Guyana: Inactivated Polio Vaccine (IPV) Introduction Plan

Version date: January 20, 2015

Updated version: 16th February, 2015

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Table of ContentsExecutive summary

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

2. Overview of IPV

2.1 Vaccine preference

2.2 Country licensure status

2.3 Target population and vaccine supply

3. Introduction and implementation considerations

3.1 Policy development

3.2 National coordination mechanism to ensure the successful introduction

3.3 Affordability and financial sustainability

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

3.5 Waste management and injection safety

4. Situational analysis of the immunization programme

4.1 General context of the country

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

4.3 Findings from recent programme reviews

4.3.1 EVM assessment findings and improvement plan

4.4 Stock management

5. Monitoring and evaluation

5.1 Updating of monitoring tools

5.2 Events Supposedly Attributable to Vaccination or Immunization (ESAVI) monitoring and reporting

6. Advocacy, communication, and social mobilization

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Executive summary

In accordance with the PAHO TAG’s renewed efforts toward global polio eradication and endorsement of the targets, objectives and timelines for the World Health Organization’s Polio Eradication and Endgame Strategic Plan, 2013-2018, the Government of Guyana has developed a plan for integrating IPV into the routine immunization schedule, nationwide. The introduction of IPV is an important component of the strategic goals of disease eradication and routine immunization strengthening that contribute to the efforts of Guyana’s EPI program under the larger umbrella of Maternal and Child Health. This comprehensive strategy has led to the interruption of polio transmission in 1962 in Guyana contributing to PAHO region becoming the first region in the world to be certified polio-free by WHO. Sustaining gains on polio and other vaccine preventable diseases and building on this success through the introduction of new vaccines is a top priority for Guyana.

Although IPV is currently used in Guyana to vaccinate children with special needs (i.e. HIV-exposed infants). Nationwide introduction of IPV into the routine immunization schedule supports the regional and global mission of achieving the polio Endgame, including the eventual cessation of OPV. The cessation of OPV beginning with the withdrawal of the type 2 component of OPV in 2016 increases the risk of type 2 vaccine-derived polio virus and wild poliovirus outbreaks. IPV is a crucial part of the endgame as it would mitigate these risks resulting from a cumulative accumulation of children susceptible to type-2 polio. Guyana has had success with recent vaccine introductions including PCV13, Rotarix and HPV. Introduction of IPV will utilize lessons learned from these experiences.

The Government of Guyana is requesting full support from GAVI for introducing one dose of IPV and supplies without any country co-financing in year one. Under the assumption that Guyana would vaccinate 95% of the birth cohort during the first full year of IPV use, the cost to GAVI for the first year is estimated to be ~ USD $99,999 for the 1-dose presentation at $2.80 per dose according to UNICEF prices for the 1-dose presentation. The cost to GAVI will be in the following years will be $60,068 in 2016, $60,807 in 2017 and $61,554 in 2018. Guyana is also requesting the GAVI vaccine introduction grant (VIG) in the lump sum of USD 100,000 to support the IPV introduction activities described in this Plan. After 1 year of implementation of 1 dose of IPV in the routine immunization schedule (one dose of IPV followed by 2 doses of OPV and 2 OPV boosters), the Government of Guyana has decided to self-finance an additional dose (2 IPV doses followed by 1 OPV dose and 2 OPV boosters) in order to achieve PAHO TAG’s currently recommended schedule. It is understood that GAVI support is guaranteed through 2024 (subject to funding renewal for GAVI for providing IPV support to countries after 2018). As Guyana has recently introduced several vaccines as well as financed an improvement plan as a result of a recent EVM, only minimal country financing (beyond the VIG) will be needed for one-time costs associated with IPV introduction. No funding gaps are expected. Estimated costs to Guyana for self-procuring and introducing a second dose in the second year will be $264,846 (estimate based on current UNICEF costs of $2.80).

The Ministry of Health and Guyana’s EPI Programme, in collaboration with PAHO and GAVI, has developed a Transition Plan for the Strengthening of Immunization Services in Guyana. The plan covers areas such as policy, supplies, cold chain, human resources, information systems, surveillance, social mobilization and monitoring for the years 2015-2017.

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Guyana’s decision making body, the ICC has considered the PAHO TAG’s recommendation on the introduction of IPV as part of the regions efforts toward global polio eradication. An internal core IPV introduction team including representatives from PAHO Guyana office, the EPI program and international consultants proposed this plan to the ICC where it has been approved and endorsed. One dose of IPV is to be administered at 2 months of age (alongside the first dose of pentavalent vaccine). Nationwide introduction of IPV is planned to take place in June of 2015. Guyana’s preference is for 1-dose presentation due to current licensure status in country, similarities in presentation with other vaccines given at the 2 month contact, the small birth cohort and due to high rates of wastage associated with the 5-dose and 10-dose presentation.

The EPI programme in Guyana has repeatedly provided coverage >90% for all EPI antigens. The programme is ensured of its ability to absorb IPV into the routine immunization schedule due to its recent success with PCV13 and Rotarix vaccines. A recent EVM in 2014 demonstrated the available storage and transportation capacity at all levels and described the numerous strengths of the current system. There is currently no cold volume shortage with current procurement practices and the minimal added volume of IPV can be absorbed at all levels. The EVM evaluation produced an Improvement Plan to sustain the high performance and address major challenges. The total cost of the Improvement Plan for three years was estimated at $384,688. An Event Supposedly Attributed to Vaccination or Immunization (ESAVI) reporting system is in place and has the capacity to handle any additional reporting associated with IPV. An integrated and functional surveillance system for vaccine preventable diseases in in place at all levels, and Guyana has consistently achieved the WHO certification standards in AFP surveillance.

The Ministry of Health will undertake necessary IPV specific planning needed to ensure the smooth introduction of another new vaccine into the routine immunization schedule. Key planning activities prior to the June 2015 introduction date include stakeholder engagement, refining the introduction strategy and developing a timeline as well as confirming cold chain readiness, training, social mobilization and monitoring and evaluation.

Key risks of introducing IPV include the financial burden of simultaneous transition from donor support to country financing in parallel programs and graduating from GAVI financing for vaccine support. The temperature monitoring aspect of the cold chain management system was identified as an area for improvement during the recent EVM. It should be noted that IPV is a freeze-sensitive vaccine which needs proper temperature monitoring. Prior to IPV introduction, it is envisioned that this area will be improved. Guyana will develop a crisis communication plan should issues arise associated with community acceptability or introduction of a new vaccine. IPV introduction presents an opportunity to update monitoring forms and revise training materials to be utilized during refresher trainings in advance of the introduction date.

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ACRONYMS AND ABBREVIATIONS

BCG Bacillus Calmette–GuérinbOPV Bivalent Oral Polio VaccineCARPHA Caribbean Public Health Agency CIDA Canadian International Development AgencycVDPVs circulating Vaccine-Derived PoliovirusDPT Diphtheria, Pertussis, and TetanusEEFO Earliest-Expiry-First-OutEPI Expanded Programme on ImmunizationESAVI Events Supposedly Attributable to Vaccination or Immunization EVM Effective Vaccine ManagementFAQ Frequently Asked QuestionsGAVI Global Alliance for Vaccines and ImmunizationsGDP Gross Domestic ProductGSIP Guyana Safer Injection ProjectHIV Human Immunodeficiency VirusHPV Human papillomavirusICC Inter-Agency Coordinating Committee IEC Information, Education, CommunicationIPV Inactivated Polio VaccineJRF Joint Reporting FormKAPB Knowledge, Attitude, Practice, and Behaviour (Beliefs)LD Lowest DeliveryMCH Maternal Child HealthMDVP Multi-Dose Vial PolicyMIS Management Information Systems [IMS]MMR Measles, Mumps and Rubella MYP Multi-Year PlanOPV Oral polio vaccineOPV2 OPV second doseOPV3 OPV third dosePAHO Pan American Health OrganizationPCV13 Pneumococcal Conjugate Vaccine 13 (called PCV13 or Prevnar 13)PEPFAR President’s Emergency Plan for AIDS Relief PR PrimaryRHA Regional Health AuthoritiesSAGE Strategic Advisory Group of Experts on ImmunizationSD Service DeliverySOP Standard Operating ProcedureTAG Technical Advisory GrouptOPV Trivalent oral polio vaccineUNICEF United Nations Children’s FundUSAID United States Agency for International DevelopmentVAPP Vaccine-Associated Paralytic PoliomyelitisVIG Vaccine Introduction GrantWER Weekly Epidemiological RecordWHO World Health Organization

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1. Justification for introduction of IPV and national decision-making processIn 2013, the World Health Assembly endorsed The Polio Eradication and Endgame Strategic Plan which addresses the eradication and containment of polio caused not just by wild viruses but also cases associated with oral polio vaccine (OPV). To address risks associated with OPV use, the Plan calls for a phased withdrawal of OPV globally beginning with removal of the type 2 component of OPV through a switch globally from trivalent OPV (tOPV) to bivalent OPV (bOPV, containing only types 1 and 3) in 2016. To ensure that a substantial proportion of the population is protected against type 2 polio after OPV2 withdrawal, the WHO’s Strategic Advisory Group of Experts (SAGE) has recommended that all countries introduce at least one dose of inactivated polio vaccine (IPV) in their routine immunization programs before end of 2015, prior to the tOPV-bOPV switch. SAGE recommends that all polio endemic and high-risk countries develop a plan for IPV introduction by mid-2014.

Figure 1. Objective 2 of The Polio Eradication and Endgame Plan 2013-2018 addresses the Endgame through three distinct stages

In July, 2014, the PAHO Technical Advisory Group on Vaccine-preventable Diseases (TAG) issued specific recommendations for the Region of the Americas on IPV introduction. TAG supports the global polio eradication efforts which include eventual cessation of OPV vaccine from routine vaccination progress. To prepare for this event, PAHO TAG endorses the preference of two doses of IPV, to be administered with the first and second Diphtheria, Pertussis-Tetanus (DPT) doses to be followed by two OPV doses. The PAHO TAG also endorses the use of a single dose of IPV, to be administered with the first DPT dose to be followed by three OPV doses.

The last poliomyelitis case in Guyana was reported in 1962. The last poliomyelitis case to be reported in the Region of the Americas was detected in 1991 in Peru. The Region was certified polio free in 1992 by the Global Commission for the Certification of the Eradication of Polio, making the Region of the Americas the first region in the world to do so. DTP3 and OPV3 coverage were both found to be 95% in 2013 according to the Joint Reporting Form. An evaluation of surveillance data reported to

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WHO from Caribbean member states found an annualized non-polio AFP rate of 1.82, which meets WHO standards for sensitivity of surveillance. (WER No 37, 12 Sept 2014) In Guyana, 11 AFP cases were reported in 2013 leading to an annualized non-polio AFP rate of 1.42. No VAPP cases have been confirmed from CARPHA.

Guyana and the entire region of the Americas have successfully maintained polio-free status for many years. However, as long as polio exists anywhere all children remain at risk. As the PAHO TAG supports renewed global efforts for polio eradication and endgame goals, Guyana wishes to contribute to completion of the global endgame strategy by introducing IPV into the routine immunization schedule. Introduction of 1 dose of IPV will mitigate risks associated with type 2 components of OPV withdrawal in order to reduce chances of importation of cVDPVs and re-emergence of type 2 polio in an increasingly globalized world.

Guyana has an Inter-Agency Coordinating Committee (ICC) on Immunization as the main decision making body in all matters related to immunizations. It has been in place since 2001, and is comprised of officials from the Ministries of Health and Finance, along with representatives from UNICEF, PAHO/WHO, and CIDA. They meet approximately 2-4 times per year. During the March 2014 meeting the ICC discussed the correspondence from PAHO regarding sequential IPV-OPV schedules and agreed to consider the recommendation from the PAHO TAG to introduce 1 dose of IPV followed by 3 doses of OPV. The ICC endorsed the IPV proposal on the 11th December, 2014 (see attached signatures of ICC members).

Since 2005, Guyana has used IPV to vaccinate HIV-exposed children born to mothers who are HIV positive, a target population of about 200. In Guyana, stand-alone IPV is already registered by the Food and Drug Department. In keeping with International standards, IPV is preferred for asymptomatic HIV-exposed children because of the decreased risk of vaccine derived poliomyelitis [National Reference EPI Manual Guyana – 2012]. The guideline for infants born to mothers who are HIV positive recommends the first dose at 2 months, the second dose at 4 months, the third dose at 6 months, a booster at 18 months, and lastly another booster at 45 months. As a result, approximately 600 doses are administered each year in a 5-dose schedule, in place of OPV.

In accordance with PAHO TAG recommendations, Guyana has decided to introduce IPV nationwide into the routine immunization schedule. The Ministry of Health’s EPI program has decided to target introduction for June 2015 and is undertaking necessary planning to universally introduce the vaccine. The table below outlines the schedule:

Table 1; Vaccination Schedule with proposed changes

Year Dose 1 Dose 2 Dose 3 Dose 4 Dose 5

Age 2 months 4 months 6 months 18 months 45 months

Other Vaccines Pentavalent, PCV13, Rotarix

Pentavalent, PCV13, Rotarix

Pentavalent, PCV13, DPT, MMR DPT

Year 1 (2015) Primary IPV dose tOPV tOPV tOPV Booster tOPV Booster

Year 2 (2016) Jan - Apr Primary IPV dose IPV tOPV tOPV Booster tOPV Booster

Year 2 (2016) May - Dec Primary IPV dose IPV bOPV bOPV Booster bOPV Booster

The ICC has also reviewed table 1 and approved the schedule. 7

Guyana received GAVI support for Pentavalent vaccine in 2001, PCV13 vaccine in 2011 and Rotarix vaccine in 2012 and has maintained high coverage (over 90%) for all three vaccines. HPV vaccine was introduced in 2012 for girls aged 9-13 through a donation from the Gardasil manufacturer as a pilot. Proper planning took place prior to prior to introduction for all vaccines including training and social mobilization activities. The Government of Guyana has met co-financing requirements for all GAVI vaccines over the 5 year period from 2008-2013. With the exception of IPV due to the urgency of the global polio endgame plan, Guyana has reached GAVI-graduating status and is in the process of phasing out GAVI support for vaccines by the end of 2015. Therefore, due to previous experience with IPV, maintenance of high vaccine coverage and experience with sustainable immunization financing, Guyana is well poised to introduce IPV at this point in time.

2. Overview of IPV

2.1 Vaccine preferenceTable B1. IPV vaccine preferences and estimated date of introduction

Preferred IPV vaccine Month and year of first vaccination

Preferred second presentation

Preferred third presentation

1-dose stand-alone IPV June 2015 5-dose stand-alone IPV 10-dose stand-alone

The planned date of IPV introduction nationwide will be June 2015.

Guyana prefers to use the WHO prequalified stand-alone IPV with the order of preference being 1-dose, 5-dose and 10-dose vials. The 1-dose IPV is already licensed in country whereas the 5 and 1-dose presentations are not. Because of the small birth cohort in Guyana as well as the presence of rural populations in hinterland areas the 1-dose preference will limit wastage. Currently Guyana is using 1-dose presentations for pentavalent and PCV13 vaccines which will be given during the same visit (at 2 months of age). These vaccines share the same target population. Although a 1-dose presentation will require more storage space than the 5 or 10-dose presentation, a recent EVM done in 2014 found storage and transport capacity at the national level to be adequate and sufficient to accommodate any new vaccines, such as IPV. IPV will require only a small amount of the total vaccine volume which currently houses 14 different vaccine presentations, used in routine immunization and among special populations.

While using the 1-dose vial would require some additional costs compared to the 5-dose, use of the 1-dose vial would only utilize a small amount of additional total cold chain space and would limit wastage. The recent EVM completed in 2014 ensured that adequate cold chain space is available at all levels to accommodate the additional space required by IPV.

2.2 Country licensure statusGuyana currently procures vaccines through the PAHO Revolving Fund. Vaccines and syringes are procured under the Drugs and Medical Supplies allocation of the Primary Health Care Budget of the Ministry of Health. Guyana has an NRA (National Regulatory Authority) called the Food and Drug

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Department which oversees licensing and regulates the use of all drugs and vaccines in the country. These vaccines are distributed through the government sector and provided at no direct cost to the client in the public sector. For IPV introduction, Guyana will accept the WHO-prequalified formulation. As IPV is already used in country, specific licensing will not be required for IPV procured through GAVI. Guyana is prepared to accept the Expedited Procedure for national registration of WHO-prequalified vaccines.

Guyana currently maintains a Standard Operating Procedure for arrival and transportation of vaccines and syringes from the airport to the Materials Management Unit at the Ministry of Health. The procedure involves proper documentation and custom clearance by the MoH. In the case of the delay in shipment or unexpected arrival within the specified period, designated personnel will notify the custom broker, customs and the National Cold Room of the delays in the arrival so that this can be quickly cleared on arrival. The Materials Management Unit is responsible for the transportation of vaccines from the airport (in a temperature controlled vehicle) and for the maintenance of the cold chain. National Cold Room nurse will examine the vaccines boxes/diluents on receipt and notice, the condition of the boxes etc., the temperature sensitive devices, including the freeze tag. The National Cold Room Nurse will complete documentation and ensure proper storage for the newly received vaccines at the National Vaccine Store.

2.3 Target population and vaccine supply Table 2: Estimated number of infants to be vaccinated with IPV in the RI programme, 2015 - 2018

Number Actuals Targets

2013 2014 2015 2016 2017 2018

Total births 15,240 15,433 15,628 15,826 16,027 16,230

Live births 15,040 15,225 15,412 15,602 15,794 15,988

Penta 1 (%) 98% 98% 98% 98% 98% 98%

IPV target in <1 (with DTP3/OPV3) 1% 0% 49% 95% 98% 98%

Number of infants to be vaccinated with IPV 196 0 7,552 15,290 15,478 15,668

3. Introduction and implementation considerations

3.1 Policy developmentThe Government of Guyana’s EPI policy is to provide vaccination for all target populations in order to eliminate the occurrence of all vaccine preventable diseases such as whooping cough, measles, poliomyelitis, tuberculosis, yellow fever, diphtheria, tetanus, mumps, rubella, haemophilus influenzae Type b and hepatitis B. Vaccines are provided free to children and adults who are both part of the national schedule.

Guyana’s immunization policy subscribes to the CARPHA/PAHO immunization policy, including policies on the elimination of measles, poliomyelitis, etc., for the introduction of new vaccines, e.g., HPV, Rotarix, and PCV13, as well as maintaining active surveillance for acute flaccid paralysis and vaccine adverse reactions in order to identify and manage cases appropriately and in a timely manner.

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The national and subnational targets are established annually based on live births, and there is a National Budgetary allocation for immunization administrative systems are in place for immunization, and there is National EPI Policy as well as a National Reference EPI Manual 2012 that guides practices and standards of care throughout all levels of the EPI program. Guyana maintains a budgeted comprehensive Multi-Year Plan covering years 2013-2017 and includes all planned immunization activities, including IPV introduction.

Guyana’s goal is to eradicate poliomyelitis. This goal is currently being pursued through high OPV coverage (98%) and the use IPV for children with special needs. Since IPV is already being used in the country in a limited way, this application for GAVI support is for the nationwide introduction of stand-alone IPV beginning in June 2015 to meet the endgame objectives and support the global withdrawal of OPV use after the eradication of polio. The most recent 2014 EVM report explicitly states that Guyana is implementing the Global Polio Eradication End-game and will add IPV to the routine immunization program.

For countries who choose to begin with the introduction of 1 dose of IPV in their routine immunization system, as is the case for Guyana, the PAHO TAG recommends administering one dose of IPV at 2 months of age followed by 2 doses of OPV and 2 additional boosters of OPV. This strategy is recommended to minimize the occurrence of VAPP cases. For Guyana, IPV will be the third injection along with PCV13 and Pentavalent vaccines.

The recommendation will be for IPV to be administered by intramuscular injection in the opposite thigh where pentavalent is currently administered. PCV13 and IPV will be given in the same thigh at sites separated by 2.5 cm. In Guyana, IPV for HIV exposed children is currently being given subcutaneously in the anterolateral thigh in infants and in the deltoid area for older children. The program recognizes that the preferred method of administration is intramuscularly as per the PAHO Practical Guide for IPV Introduction and will adjust training materials, guidelines and recommendations to reflect the change.

The National Immunization Policy will have to be revised to include IPV as part of the routine immunization program as its current information applies to special needs children only.

3.2 National coordination mechanism to ensure the successful introductionAlthough the complete IPV Introduction Timeline can found in Annex C, table 3 below outlines key milestones during the process from decision to implementation including: Pre-implementation planning and decision-making activities such as the development of the introduction strategy and timeline, approval of the GAVI application and IPV Introduction Plan by the ICC and subsequent submission to GAVI, adaptation of Information, Education, and Communication (IEC) materials, micro-planning, introduction, and post-introduction monitoring.

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Additional activities to ensure a successful introduction include reviewing routine immunization data and improvement plans; identifying weak components of the immunization system and plans to rectify; identifying poor performing and high risk districts and targeted activities planned for improving their performance; establishing technical subcommittees for cold chain and vaccine management, training, monitoring and evaluation, advocacy/communications/social mobilization, and adverse events following immunization monitoring and mobilizing human resources and developing a budget and ensuring availability of sufficient funds for the operational costs of a successful IPV introduction process.

Organization and Coordination:

In Guyana, the Central Ministry of Health deals with policy, planning and evaluation of programmes whereas the management of the Regional Programmes is done by the Regional Health Services of the Ministry of Health. Each Region is governed by Regional Authorities who employs staff and executes Expanded Programme on Immunization activities including cold chain supply and management. Vaccination services are coordinated by the Maternal and Child Health Department of the Ministry of Health.

The Immunization Manager is the de facto MCH Officer. This unit is supported by the Deputy Chief Nursing Officer who supervises the Public health nurses and team leaders of health centres in 10 Regions. There is also a National Cold Chain Nurse who is in charge of the National Cold Room and the distribution of vaccines to all regions. Other staff includes Administrative Manager, Secretary, Clerk, two Surveillance Nurses and Auxiliary Workers.

Due to this organizational structure, the introduction of one IPV dose for use by all children who would receive OPV only will be coordinated by the Maternal and Child Health Department of the Guyanese Ministry of Health and lead by the EPI Manager. The decision to implement IPV Nationally will be coordinated by the Inter-Agency Coordinating Committee (ICC).

The EPI plans to fold the introduction of IPV into regular routine immunization activities, thus no additional steering committee is envisioned to oversee the national level management of the process. Guyana has recently introduced PCV13 and Rotarix vaccines through GAVI support with success. Similar to previous introductions, the ICC will be the guiding committee for implementation of introducing IPV into the routine immunization schedule.

Guyana has recently completed a transitional plan through the GAVI process to ensure sustainability of financing and operational measures as part of a Health System Strengthening grant. This plan describes objectives in the areas of vaccines, cold chain, human resource development, information systems, surveillance, supervision, social mobilization and monitoring and evaluation. This activities in this transition plan will provide good synergy with the work necessary to implement the introduction of IPV and will provide an opportunity for IPV introduction to support overall routine immunization strengthening, a key component of the Endgame Plan.

Table 3: Timeline of the scheduled activities for IPV introduction

Month of IPV introduction plan

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Activity

Oct

-15

Nov

-15

Dec-

15

Jan-

15

Feb-

15

Mar

-15

Apr-

15

May

-15

Jun-

15

Jul-1

5

Aug-

15

Sep-

15

Oct

-15

Nov

-15

Dec-

15

May

-16

May

-17

May

-18

DesigningSenzitation meeting with all staff on IPV introduction Policy decisions, including ICC meetings Ensuring licensuring and procurement pathway Brief key stakeholders Funding Funding secured from Gavi and other partners Planning Establish procedures for implementation Adapt Information, Education and Communication (IEC) materials & develop communication plan for educating communities

Review and revise immunization forms Confirm space at regional and district cold stores Clear vaccine supply from customs BudgetingFinalise budget Financial resources received at central level Pre-arranged budget is transferred from central to region and district levels

Training & Communications Develop training plan for introducing IPV with OPV3 at DTP3/Penta 3 health contact

Microplanning at district levels Implement training plan Implement communication strategy IntroductionTransport vaccine to districts Delivery of IPV to target populationInstitute monitoring of adverse events following immunisation (AEFIs) for IPV

SupervisionSupportive supervision visits central to district Supportive supervision visits district to health facility Post-introduction monitoring (e.g., coverage, stockouts, safety monitoring, freezing assessment)

Analysis & ReportingMonthly reporting of IPV doses delivered Analyze reported IPV data Submit financial report to Gavi Submit progress report to Gavi

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3.3 Affordability and financial sustainabilityThe Government of Guyana is requesting full support from GAVI for one dose of IPV and supplies without any country co-financing. Guyana would need as estimated 7,552 doses during 2015 and 15,290 during 2016. The first year cost to GAVI for IPV and freight would be $26,432 assuming vaccine costs of $2.80 per dose for the single dose vial, target coverage of 98%, and accounting for 25% buffer stock. See table 4 below for calculations.

  2015 2016 2017 2018 TOTAL

  For half the year

1st dose by GAVI + 2nd dose by Guyana Gov't (full year)  

Target Population 7,552 15,602 15,794 15,988 54,936

Doses in the schedule 1 2

2 2  

Number vaccine doses required 7,552 31,204 31,588

31,976

$ 102,320

Doses require including 25% buffer stock 9,440 39,005 39,4

85 39,97

0 $

127,900

Cost of one IPV dose (US$) $2.80 $2.80 $2.80 $2.80  

IPV Dose 1 - GAVI $ 26,432 $ 54,607 $

55,279 $

55,958 $

192,276

Freight cost (10%) $ 2,643 $ 5,461 $

5,528 $

5,596 $

19,228

Vaccine Introduction Grant $ 100,000 $ - $

- $ - $ 100,000

Total GAVI Contribution $ 129,075

$ 60,068

$ 60,807

$ 61,554

$ 311,504

IPV Dose II - Government $ - $ 54,607 $ 55,279

$ 55,958

$ 165,844

Freight cost (10%) $ - $ 5,461 $ 5,528

$ 5,596

$ 16,584

Total Government Contribution $ -

$ 60,068

$ 60,807

$ 61,554

$ 182,428

           

Total costs $ 129,075

$ 120,135

$ 121,614

$ 123,108

$ 493,932

Cost of vaccine per child $ 17.09 $ 7.70 $

7.70 $

7.70          

The Government of Guyana also requests to receive the Vaccine Introduction Grant (VIG) lump sum of $ 100,000 (2015 estimated birth cohort of 15,452). These funds will be important for meeting the accelerated IPV timeline and, in addition to leveraging existing resources and partnerships; they will support the preparation activities described in the introduction plan.

The costs of planning and implementing the IPV introduction are included in below Table 4, whereas detailed costs under each category are listed in the Annex table attached separately (Table E2).

Nearly ninety percent of immunization financing comes from the government, a percentage that has 13

Table 4

gradually increased over time. By 2016, at the rate of current government support, the EPI programme expects to finance an additional dose of IPV, which has been outlined in the current cMYP.

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Table 5: Cost estimate for planning and introduction of IPVIPV cost calculations were based on 10% of programme operational and capital costs

Government GAVI Support

OPERATIONAL COSTS Total Cost US$ Amt. US$ Requested1. Vaccines & Injections (biological/logistics)-Immunization

supplies 29,075 29,075

2. Personnel, program management and coordination, technical assistance $128,963 $83,181 $45,782

3. Transportation & Maintenance $25,306 $16,322 $8,984 4. Training – human resources and incentives, document

production, other training and meetings $12,095 $6,747 $4,294

5. Social Mobilization / Coordination – IEC and advocacy, planning and preparations $5,716 $3,687 $2,029

6. Surveillance/ Information System-surveillance and monitoring, data management $4,477 $2,290 $1,589

7. Research $1,438 $710 $510

8. Monitoring & Evaluation $5,401 $3,483 $1,917

9. Supervision $5,197 $2,434 $1,845

SUB-TOTALS 188,592 118,855 66,950

Capital Costs 10. Vehicles- transport for implementation and supervision,

transportation and maintenance $1,990 $1,284 $706

11. Cold Chain Equipment $6,929 $4,292 $2,460

12. Other Equipment, waste management $2,274 $267 $807

SUB-TOTALS 11,194 5,842 3,974

GRAND TOTALS 228,861 124,697 99,999

Guyana is a 2016 GAVI graduating country, consequently full support from GAVI for IPV will facilitate the self-financing of other new vaccines such as PCV13 (2011), Rotarix (2012), and HPV (2012) which they currently co-pay with GAVI and which will present a much greater challenge for the country EPI. It is understood that GAVI support is guaranteed through 2024 (subject to funding renewal for GAVI for providing IPV support to countries after 2018). The Government of Guyana is committed to financing the systems and recurrent costs of introducing IPV beyond those covered by the Vaccine Introduction Grant (VIG); no gap of funding is expected.

The Government of Guyana has remained and will continue to be the major funding source for the EPI programme contributing close to 90% of its total cost, most of it through maintaining health care personnel and healthcare facilities, as well as covering current EPI costs. While currently financing the country’s co-payments towards GAVI support is through the Ministry of Health and Finance is expected to completely take over the business of financing procurement of all the vaccines phased over from donors to the Government.

Additional assistance to Guyana during cMYP 2007 to 2017 cycle was provided by the planning department of the Ministry of Health.

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Although the government of Guyana finances the overall majority of the EPI programme, GAVI, PAHO and UNICEF are the main providers of funding to support activities. GAVI supplies funding for new vaccine introduction costs and training, PAHO provides technical support for training, supervision, surveillance, social mobilization and cold chain and UNICEF provides funding for training and cold chain and social mobilization.

While GAVI continues to provide considerable support in financing PCV13 and Rotarix vaccines procurement, Guyana will graduate from this support line at the end of 2016. The Ministry of Health and Guyana’s EPI Programme are confident that the range of steps taken during 2015-2017 will allow the country to start smooth graduation from donor support programmes while gaining financial self-sustainability. At the same time, the Ministry will appreciate and explore every opportunity to continue productive cooperation with its development partners. In Table 5, the overall trend of Guyana's immunization and funding sources for the immunization program costs are stratified by source of funding and type of costs.

3.4 Overview of cold chain capacity at district, regional and central levelsIn Guyana, vaccines are received, stored at distributed from 3 levels.

1. The primary (PR) level store (generally the national store) where vaccines are received directly from the vaccine manufacturer or from an international supplier such as UNICEF Supply Division or PAHO/WHO Revolving fund. Typically, vaccines are stored in large cold rooms and freezer rooms. Guyana has one National Vaccine Store, located in the capital city of Georgetown.

2. The lowest delivery level (LD) store where vaccines are received, either from the primary store or from a subnational store. From this point they are distributed directly to service delivery points. The lowest delivery level does not normally provide any immunization services. In the vaccine supply chain system of Guyana, the regional stores play the role of the lowest distribution level. There are ten administrative regions, but only a few have effective functional vaccine storage and distribution stores.

3. Service delivery points (SD) such as health centres and health posts, where vaccines are stored for a short time before delivery to the target population – usually in a single refrigerator, but also, on a very short-term basis, in vaccine cold boxes or vaccine carriers. Each service delivery point may distribute vaccines to other service delivery points. There are 327 service delivery points in the country providing immunization services.

The national vaccine store of Guyana is located in a fenced compound with guards providing around-the-clock security. The compound is a restricted access area. The store is located in one building with three rooms, including:

● The store managers’ officer (National Cold Chain Nurse) at the entrance● A room for dry storage of 4m x 4m floor space● A big room with two cold rooms (one walk-in cold room of 40 m3 and one freezer room of

30m3), three refrigerators and five freezers

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Vaccines are stored in the walk-in cold room and transferred to the refrigerators before distribution. There is a standby generator with sufficient power to run all equipment in the store.

Overall, Guyana’s vaccine supply chain has reported high scores during the period reviewed in its baseline EVM assessment, which was conducted from 14 to 18 July, 2014. Standard processes are put in place and followed by staff. All facilities were found to have sufficient cold storage capacity for storing their vaccines, as well as producing ice-packs for transport or outreach. There is no cold volume shortage currently, with current procurement practices. The cold storage at Guyana’s National Vaccine Store is currently not stressed and there is no need to add additional appliances at this time. Introduction of one dose of IPV will increase storage volume requirement by only 2.4% As no other new vaccine introductions are planned for the immediate future and the existing cold chain capacity is expected to be adequate for accommodation of IPV to be introduced into the routine immunization schedule. The minimal volume added at all levels can be absorbed at all levels.

The EVM noted two main areas where challenges remain. While the manual temperature recording system was well established in all facilities, the programme had not implemented continuous temperature recording devices, since this was not indicated in the programme previously. There were also interruptions of temperature reading and plotting during weekends and holidays in many facilities at the lowest distribution level stores and service point stores. Continuous temperature recording devices are required to ensure the vaccine storage conditions are optimally controlled, an important factor in the management of IPV, a freeze sensitive vaccine. Additionally, while EVM recommends the use of freeze indicators for transporting freeze-sensitive vaccines when packing with conditioned ice-packs, the programme had not yet implemented this recommendation at the time of the review. Significant efforts were made to ensure the correct conditioning of ice-packs, yet in some facilities correct conditioning of ice-packs were not being done in the passive containers with freeze-sensitive vaccines. IPV introduction provides an important opportunity to initiate modifications and rectify these situations.

The EVM assessment found maintenance to be a strong area. Planned preventive maintenance was organized at each level, with well operating outsourced maintenance for major cold chain equipment at the primary level. Sufficient funding exists at local levels to ensure an ongoing power supply and to maintain any new cold chain equipment that may be introduced as a result of this EVM.

3.5 Waste management and injection safety In Guyana, sharps wastes are collected from all health facilities and taken to the Georgetown Hospital Medical Wastes Disposal Unit. Other approved waste disposal sites (medical waste incinerators) exist in the regions for service points beyond the Georgetown Hospital catchment area.

A waste management assessment was carried out in 2011 with the support of USAID, and a national waste management plan was developed. Guyana Safer Injection Project (GSIP) implemented from 2004 to 2010 was originally implemented to ensure that key national and local stakeholders had developed the capacity, including knowledge, skills and resources, as well as the interest, motivation and institutional support to manage, maintain and improve injection safety in the future. The later assessment focused on country ownership and sustainability of injection safety practices and interventions in the health care system in Guyana. GSIP’s activities were organized under four

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functional areas: safe and appropriate injection use, worker protection, waste management and quality assurance and improvement. Among the key activities GSIP successfully carried out were:

● Building the capacity of 71 health workers to serve as Injection Safety Trainers● Supporting the Trainers to reach over 800 health workers with in service injection safety

trainers● Integrating Injection Safety into the training curricula for four cadres of allied health workers● Upgrading the capacity of Environmental Health Assistants to support health facilities to

dispose of sharps waste safely ● Reinforcing the national Injection Safety Certification system, which assesses health facilities

compliance with 30 Injection Safety Standards● Supporting seven facilities to achieve Injection Safety Certification

While waste management and injection safety will be continually monitored, no changes to the current system are expected to be needed to accommodate IPV. Injection safety and waste management will be addressed during health worker training prior to IPV introduction. For most vaccines, Guyana self-procures vaccine delivery devices, in addition to vaccines themselves, through the PAHO Revolving Fund.

3.6 Health worker training and supervisionThe cMYP describes a programmatic objective to enhance the knowledge and skills of EPI health workers at all levels of the system on the following topics: vaccination policies and techniques, biosafety, cold chain operation and maintenance, surveillance and supervision. A National EPI Reference Manual was published in 2012 and was used to conduct training on the following topics in all regions: cold chain management; specimen collection and handling; computer literacy; and administrative skills for supervisors. This document will need to be revised based on new information associated with IPV introduction.

Health workers have been trained on IPV administration as IPV is now given to special risk groups (HIV exposed infants). IPV introduction will require an additional training as this is the first time IPV will be given universally, as part of the routine immunization schedule. The EPI program has experienced difficulties with staff turnover; therefore additional refresher training will be planned prior to the introduction date. IPV is given intramuscularly for the selected groups and with IPV national routine programme, this will be continued. Training materials will be adapted from templates developed by WHO.

3.7 Risks and challengesSeveral areas have been described as challenges in the EPI Programme. These challenges include:

● Difficulties in maintaining high vaccination coverage in hinterland areas and river communities especially Regions 1, 7, 8 and 9.

● Maintenance of the cold chain at regional levels e.g. solar systems● Difficulties in access to vaccination in remote hinterland communities● Social communication support in the implementation of new vaccines.● Updated technology for cold chain monitoring at the national and regional level

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For the introduction of IPV, several challenges may arise. Potential challenges associated with IPV introduction and the activities planned to mitigate them are presented below.

Table 6: Risks and mitigation strategies for IPV introduction

Risks Mitigation

Financial: Guyana is currently phasing out of several funded programs (PEPFAR and Global Fund) including graduating from GAVI support for PCV and rotavirus vaccine. The Government of Guyana is planning to finance an additional dose of IPV in the future (beyond GAVI support for 1 dose) and competing priorities may place a strain on the financial system.

The government has established a transition plan for the future sustainable financing of other health programs. The EPI program budget is updated on a yearly basis to address rising financial needs.

Community acceptability: The acceptability of introducing a vaccine for a disease that has been eliminated in the region could be low with decision-makers, health workers, and parents, jeopardizing trust in the immunization program and posing barriers for introduction of other priority new vaccines that are crucially needed. Vaccines are generally well accepted in Guyana making this risk low, however, social mobilization in the area of new vaccines has been documented as a challenge.

A strong communications and advocacy strategy will be needed with clear, succinct, and convincing messages for the rationale for introducing IPV and withdrawing OPV. Leveraging partnerships with stakeholders and international organizations to gain broad buy-in from decision makers for the introduction of IPV as a critical step in the eradication and endgame of polio globally. Ensuring that funding will exist beyond 2018 will also be necessary for continued support from decision-makers. Timely development and dissemination of IEC materials is important.

Safety of IPV: In the event of a serious/fatal ESAVI event temporally associated with IPV could cause safety concerns for newly introduced vaccines or spread rumors detrimental to the polio eradication program.

Focused efforts to strengthen the national ESAVI system include: updating definitions ensuring reporting mechanisms are in place ensuring validation is standardized and documented, and making sure timely and appropriate causality assessment is conducted. The program will also ensure that the system is capable of handling more cases and will conduct refresher training in ESAVI management and reporting for staff at the district and health centre levels to encourage robust reporting of ESAVIs through the system. A crisis communication plan will be developed as part of the communication strategy for IPV introduction, should the unlikely event of an ESAVI occur in association with IPV.

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Cold chain: IPV is freeze sensitive and potency may be affected if subjected to extreme cold. Temperature monitoring was identified as an area for improvement through the EVM. Improper temperature monitoring or conditioning of ice packs could lead to damaged vaccine.

The currently underway EVM improvement plan includes: Training and supervision to ensure appropriate icepack conditional practices; including Freeze-tags/log-tags/data-logger for all IPV vaccine shipments packed with conditioned ice packs; evaluations and intervention strategies to ensure improvement based on the EVM and proper maintenance of cold chain.

Surveillance: Maintaining strong surveillance (AFP) functionality everywhere is a crucial component of the Eradication and Endgame Strategy. With increased movement of populations, and persisting WPV cases in parts of the world, surveillance lapses may risk undetected introduction and circulation in the community.

Maintaining certification-level standards for AFP surveillance in Guyana is important. Timely development of an updated global and regional strategy for surveillance and containment, ensuring effective implementation and compliance with this strategy is crucial.

4. Situational analysis of the immunisation programme

4.1 General context of the countryGuyana covers an area of 83,000 square miles (215,000 square kilometres) and is located along the north-eastern coast of South America. The population, estimated at 770,794 in the 2012 Bureau of Statistics Census, is clustered primarily within the five smaller coastal regions. By contrast, the four main hinterland (interior) regions are very sparsely populated, covering nearly three-quarters of Guyana’s land mass but containing only 10% of the population. In 2012, 26.2% of the population of Guyana was less than 15 years old, 68.6% was between 15-64 years old, and 5.2% was over 65 years old.

As a growing economy, Guyana is classified as a lower-middle income country, with a GDP per capita of USD 3,750, 21% unemployment rate, and 35% poverty rate, with 19% of the population living in extreme poverty. Despite these indicators, the poverty level assessed by the World Bank in 2008 is a 7.8% reduction since 1999. Significant progress has been made by the Government of Guyana over the past few years in reaching macroeconomic stability with its pro-growth orientation driving investments, expansion, and diversification of its economic base, and while Guyana’s economic and social development problems persist, the macro-economic growth trends have contributed to reductions in the disparities between and among the 10 administrative regions and urban centres, with greater equity in the access to service delivery; land rights and improved conditions of life in the Amerindian communities.

Guyana has 10 administrative regions, and its capital Georgetown is located in Region 2. The health system is highly decentralized under the 2005 RHA Act with Regional Health Authorities and the Georgetown Public Hospital Corporation responsible for health services. The service delivery model is

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founded on Primary Health Care principles of equitable distribution of services, inter-sectoral collaboration and community participation. As illustrated in the Guyana-PAHO Country Cooperation Strategy, the model of health service delivery is based on a 5-tiered upward-moving referral system. Level I includes 214 health posts (the most basic health facility); Level II – 136 health centres; Level III – 21 district hospitals, Level IV – 5 regional hospitals; and Level V comprises Georgetown Public Hospital Corporation which serves as the General Hospital for the Greater Georgetown Area and the tertiary care referral hospital for the country and the national mental health facility located in New Amsterdam.

The Government of Guyana’s EPI policy is to provide vaccination for all target populations in order to eliminate all vaccine preventable diseases.

4.2 Geographical, economic, policy, cultural, gender and social barriers to immunizationTable B2. Trends in national vaccine coverage

Trends of national vaccine coverage (percentage)

Vaccine Vaccine UsedTarget population

(number by age and sex, if available)

Coverage reported (JRF)

Most recent year 2013

Previous year 2012

BCG 10-dose (Serum Insititue of India (PAHO RF))

15,040 98% 98 %

OPV 3 20-dose (Novartis (PAHO RF + other))

15,040 98% 97%

DTP 1 / Penta 1

1-dose (LGLife) 15,040 98% 99%

DTP 3 / Penta 3

1-dose (LGLife) 15,040 98% 97%

MMR 1-dose and 10-dose (S11 (PAHO RF + other))

14,500 100% 99%

MMR 2 1-dose and 10-dose (S11 (PAHO RF + other))

13,946 95% 90%

PCV13-1 1-dose (Wyeth) 15,040 98% 94%PCV13- 2 1-dose (Wyeth) 15,040 96% 90%Rotarix 1 1-dose (Merck) 15,040 97 % 91%Rotarix 2 1-dose (Merck) 15,040 94% 91%Yellow Fever

10-dose (Pasteur (PAHO RF + other))

14,500 100% 99%

Challenges to Immunization

Four of Guyana’s ten administrative regions (1, 7, 8 and 9) are classified as interior or hinterland regions. These areas are mostly rural, hard-to-reach and sparsely populated. While demand for health services is high (clinic visits are culturally advisable) access to health services in rural areas remains Guyana’s main barrier to immunization, creating a challenge to maintaining high immunization coverage in those areas. The climate of Guyana is prone to climatic variations and flooding making transportation difficult at times. Additional challenges related to hinterland regions are access to cold chain equipment and retention of skilled health staff.

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Gender inequities are not expected to exist in Guyana due to generally high overall coverage for all antigens. Guyana has also recently introduced HPV vaccine to girls aged 10-13. The Ministry of Health has started to report immunization data stratified by gender in some regions in 2013. It is expected that all regions will be reporting by gender by the end of 2014. Preliminary analyses have shown some slight differences in coverage but gender variations will continue to be monitored.

4.3 Findings from recent programme reviews The last EPI Review took place in 2008 and another review will take place in 2017. Given the recent new vaccine introductions for PCV13 and Rotarix, impact assessments are planned using surveillance data for these two diseases. Nationally, the EPI program holds review activities three times per year to evaluate regional level activities and discuss best practices. These meetings include supervisors of health centers, midwives and doctors as well as representatives from PAHO and WHO. Main points discussed during the last meeting included untimely submission of reports, accurate documentation of charts, verification of the MCH/EPI data used. Findings are compiled annually into an EPI Report.

Lessons learnt from previous vaccine introductions will be used to ensure a smooth introduction of IPV . Main lessons learned from PCV13, Rotarix and HPV vaccine introduction are:

● A phased approach to introduction can allow for time to adjust policies and activities as needed and ease financial and operational strains associated with new vaccine activities.

● Updating materials and retraining staff is a crucial part of introducing a new vaccine and also provides an opportunity to reinforce skills and strengthen the routine immunization system.

● Political support within each province / district eases constraints and contributes to community acceptability of new vaccines.

● Staff commitment is essential to high coverage and a successful vaccine introduction

4.3.1 EVM assessment findings and improvement plan The Effective Vaccine Management Assessment was conducted from the 4th to the 21st of July 2014. The standard WHO/UNICEF EVM assessment tool was used to identify the key strengths and weaknesses in nine different areas of vaccine management at each of four levels of the vaccine supply chain, and makes recommendations to address any weaknesses. Mean scores at 3 levels of the supply chain for all nine EVM criteria are presented in Table, 7.

Table 7: Mean EVM criteria scores (%) by three levels of the supply chain in Guyana

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Findings from the assessment recommended that the programme continues its efforts in the areas where high performance have been achieved, while investing in new improvement interventions to address identified challenges. As a result of the EVM assessment, an Improvement Plan was developed to address challenges identified. The plan typically includes the activities, schedule, budget, responsible person(s) for carrying out each activity, and indicator for monitoring the accomplishment. The EVM Improvement Plan of Guyana covers a period of three years, from 2015 to end of 2017. A total of US$ 384,688 will be required to implement the Improvement Plan. The detailed activities are presented in Annex 2 of the attached EVM assessment. Areas for improvement, identified in the EVM assessment, include:

Temperature monitoring:

● Conduct a controlled temperature monitoring study, using WHO protocol to profile temperatures of the vaccine supply chain

● Equip cold/freezer rooms at the national vaccine store with continuous temperature monitoring devices with dial-out alert function

● Ensure at the lower levels (LD, SP), temperature reading and plotting during weekends and holidays

● Provide continuous temperature monitoring devices for all refrigerators (Assign shifts during weekends and holidays for physical check-ins)

● Revise the temperature chart to formally include alarm events and remedial actions to be taken

● Update all staff knowledge on temperature sensitivity of vaccines

Buildings, equipment, and transport:

● Equip the National Vaccine Store with telephone and internet connectivity● Equip all regional refrigerators and freezers with voltage regulators for connection to the

electricity grid● Provide fire extinguishers for all health centres lacking at least one, and ensure annual

maintenance checks are implemented for all fire extinguishers● Reinforce protection against termites of the building at lower levels (LD, SP)● Align national specifications with WHO standards when new equipment (refrigerators) is

procured

Maintenance:

● Maintain good performance at the national vaccine store and in the decentralized planning of preventive maintenance at the lower levels (LD, SP)

● Improve documentation of maintenance activities at the lower levels of the equipment by keeping equipment maintenance history forms.

Stock Management:

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● Consider the introduction of computerized stock management at the national vaccine store● Establish proper stock recording for diluents and safe injection equipment at the lower levels

(LD, SP)

Distribution:

● Reinforce knowledge and skills of all staff on conditioning ice-packs● Implement the use of freeze indicators for packing freeze-sensitive vaccines

Vaccine management:

● Complement the existing SOPs and EPI manual to update guidance on shake test procedures and multi-dose vial policy (MDVP)

Information System Management and Supportive Functions:

● Update EPI field guide to provide orientation for new staff● Update the list of key Standard Operating Procedures (SOPs) at lower levels (LD, SP), including

IEC (Information, Education, Communication) materials, and for the different aspects of supply chain procedures in detail

● Integrate key EVM criteria indicators into the EPI supportive supervision activities● Ensure documentation of planned and implemented trainings● Reinforce documentation of supervisory visits

4.4 Stock management The 2014 EVM confirmed that there was a manual stock control system in place. All vaccine arrivals and vaccine dispatches were recorded and stock balances updated within one working day of the transaction. The stock records for vaccines recorded all the information required according to the EVM standards. However, for diluents, there were no bin cards for recording transactions. The store staff regularly updated the summary of the stocks including diluents. A 24 hours advance notice was made by phone for requisition of vaccines. The process of selecting vaccines was based on the EEFO principal, and the vaccines with earlier expiry dates were removed before those with later expiry dates and transferred from the cold room to the refrigerators. There was a consistent match between the information in the stock record and the issue vouchers. Vaccine wastage in open vials was re-recorded in the bin card by indicating the type of wastage. The concept of critical stock levels (maximum and safety stock) was well understood by the store staff. Supply was adequate for all vaccines throughout the review period. Physical inventory were carried out once a month. Stock records for both vaccines and diluents were found to be accurate and consistent with the physical counts. Some delays were observed in the updating of the records for syringes.

Recommendations from this evaluation included:

● Establish proper recording of transaction for diluents as is being practiced for vaccines● Ensure timely recording of transactions of syringes

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While these improvements will strengthen the stock management of the entire EPI program, introduction of IPV in the routine immunization program is not likely to cause any issues with the current system. Guyana’s well-functioning stock management system is expected to easily absorb IPV.

Most of the health centres had good links with the national telecommunication network, either by using a landline or personal mobile phones. The existing transport system for delivery of vaccines to the periphery will easily accommodate IPV without need for any increase in frequency of delivery.

5. Monitoring and evaluationTHE EPI Programme is guided by the following objectives and tracks the following performance indicators:

Objectives Performance IndicatorsImmunize all children by the age of one year with the following antigens, BCG, OPV and the pentavalent vaccine (DPT, Hepatitis B and Haemophilus Influenza b), Rotarix, PCV 13, IPV for children with special needs

Percentage of children under 1 year who have received one dose of BCG at birth.Percentage of children who have received one dose of MMR at 12 months.

Vaccination young females 10-13 years with three doses of HPV.

Percentage of children who have received a booster dose of MMR at 3 years 9 months.

Vaccinate all children at 12 months with Measles, Mumps and Rubella and Yellow Fever vaccines.

Percentage of children under 7 years who have received 5 doses of DPT vaccine.

Vaccinate all children with a second dose of MMR at the age of 18 months.

Percentage of adults who have received two doses of MMR and one dose of yellow fever.

Ensure that all children are fully immunized before admission to nursery schools.

Percentage of at risk (i.e. health workers, factory workers, child care providers, etc.) groups vaccinated with hepatitis B and DT (diphtheria and tetanus) vaccines.

Eradicate poliomyelitis, eliminate measles and indigenous rubella cases and therefore reduce Congenital Rubella Syndrome.

Percentage of children immunized by age 1 year against poliomyelitis, diphtheria, whooping cough (pertussis), tetanus, tuberculosis, hepatitis B, haemophilus influenzae type b.

Maintain active surveillance for rash with fever, acute flaccid paralysis, and vaccine adverse reactions in order to identify and manage cases appropriate and in a timely manner.

The percentage of children twelve months and over who received one dose of yellow fever vaccine and one dose of MMR vaccine.

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5.1 Updating of monitoring toolsMonitoring tools will need to be updated to reflect changes in the immunization schedule and provide relevant information on IPV. Forms will carefully differentiate between IPV and OPV to ensure data quality. The MoH has enabled flexibility in this process by including blank spaces on the current immunization cards in which to denote newly introduced vaccines. All tools will be updated along with other recent changes to the forms in order to minimize costs associated with printing and distribution. Some revisions to be made include:

● EPI Manual- currently describes IPV for use in HIV exposed infants. The document will also need to be updated to reflect the preferred IM administration method.

● Routine immunization schedule ● Tally sheets● Immunization Cards ● Wall charts – Monitoring immunization forms / CARPHA sheets● Computerized databases

The country will continue to collect data on vaccine delivery by sex, as was began in 2014.

5.2 Events Supposedly Attributable to Vaccination or Immunization (ESAVI) monitoring and reportingThe EPI program in Guyana defines ESAVI as any event that is believed to be caused by immunization. Reported adverse events can either be true adverse events or coincidental adverse events that are not due to the vaccination process but are temporally associated with immunization. In Guyana ESAVI are classified into five categories:

1. Vaccine reaction: event caused or precipitated by the vaccine when given correctly, caused by the inherent properties of the vaccine

2. Program error: event caused by an error in vaccine preparation, handling or administration3. Coincidental: event that happens after immunization but not caused by the vaccine (a chance

association)4. Injection reaction: event from anxiety about, or pain from, the injection itself rather than the

vaccine5. Unknown: Events cause cannot be determined

Systemic and serious reactions occurring within set time frames are reportable in Guyana, which has identified a list of reportable ESAVI. A standard epidemiologic investigation and laboratory testing by working hypothesis follows the report. Guidelines are available for communicating with the media in topics related to ESAVI. Consultation with manufacturers and PAHO/WHO is advised before making a decision on changes to the vaccination schedule. The ESAVI guidelines in the EPI reference manual will be updated to include information on IPV and the same structure used to report and investigate events associated with other vaccines will also apply to IPV. The current ESAVI monitoring and reporting system as is, is expected to sufficiently support IPV after it is introduced.

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6. Advocacy, communication, and social mobilisation

As IPV is currently being used for special populations in Guyana, there will be no specific launch activity to announce introduction of the IPV into the routine immunization schedule. The Ministry of Health will collaborate with PAHO, UNICEF and other global partners to leverage the use of existing tested messages and materials to develop a strategy appropriate for the needs of the Guyanese population for this particular vaccine introduction. Communication materials and informational presentations developed by WHO will be adapted as necessary and utilized for advocacy among stakeholders, health worker training, and community education.

The IPV introduction communication activities will place emphasis on the following strategies:

● To create awareness and demand for IPV and other vaccines● To maintain communications achievements related to:

○ To fostering trust○ Maintaining high immunization coverage○ Continuing strong community support for the immunization structure○ Leveraging existing tools used for previous new vaccine introductions and routine

immunization strengthening ● To enhance reporting and detection of potential AEFI● Develop a crisis communication plan should rumours or misinformation arise

The following strategies to enhance social mobilization and communication were developed as part of the EPI transition plan and will apply to communication activities for IPV introduction.

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References:

The following documents were used to compile this report:

1. Current data on polio cases and surveillance indicators. Available at http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx (Last accessed, 30 October 2014)

2. SAGE position & WHO position paper [http://www.who.int/wer/2014/wer8901/en/index.html]

3. Guyana MDG Report 2007

4. World Bank 2008 Assessment of Poverty in Guyana

5. 1999 Living Conditions Survey, Government of Guyana

6. IMF November 2010, February 2011 assessments

7. GAVI Annual Progress Report 2013

8. National Reference EPI Manual-2012, Guyana. 4th edition revised.

9. Guyana Safer Injection Project final report, November 2012. USAID http://pdf.usaid.gov/pdf_docs/PA00HVZ5.pdf

10. Overview of Guyana’s Expanded Programme on Immunization in 2013, January to June 2014 National EPI coverage Review

11. Guyana GAVI transition plan

12. Standard Operating Procedure for the arrival and transportation of vaccines/syringes from the airport to Materials Management Unit

13. Guyana Multi-Year Report, 2007-2012

14. March 2014 ICC minutes

15. Report from EPI managers meeting

16. 2013 EPI Report

17. Guyana HPV Proposal to Gardasil, 2010

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