[V1.5.2]

Gavi

Application Form for Country ProposalsFor Support to:

Routine New Vaccines Support

Submitted by

The Government of

LesothoDate of submission: 15 October 2015

Deadline for submission: 8 September 2015

Select Start and End Year of your Comprehensive Multi-Year Plan (cMYP)

Start Year 2017 End Year 2017

Form revised in 2015

(To be used with Guidelines of October 2014)

Please submit the Proposal using the online platformhttps://AppsPortal.gavialliance.org/PDExtranet

Enquiries to: proposals@gavi.org or representatives of a Gavi partner agency. Unless otherwise specified, the documents can be shared with Gavi partners, collaborators and the general public. The Proposal and attachments must be submitted in English, French, Spanish, or Russian.Note: Please ensure that the application has been received by Gavi on or before the day of the deadline.Gavi is unable to return submitted documents and attachments to countries.

GaviGRANT TERMS AND CONDITIONS

FUNDING USED SOLELY FOR APPROVED PROGRAMMESThe applicant country ("Country") confirms that all funding provided by the Gavi will be used and applied for the sole purpose of fulfilling the programme(s) described in the Country's application. Any significant change from the approved programme(s) must be reviewed and approved in advance by the Gavi. All funding decisions for the application are made at the discretion of the Gavi Board and are subject to IRC processes and the availability of funds.

AMENDMENT TO THE APPLICATIONThe Country will notify the Gavi in its Annual Progress Report if it wishes to propose any change to the programme(s) description in its application.The Gavi will document any change approved by the Gavi, and the Country's application will be amended.

RETURN OF FUNDSThe Country agrees to reimburse to the Gavi all funding amounts that are not used for the programme(s) described in its application. The country's reimbursement must be in US dollars and be provided, unless otherwise decided by the Gavi, within sixty (60) days after the Country receives the

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Gavi's request for a reimbursement and be paid to the account or accounts as directed by the Gavi.

SUSPENSION/ TERMINATIONThe Gavi may suspend all or part of its funding to the Country if it has reason to suspect that funds have been used for purpose other than for the programmes described in the Country's application, or any Gavi-approved amendment to the application.The Gavi retains the right to terminate its support to the Country for the programmes described in its application if a misuse of Gavi funds is confirmed.

ANTICORRUPTIONThe Country confirms that funds provided by the Gavi shall not be offered by the Country to any third person, nor will the Country seek in connection with its application any gift, payment or benefit directly or indirectly that could be construed as an illegal or corrupt practice.

AUDITS AND RECORDSThe Country will conduct annual financial audits, and share these with the Gavi, as requested. The Gavi reserves the right, on its own or through an agent, to perform audits or other financial management assessment to ensure the accountability of funds disbursed to the Country.

The Country will maintain accurate accounting records documenting how Gavi funds are used. The Country will maintain its accounting records in accordance with its government-approved accounting standards for at least three years after the date of last disbursement of Gavi funds. If there is any claims of misuse of funds, Country will maintain such records until the audit findings are final. The Country agrees not to assert any documentary privilege against the Gavi in connection with any audit.

CONFIRMATION OF LEGAL VALIDITYThe Country and the signatories for the Country confirm that its application, and Annual Progress Report, are accurate and correct and form legally binding obligations on the Country, under the Country's law, to perform the programmes described in its application, as amended, if applicable, in the APR.

CONFIRMATION OF COMPLIANCE WITH THE Gavi TRANSPARANCY AND ACCOUNTABILITY POLICYThe Country confirms that it is familiar with the Gavi Transparency and Accountability Policy (TAP) and complies with the requirements therein.

USE OF COMMERCIAL BANK ACCOUNTSThe Country is responsible for undertaking the necessary due diligence on all commercial banks used to manage Gavi cash-based support. The Country confirms that it will take all responsibility for replenishing Gavi cash support lost due to bank insolvency, fraud or any other unforeseen event.

ARBITRATIONAny dispute between the Country and the Gavi arising out of or relating to its application that is not settled amicably within a reasonable period of time, will be submitted to arbitration at the request of either the Gavi or the Country. The arbitration will be conducted in accordance with the then-current UNCITRAL Arbitration Rules. The parties agree to be bound by the arbitration award, as the final adjudication of any such dispute. The place of arbitration will be Geneva, Switzerland

. The languages of the arbitration will be English or French.

For any dispute for which the amount at issue is US$ 100,000 or less, there will be one arbitrator appointed by the Gavi. For any dispute for which the amount at issue is greater than US $100,000 there will be three arbitrators appointed as follows: The Gavi and the Country will each appoint one arbitrator, and the two arbitrators so appointed will jointly appoint a third arbitrator who shall be the chairperson.

The Gavi will not be liable to the country for any claim or loss relating to the programmes described in the application, including without limitation, any financial loss, reliance claims, any harm to property, or personal injury or death. Country is solely responsible for all aspects of managing and implementing the programmes described in its application.

1. Application SpecificationPlease specify for which type of Gavi support you would like to apply to.

Type of Support Vaccine Start Year End Year Preferred second presentation[1]Routine New

Vaccines Support Rotavirus, 2-dose schedule 2017 2017 Rotavirus, 3-dose schedule

[1] Gavi may not be in a position to accommodate all countries first product preferences, and in such cases, Gavi will contact the country and partners to explore alternative options. A country will not be obliged to accept its second or third preference, however Gavi will engage with the country to fully explore a variety of factors (such as implications on introduction timing, cold chain capacity, disease burden, etc.) which may have an implication for the most suitable selection of vaccine. If a country does not indicate a second or third preference, it will be assumed that the country prefers to postpone introduction until the first preference is available. It should be noted that this may delay the introduction in the country.

2. Table of Contents1. Application Specification

2. Table of Contents

3. Executive Summary

4. Signatures4.1. Signatures of the Government and National Coordinating Bodies

4.1.1. Government and the Inter-Agency Coordinating Committee for Immunisation

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4.1.2. National Coordinating Body - Inter-Agency Coordinating Committee for Immunisation4.1.3. Signature Table for the Coordinating Committee for Immunisation

4.2. National Immunization Technical Advisory Group (NITAG)4.2.1. The NITAG

5. Immunisation Programme Data5.1 Background information

5.1.1 Lessons learned5.1.2 Health planning and budgeting5.1.3 Preparatory activities5.1.4 Gender and equity5.1.5 Data quality

5.2. Baseline and Annual Targets (NVS Routine Support)5.3. Targets for Preventive Campaign(s)

6. New and Under-Used Vaccines (NVS Routine)6.1. Assessment of burden of relevant diseases (if available)6.2 Requested vaccine (Rotavirus, 2-dose schedule)

6.2.1 Co-financing information6.2.2 Specifications of vaccinations with new vaccine6.2.3 Portion of supply to be procured by the country (and cost estimate, US$)6.2.4 Portion of supply to be procured by the Gavi (and cost estimate, US$)6.2.5 New and Under-Used Vaccine Introduction Grant6.2.6 Integrated disease control6.2.7 Technical assistance

7. NVS Preventive Campaigns

8. Procurement and Management8.1 Procurement and Management of New and Under-Used Vaccines Routine8.2 Procurement and Management for NVS Preventive Campaign(s)8.3 Product Licensure8.4 Vaccine Management (EVSM/EVM/VMA)8.5 Waste management

9. Additional Comments and Recommendations from the National Coordinating Body (ICC/HSCC)

10. List of documents attached to this proposal

11. AnnexesAnnex 1 - NVS Routine Support

Annex 1.1 Rotavirus, 2-dose scheduleTable Annex 1.1 A Rounded up portion of supply that is procured by the country and estimate of relative costs in US$Table Annex 1.1 B Rounded up portion of supply that is procured by Gavi and estimate of relative costs in US$Table Annex 1.1 C Summary table for vaccine Rotavirus, 2-dose scheduleTable Annex 1.1 D Estimated numbers for Rotavirus, 2-dose schedule, associated injection safety

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material and related co-financing budget (page 1)Annex 2 - NVS Routine – Preferred Second Presentation

Annex 2.1 Rotavirus, 3-dose scheduleTable Annex 2.1 A Rounded up portion of supply that is procured by the country and estimate of relative costs in US$Table Annex 2.1 B Rounded up portion of supply that is procured by Gavi and estimate of relative costs in US$Table Annex 2.1 C Summary table for vaccine Rotavirus, 3-dose scheduleTable Annex 2.1 D Estimated numbers for Rotavirus, 3-dose schedule, associated injection safety material and related co-financing budget (page 1)

Annex 3 - NVS Preventive campaign(s)Annex 4

Table Annex 4A: Commodities CostTable Annex 4B: Freight cost as percentage of valueTable Annex 4C: Intermediate - Minimum country's co-payment per dose of co-financed vaccine.Table Annex 4D: Wastage rates and factorsTable Annex 4E: Vaccine maximum packed volumes

12. Banking Form

3. Executive SummaryPlease provide a summary of your country's proposal, including the following the information:

For each specific request, NVS routine support or NVS campaign : The duration of support The total amount of funds requested Details of the vaccine(s), if applicable, including the reason for the choice of presentation Projected month and year of introduction of the vaccine

Relevant baseline data, including: DTP3 and Measles coverage data (as reported on the WHO/UNICEF Joint Reporting Form) Birth cohort, targets and immunisation coverage by vaccines

Country preparedness Summary of EVM assessment and progress on EVM improvement plan

The nature of stakeholders' participation in developing this proposal Inter-Agency Coordinating Committee Partners, including CSO involvement

BackgroundRotavirus is the leading cause of death due to diarrhoea in children below the age of five years with mortality of more than 453,000 each year. According to Gavi, 12% of children under five years of age die from diarrhea, disproportionately in developing countries. Benefits of rotavirus vaccine have been reported in countries that are already using the vaccine. In Lesotho, diarrhoea is one of the diseases most responsible for childhood hospitalizations, with about 12% of children experiencing diarrhoea in the two weeks before the 2014 Lesotho Demographic and Health Survey, and 51% of those cases sought treatment from a health provider (LDHS, 2014). Meanwhile, in 2013, out of total cases enrolled and investigated at three sentinel

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sites, 55% tested positive for Rotavirus, similarly, in 2014 43% tested positive. These results demonstrate the potential of Lesotho to reduce morbidity and mortality related to Rotavirus substantially by rolling out the Rotavirus vaccine and integrating it into the routine immunization schedule. 

In the sub-region, significant and commendable reduction in the rotavirus related hospitalization in two countries notably Malawi and Republic of South Africa has been reported: 64% and 57% respectively (Lancet, 28 January 2015). The two studies aimed at evaluating effectiveness of Rota vaccine demonstrated a commendable protection by rotavirus vaccine against rotavirus related hospitalizations in both countries. In an attempt to contribute towards global efforts to achieve MDG4, Gavi has been providing support to developing countries since 2000 and as indicated above, the impact of support has been observed in Malawi, being a Gavi supported country.

Baseline dataThe 2015 birth cohort in Lesotho was estimated at 57,242 (Gavi Factsheet). Meanwhile, the targeted population of a Rotavirus vaccine introduction in Lesotho is similar to DPT-HepB+Hib (pentavalent) vaccine, and would be projected to influence a cohort of 54,121 (2015, Gavi Factsheet) surviving infants annually. The current measles coverage is estimated at 90.1% (LDHS, 2014). The expectation of the Rotavirus vaccine introduction into routine immunization would aim to align the schedule at 6 weeks and 10 weeks with DPT1 and DPT2. The official country estimate of DPT3 coverage was 69% in 2014. The target coverage for Rota2 is to be 75% in year 1 and 80% in year 2 after introduction. This coverage figure assumes a full year cohort 

Request for supportThe country will require funds to cover operational costs and vaccine procurement.  It is on this account that Lesotho is mobilizing resources from Gavi in the amount of $100,000 (as per the minimum lump sum to Gavi eligible countries) to support the introduction of rotavirus vaccine into the national routine immunization schedule. This proposal requests co-financing support from Gavi for a five-year period beginning in February 2017 and continuing until January 2022. Lesotho is applying for the Rotavirus liquid 2-dose schedule (ROTARIX) as the first preference and the 3-dose schedule (ROTATEQ) as second preference.  Rotarix is the preferred product due to its more limited impact on cold chain capacity due to smaller volume, its VVM, and its smaller number of doses placing fewer burdens on HCW.

Lesotho has existing successful co-financing relationships that have informed the financing model for the Rotavirus vaccine: Pentavalent vaccine, which was introduced in 2008 with support ending in 2016, and PCV, which Lesotho will be beginning its co-financing of in 2015. Therefore, the plan is to launch the Rotavirus vaccine during the first quarter of 2017 (February). Thus, during 2017 Lesotho will require vaccine for 100% of the annual live births; during 2018 Lesotho will require vaccine for 100% of live births. The Rotavirus vaccine will follow the already existing routine immunization schedule, the same cohort that will receive pentavalent, will also be eligible to receive rotavirus vaccine at the administration of Pentavalent 1 & 2 at 6 and 10 weeks, respectively. The program will follow the existing administrative data, monitoring and evaluation processes outlined in the WHO/UNICEF Joint Reporting Form (JFR).

Country preparednessThe last EVM was conducted in 2014 and the results indicated that the country has enough storage capacity at all levels to accommodate introduction of all planned new vaccines. In addition, according to country EPI cold chain planning, the country has sufficient storage capacity beyond 2020 at central vaccine store and 2017 at district level. However, weaknesses in vaccine management, immunization supply chain and logistics were identified, including lack of current status of cold chain equipment at health facility level. In order to address identified gaps, cold chain inventory was conducted in September 2015 to assess the status of equipment. The information from the cold chain inventory report will be integrated into the cold chain distribution plan and the EVM improvement plan.

Participation of stakeholders in developing this proposalDevelopment of this application has been a joint effort between the Ministry of Health, WHO, UNICEF and Gavi. The team engaged in country consultations and the processes continued and external technical support was sourced from WHO/HQ, IST and UNICEF ESARO for duration of five days whereby supportive supervision was provided to country team to ensure that, a quality country application is produced and submitted to Gavi on the due date.

4. Signatures

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4.1. Signatures of the Government and National Coordinating Bodies4.1.1. Government and the Inter-Agency Coordinating Committee for ImmunisationThe Government of Lesotho would like to expand the existing partnership with the Gavi for the improvement of the infants routine immunisation programme of the country, and specifically hereby requests Gavi support for:

Rotavirus, 2-dose schedule routine introduction

The Government of Lesotho commits itself to developing national immunisation services on a sustainable basis in accordance with the Comprehensive Multi-Year Plan presented with this document. The Government requests that the Gavi and its partners contribute financial and technical assistance to support immunisation of children as outlined in this application.

Table(s) 6.2.4 in the NVS Routine section of this application shows the amount of support in either supply or cash that is required from the Gavi. Table(s) 6.2.3 of this application shows the Government financial commitment for the procurement of this new vaccine (NVS support only).

Following the regulations of the internal budgeting and financing cycles the Government will annually release its portion of the co-financing funds in the month of April.

The payment for the first year of co-financed support will be around April 2017 for Rotavirus, 2-dose schedule.

Please note that this application will not be reviewed or recommended for approval by the Independent Review Committee (IRC) without the signatures of both the Minister of Health and Minister of Finance or their delegated authority. These signatures are attached as DOCUMENT NUMBER : 1 and 2 in Section 10. Attachments.

Minister of Health (or delegated authority) Minister of Finance (or delegated authority)Name Hon. Dr. 'MOLOTSI MONYAMANE Name HON. DR. MAMPHONO KHAKETLA

Date Date

Signature Signature

This report has been compiled by (these persons may be contacted in case the Gavi Secretatiat has queries on this document):

Full name Position Telephone EmailMs. Lineo Mathule UNICEF, EPI Focal Point +266 22315801 lmathule@unicef.org

Ms. Popo Ntjona National EPI Programme Manager +266 58086105 popontjona@yahoo.com

Ms. Selloane Maepe WHO EPI Officer +266 58865757 maepes@who.int

Ms. Thato Mokhehle National EPI Logistics Assistant +266 58014319 tmokhehle30@gmail.com

4.1.2. National Coordinating Body - Inter-Agency Coordinating Committee for Immunisation

Agencies and partners (including development partners and NGOs) supporting immunisation services are co-ordinated and organised through an inter-agency coordinating mechanism (ICC, Health Sector Coordinating Committee (HSCC), or equivalent committee). The ICC, HSCC, or equivalent committee is responsible for coordinating and guiding the use of the GaviGavi NVS routine support and/or campaign support. Please provide information about the ICC, HSCC, or equivalent committee in your country in the table below.

Profile of the ICC, HSCC, or equivalent committee

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Name of the committee Lesotho ICC

Year of constitution of the current committee 1996

Organisational structure (e.g., sub-committee, stand-alone) Stand alone

Frequency of meetings Quarterly and or when there is need

The Terms of Reference or Standard Operating Principles for the ICC, including details on the ICC membership, quorum, dispute resolution process and meeting schedules is attached as DOCUMENT NUMBER : 4.

Major functions and responsibilities of the ICC/HSCC:

Major functions of the ICC include the following:

1. Coordination:The ICC coordinates partners with the aim of fostering strong partnerships, which facilitate planning resources and sharing of technical inputs. This ultimately will lead to effective utilization of available resources.

2. Advocacy:The committee lobbies on behalf of the programme at the higher administrative and political levels in the country and internationally to improve programme performance

3. Resource Mobilization:It is the responsibility of ICC to review and endorse National EPI programme plans, as well as mobilize resources for the programme both locally and internationally.

4. Transparency and accountability:Since ICC is responsible for mobilizing resources for EPI, the committee is obliged to review and monitor use of such funds and other resources together with EPU unit, provides feedback to donors and other relevant stakeholders as need arise.

5. Advisory role:ICC plays an advisory role to the Ministry of Health in matters that affect and pertain to National EPI programme

6.Monitoring and Evaluation:The ICC is further responsible for ensuring periodic programme reviews, monitoring through quarterly meetings and timely sharing of EPI reports with relevant authorities both locally and internationally. The M&E program is intended to ensure operationalisation of technical guidelines for better achievement of programme standard indicators.

7. Social Mobilization:One of the critical tasks of ICC is to support communication on immunizations and vaccines to ensure wider publicity of the programme.

Please describe how partners have provided support in preparation of the proposal:

In-country meetings were held with technical support from WHO and UNICEF to prepare all relevant materials needed to compile this application. This was followed by a five-day workshop organised by WHO and UNICEF and other EPI partners such as Gavi. During this workshop, the country comprehensive Multi-Year Plan was updated to accommodate costing of new vaccines due to be introduced, including the Rotavirus vaccine, which this application addresses. Further support was sought to update cold chain planning tool and national EPI vaccine and logistics forecasting tool to facilitate assessment of future needs of the country in terms of storage capacity for both vaccines and vaccine supplies at national and district stores. Preparation of this proposal was supported by materials made available for reference purposes. In addition, during the workshop, there was close and continuous supportive supervision by facilitators throughout the process. This provided opportunity for revision of the application while in process to ensure that all parameters required have been included in the proposal.  Partners were also able to review the application materials one final time prior to submission to the ICC for approval.  

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The decision to introduce the rotavirus vaccine was originally taken by members of the ICC during its meeting of 30th September 2014 after reviewing diarhoeal disease morbidity and mortality reports in the country.  This specific application resubmission was endorsed again by the ICC on 2nd September 2015.  

4.1.3. Signature Table for the Coordinating Committee for Immunisation

We the members of the ICC, HSCC, or equivalent committee [1] met on the 02/09/2015 to review this proposal. At that meeting we endorsed this proposal on the basis of the supporting documentation which is attached. The minutes of the meeting endorsing this proposal are attached as Document number 5. The signatures endorsing the proposal are attached as Document number 6 (please use the list for signatures in the section below).

Please refer to Annex C of the ‘Gavi HSS and NVS General Guidelines’ for more information on ICCs.

Function Title / Organisation Name

Please sign below to indicate the

attendance at the meeting where the

proposal was endorsed

Please sign below to indicate the

endorsement of the minutes where the

proposal was discussed

Chair Minister of Health Dr. 'MOLOTSI MONYAMANE

Secretary Ministry of Health/ EPI Manager MS. POPO NTJONA

MembersRefer to attachment Signatures endorsing the proposal

attached

By submitting the proposal we confirm that the quorum has been met. Yes

The minutes from the three most recent ICC meetings are attached as DOCUMENT NUMBER : 7.

4.2. National Immunization Technical Advisory Group (NITAG)

Has a NITAG been established in the country ? No

In the absence of a NITAG, countries should clarify the role and functioning of the advisory group and describe plans to establish a NITAG. This document is attached as (Document Number: 10)

5. Immunisation Programme Data5.1 Background information

Please complete the table below, using data from available sources. Please identify the source of the data, and the date. Where possible use the most recent data and attach the source document.

▪  Please refer to the Comprehensive Multi-Year Plan for Immunisation (cMYP) (or equivalent plan) and attach a complete copy (with an Executive Summary) as DOCUMENT NUMBER 11. Please attach the cMYP costing tool as DOCUMENT NUMBER 12.

▪  Please attach relevant Vaccine Introduction Plan(s) as DOCUMENT NUMBER : 14▪  Please refer to the two most recent annual WHO/UNICEF Joint Reporting Forms (JRF) on Vaccine

Preventable Diseases▪  Please refer to Health Sector Strategy documents, budgetary documents, and other reports, surveys etc,

as appropriate.▪  Please refer to the attached risk assessments in the case of yellow fever and meningitis A mass preventive

campaigns.

Please use the most recent data available and specify the source and date.

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Figure Year SourceTotal population 1,888,677 2014 BoS

Birth cohort 54,772 2014 BoS

Infant mortality rate (per 1000) 59 2014 LDHS

Surviving infants[1] 51,540 2014 BoS

GNI per capita (US$) 1,350 % 2014 World Bank/Gavi NVS Guidelines

Total Health Expenditure (THE) as a percentage of GDP

14 % 2014 MoH Annual Joint Review

General government expenditure on health (GGHE) as % of General government expenditure

12 % 2009 world Health Report

[3] Surviving infants = Infants surviving the first 12 months of life

5.1.1 Lessons learnedRoutine New Vaccines Support

If new or under-used vaccines have already been introduced in your country, please give details of the lessons learned from previous introduction(s) specifically for: storage capacity, protection from accidental freezing, staff training, cold chain, logistics, coverage and drop-out rates, wastage rate, etc., and suggest action points or actions taken to address them. Please refer to previous Post Introduction Evaluations (PIE), if applicable. If they are included in the Introduction Plan, please cite the section only.

Lessons Learned Action Points

COLD CHAIN1. Contingency plans not available at all levels to deal with prolonged power outage or unexpected breakdown of cold chain equipment.

While temperature monitoring is done well during working days, this is not the case during weekends and holidays.

Develop country SOPs which will include other aspects of cold chain, vaccine and logistics management both national, district and service delivery point.

Build a repair and maintenance system for the cold chain supplies that addresses power outage challenges and supply breakdowns.

Rollout of Fridgetags and training for all relevant staff on temperature monitoring trends, identifying excursions, and the appropriate response to any excursions.

Temperature charts provided to health facilities.

STAFF CAPACITYInadequate skills to carry out immunization services

Improve training for district and national level staff on EPI using MLM.

Ahead of introduction provide HCW training on vaccines, including Rotavirus Vaccine and Pentavalent, immunization services, schedule, proper supply usage, and filling out vaccination cards.

PLANNINGPlans available at national level but non existent at district and health facility level.

No launch activities were conducted at sub-national level, missing opportunity to mobilze local communities

Creation of an introduction plan at the national level and corresponding district and health center level micro plans.

Inclusion of expanded training programs on Rotavirus vaccine introduction at each district and health center level.

Each district will have a comprehensive introduction micro plan including social mobilization activities, such as radio, etc. and district level trainings to reach health facilities and encourage uptake of the Rotavirus vaccine.

Conducting a pre-introduction assessment of the routine immunization program landscape. Within 6-12 months of introduction, a post introduction assessment will be conducted to identify any bottlenecks or challenges with the Rotavirus vaccine introduction.

COVERAGE, DROP OUT RATE and WASTAGE MONITORINGThere is general lack of knowledge on target populations, coverage, wastage, and dropout rates at the facility level. Coverage data is tracked but is not used for action

EPI tools, policy updated, printed and distributed to districts and health facilities. This includes: EPI monitoring charts, vaccine log books, and vaccine wastage monitoring forms.

Target population targets are provided to all health facilities and head

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count of under five children is encouraged.

Ensure that there has been adequate training on data collecting, recording, and use throughout the pre-introduction phase, as well as including a post introduction assessment of data quality.

WASTE MANAGEMENT AND INJECTION SAFETYNon-adherence to waste management guidelines in some health facilities.

Unavailability of transport hindered timely collection of filled safety boxes in some health facilities and some districts experienced fuel shortages, thereby disrupting burning of waste.

Incorporated waste management and guidelines in the district microplan. Ensure availability of waste disposal material and equipment.

Plan and guidelines on waste management that is made easily available and in use at all points of the immunization service delivery.

Ensuring that there has been adequate training on waste management and injection safety at all health facilities

Purchase of additional vehicles to support timely collection of filled safety boxes from HF.

AEFI MONITORINGNo written guidelines for monitoring and reporting on AEFI are available at all levels including national level. Reporting forms not available in most health facilities with some health workers reporting that AEFIs are only mentioned during preparations of campaigns.

IDRS guidelines adapted and AEFI reporting formed part of the package. However, efforts are in place to have AEFI surveillance system established in the country.

5.1.2 Health planning and budgeting

Please provide information on the planning and budgeting cycle in your country

The Government of Lesotho (GoL) budget cycle runs from April to March of the following year. Relevant planning document is health sector policy framework which derives directly from broad government objectives outlined in the country Vision 2020 Document, 2012-2017 National Health sector Policy and the 2012-2017 National Health strtategic Plan (NHSP).

Please indicate the name and date of the relevant planning document for health

National Health Sector Policy 2012-2017

Is the cMYP (or updated Multi-Year Plan) aligned with the proposal document (timing, content, etc.)

he cMYP has been updated and is aligned with national health goals as outlined in the National Health Strategic Plan (NHSP) and expands on the immunizations as indicated in the maternal and child health cluster of the NHSP in terms of timing and content. Overall, the cMYP articulates the immunization goals to be achieved in order to effectively contribute to the attainment of national global and goals, in particular, MDG4 for child survival.

Please indicate the national planning budgeting cycle for health

1st April to 31st March the following year

Please indicate the national planning cycle for immunisation

1st April to 31st March the following year

5.1.3 Preparatory activities

Please provide an outline of all preparatory activities for vaccine(s) introduction or campaigns. If they are included in detail the Introduction Plan and/or Plan of Action, please cite the sections only.

A detailed introduction plan with timelines is included in the Introduction Plan, Section 7. In summary, the plan

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includes: 

Planning, coordination and resource mobilization

· ·    Present rotavirus vaccine application to ICC for review and approval· ·    Brief MoH heads of units and other stakeholders on the new vaccine planned to be introduced· ·    Share and update members of the EPI technical working group (TWG) on the progress of new

vaccine application· ·    Secure funding from Government, Gavi and other partners· ·    Draw rotavirus introduction timelines· ·    Set up of a NVI task force, which will meet every week, charged with tracking the NVI plan and

regularly refining activities as needed, as well as securing a plan for funding non-Gavi funded NVI activities 

Cold Chain

· ·    Update cold chain inventory and create repair and replacement plan· ·    Maintenance and replacement of equipment where indicated· ·    Conduct training cold chain technicians and other health workers on cold chain 

Vaccines and Logistics

· ·    Procure rotavirus vaccine/place an order through UNICEF· ·    Vaccine available in the country at least three months prior to introduction· ·    Vaccine distributed to districts and health facilities· ·    Vaccine available in the districts and health facilities before the launch

Training

· ·    Develop training plan for introducing rotavirus vaccine· ·    Develop/adapt training materials and guidelines, including refresher components on EPI basics· ·    Orient other programme officers/heads of department on the new vaccine· ·    Conduct Training of Trainers (ToT) at national level· ·    Conduct cascade training for districts -  health center workers/development of microplans

Programme Management

· ·    Conduct supportive supervision: national to districts and districts to health facilities before the launch to assess level of preparedness and address any emerging gaps

· ·    Printing of updated data tools and training on data quality and new tools for HCWs· ·    Early post launch assessment· ·    Post Introduction Evaluation

Advocacy, communication and social mobilization

· ·    Develop a plan to implement communication and social mobilization activities· Train Village Health Workers on rota vaccine· Train Health Center Committees on rota vaccine· Train district-level leaders on rota vaccine

Injection and Immunization safety

· ·    Establish AEFI surveillance system: 

5.1.4 Gender and equity

Please describe any barriers to access, utilisation and delivery of immunisation services at district level (or equivalent) that are related to geographic, socio-economic and/or gender equity. Please describe actions taken to mitigate these barriers and highlight where these issues are addressed in the vaccine introduction plan(s).

In Lesotho, all children are eligible to receive free immunization services regardless of geographic location, socio-economic status or gender. The 2014 LDHS estimates that the vaccine coverage rate for all basic vaccinations is equal for males and females at 68.3%. Similarly, vaccination rates are not significantly higher

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in urban areas than in rural areas at 70.1% and 67.6% respectively (2014 LDHS). There is some range in the vaccination rates of infants according to wealth with those in the middle quintile receiving the highest rate of vaccine coverage at 81.5% and those in the bottom quintile receiving the lowest at 59.7%, surprisingly those in the highest quintile have nearly the mean vaccination coverage at 68.4% (2014 LDHS). As a marker of geographic equity, only two of ten districts have a DTP3 coverage rate below 80%. However, given the potential for topography as a barrier to vaccination access Lesotho, MoH has put in place a number of measures to ensure that services are provided to the community. These include the Lesotho Flying Doctor Service, which provides support to remote facilities, and HSS funds that are being utilized to address support systems for areas that may be at risk of becoming bottlenecks to vaccine delivery services, such as transport and funds to support health worker facilitation of community outreach. 

Discuss how equity issues (geographic, socio-economic and/or gender) are being taken into account in the design of social mobilisation and other strategies to increase immunisation coverage. Highlight where these issues are addressed in the vaccine introduction plan(s).

All children are eligible to receive immunizations irrespective of geographic location. However, the terrain of the country becomes a barrier to provision of immunization services, especially during rainy seasons when rivers are in flood and during winter whereby snowfalls are experienced. In that regard, existing community structures such as village health workers, local chiefs, community counsels, church leaders and other community workers have been instrumental in supporting social mobilization activities. Availability of communication networks plays an important role. This becomes more visible during implementation of supplementary immunization activities. Therefore, with introduction of rotavirus, the plan is to develop health facility and district microplans to ensure that hard -to-reach communities are mapped in terms of number of children residing there, which will facilitate the assessment of appropriate resources and strategies to be employed to reach them on quarterly basis. 

Please indicate if sex disaggregated data is collected and used in immunisation routine reporting systems.

In Lesotho, sex-disaggregated vaccination data is routinely collected and reported into the DHIS2 HMIS system.  Gender-disaggregated data is also collected during the 5-yearly DHS. There are no documented gender barriers to immunization and the basic vaccination coverage rate is equal for boys at girls at 68.3% (2014 LDHS). Moreover, country EPI policy clearly states that immunization services should be offered to all eligible children regardless of gender. Similarly, health education sessions held during ANC visits emphasize the importance of providing immunizations to all children. Furthermore, any other communication and social mobilization activities and messages are delivered in such a way that parents of boy and girl children get equal opportunities to receive immunization services. Similarly, gender of health care providers does not affect delivery of immunization services.

Is the country currently in a situation of fragility (e.g. insecurity, conflict, post-conflict, refugees/and or displaced persons and recent, current or potential environmental disaster, such as flooding, earthquake or drought or others)? If Yes, please describe how these issues may impact your immunisation programme, planning for introduction of routine vaccines or campaigns and financing of these activities.

Lesotho is not in a situation of instability.  

If available, please provide additional information and documents on subnational coverage data, e.g. comparing urban/rural districts or districts with highest/lowest coverage, etc.

The LDHS 2014 provided an opportunity for validation of routine immunization administrative data. Coverage for individual antigens is estimated to be high, with 80% districts achieving DTP3 coverage above 80% and 20% districts achieving between 60 and 80% (LDHS 2014). Coverage ranges cannot be explained by difference in urban and rural services as vaccination rates are not significantly higher in urban areas than in rural areas at 70.1% and 67.6% respectively (2014 LDHS). While there is some disparity in vaccination coverage among Lesotho’s 10 districts (ranging from 47.5% to 79.5%), overall the immunization coverage of children across different demographic factors still shows limited correlation either gender, topographical or wealth disparities.

In Lesotho, national household surveys that are routinely carried out are the EPI cluster survey, last conducted in 2013, which included the post measles SIA evaluation, as well as the Lesotho Demographic and Health Survey last conducted in 2014. The EPI cluster survey did not assess immunizations based on gender,

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instead it considered in terms of difficult terrain. The 2014 LDHS, on the other hand, assessed gender related provision of vaccinations and reported same coverage for basic vaccination (68.3%) for both males and females, which indicates that all children in Lesotho have equal opportunities to immunizations. In relation to equity, two household surveys showed higher coverage in the urban than rural areas mainly due to ease of access to services in urban than rural. Activities to assess equity related barriers are not included this application as the Rotavirus vaccine will be integrated into the routine country household surveys nor has there historically been concerns around gender equity barriers.

Please describe what national surveys take place routinely in country to assess gender and equity related barriers. Highlight whether this application includes any activities to assess gender and equity related barriers.

In Lesotho, national household surveys  that are routinely carried out are EPI cluster survey and the last exercise was conducted in 2013 included in the post measles SIA  evaluation and the other survey is Lesotho demographic and health survey which was conducted in 2014.. Cluster survey did not  assess immunizations based on gender but equity in terms of  difficult terrain was assessed. The 2014 LDHS, on the other hand assessed gender related around provision of vaccinations and reported same coverage (68.3%) for both males and females which indicates that all children in Lesotho have equal opportunities to immunizations. In relation to equity, the two household surveys showed high coverage in the urban than rural areas mainly due to ease of access to services in urban than rural. Activities to assess and equity related barrier are not included in the application as rotavirus vaccine will form part of routine country  household surveys. 

5.1.5 Data quality

Please attach a data quality assessment (DQA), report if one has been completed within the previous 48 months (DOCUMENT NUMBER: 13). If available, an improvement plan and progress report on the implementation of the improvement plan should also be submitted (DOCUMENT NUMBER: 16, DOCUMENT NUMBER: 17).If DQA not available, please briefly describe plans to establish mechanisms for data quality assessment.

Data quality has been documented as a challenge in Lesotho on several occasions: Gavi DQA of 2008, Data Quality Self -assessment of 2012, EPI cluster survey conducted in 2013 and comprehensive EPI review of 2014. Therefore the country is planning to embark on the following priorities to address data quality issues:

· ·    Develop and implement data quality improvement plan· ·    Reinforce use of village health registers to complement the use of under five clinic registers· ·    Strengthen defaulter tracking efforts· ·    Encourage head count of all children under the age of five to determine target population for health

centers· ·    Revitalize the use of District Vaccination Data Management Tool (DVDMT)· ·    Ensure that there has been adequate training on data collecting, recording, and use throughout the

pre-introduction phase, as well as including a post introduction assessment of data qualityPlease indicate what routine mechanisms to independently assess the quality of administrative data are in place, and if so what these mechanisms are and how they enable the country to track changes in data quality over time.

There are two routine household surveys that are used as mechanisms to independently assess the quality of administrative data: the EPI cluster survey, last in 2013, and the 2014 LDHS. Results from these surveys inform and guide the M&E unit of the Ministry of Health, as well as the programme, to put in place efforts to improve the quality of admin data. The Annual Joint Review process includes data validation through visits to a sample of facilities to review routine data, including immunization data.  At the facility level, health center committees assist with head counts for catchment population verification.   

Please detail what household surveys have been conducted in recent years to independently assess immunisation coverage and equity, and describe any survey plans for the coming five year period.

The demographic and health survey (DHS) conducted in 2014 provided opportunity for routine administrative data to be validated. The country conducted an EPI cluster survey at end 2014 and hopes to conduct EPI cluster survey as a component of post campaign evaluation following the planned routine integrated measles

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SIAs in 2016.  The next DHS will take place in 2019.

5.2. Baseline and Annual Targets (NVS Routine Support)

Please refer to cMYP pages to assist in filling-in this section.

NumberBase Year Baseline and

Targets

2014 2017

Total births 54,772 54,903

Total infants’ deaths 3,232 3,239

Total surviving infants 51,540 51,664

Total pregnant women 54,722 54,903

Target population vaccinated with OPV3[1]

OPV3 coverage[2] 67 % 80 %

Target population vaccinated with DTP1[1] 38,172 42,571

Target population vaccinated with DTP3[1] 37,060 41,331

DTP3 coverage[2] 72 % 80 %

Wastage[3] rate in base-year and planned thereafter (%) for DTP 5 5

Wastage[3] factor in base-year and planned thereafter for DTP 1.05 1.05

Target population vaccinated with 1st dose of Rotavirus 0 39,910

Target population vaccinated with the last dose of Rotavirus 0 38,748

Rotavirus coverage[2] 0 % 75 %

First Presentation: Rotavirus, 2-dose schedule

Wastage[3] rate in base-year and planned thereafter (%) 0 5

Wastage[3] factor in base-year and planned thereafter (%) 1.00 1.05

Maximum wastage rate value for Rotavirus, 2-dose schedule 5 % 5 %

Second Presentation: Rotavirus, 3-dose schedule

Wastage[3] rate in base-year and planned thereafter (%) 5 5

Wastage[3] factor in base-year and planned thereafter (%) 1.05 1.05

Maximum wastage rate value for Rotavirus, 3-dose schedule 5 % 5 %

Target population vaccinated with 1st dose of Measles 30,611 40,685

Measles coverage[2] 59 % 79 %

Annual DTP Drop out rate [ ( DTP1 – DTP3 ) / DTP1 ] x 100 3 % 3 %

[1] Indicate total number of children vaccinated with either DTP alone or combined[2] Number of infants vaccinated out of total surviving infants

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[3] The formula to calculate a vaccine wastage rate (in percentage): [ ( A - B ) / A ] x 100. Whereby: A = the number of doses distributed for use according to the supply records with correction for stock balance at the end of the supply period; B = the number of vaccinations with the same vaccine in the same period.

[1] Indicate total number of children vaccinated with either DTP alone or combined[2] Number of infants vaccinated out of total surviving infants[3] The formula to calculate a vaccine wastage rate (in percentage): [ ( A - B ) / A ] x 100. Whereby: A = the number of doses distributed for use according to the supply records with correction for stock balance at the end of the supply period; B = the number of vaccinations with the same vaccine in the same period.

5.3. Targets for Preventive Campaign(s)

No NVS Prevention Campaign Support this year

6. New and Under-Used Vaccines (NVS Routine)

6.1. Assessment of burden of relevant diseases (if available)

If already included in detail in the Introduction Plan or Plan of Action, please cite the section only.

Disease Title of the assessment Date ResultsRotavirus Rotavirus sentinel surveillance 2013 to 2015 Lesotho established rotavirus sentinel

surveillance in 2013 at one site. In 2014, two more sites were added for a total of 3 sentinel surveillance sites for Rotavirus. Prior to assessment of the disease burden through sentinel surveillance, data on morbidity due to diarrhoeal diseases was collected through routine morbidity system. The routine 2012/2013 annual joint review (AJR) showed that among hospitalization related childhood diseases, diarrhoea accounted for 9% (2012/2014 AJR). On the other hand, the 2014 LDHS report depicted that diarrhoea is the second most common disease for which treatment from health facility or provider is sought; 63% of children treated for acute respiratory infections (ARI) and 51% treated for diarrhoea. In addition, sentinel surveillance reports indicate that, during the first year (2013) of enrollment of rotavirus cases, 55% of cases tested positive for rotavirus, and in 2014, 43% tested positive for the disease. While global data on burden of rotavirus diarrhoea is available as a reference, the results from the sentinel surveillance demonstrates functionality of the system and availability of Rotavirus burden data to inform decision on the introduction of rotavirus vaccine into routine immunization schedule for Lesotho. Thus, this is an indication that, rotavirus surveillance will allow greater understand of the effectiveness of the vaccine

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against Rotavirus-related hospitalization.

6.2. Requested vaccine (Rotavirus, 2-dose schedule)As reported in the cMYP, the country plans to introduce Rotavirus, using Rotavirus, 2-dose schedule.When is the country planning to introduce this vaccine? February 2017Please note that, due to a variety of factors, the launch date may vary compared to the date stipulated in the application. Gavi will work closely with countries and their partners to address these issues.

6.2.1. Co-financing informationIf you would like to co-finance an amount higher than the minimum, please provide information in Your co-financing row.

Country group Intermediate

Year 12017

Minimum co-financing 0.20

Your co-financing (please change if higher) 0.26

6.2.2. Specifications of vaccinations with new vaccine

Data fromYear 12017

Number of children to be vaccinated with the first dose Table 5.2 # 39,910

Number of children to be vaccinated with the second dose Table 5.2 # 38,748

Immunisation coverage with the second dose Table 5.2 # 75 %

Country co-financing per dose Table 6.2.1 $ 0.26

6.2.3. Portion of supply to be procured by the country (and cost estimate, US$)

2017Number of vaccine doses # 12,100

Number of AD syringes # 0

Number of re-constitution syringes # 0

Number of safety boxes # 0

Total value to be co-financed by the Country [1] $ 27,500

[1] The co-financing amount for intermediate and graduating countries indicates costs for the vaccines, related injection safety devices and any freight charges. The total co-financing amount does not contain the costs and fees of the relevant Procurement Agency, such as contingency buffer and handling fees. Information on these extra costs and fees will be provided by the relevant Procurement Agency as part of the cost estimate to be requested by the Country.

6.2.4. Portion of supply to be procured by the Gavi (and cost estimate, US$)

2017

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Number of vaccine doses # 93,000

Number of AD syringes # 0

Number of re-constitution syringes # 0

Number of safety boxes # 0

Total value to be co-financed by Gavi $ 210,000

6.2.5. New and Under-Used Vaccine Introduction Grant

Calculation of Vaccine Introduction Grant for the Rotavirus, 2-dose schedule

Year of New Vaccine Introduction Births (from Table 5.2) Share per Birth in US$ Total in US$

2017 54,903 0.80 100,000

The Grant will be based on a maximum award of $0.80 per infant in the birth cohort with a minimum starting grant award of $100,000

Please describe how the Gavi Vaccine Introduction Grant will be used to facilitate the timely and effective implementation of critical activities in advance of and during the introduction of the new vaccine (refer to the cMYP and the Vaccine Introduction Plan).

Gavi vaccine introduction grant will be used to support the following activities:•    Training of health workers and health promotion officers. This will include adaptation of WHO rotavirus materials and printing of the field guide and other materials.  Training will then be conducted through cascaded trainings, starting with 36 national-level Training of Trainers, who will be Public Health Nurses drawn two from each of 18 district hospital health areas.  These TOTs will then be responsible for training an average of 3 health workers from each facility in their catchment area, with more from large facilities, and fewer from smaller facilities.  Government of Lesotho will cover part of the training costs, and the transportation costs of health workers for central training, There will also be one centralized training for health promotion officers, also funded by Government funds.  Therefore, the VIG funding will cover printing of materials, and some of the costs of delivering facility-based trainings.  •    Social mobilization, IEC, and advocacy.  Vaccine introduction grant will support the costs of developing, pretesting, and printing IEC materials including posters and banners.  These materials will then be used in trainings of Village Health Workers, Health Center Committees, and sensitization meetings with district leaders in each of the 10 administrative districts.  There will be one central-level launch and 9 small-scale district launches.   All of the social mobilization costs will be paid for with Gavi VIG funds.  

Additional costs will be covered by government and by partners, as follows:  

•    Programme Management costs including supportive supervision will be covered by the Government of Lesotho, and surveillance costs will be covered by WHO.  •    Distribution costs for the vaccine will be covered by the routine MOH budget, as the vaccine will be distributed together with the routine allocations to districts and to facilities.  •    WHO will cover the cost of a Post-Introduction Evaluation.

A detailed budget is attached and included in the Introduction Plan.  

Please complete the ‘Detailed budget for VIG / Operational costs’ template provided by Gavi and attach as a mandatory document in the Attachment section.

Detailed budget attached as Document No. 28.

Where Gavi support is not enough to cover the full needs, please describe other sources of funding and the expected amounts to be contributed, if available, to cover your full needs.

In the event that GAVI VIG funds are not sufficient to cover planned costs, resources will be mobilized from the government and in country health development partners including WHO, UNICEF, and CHAI to meet full operational needs.

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6.2.6.Integrated disease controla) Has the country introduced Pneumococcal vaccine? Please describe other existing interventions for prevention and treatment of pneumonia and diarrhoea, and the status of implementation.

Lesotho’s Child Survival Strategy defines an integrated framework for addressing pneumonia, diarrhea, and other threats to child survival in Lesotho.  Vaccines are a critical part of this strategy.  Pneumococcal vaccine was introduced in July 2015, and this application seeks support to introduce rotavirus vaccine in 2017.   Additionally, there are there existing interventions in the country to respond to pneumonia and diarrhea, including the nutrition programme, PMTCT, disease surveillance and response, and Integrated Management of Childhood Illnesses.  All of these are coordinated through the Family Health Division of the Ministry of Health and are currently enacted in both policy and practice.  Some of the named approaches, however, require strengthening. Below is the description of the programs for prevention and treatment of pneumonia and diarrhoea, as well as their implementation status.

1. PROTECTION

NutritionThe Government of Lesotho’s Nutrition programme is guided by the Nutrition Strategy.  Nutrition and breastfeeding are an integral part of child survival interventions in Lesotho, as well as a top priority of the country and the nutrition unit. These activities are promoted through the engagement, involvement and commitment of Her Majesty Queen who is a Breastfeeding Champion, and his Majesty the King who is the African Union Nutrition Champion. Furthermore, administration of vitamin A as part of measles case management and deworming interventions are provided alongside immunizations, during both routine and integrated supplementary immunization activities.  Lesotho supports a school feeding program for older children.  Lesotho also recently implemented a survey in order to determine the distribution of schistosomiasis and Soil-transmitted helminthiasis among the general population living in Lesotho and implement deworming strategies for the national control and elimination of these NTDs. The final report of the mapping exercise will be completed during the 2015/16 financial year.    

Status of ImplementationExclusive breast feeding is encouraged from birth until the child reaches six months of age and supplementary feeding can be introduced thereafter. Currently, 67% of children under the age of 6 months are exclusively breastfed (LDHS 2014) against a global target of 50%.  Vitamin A and deworming tablets are administered to all eligible children starting from six months until the age of 59 months. These interventions are provided during both routine and supplementary immunization activities.

2. PREVENTION

ImmunizationsIt is known that pneumonia is one of the complications of measles, therefore, measles first and second doses are provided routinely to all children at the age of 9 months and 18 months, respectively, as well as during supplementary activities. Pertussis and Hib vaccines, in a combination form (DTP-HepB-Hib), are also part of routine immunization Schedule. Therefore, the newly introduced Rota vaccine will become part of the country immunization schedule.  

Status of implementation

Immunizations with measles vaccine, and pertussis and Hib continue to be provided routinely in all health facilities offering immunization services in the country. Integrated measles SIAs are conducted every three years.  While the EPI Policy states that immunizations should be provided on daily basis, the 2013 comprehensive EPI review revealed that in some health facilities, vaccinations are provided on a scheduled basis. In order to address that gap, staffing level at health facility level has been increased to improve the provision of primary health care services, especially immunizations. In addition, the country received funds from Gavi in support of health systems and another expectation from this support is implementation of outreach services to hard to reach communities which are not able to access services on routine basis.

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Prevention of transmission from mother to child (PMTCT) The PMTCT programme was established in 2013 in Lesotho and has been implemented in all ten districts of the country, with the initiative rolled out to all 216 facilities.  

Status of implementation

PMTCT services are currently ongoing with the support and participation of existing community structures including health center committees in 40% of districts. Facility-based PMTCT services have coverage reaching 93% in Q1 2015 (MOH, 2015).   

Integrated Disease Surveillance and Response

Diarrhoea and pneumonia are among the list of national priority diseases. Data on these diseases is shared through monthly reports from all health facilities in the country with relevant administrative levels and stakeholders including UNICEF and WHO and appropriate interventions are mounted where needed. Lesotho is among the countries that are participating in PBM and Rota sentinel surveillance in Africa. PBM surveillance was established in 2010 and Rota in 2013 with the purpose of assessing burden of diseases to provide data for both diseases to guide decisions to introduce new vaccines as well assessing impact of vaccines post introduction. 

Status of implementation

Monthly data reports continue to flow from participating sites to be shared with relevant stakeholders including WHO and UNICEF. In addition, regular PBM and Rotavirus surveillance review meetings are convened on quarterly basis where data from the sites is shared and identified gaps addressed including harmonization of data from participating sites with the central PBM and Rotavirus databases. PBM and rotavirus sentinel surveillance activities are technically and financially supported by WHO including procurement of laboratory reagents. Regarding surveillance performance: in 2013 when Rotavirus sentinel surveillance was established, 55% of all cases enrolled for investigation, tested positive and 43% in 2014 also tested positive for rotavirus. The country is therefore able to evaluate impact of Hib vaccine, PCV and rotavirus vaccines on the hospital related Rotavirus diarrhoea and other mentioned childhood illnesses.

3. TREATMENT

Integrated management of childhood illnesses (IMCI)IMCI guidelines are available in the country and have recently undergone revision. These are made available at the health facilities for ease of reference in the management of childhood diseases including diarrhoea and pneumonia. Health workers have been trained and stock levels of essential drugs used for management of childhood illnesses are maintained at desired levels. Case management for diarrhoea includes administration of zinc and ORS. At community level, under the guidance of trained village health workers, mothers are encouraged to prepare homemade salt sugar solution to administer to children having diarrhoea and severe cases are referred to the nearest health facility for further management. Children presenting with diarrhoea are managed in all health facilities including hospitals using ORS, zinc, vitamin A, antibiotics and /or oxygen.

Status of implementation

All cases presenting with diarrhoea are managed at the community level by trained village health workers. Cases that cannot be managed at that level are referred to the nearest health facility.

b) Please describe, based on a review of current policies, where there may be a gap in policies that might affect supply and delivery of low-osmolarity ORS, zinc, and antibiotics to facilities and/or Community Health Workers.

Refer to child survival strategy

c) Please describe any considerations of how Rotavirus vaccination could be used to strengthen joint delivery of services and communication about healthy actions like exclusive breastfeeding and hand washing with soap, and improve water and sanitation, and guidance around care-seeking behaviours.

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Rotavirus vaccination cannot be a standalone intervention, but could be used to strengthen delivery of joint services and communication about health actions like exclusive breastfeeding, hand washing with soap, improved water and sanitation, and guidance around care seeking behaviors. Lesotho is currently undertaking community led total sanitation (CLTS), the main objective of which is to eliminate open defaecation (ODF) in communities. CLTS achieves elimination of ODF by triggering communities to realize the dangers of open defaecation using a participatory community approach that enforces disgust of open defaecation. In these triggered villages, communities construct basic sanitation latrines, which appear at the lowest level of the sanitation ladder. Therefore, the project aims to interrupt the oral-faecal route of infection transmission and thereby reduce diarrhoeal diseases. In addition, promotion of exclusive breastfeeding also reduces early introduction of complementary foods, which is another possible cause of diarrhoeal diseases. Hand washing initiatives always accompany all community-based initiatives to reduce faecal oral contamination. All is achieved through communication on health actions. This project presents an opportunity for integrating rotavirus vaccinations with WASH interventions. The programme is joint effort with local NGOs on construction o of latrines and promotion of WASH practices in the communities and schools.

d) What are the potential barriers to integration of activities?.(Consider for example the following components: policy development, management and coordination, supply and data management, service delivery, financing, health worker training, communication and social mobilisation, monitoring and evaluation).

Potential barriers to integration of activities pertain to communication, social mobilization and monitoring behavior change. These challenges will be mitigated by combining the proposed activities during social mobilization and communication plans.  The MOH has developed a draft social mobilization and communication plan for immunization – this plan will be broadened to include the other interventions related to diarrhea.  This integrated plan will be implemented by the same sub-national structures.  Districts will be responsible for developing their own subnational plans, based on the integrated strategy.   Advocacy and inclusion of CLTS in the rural water and sanitation policy may also present a challenge.  CLTS is currently being piloted by the Ministry of Water in one district, in order to provide evidence for policy makers about the importance of the strategy, and potentially to include this approach in national policy.  

e) Has the country developed a roadmap or strategy for strengthening a comprehensive approach to pneumonia and/or diarrhoea prevention and treatment? YesIf Yes, please attach and refer to section 10. Attachments (Document N°24).

If No, please indicate potential area(s) of support required to develop and implement such a plan in the “Technical assistance” section below.

6.2.7.Technical assistancePlease describe any particular area(s) the Ministry would require technical assistance to support the introduction of Rotavirus. Please consider the support in the context of developing and implementing an integrated approach to disease prevention and control.

Although effective interventions have been established in the country, they are not always pooled together to achieve maximum benefit. In order to close the gap, the Ministry requires technical support to develop an integrated approach to prevention, treatment and control of pneumonia and diarrhoea. This approach will pull together all critical services and interventions to create healthy environments, promote practices known to protect children from diseases and ensure that every child has access to proper and appropriate preventive and treatment measures.  The MOH may also require technical assistance with post introduction evaluation of the Rotavirus vaccine introduction. 

7. NVS Preventive CampaignsNo NVS Prevention Campaign Support this year

8. Procurement and Management

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8.1 Procurement and Management of New and Under-Used Vaccines Routine

Note: The PCV vaccine must be procured through UNICEF to be able to access the price awarded by the Advance Market Commitment (AMC).

a) Please show how the support will operate and be managed including procurement of vaccines (Gavi expects that most countries will procure vaccine and injection supplies through UNICEF or PAHO’s Revolving Fund):

Lesotho procures all vaccines; traditional, new and under-used through UNICEF supply division. Therefore a similar arrangement will be followed for the Rotavirus vaccine.

b) If an alternative mechanism for procurement and delivery of vaccine supply (financed by the country or the Gavi) is requested, please document

A description of the mechanism and the vaccines or commodities to be procured by the country Assurance that vaccines will be procured from the WHO list of pre-qualified vaccines, indicating the

specific vaccine from the list of pre-qualification. For the procurement of locally-produced vaccines directly from a manufacturer which may not have been prequalified by WHO, assurance should also be provided that the vaccines purchased comply with WHO’s definition of quality vaccines, for which there are no unresolved quality problems reported to WHO, and for which compliance is assured by a fully functional National Regulatory Authority (NRA), as assessed by WHO in the countries where they are manufactured and where they are purchased.

There is no alternative mechanism for procurement and delivery of routine vaccines used in the country. All vaccines are procured through UNICEF. Though a national drug regulatory authority does not exist in the country, there is the Pharmaceuticals Department in the Ministry of Health that is responsible for regulation and registration of medicinal products in the country.  

c) If receiving direct financial support from Gavi (such as operational support for campaigns or VIG activities), please indicate how the funds should be transferred by Gavi.

Funds for VIG activities should be directly transferred to the country following Government financial procedures and arrangements that are already in place.

d) Please indicate how the co-financing amounts will be paid (and who is responsible for this)

The Government of Lesotho will co-finance the vaccine with Gavi and funding will be sourced from the Ministry of Health recurrent budget for the fiscal year. Funds will be transferred to UNICEF as per arrangement and memorandum of understanding between UNICEF and MoH to this effect.  ICC is agreeable to this arrangement and funds equivalent to co-financing requirements will be deposited to UNICEF by Chief Accounting Officer of the Ministry Health.

e) Please describe the financial management procedures that will be applied for the management of the NVS direct financial support, including procurement.

A new vaccine breakdown budget will be developed to cost all pre-introduction activities to be undertaken. Overall management of NVS cash will be the responsibility of MoH. The funds will be directed to Central Bank of Lesotho where a foreign currency denominated account (FCDA) already exists to receive funds from Gavi. These funds will further be transferred to MoH to be managed through MoH Project Accounting Unit (PAU).

f) Please outline how coverage of the introduced vaccine will be monitored, reported and evaluated (refer to cMYP and Introduction Plan)

Data on the Rotavirus vaccine will form part of routine immunization monitoring and will be subjected to similar data management processes already in place for other vaccines provided in the country. At the service delivery point, Rotavirus vaccine data will be captured using the already in use data recording tools analysed and interpreted to facilitate planning for future sessions tracking of defaulters. From health center, this goes several levels such as district and national up to a point where it is shared with EPI partners, both in country and outside. On quarterly basis, during ICC, Rotavirus vaccine will be among the antigens whose data and

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coverage will be shared with members of the coordinating committee. It is worth mentioning that Rotavirus vaccine data will undergo periodic validation processes that are undertaken through implementation of household surveys. Like other new and introduced vaccines, post introduction evaluation will be carried out within one year of introduction as per WHO guidelines on new vaccine introductions.

g) If applying for measles second dose, does the country wish to have the support in cash or in-kind? N/A

8.2 Procurement and Management for NVS Preventive Campaign(s)No NVS Prevention Campaign Support this year

8.3 Product LicensureFor each of the vaccine(s) requested, please state whether manufacturer registration and/or national vaccine licensure will be needed in addition to WHO prequalification and, if so, describe the procedure and its duration. In addition, state whether the country accepts the Expedited Procedure for national registration of WHO-prequalified vaccines.

Note that the necessary time for licensure should be factored into the introduction timeline and reflected in the Vaccine Introduction Plan or Plan of Action.

At present, there is no drug regulatory authority in Lesotho, however the Pharmaceuticals Directorate in the Ministry of Health oversees introduction of new products and product selection.  Therefore the government relies on WHO prequalification status for new vaccines. Vaccines that are WHO prequalified and imported through UNICEF SD can be used in the population, but since the product has not been previously registered, a waiver will be required for each shipment.  There is no challenge anticipated in obtaining this waiver.  

For each of the vaccine(s) requested, please provide the actual licensure status of the preferred presentation and of any alternative presentations, if required.

WHO prequalified only

Please describe local customs regulations, requirements for pre-delivery inspection, special documentation requirements that may potentially cause delays in receiving the vaccine. If such delays are anticipated, explain what steps are planned to handle these.

Lesotho does not encounter delays related to customs, inspection, or documentation. 

Please provide information on NRA in the country, including status (e.g. whether it is WHO-certified). Please include points of contact with phone numbers and e-mail addresses. UNICEF will support the process by communicating licensing requirements to the vaccine manufacturers where relevant.

There is currently no drug regulatory authority in Lesotho.  However, the Ministry of Health is in the process of forming such an authority.  

8.4 Vaccine Management (EVSM/EVM/VMA)It is mandatory for countries to conduct an Effective Vaccine Management (EVM) assessment prior to an application for introduction of new vaccine. This EVM should have been conducted within the preceding 36 months.

When was the EVM conducted? December 2014

Please attach the most recent EVM assessment report (DOCUMENT NUMBER : 25,26,27), the corresponding EVM improvement plan (DOCUMENT NUMBER : 26) and progress on the EVM improvement plan (DOCUMENT NUMBER : 27). The improvement plan should include a timeline, budget of committed resources for these activities and funding gaps, if any, as well as M&E indicators to monitor progress of implementation.

If any of the above mandatory documents (EVM Assessment Report, EVM Improvement Plan, Progress on the EVM Improvement Plan) are not available, please provide justification and reference to additional

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documents such as PIE and External EPI Reviews.

When is the next Effective Vaccine Management (EVM) Assessment planned? September 2017

EVM assessment report and improvement plan will be attached to the application

8.5 Waste management

Countries must have a detailed waste management and monitoring plan as appropriate for their immunisation activities. This should include details on sufficient availability of waste management supplies (including safety boxes), the safe handling, storage, transportation and disposal of immunisation waste, as part of a healthcare waste management strategy. Please describe the country’s waste management plan for immunisation activities (including campaigns).

There is a waste management plan and EPI policy to guide safe handling, storage, transportation and disposal of waste. The country follows a three-bin system and sharps are deposited into a puncture resistant safety box provided in all health facilities, which offer immunization services. The main method of waste disposal is incineration and all safety boxes are collected from the health facilities and transported to the hospitals for incineration.

9. Additional Comments and Recommendations from the National Coordinating Body (ICC/HSCC)

Comments and Recommendations from the National Coordinating Body (ICC/HSCC)

10. List of documents attached to this proposal

10.1. List of documents attached to this proposal

Document Number Document Section Mandatory File

1 MoH Signature (or delegated authority) of Proposal 4.1.1

signatures.pdfFile desc: The minister of health signed the proposal.Date/time : 08/09/2015 12:00:39Size: 785 KB

2 MoF Signature (or delegated authority) of Proposal 4.1.1

MoF Signature.pdfFile desc: The document was also signed by minister of finance.Date/time : 08/09/2015 01:27:59Size: 257 KB

3 MoE signature (or delegated authority) of HPV Proposal 4.1.1

No file loaded

4 Terms of Reference for the ICC 4.1.2 ICC ToRs for ICC doc Sept 2015.pdfFile desc:

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Date/time : 08/09/2015 12:38:24Size: 245 KB

5 Minutes of ICC/HSCC meeting endorsing Proposal 4.1.3

ICC meeting minutes 2_9_15.pdfFile desc: Minutes from endorsement meeting attached. Date/time : 08/09/2015 12:31:08Size: 39 KB

6 Signatures of ICC or HSCC or equivalent in Proposal 4.1.3

signatures.pdfFile desc: Members of the ICC also signed the proposal. Date/time : 08/09/2015 12:01:15Size: 785 KB

7 Minutes of last three ICC/HSCC meetings 4.1.3

ICC.zipFile desc: Minutes of the ICC which took place between December 2014 and August 2015.Date/time : 08/09/2015 01:21:30Size: 948 KB

8 A description of partner participation in preparing the application 4.1.3

No file loaded

9Minutes of NITAG meeting with specific recommendations on the NVS introduction or campaign

4.2

No file loaded

10Role and functioning of the advisory group, description of plans to establish a NITAG

4.2.1

Memo on NITAG in Lesotho FINAL.docxFile desc: Briefing document to describe current status and planned activities in relation to establishment of the NITAG in Lesotho.Date/time : 08/09/2015 07:28:22Size: 15 KB

11 comprehensive Multi Year Plan - cMYP 5.1

Lesotho_cMulti_Year_Plan_2013-2017 updated in Sept 2015 for submission.docFile desc: Date/time : 08/09/2015 02:18:02Size: 1 MB

12 cMYP Costing tool for financial analysis 5.1 LesothocMYP Costing data 9_8_15.xlsxFile desc: Date/time : 08/09/2015 02:10:02

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Size: 3 MB

13

Monitoring and evaluation and surveillance (M&E) plan for the support requested, within the context of the country’s existing monitoring plan for the EPI programme

5.1.5

NATIONAL IMMUNIZATION MONITORING TABLE LESOTHO.docxFile desc: M&E plan for LesothoDate/time : 08/09/2015 12:43:06Size: 16 KB

14 Vaccine introduction plan 5.1

Updated Rota intro plan 20151013.pdfFile desc: revised rotavirus introduction planDate/time : 15/10/2015 07:48:10Size: 727 KB

15Introduction Plan for the introduction of RCV / JE / Men A into the national programme

7.x.4

No file loaded

16 Data quality assessment (DQA) report 5.1.5

No file loaded

17 DQA improvement plan 5.1.5

No file loaded

19 HPV roadmap or strategy 6.1.1

No file loaded

20 Introduction Plan for the introduction of RCV into the national programme 7.x.4

No file loaded

21 HPV summary of the evaluation methodology 5.1.6

No file loaded

22 Evidence of commitment to fund purchase of RCV for use in the routine system in place of the first dose of MCV

7.x.3 No file loaded

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23 Campaign target population documentation 7.x.1

No file loaded

24

Roadmap or strategy for strengthening a comprehensive approach to pneumonia and/or diarrhoea prevention and treatment

6.x.6

Final -The Child Survival Strategy for Lesotho .docFile desc: The Child Survival Strategy for Lesotho describes the comprehensive approach to pneumonia and diarrhoea prevention and treatment, together with other child survival interventions.Date/time : 08/09/2015 12:29:04Size: 173 KB

25 EVM report 8.3

EVM_reportKingdom of Lesotho_2014.docxFile desc: EVM was conducted in December 2014.Date/time : 08/09/2015 12:02:37Size: 706 KB

26 Improvement plan based on EVM 8.3

EVMA RECOMMENDATIONS AND IMPLEMENTATION PLAN.docFile desc: Recommendations and improvement plan based on the 2014 EVMDate/time : 08/09/2015 12:06:06Size: 103 KB

27 EVM improvement plan progress report 8.3

EVMA Implementation plan update October 2015.pdfFile desc: EVM progress report as of 7 October 2015Date/time : 15/10/2015 07:42:28Size: 259 KB

EVM progressReport.docxFile desc: EVM progress report is not yet available it will be conducted monthly.Date/time : 08/09/2015 11:59:43Size: 13 KB

28 Detailed budget template for VIG / Operational Costs

6.x,7.x.2 Lesotho Rota VIG budget detail FINAL.xlsxFile desc: Excel file with detailed assumptions and activities for Rota introduction activities. Date/time : 08/09/2015 06:37:51

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Size: 24 KB

29

Risk assessment and consensus meeting report for Meningitis / Yellow Fever: (for yellow fever please include information required in the NVS guidelines on YF Risk Assessment process)

7.1

No file loaded

30 Plan of Action for campaigns 7.1, 7.x.4

No file loaded

Other

CCI Update Initial Findings Report Sept 2015.pdfFile desc: Most recent CCI - initial findings from the CCI rapid update. Date/time : 08/09/2015 12:58:16Size: 495 KB

11. Annexes

Annex 1 - NVS Routine Support

Annex 1.1 - NVS Routine Support (Rotavirus, 2-dose schedule)Table Annex 1.1 A: Rounded up portion of supply that is procured by the country and estimate of relative costs in US$

2017Number of vaccine doses # 12,100

Number of AD syringes # 0

Number of re-constitution syringes # 0

Number of safety boxes # 0

Total value to be co-financed by the Country [1] $ 27,500

Table Annex 1.1 B: Rounded up portion of supply that is procured by Gavi and estimate of relative costs in US$

2017Number of vaccine doses # 93,000

Number of AD syringes # 0

Number of re-constitution syringes # 0

Number of safety boxes # 0

Total value to be co-financed by Gavi $ 210,000

Table Annex 1.1 C: Summary table for vaccine Rotavirus, 2-dose schedule

ID Data from 2017

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Number of surviving infants Table 5.2 # 51,664

Number of children to be vaccinated with the first dose Table 5.2 # 39,910

Number of children to be vaccinated with the second dose Table 5.2 # 38,748

Immunisation coverage with the second dose Table 5.2 % 75 %

Number of doses per child Parameter # 2

Estimated vaccine wastage factor Table 5.2 # 1.05

Number of doses per vial Parameter # 1

AD syringes required Parameter # No

Reconstitution syringes required Parameter # No

Safety boxes required Parameter # No

cc Country co-financing per dose Table 6.4.1 $ 0.26

ca AD syringe price per unit Table Annexes 4A $ 0.448

cr Reconstitution syringe price per unit Table Annexes 4A $ 0

cs Safety box price per unit Table Annexes 4A $ 0.0054

fv Freight cost as % of vaccines value Table Annexes 4B % 3.00 %

Table Annex 1.1 D: Estimated numbers for Rotavirus, 2-dose schedule, associated injection safety material and related co-financing budget (page 1)

Formula 2017Total Government Gavi

A Country co-finance V 11.51 %

B Number of children to be vaccinated with the first dose Table 5.2 39,910 4,593 35,317

C Number of doses per child Vaccine parameter (schedule) 2

D Number of doses needed B x C 79,820 9,185 70,635

E Estimated vaccine wastage factor Table 5.2 1.05

F Number of doses needed including wastage D x E 83,811 9,644 74,167

G Vaccines buffer stock

Buffer on doses needed = (D - D of previous year) x 25% Buffer on wastages = ((F - D) - (F of previous year - D of previous year)) x 25%, = 0 if negative result G = [buffer on doses needed] + [buffer on wastages]

20,953 2,411 18,542

I Total vaccine doses neededRound up((F + G) / Vaccine package size) * Vaccine package size

105,000 12,082 92,918

J Number of doses per vial Vaccine parameter 1

K Number of AD syringes (+ 10% wastage) needed (D + G) x 1.11 0 0 0

L Reconstitution syringes (+ 10% wastage) needed (I / J) x 1.11 0 0 0

M Total of safety boxes (+ 10% of extra need) needed (I / 100) x 1.11 0 0 0

N Cost of vaccines needed I x vaccine price per dose (g) 230,959 26,575 204,384

O Cost of AD syringes needed K x AD syringe price 0 0 0

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per unit (ca)

P Cost of reconstitution syringes needed L x reconstitution price per unit (cr) 0 0 0

Q Cost of safety boxes needed M x safety box price per unit (cs) 0 0 0

R Freight cost for vaccines neededN x freight cost as of % of vaccines value (fv)

6,301 726 5,575

S Freight cost for devices needed(O+P+Q) x freight cost as % of devices value (fd)

0 0 0

T Total fund needed (N+O+P+Q+R+S) 237,260 27,300 209,960

U Total country co-financingI x country co-financing per dose (cc)

27,300

V Country co-financing % of Gavi supported proportion U / T 11.51 %

Annex 2 - NVS Routine – Preferred Second Presentation

Annex 2.1 - NVS Routine Support (Rotavirus, 3-dose schedule)Table Annex 2.1 A: Rounded up portion of supply that is procured by the country and estimate of relative costs in US$

2017Number of vaccine doses # 12,100

Number of AD syringes # 0

Number of re-constitution syringes # 0

Number of safety boxes # 0

Total value to be co-financed by the Country [1] $ 27,500

Table Annex 2.1 B: Rounded up portion of supply that is procured by Gavi and estimate of relative costs in US$

2017Number of vaccine doses # 93,000

Number of AD syringes # 0

Number of re-constitution syringes # 0

Number of safety boxes # 0

Total value to be co-financed by Gavi $ 210,000

Table Annex 2.1 C: Summary table for vaccine Rotavirus, 3-dose schedule

ID Data from 2017Number of surviving infants Table 5.2 # 51,664

Number of children to be vaccinated with the first dose Table 5.2 # 39,910

Number of children to be vaccinated with the third dose Table 5.2 # 38,748

Immunisation coverage with the third dose Table 5.2 % 75 %

Number of doses per child Parameter # 3

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Estimated vaccine wastage factor Table 5.2 # 1.05

Number of doses per vial Parameter # 1

AD syringes required Parameter # No

Reconstitution syringes required Parameter # No

Safety boxes required Parameter # No

cc Country co-financing per dose Table 6.4.1 $ 0.26

ca AD syringe price per unit Table Annexes 4A $ 0.448

cr Reconstitution syringe price per unit Table Annexes 4A $ 0

cs Safety box price per unit Table Annexes 4A $ 0.0054

fv Freight cost as % of vaccines value Table Annexes 4B % 7.00 %

Table Annex 2.1 D: Estimated numbers for Rotavirus, 3-dose schedule, associated injection safety material and related co-financing budget (page 1)

Formula 2017Total Government Gavi

A Country co-finance V 8.13 %

B Number of children to be vaccinated with the first dose Table 5.2 39,910 3,243 36,667

C Number of doses per child Vaccine parameter (schedule) 3

D Number of doses needed B x C 119,730 9,729 110,001

E Estimated vaccine wastage factor Table 5.2 1.05

F Number of doses needed including wastage D x E 125,717 10,215 115,502

G Vaccines buffer stock

Buffer on doses needed = (D - D of previous year) x 25% Buffer on wastages = ((F - D) - (F of previous year - D of previous year)) x 25%, = 0 if negative result G = [buffer on doses needed] + [buffer on wastages]

31,430 2,554 28,876

I Total vaccine doses neededRound up((F + G) / Vaccine package size) * Vaccine package size

157,500 12,797 144,703

J Number of doses per vial Vaccine parameter 1

K Number of AD syringes (+ 10% wastage) needed (D + G) x 1.11 0 0 0

L Reconstitution syringes (+ 10% wastage) needed (I / J) x 1.11 0 0 0

M Total of safety boxes (+ 10% of extra need) needed (I / 100) x 1.11 0 0 0

N Cost of vaccines needed I x vaccine price per dose (g) 472,500 38,391 434,109

O Cost of AD syringes needed K x AD syringe price per unit (ca) 0 0 0

P Cost of reconstitution syringes needed L x reconstitution price per unit (cr) 0 0 0

Q Cost of safety boxes needed M x safety box price per unit (cs) 0 0 0

R Freight cost for vaccines neededN x freight cost as of % of vaccines value (fv)

31,500 2,560 28,940

S Freight cost for devices needed (O+P+Q) x freight cost as % of devices

0 0 0

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value (fd)

T Total fund needed (N+O+P+Q+R+S) 504,000 0 504,000

U Total country co-financingI x country co-financing per dose (cc)

40,950

V Country co-financing % of Gavi supported proportion U / T 8.13 %

Annex 3 - NVS Preventive campaign(s)

No NVS Prevention Campaign Support this year

Annex 4

Table Annex 4A: Commodities Cost

Estimated prices of supply are not disclosed

Table Annex 4B: Freight cost as percentage of value

Vaccine Antigen Vaccine Type 2017

Rotavirus, 2-dose schedule ROTA 2.73 %

Table Annex 4C: Intermediate - Minimum country's co-payment per dose of co-financed vaccine.

Vaccine 2017Rotavirus, 2-dose schedule 0.2

Table Annex 4D: Wastage rates and factors

The following table shows the wastage rates for routine and campaign vaccines, set for 2017.

Vaccine dose(s) per vial Maximum Vaccine wastage rate*

Benchmark Wastage Rate**

Routine CampaignHPV bivalent, 2 dose(s) per vial, LIQUID 2 10 % 10 %

HPV quadrivalent, 1 dose(s) per vial, LIQUID 1 5 % 5 %

JE, 5 dose(s) per vial, LYOPHILISED 5 10 % 10 %

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Measles second dose, 10 dose(s) per vial, LYOPHILISED 10 40 % 40 %

Meningococcal A, 10 dose(s) per vial, LYOPHILISED 10 50 % 10 %

MR, 10 dose(s) per vial, LYOPHILISED 10 15 % 15 %

Pneumococcal (PCV10), 2 dose(s) per vial, LIQUID 2 10 % 10 %

Pneumococcal (PCV13), 1 dose(s) per vial, LIQUID 1 5 % 5 %

Rotavirus, 2-dose schedule 1 5 % 5 %

Rotavirus, 3-dose schedule 1 5 % 5 %

Yellow Fever, 10 dose(s) per vial, LYOPHILISED 10 40 % 40 %

Yellow Fever, 5 dose(s) per vial, LYOPHILISED 5 10 % 10 %

Comments:

* Source - WHO indicative wastage rates

** Source - Country APRs and studies, approved by WHO, UNICEF, and the Gavi Secretariat

Note: HPV demonstration project wastage rates are the same as for the national introduction of the vaccine

Table Annex 4E: Vaccine maximum packed volumes

Kindly note that this table is for reference purposes only and includes Gavi- and non Gavi-supported vaccines.

Vaccine product Designation Vaccine formulation

Admin route

No. Of doses in

the schedule

Presentation (doses/vial,

prefilled)

Packed volume vaccine

(cm3/dose)

Packed volume diluents

(cm3/dose)BCG BCG lyophilized ID 1 20 1.2 0.7

Diphtheria-Tetanus DT liquid IM 3 10 3

Diphtheria-Tetanus-Pertussis DTP liquid IM 3 20 2.5

Diphtheria-Tetanus-Pertussis DTP liquid IM 3 10 3

DTP liquid + Hib freeze-dried DTP+Hib liquid+lyop. IM 3 1 45

DTP-HepB combined DTP-HepB liquid IM 3 1 9.7

DTP-HepB combined DTP-HepB liquid IM 3 2 6

DTP-HepB combined DTP-HepB liquid IM 3 10 3

DTP-HepB liquid + Hib freeze-dried DTP-Hib liquid IM 3 10 2.5

DTP-HepB liquid + Hib freeze-dried

DTP-HepB+Hib liquid+lyop. IM 3 1 22

DTP-HepB-Hib liquid DTP-HepB+Hib liquid+lyop. IM 3 2 11

DTP-HepB-Hib liquid DTP-HepB-Hib liquid IM 3 10 4.4

DTP-HepB-Hib liquid DTP-HepB-Hib liquid IM 3 2 13.1

DTP-HepB-Hib liquid DTP-HepB-Hib liquid IM 3 1 19.2

DTP-Hib combined liquid DTP+Hib liquid+lyop. IM 3 10 12

DTP-Hib combined liquid DTP-Hib liquid IM 3 1 32.3

Hepatitis B HepB liquid IM 3 1 18

Hepatitis B HepB liquid IM 3 2 13

Hepatitis B HepB liquid IM 3 6 4.5

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Hepatitis B HepB liquid IM 3 10 4

Hepatitis B UniJect HepB liquid IM 3 Uniject 12

Hib freeze-dried Hib_lyo lyophilized IM 3 1 13 35

Hib freeze-dried Hib_lyo lyophilized IM 3 2 6

Hib freeze-dried Hib_lyo lyophilized IM 3 10 2.5 3

Hib liquid Hib_liq liquid IM 3 1 15

Hib liquid Hib_liq liquid IM 3 10 2.5

Human Papilomavirus vaccine HPV liquid IM 3 1 15

Human Papilomavirus vaccine HPV liquid IM 3 2 5.7

Japanese Encephalitis JE_lyo lyophilized SC 1 5 2.5 2.9

Measles Measles lyophilized SC 1 1 26.1 20

Measles Measles lyophilized SC 1 2 13.1 13.1

Measles Measles lyophilized SC 1 5 5.2 7

Measles Measles lyophilized SC 1 10 3.5 4

Measles-Mumps-Rubella freeze dried MMR lyophilized SC 1 1 26.1 26.1

Measles-Mumps-Rubella freeze dried MMR lyophilized SC 1 2 13.1 13.1

Measles-Mumps-Rubella freeze dried MMR lyophilized SC 1 5 5.2 7

Measles-Mumps-Rubella freeze dried MMR lyophilized SC 1 10 3 4

Measles-Rubella freeze dried MR lyophilized SC 1 1 26.1 26.1

Measles-Rubella freeze dried MR lyophilized SC 1 2 13.1 13.1

Measles-Rubella freeze dried MR lyophilized SC 1 5 5.2 7

Measles-Rubella freeze dried MR lyophilized SC 1 10 2.5 4

Meningitis A conjugate Men_A lyophilized IM 1 10 2.6 4

Meningitis A/C MV_A/C lyophilized SC 1 10 2.5 4

Meningitis A/C MV_A/C lyophilized SC 1 50 1.5 3

Meningitis W135 MV_W135 lyophilized SC 1 10 2.5 4

Meningococcal A/C/W/ MV_A/C/W lyophilized SC 1 50 1.5 3

Meningococcal A/C/W/Y MV_A/C/W/Y lyophilized SC 1 10 2.5 4

Monovalent OPV-1 mOPV1 liquid Oral 20 1.5

Monovalent OPV-3 mOPV3 liquid Oral 20 1.5

Pneumo. conjugate vaccine 10-valent PCV-10 liquid IM 3 1 11.5

Pneumo. conjugate vaccine 10-valent PCV-10 liquid IM 3 2 4.8

Pneumo. conjugate vaccine 13-valent PCV-13 liquid IM 3 1 12

Polio OPV liquid Oral 4 10 2

Polio OPV liquid Oral 4 20 1

Polio inactivated IPV liquid IM 3 PFS 107.4

Polio inactivated IPV liquid IM 3 10 2.5

Polio inactivated IPV liquid IM 3 1 15.7

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Rota vaccine Rota_liq liquid Oral 2 1 17.1

Rota vaccine Rota_liq liquid Oral 3 1 45.9

Tetanus Toxoid TT liquid IM 2 10 3

Tetanus Toxoid TT liquid IM 2 20 2.5

Tetanus Toxoid UniJect TT liquid IM 2 Uniject 12

Tetanus-Diphtheria Td liquid IM 2 10 3

Yellow fever YF lyophilized SC 1 5 6.5 7

Yellow fever YF lyophilized SC 1 10 2.5 3

Yellow fever YF lyophilized SC 1 20 1.5 2

Yellow fever YF lyophilized SC 1 50 0.7 1

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12. Banking FormIn accordance with the decision on financial support made by the Gavi, the Government of Lesotho hereby requests that a payment be made via electronic bank transfer as detailed below:

Name of Institution (Account Holder):

Address:City Country:Telephone no.: Fax no.:

Currency of the bank account:For credit to:Bank account's title:Bank account no.:Bank's name:

Is the bank account exclusively to be used by this program?

By who is the account audited?

Signature of Government's authorizing official

SealName:

Title:

Signature:

Date:

FINANCIAL INSTITUTION

Bank Name:

Branch Name:

Address:

City Country:

Swift Code:

Sort Code:

ABA No.:

Telephone No.:

FAX No.:

CORRESPONDENT BANK(In the United States)

I certify that the account No is held by at this banking institutionThe account is to be signed jointly by at least (number of signatories) of the following authorized signatories:

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1 Name:Title:

2 Name:Title:

3 Name:Title:

Name of bank's authorizing official

Signature:

Date:Seal:

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