPV will be monitored and managed using the existing AEFI surveillance system.What is yet to be done is for Health Centers and districts to have line lists or registers for AEFI even if to document zero reporting which will be addressed before the introduction of IPV.

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6. Advocacy, communication, and social mobilizationAdvocacy to seek support for IPV started as soon as the Government received official communication on the global decision to introduce IPV. More advocacy to seek support for this new vaccine will target key decision makers at national, district and lower levels in the country. This will be done through; briefs and advocacy dialogue meetings. The introduction of IPV was discussed and approved by ICC meeting that was held on 13th May 2014, the meeting was chaired by Hon. Minister of Health and attended by key immunization partners including representative of civil society and other ministry of health officials attended the mentioned meeting.

During the 2014 EPI managers meeting, participants raised their concerns on multiple injections and perceptions of care-givers and health workers towards multiple injections. The Ministry of Health together with UNICEF has planned to conduct an IPV acceptability study which will help to document the perceptions and concerns of health providers especially vaccinators including the feasibility, acceptability and will provide insight that will help in the preparation and introduction process. EPI managers also were concerned by the impact this can cause related to coverage and social normsdue to fear of care-givers on multiple injections and which can result in drop out.This study will help to know the acceptability of IPV by caregivers/mothers and will help to develop evidence based communication plan and messages for IPV introduction.

Development of messages and materials will be based on the selected communication strategy and the available literature on IPV. The process will entail the following key activities:

Develop an advocacy and communication plan of action Develop, design, pre-test and mass produce health promotion materials and messages for both print

and electronic media in the commonly understood/local languages Air Radio and TV Programs and print media Monitor all messages and materials being circulated.It is important to note that the key message areas will address the following among others: safety of the vaccine; reasons for introduction of IPV; benefits of IPV in light of polio eradication; the schedule; advantages of IPV like that of posing no risk of vaccine associated paralysis and that it triggers an excellent protective immune response in most children.

Anything that is new and very important needs to be launched. This activity serves both for advocacy and mobilization. Therefore, a national launch will be conducted and used as an opportunity to strengthen immunization services in the country. Efforts will be made to have a high level dignitary preside over the function. Districts will also be encouraged and supported to hold follow up mini launches in their respective districts.

In order to gain support for IPV in the community, meetings and visits will be made by the 45,000 community health workers who will have beenoriented in interpersonal communication and the mobilization strategy messages and on use of mobilization materials for IPV introduction.

Health Workers will also be brought on board and will be expected to play a crucial role in raising community awareness on the new vaccine.

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