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Republic of Ghana

RTS,S Malaria Vaccine Technical Brief

Ghana

August 2016

Foreword

Malaria kills nearly 600,000 people a year globally and causes illness in many more, about 90% of

whom are in sub-Saharan Africa and 83% of whom are children under the age of five. In Ghana,

malaria causes about 2,000 deaths annually, approximately 48% of which afflict children under the

age of five, and is a major cause of hospital attendance, contributing to an estimated 30% of

admissions.

Ghana has made notable progress in malaria prevention and control with existing interventions,

significantly contributing to a reduction in malaria-related deaths. However, the country continues to

have a significant disease burden and could benefit from the deployment of additional tools in the

fight against malaria. A safe, effective, and well-tolerated malaria vaccine could be a potentially

important tool for malaria control.

Since 2006, Ghana has contributed to the development of the RTS,S malaria vaccine in collaboration

with PATH, GlaxoSmithKline (GSK), and other scientists around the world. In January 2016, the

World Health Organization (WHO) issued a position paper calling for large-scale pilot

implementations of RTS,S in children 5 to 9 months of age, alongside other malaria control

interventions in settings of moderate-to-high parasite transmission in sub-Saharan Africa. The pilot

implementation programme will compile evidence on the feasibility, impact, and safety of the vaccine

delivered in country immunization programs alongside other currently recommended malaria control

measures.

In January 2016, Ghana expressed interest to collaborate with WHO in the RTS,S malaria vaccine

pilot implementations. This document comes as a handy summary of the RTS,S vaccine background,

data, and information to support policy- and decision-makers in making an evidence-based decision

on the introduction and use of a malaria vaccine in Ghana.

This brief was drafted by the Ghana Malaria Vaccine Technical Working Group (TWG)—a

subcommittee of the National Malaria Control Program (NMCP) composed of representatives from

the Ghana Health Service (GHS), members of academia and multilaterals, and compiled with support

from PATH, an international nongovernmental organization (NGO). I am grateful to them.

My acknowledgment also goes to all other collaborators—especially WHO—for supporting the

development of this technical brief which will facilitate informed decision-making to introduce a

malaria vaccine in Ghana or otherwise.

Thank you,

Honorable Alex Segbefia

Minister of Health, Ghana

Acknowledgment

The Ministry of Health/Ghana Health Service is grateful to the task team of the Malaria Vaccine

Technical Working Group—a subcommittee of the National Malaria Control Programme for the

development of the technical brief for the RTS,S/AS01 malaria vaccine, including compiling and

reviewing the various drafts. We are also grateful to all partners—particularly PATH and WHO—for

their support and useful comments that have enriched this technical brief. We thank all of the

members of the Technical Working Group for their inputs and editorial comments.

The following are the task team members that compiled background information and drafted the

technical brief, as well as reviewers:

1. Dr. Samuel O. Sackey, TWG Chair, School of Public Health, University of Ghana

2. Prof. Isabella Quakyi, Former TWG Chair, College of Health Sciences, University of Ghana

3. Prof. Edwin A Afari, School of Public Health, University of Ghana

4. Dr. Felicia Owusu-Antwi, World Health Organization, Ghana

5. Dr. Constance Bart-Plange, National Malaria Control Program, Ghana Health Services

6. Mr. James Frimpong, National Malaria Control Program, Ghana Health Services

7. Ms. Vivian N. A. Aubyn, National Malaria Control Program, Ghana Health Services

8. Mr. Fred Osei-Sarpong, Expanded Program on Immunization, Ghana Health Services

9. Mr. John Frederick Dadzie, Expanded Program on Immunization, Ghana Health Services

10. Dr. George Bonsu, Expanded Program on Immunization, Ghana Health Services

11. Dr. K.O. Antwi-Agyei, PATH Consultant

12. Dr. Kwaku Poku Asante, KintampoHealth Research Centre

13. Dr. Seth Owusu-Agyei, Kintampo Health Research Centre

14. Prof. Tsiri Agbenyega, School of Medical Sciences (KNUST)/Agogo Malaria Research Centre

15. Prof. Daniel Ansong, School of Medical Sciences (KNUST)/Agogo Malaria Research Centre

16. Ms. Delese Darko, Food and Drugs Authority

17. Ms. Patience Dapaah, PATH

18. Mr. John Bawa, PATH

19. Mr. Kofi Aburam, PATH

20. Ms. Kelli Cappelier, PATH

Contents

Foreword .................................................................................................................................................. i

Acknowledgment .................................................................................................................................... ii

Contents .................................................................................................................................................. 1

List of Acronyms .................................................................................................................................... 1

Executive Summary ................................................................................................................................ 4

Introduction ............................................................................................................................................. 7

1. Background ..................................................................................................................................... 8

1.1 Country demographic summary .................................................................................................. 8

1.2 Administration and governance system ...................................................................................... 9

1.3 Organization of health system ................................................................................................... 10

1.4 Health Status ............................................................................................................................. 10

1.4.1 Child health .......................................................................................................................... 11

1.4.2 Infant mortality .................................................................................................................... 13

1.5 Overview of the National Immunization Programme ............................................................... 14

1.5.1 Historical overview of immunization .................................................................................. 14

1.5.2 EPI-related Health Indicators ............................................................................................... 16

1.5.3 Considerations for deciding to introduce a New Vaccine .................................................... 18

1.5.4 Planned New Vaccine Introductions .................................................................................... 18

1.5.5 Candidate vaccines under consideration for introduction .................................................... 18

1.6 Overview of National Malaria Control Programme .................................................................. 18

2. Epidemiology of Malaria .............................................................................................................. 20

2.1 Population at risk ...................................................................................................................... 20

2.2 Malaria parasite endemicity ...................................................................................................... 20

2.3 Morbidity and Mortality............................................................................................................ 20

2.4 Coverage of Key Malaria Interventions .................................................................................... 22

3. RTS,S vaccine ............................................................................................................................... 25

3.1 RTS,S vaccine history, characteristics, and technical specifications ........................................ 25

3.2 RTS,S Vaccine safety ............................................................................................................... 26

3.3 RTS,S Vaccine efficacy ............................................................................................................ 27

3.4 Co-administration with other vaccines ..................................................................................... 28

3.5 Special risk groups .................................................................................................................... 28

4. Status of other malaria vaccines in development .......................................................................... 29

5. Economic and Financial considerations ........................................................................................ 29

5.1 Economic burden of disease ..................................................................................................... 29

Malaria Vaccine Technical Brief Ghana – August 2016 2

5.2.1 Estimated public health impact ............................................................................................ 30

5.2.3 Estimated cost-effectiveness ................................................................................................ 32

5.3 Vaccine price, donor subsidy, and national affordability.......................................................... 34

6. Programmatic considerations ........................................................................................................ 34

6.1 Proposed Immunization Schedule for RTS,S............................................................................ 34

6.2 Cold chain capacity ................................................................................................................... 35

6.2.1 Cold chain capacity at national level ................................................................................... 35

6.2.2 Cold chain capacity at regional level ................................................................................... 36

6.2.3 Cold chain capacity at district and health facility levels ...................................................... 37

6.3 Service delivery ........................................................................................................................ 37

6.4 Human resource capacity .......................................................................................................... 39

6.5 Current routine data monitoring (immunization and malaria) and ability to evaluate rollout of

vaccine .................................................................................................................................................. 39

6.7 Surveillance and pharmacovigilance ........................................................................................ 40

6.7.1 Malaria disease surveillance ......................................................................................... 41

6.7.2 AEFI surveillance ......................................................................................................... 41

6.8 Strengths and weaknesses of the immunization program ......................................................... 42

6.8.1 Vaccine supply and quality ........................................................................................... 42

6.8.2 Logistics ........................................................................................................................ 42

6.8.3 Service delivery............................................................................................................. 42

6.8.4 Advocacy and communication ...................................................................................... 43

6.8.5 Surveillance ................................................................................................................... 43

6.8.6 Program management ................................................................................................... 43

6.8.7 Human and institutional resources ................................................................................ 43

6.8.8 Sustainable financing .................................................................................................... 43

7. Sociocultural environment ............................................................................................................ 44

7.1 Community perceptions of malaria, malaria interventions, and vaccines ................................. 44

7.2 Communications strategies and frameworks ............................................................................ 44

References ............................................................................................................................................. 47

Appendices ............................................................................................................................................ 52

Appendix 1: Malaria vaccine TWG terms of reference ........................................................................ 52

Appendix 2: Overview of pivotal phase 3 trial findings1 ...................................................................... 53

Appendix 3: RTS,S vaccine characteristics and presentation ............................................................... 54

Appendix 6: Vaccine efficacy against clinical and severe malaria by study site in the 6-12 weeks age

category6 ............................................................................................................................................... 57

Appendix 7: Cases of clinical and severe malaria averted at each site during 48 months follow-up in

the 5-17 months age category6 .............................................................................................................. 58

Appendix 8: Global malaria vaccine pipeline ....................................................................................... 59

Malaria Vaccine Technical Brief Ghana – August 2016 3

Appendix 9: Model predictions of clinical cases and deaths averted per 100,000 fully vaccinated

children8 ................................................................................................................................................ 60

Appendix 10: Cost in USD per clinical case or DALY averted as a function of baseline endemicity. 8

.............................................................................................................................................................. 61

Appendix 11: Cost-effectiveness and public health impact limitations8 ............................................... 62

Appendix 13: Summary findings from the Ghana malaria vaccine community perceptions research10

.............................................................................................................................................................. 67

Malaria Vaccine Technical Brief Ghana – August 2016 | 1

List of Acronyms

5YPOW five-year program of work

ACT artemisinin-based combination therapy

AEFI adverse event following immunization

AESI adverse event of special interest

AFP acute flaccid paralysis

AIDS acquired immune deficiency syndrome

ATP According-to-Protocol

BCG Bacillus Calmette-Guérin

C4D UNICEF Communication for Development program

CE cost-effectiveness

CHAG Christian Health Association of Ghana

CHMP Committee for Medicinal Products for Human Use

CHPS Community Health Planning Services

CHPW Child Health Promotion Week

cMYP comprehensive multi-year plan for immunization

CSO civil society organization

CWC Child Welfare Clinic

DALY disability-adjusted life year

DCD Diseases Control and Prevention Department

DCE District Chief Executive

DFID Department for International Development

DHIMS District Health Information Management System

DHMT District Health Management Team

DHS Demographic and Health Survey

DPT diphtheria-pertussis-tetanus

DTwP diptheria toxoid, tetanus, and pertussis

DVDMT District Vaccination Data Management Tool

EMA European Medicines Agency

EPI Expanded Programme on Immunization

EU European Union

EVMA Effective Vaccine Management Assessment

FDA Food and Drugs Authority

FSP financial sustainability plan

GDHS Ghana Demographic and Health Survey

GDP gross domestic product

GHS Ghana Health Services

GLSS Ghana Living Standards Survey

GMC geometric mean concentration

GNI gross national income

GPEI Global Polio Eradication Initiative

GPRS Ghana Poverty Reduction Strategy

GSK GlaxoSmithKline

hepB hepatitis B

Hib Haemophilus influenzae

HIV human immunodeficiency virus

HPV human papillomavirus

HSMTDP Health Sector Medium-Term Development Plan

ICC Inter-agency coordinating committee

ICER incremental cost-effectiveness ratio

IDSR Integrated Disease Surveillance and Response framework


IEC information, education and communication

IMR infant mortality rate

IPTc intermittent preventive treatment of malaria in children

IPTi intermittent preventive treatment of malaria in children

IPV inactivated polio vaccine

IRS indoor residual spraying

ITN insecticide-treated bed net

LLIN long-lasting insecticide-treated nets

MDA ministries, departments, and agencies

MDG Millennium Development Goal

MDVP Multi-Dose Vial Policy

Men A Meningococcal Conjugate Vaccine type A

MICS Multiple Indicator Cluster Survey

MLM mid-level managers

MNT maternal/neonatal tetanus

MOH Ministry of Health

MPAC Malaria Policy Advisory Committee

MR measles-rubella vaccine

MTHS medium term health strategy

MVI Malaria Vaccine Initiative

NCC national polio certification committee

NGO nongovernmental organization

NID National Immunization Day

NITAG National Immunization Technical Advisory Group

NMCC National Malaria Communication Committee

NMCP National Malaria Control Program

NNT neo-natal tetanus

NPEC national polio expert committee

NRA National Regulatory Authority

NSP National Strategic Plan

NTF National Polio Laboratory Containment Task Force

OPV oral polio vaccine

ORS oral rehydration solution

PBM pediatric bacterial meningitis

PCV pneumococcal conjugate vaccine

PFA Partnership Framework Agreement

PfPR parasite prevalence

PHC Population and Housing Census

PHD Public Health Division

PHI public health impact

PMI President’s Malaria Initiative

PSPQ Programmatic Suitability for Prequalification

RBM Roll Back Malaria Initiative

RCC Regional Coordinating Councils

RHD Regional Health Directorate

SAE serious adverse events

SAGE Strategic Advisory Group of Experts on Immunization

SDHMT Sub-District Health Management Team

SIA supplemental immunization activities

SMC seasonal malaria chemoprevention

SP sulfadoxine-pyrimethamine

TBA Traditional birth attendants

TOT Training of Trainers

TT tetanus toxoid

TWG Technical Working Group


U5MR under-five mortality rate

USAID United States Agency for International Development

VE vaccine efficacy

VIG vaccine introduction grants

VPD vaccine-preventable disease

VVM vaccine vial monitor

WER Weekly Epidemiological Record

WHA World Health Assembly

WHO World Health Organization

WICR walk-in cold room

WIFA women in their fertility ages

WPV wild poliovirus


Executive Summary

Purpose

Since 2006, Ghana has contributed to the development of the RTS,S/AS01 malaria vaccine— also

known as Mosquirix™, but referred to hereafter as RTS,S—in collaboration with PATH,

GlaxoSmithKline (GSK, the vaccine manufacturer) and other scientist across the world. In January

2016, Ghana responded to the World Health Organization (WHO) call for national ministries of health

to express interest in collaborating in the RTS,S malaria vaccine pilot implementation programme,

which was reaffirmed in March 2016. Furthermore, WHO is planning a delegation visit with partners

from PATH and GSK to meet with high-level Ministry of Health (MOH) and Ghana Health Service

(GHS) officials to discuss Ghana’s potential participation in the RTS,S malaria vaccine pilot

implementation programme.

This document is a summary of the RTS,S vaccine background, data, and information to support

policy- and decision-makers in making an evidence-based decision on the use of a malaria vaccine in

Ghana. This brief was drafted by the Ghana Malaria Vaccine Technical Working Group (TWG), a

subcommittee of the National Malaria Control Program (NMCP), composed of representatives from

the GHS, WHO, members of academia and multilaterals, and compiled with support from PATH—an

international nongovernmental organization (NGO).

Background and rationale

Ghana has made notable progress in malaria prevention and control, with existing interventions

significantly contributing to a reduction in malaria-related deaths. However, the country continues to

have a significant disease burden and could benefit from the deployment of additional tools in the

fight against malaria. A well-tolerated and effective vaccine with an acceptable safety profile could be

a potentially important tool for malaria control.

In January 2016, WHO issued a position paper calling for large-scale pilot implementations of the

RTS,S malaria vaccine in children 5 to 9 months of age, alongside other malaria control interventions

in settings of moderate-to-high parasite transmission in Africa. Specifically, “WHO recommends that

the pilot implementations use the 4-dose schedule of the RTS,S vaccine in 3 to 5 distinct

epidemiological settings in sub-Saharan Africa, at subnational level, covering moderate-to-high

transmission settings,” with three doses administered to children between 5 and 9 months of age,

followed by a fourth dose 15–18 months later.1 The pilot implementation programme will compile

evidence on the feasibility, impact, and safety of the vaccine when delivered through a country routine

immunization program alongside other currently recommended malaria control measures.

Ghana malaria burden of disease

In Ghana, malaria causes nearly 2,000 deaths annually, approximately 48% of which affect children

under the age of five, and is a major cause of hospital attendance, contributing to an estimated 30% of

admissions.2 Plasmodium falciparum is the predominant malaria parasite in Ghana, causing

approximately 80 to 90% of severe illness and death, particularly in children under five years of age

and pregnant women.2 Malaria prevalence is generally stable in Ghana, with endemicity ranging from

intermittent transmission in the Greater Accra Region to intense seasonal transmission in the Upper

West Region. There is seasonal transmission in the rest of the country.3


RTS,S malaria vaccine

RTS,S is the only candidate malaria vaccine to have received a positive regulatory assessment, which

was issued by the European Medicines Agency (EMA) Committee for Medicinal Products for Human

Use (CHMP), under the Article 58 review process.a The Article 58 procedure allows EMA’s CHMP

to adopt a scientific opinion, in cooperation with WHO, on a medicinal product for human use that is

intended exclusively for markets outside of the European Union (EU). This assessment requires

medicinal products to meet the same standards as those intended for use in the EU. The vaccine

development spanned a 30-year process, with completion of phase 3 efficacy and safety trials across

seven sub-Saharan African countries in 2014, including Ghana. At present, no regulatory authority in

the African region has licensed RTS,S for use as a malaria vaccine.4

Ghana participated in the RTS,S phase 3 clinical trial, with two research centres—Agogo and

Kintampo Health Research Centre. Currently, Ghana is participating in a baseline study through the

Kintampo and Navrongo Health Research Centres to evaluate adverse events of specific interest and

make the centers eligible for participation in the RTS,S phase 4 studies. These studies would

commence following successful application to national regulatory authorities by GSK, as RTS,S will

need to be licensed prior to the initiation of vaccination in the pilot implementations and phase 4

studies.

Vaccine efficacy

The phase 3 clinical trial studied two age groups—infants aged 6-12 weeks and young children 5–17

months of age at first vaccination. WHO has recommended use of the vaccine among young children

due to higher efficacy and projected impact. Results among children 5-17 months of age at first

vaccination showed highest efficacy shortly after vaccination, which waned over time. More

specifically:

Three doses of RTS,S reduced clinical malaria by approximately half at one year of follow-up, by

46% at 18 months of follow-up, and by 26% at 48 months of follow-up, compared to children

immunized with a comparator vaccine.5, 6

A fourth dose of RTS,S, administered at 18 months after the primary series was shown to enhance

protection and reduce the number of clinical malaria cases by 39% at 48 months of follow-up.5

Efficacy results were achieved on top of existing malaria interventions, such as insecticide-treated bed

nets, which were used by nearly 80% of the trial participants.

The phase 3 efficacy and safety trial showed that the vaccine candidate could provide meaningful

public health benefit by reducing the burden of malaria when used alongside currently available

interventions such as bed nets and insecticides.5

Vaccine safety

RTS,S displayed an acceptable safety and tolerability profile throughout the entire phase 3 study.

Adverse events following immunization (AEFI) included local reactions (such as pain or swelling),

which were observed more frequently after RTS,S administration compared to children immunized

a The RTS,S vaccine has received a positive Scientific Opinion by EMA in accordance with Article 58 of Regulation (EC) No 72/2004 which

allows the Agency’s Committee for Medicinal Products for Human Use (CHMP) to give opinions, in cooperation with WHO, on medicinal products for human use that are intended exclusively for markets outside of the European Union (EU). For more information: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000157.jsp, accessed January, 2016.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000157.jsp


with a comparator vaccine.7 The incidence of fever one week after vaccination was higher in children

who received the RTS,S vaccine than in those receiving the comparator vaccine. In some, this resulted

in febrile reactions that were accompanied by generalized convulsive seizures, but all affected

children recovered fully within seven days.

The rates of other serious adverse events seen in the trial (mainly medical events requiring

hospitalization, regardless of whether they were considered to be caused by the study vaccine) were

comparable between the RTS,S and control recipients, except for cases of meningitis and cerebral

malaria, which were reported in low numbers more often in the RTS,S group. According to EMA, the

imbalance of meningitis cases is most likely to be a chance finding, as some of these cases occurred

years after vaccination without any obvious relationship to vaccination. The increased occurrence of

meningitis and risk for severe malaria—including cerebral malaria—will be followed closely in phase

4 studies and the pilot implementations.

RTS,S estimated public health impact and cost-effectiveness

RTS,S vaccine’s public health impact and cost-effectiveness modelled estimates projected the

vaccine’s potential to have a substantial public health impact when used alongside other malaria

control measures, most notably in areas of moderate-to-high transmission. The vaccine is estimated to

avert 116,500 (30,900-160,000) cases of clinical malaria and 484 (195-838) deaths per 100,000

vaccinated children under a 4-dose schedule for areas with parasite prevalence between 10% and

65%. This translates to approximately 1 malaria death prevented for every 200 children fully

vaccinated. Using a vaccine price proxy of $5 per dose equates to $87 ($42-244) per disability-

adjusted life year (DALY) averted.8 In Ghana the entire country has parasite prevalence (PfPR2-10)

greater than 10%, with 7 out of 10 regions above 20%, suggesting that RTS,S has the potential to have

a significant public health impact.3

RTS,S malaria vaccine and the Ghana context

RTS,S has been recommended for use alongside other malaria control interventions, so

implementation of RTS,S should be considered as an additional tool to current malaria control

interventions outlined in the 2014-2020 National Malaria Strategic Plan. The Ghana Expanded

Programme on Immunization (EPI) is high-performing and has been able to absorb new vaccines into

its program with limited disruption to its health system.

RTS,S is a four-dose regimen with a proposed vaccination schedule at 6, 7, 9, and 24 months (or 15-

18 months after the third dose). The 6-month visit will align with the vitamin A supplementation, an

already-established visit with 70% coverage,9 and the 9-month visit will align with the first dose of

measles-rubella vaccination (MR1). Therefore the RTS,S regimen will introduce two new visits at 7

months and approximately 24 months. To achieve optimal coverage for new visits, RTS,S

implementation could build on the well-established Community Health Planning Services (CHPS)

Strategy of integrated service delivery.

Communication and social mobilization will be critical to ensure timely vaccination and optimal

coverage of all four RTS,S doses, in addition to sensitizing populations on continued use of other

malaria control interventions. A sociocultural research study on community perceptions of a malaria

vaccine conducted in Ghana found potential for high acceptance of a malaria vaccine and a shared

understanding that malaria prevention requires a comprehensive approach.10 Data from this research

has informed a draft malaria vaccine communication plan for Ghana, developed under the leadership

of the National Malaria Communications Committee, as a collaborative effort across the NMCP, EPI,

health promotion, and other expertise.


Introduction

Malaria kills nearly 600,000 people a year globally and causes illness in hundreds of millions more,

about 90% of whom are in sub-Saharan Africa and 83% of whom are children under the age of five.

In Ghana, malaria causes about 2,000 deaths annually.2 Although existing interventions have helped

to reduce malaria deaths significantly over the past decade, malaria remains a leading cause of

morbidity and mortality among children under the age of five. A well-tolerated and effective vaccine

with an acceptable safety profile could add an important component to malaria control.

The RTS,S malaria vaccine is currently the most advanced malaria vaccine candidate globally, having

successfully completed phase 3 clinical trials, findings which were published April 14, 2015, in The

Lancet.6 Under the Article 58 procedure, EMA’s CHMP gave a positive scientific opinion after a

collaborative review of the data with WHO for use of RTS,S outside of the European Union (EU).11

Results from the trial show that the RTS,S malaria vaccine has the potential to make a meaningful

public health impact and contribute to malaria control when used alongside other effective control

measures, especially in areas of high transmission.

On January 29, 2016, WHO published its position paper on the RTS,S malaria vaccine in the Weekly

Epidemiological Record (WER), confirming the joint advice from the Strategic Advisory Group of

Experts on Immunization (SAGE) and Malaria Policy Advisory Committee (MPAC), recommending

that the vaccine be implemented through large-scale pilot implementations.

WHO recommends that the pilot implementations use the four-dose schedule of the RTS,S vaccine in

3–5 distinct epidemiological settings in sub-Saharan Africa, at subnational level, covering “moderate-

to-high transmission settings,” with three doses administered to children between 5 and 9 months of

age, followed by a fourth dose 15–18 months later. It is recommended that the pilots involve

sufficiently large populations to assess, among other things, (1) the feasibility of providing all four

doses of RTS,S to the target age group through existing health services; (2) the impact of RTS,S on

child mortality; and (3) evidence of any causal relationship between RTS,S and either meningitis or

cerebral malaria, in the context of surveillance of adverse events; as well as the compilation of

evidence on the functioning of country immunization programs and the use of currently recommended

malaria control measures.1

In December 2015, WHO made a call to sub-Saharan African countries to express interest for

participation in the RTS,S malaria vaccine pilot implementation programme. Ghana submitted an

expression of interest in January 2016 and received confirmation from WHO in February 2016, at

which point Ghana confirmed its interest to participate in the pilot implementation programme. Ghana

participated in the RTS,S phase 2 and 3 clinical trials, and is also participating in the pending phase 4

studies.

If the pilot implementation programme has a favourable response from Ghana, and funding is

confirmed, a licensure application from GSK (the manufacturer) through the Food and Drugs

Authority (FDA) in Ghana would then follow.

Malaria Vaccine Technical Working Group

Since 2009, representatives from the GHS, RTS,S vaccine trial research centers, members of

academia, and multilaterals—with support from WHO and PATH—formed a malaria vaccine TWG

to compile, evaluate, and synthesize data and information needed for Ghana policymakers to make an

evidence-based decision on use of a malaria vaccine. The TWG was established as a subcommittee of

the NMCP. This technical brief has been compiled by the malaria vaccine TWG members for


consideration by policymakers and program managers. TWG terms of reference can be found in

Appendix 1.

Policy pathway

As RTS,S is a new vaccine being considered, it is important that the data and evidence are evaluated

by necessary policy- and decision-makers to enable an evidence-based decision on its use in Ghana.

Because there is currently no National Immunization Technical Advisory Group (NITAG) in Ghana,

the TWG has filled the role of compiling data and evidence in a technical brief. As illustrated in

Figure 1, the technical brief will be shared with the GHS senior managers including the District

Health System (DHS), EPI, NMCP, and the Policy, Planning, Monitoring and Evaluation Division

(PPME). The senior managers will have the opportunity to conduct an initial review of the data and to

request more data and information, as needed. The technical brief will then be shared with the

Immunization and Malaria Interagency Coordinating Committees (ICC and MICC) to conduct a joint

review of the data and information available. The TWG is prepared to support the coordinating and

planning of these meetings, including the presentation of key data and information. The TWG will be

available to provide support compiling any additional information needed to support a policy

recommendation for use of RTS,S in Ghana. It is assumed that this technical brief will be used in the

context of the RTS,S pilot implementation programme and will be updated based on evidence

generated in the pilots for a future policy decision.

1. Background

1.1 Country demographic summary

Ghana is centrally located on the west coast of Africa, sharing borders with three French-speaking

countries: Burkina Faso (548 km) to the north, Cote d’Ivoire (668 km) to the west and Togo (877 km)

to the east. In the south are the Gulf of Guinea and the Atlantic Ocean, which form the coastline of

Ghana. The country is stratified into three vegetative zones—coastal lands and semi-deciduous forest

from the south into the middle belt, and savannah regions in the north towards Burkina Faso. Ghana

has a tropical climate with two major seasons – a dry (harmattan) season and a wet (rainy) season.

Administratively, the country is divided into 10 regions and 216 decentralized districts since 2012,

with an estimated 2015 population of 27,971,256 (GSS, 2010). The Ashanti and Greater Accra

Regions are the most populated with 5,461,534 (19.5%) and 4,671,362 (16.7%) of the country’s

population, respectively. The Upper East and Upper West Regions in northern Ghana are the least

populated, with 11,110,863 (4.0 %) and 771,394 (2.8 %), respectively.

Malaria vaccine TWG ICC/MICCSenior

ManagersMOH

Health sector working group

Malaria vaccine TWG

Figure 1. Malaria vaccine policy pathway, Ghana.


Table 1. Population Distribution by Region – 201512

NATIONAL TARGET POPULATION BY REGION – 2015

Region

No. of

Districts Regional

Projection

% of

National

population

Target Population less

than 1 year and expected

pregnancy (4%)

Target

Population for

WIFA (24%)

1 Ashanti 30 5,461,534 19.5 218,461 1,310,768

2 Brong Ahafo 27 2,589,256 9.3 103,570 621,421

3 Central 20 2,564,978 9.2 102,599 615,595

4 Eastern 26 2,921,493 10.4 116,860 701,158

5 Greater Accra 16 4,671,362 16.7 186,854 1,121,127

6 Northern 26 2,860,449 10.2 114,418 686,508

7 Upper East 13 1,110,863 4.0 444,35 266,607

8 Upper West 11 771,394 2.8 30,856 185,135

9 Volta 25 2,396,608 8.6 95,864 57,5186

10 Western 22 2,623,319 9.4 104,933 629,597

National 216 27,971,256 100 1,118,850 6,713,101

Although 50.9% of the population lives in urban areas, the level of urbanization varies for each of the

ten regions. Greater Accra has the highest proportion of urban population (90.5%), with Ashanti Region

having the second highest (60.6%). The Upper West has the lowest proportion of urban population

(16.3%).

Ghana has a youthful population consisting of a large proportion of children under-15 years and a

small proportion of elderly persons (65 years and older). Life expectancy is estimated at 56 years for

men and 57 years for women, while the adult literacy rate (age 15 and above) is estimated to be 65%.

An estimated 97.6% of the population is Ghanaian while 2.4% is non-Ghanaian. The household

structure is becoming more nuclear with the majority of households headed by males (65.3%).

Ghana has a predominant agricultural sector (small-scale peasant farming) absorbing 55.8%13 of the

adult labor force; a small, capital intensive mining sector; and a growing informal sector (small

traders and artisans, technicians and businessmen).

1.2 Administration and governance system

Ghana operates a multi-party democracy. At the national level, the head of state is an elected

president assisted by a cabinet, an elected parliament, and an independent judiciary. There are national

institutions responsible for policy and strategy development consisting of ministries, departments, and

agencies (MDAs). There are ten regional ministers who head their respective Regional Coordinating

Councils (RCCs). The next administrative level is the district-level, which is headed by a politically

appointed district chief executive (DCE), who is head of the District Assembly. This division of the

country into regions, districts, unit committees, and other units has implications for health

administration and management in the country.

A traditional system of governance operates concurrently with the modern governmental structure.

The traditional system consists of kingdoms, chiefdoms and traditional councils that play influential

roles in socioeconomic, political, health and developmental matters within their jurisdiction. These

traditional systems are critical to the success of development programs in the country. Together, both

the modern government structure and traditional system constitute the governance in the country.


1.3 Organization of health system

Ghana’s health sector operates a decentralized system with established mechanisms that coordinate

policy formulation, resource mobilization, policy implementation and monitoring and evaluation of

activities.14 The health sector is split into a policymaking arm and a service delivery arm. The

Ministry of Health (MOH) is the policymaking arm and maintains its role as the central decision-

making body in health matters, and maintains the responsibility to recruit, train and manage staff

postings to its agencies and to remunerate health workers on government payroll. The training of

health professionals for the health sector is by both public and private health-training institutions that

have been accredited.

The health care system in Ghana is organized under four main categories of delivery systems—

public, private-not-for-profit, private-for-profit, and traditional.15 GHS, faith-based institutions

including the Christian Health Association of Ghana (CHAG) and Islamic Health, quasi-government

health institutions (including universities and security services), teaching hospitals, and the private

sector are responsible for health service delivery.

GHS is the largest service delivery agency and operates through the public-owned facilities. The faith-

based institutions and private sector provide about 40% of service delivery. The health sector also

recognizes the role of herbal medicine practitioners as alternative medical practitioners and has

licensed the services to regulate their practice. Traditional birth attendants (TBAs) and the traditional

healers are also recognized as key players in community health and complement the work of the

orthodox medical system to enhance health services.

Health service delivery is organized at three levels—national, regional, and district. The district level

is further divided into a number of sub-districts and incorporates a community-level health delivery

system. Public health services are delivered through a hierarchy of hospitals, health centers, maternity

homes and clinics including a CHPS strategy. Health services cover primary care through secondary

to tertiary services organized at five levels: community, sub-district, district, regional and teaching

hospitals (specialized). Community and sub-district levels provide primary care, with district and

regional hospitals providing secondary health care.

The regulatory system of the health sector is coordinated by a number of agencies of the MOH

including the Foods and Drugs Authority (FDA), Pharmacy Council, and Professional Bodies. These

ensure that health service provision and health care practice are within agreed quality and safety

standards. Civil society organizations (CSOs) and non-governmental organizations (NGOs) also play

a significant role in delivering health services, especially in communities. They are effective media

for community mobilization for service delivery including immunization.

The procurement of key commodities for service delivery is done centrally, and commodities and

supplies are distributed via the Central Medical Store to the various Regional Medical Stores and then

down to the district-level facilities and health facilities at the periphery. Financial management is

decentralized down to the district level with sub-districts and CHPS zones with oversight from the

District Health Management Teams (DHMTs).

1.4 Health Status

Ghana is making progressive improvements in the health status of the population. However, the

country is confronted with the double burden of disease across all ages and sexes, with non-

communicable diseases becoming the major cause of morbidity and mortality alongside the existing

and emerging communicable diseases.


1.4.1 Child health

Child health has significantly improved over the years, with the child survival rates increasing as a

result of the high impact health care services and economic progress. Despite these efforts, 1 in 11

Ghanaian children die before their fifth birthday, largely from preventable childhood diseases. In

2000, Ghana recorded an under-five mortality rate (U5MR) of 167 per 1,000 live births that declined

to 90 per 1,000 live births in 2010, an estimated 46% decline. This decline indicates that Ghana,

although making progress, still could not achieve the Millennium Development Goal (MDG) 4 target

of 39.9 per 1,000 live births by 2015, as the progress was slow.

Variations across the country show that U5MR is comparatively lower in urban than in rural areas.

According to the 2010 Ghana Population and Housing Census (PHC), U5MR in rural areas is 90

deaths per 1,000 live births compared to 83 deaths per 1,000 live births in urban areas. Mortality is

higher among male children than among female children—comparative U5MR for male and female

children in urban areas were 92 and 76 deaths per 1,000 live births, respectively. Similarly in rural

areas, U5MR among male and female children were 98 and 82 deaths per 1,000 live births,

respectively.12

The 2011 Multiple Indicator Cluster Survey (MICS 2011)16 estimated that there were twice as many

under-fives dying per 1,000 live births in the poorest wealth quintile in comparison to the richest.

There were marked variations observed from regional results. As shown in Figure 2, the U5MR has

reduced across all regions in Ghana, with the largest decline recorded in the Greater Accra region

(110%), while Upper East Region recorded the lowest decline (approximately 40%).12,20 The Upper

West Region recorded the highest U5MR of 128 deaths per 1,000 live births, while the minimum was

72 deaths per 1,000 live births in Greater Accra. Poverty is a major contributor to the probability of a

child dying before the age of five years. This is evident in the three northern regions and the Central

Region—classified as the four most deprived regions of Ghana. These regions consistently record

relatively higher mortality rates than the national average. As illustrated in Figure 3, malaria continues

to be a leading cause of under 5 mortality in Ghana.


Figure 2. Under-five mortality rate by region in Ghana, 2000–2014.18,19,12,20,17,16

Figure 3: Distribution of causes of death among children under 5 years in Ghana, 2008.21

0

20

40

60

80

100

120

140

160

180

200

220

240

2000 Census DHS 2003 DHS 2008 2010 Census 2011 MICS DHS 2014

Dea

ths

per

1,0

00

live

bir

ths

Western Central Greater Accra Volta Eastern

Ashanti Brong Ahafo Northern Upper West Upper East

Malaria26%

Prematurity12%

Birth asphyxia11%

Pneumonia10%

Diarrhoea9%

Neonatal sepsis

9%

HIV/AIDS3%

Measles2%

Other18%


1.4.2 Infant mortality

The national infant mortality rate (IMR) has also declined over time. The IMR dropped from 90

deaths per 1,000 live births in 2000 to 59 deaths per 1,000 live births12. In the 2008 Ghana

Demographic and Health Survey (GDHS) report, however, IMR was 50 per 1,000 live births over the

survey period. Again, although there has been substantial progress towards achieving the MDG target

of 26 per 1,000 live births by 2015, actually achieving this target remains a major challenge.17

Wide geographical variations exist, with the probability of a child dying before the first birthday

being higher in rural areas than in urban areas (60 deaths per 1,000 live births compared with 55).

The sex variation in mortality indicates that a male child is more likely to die before age one than their

female counterparts. Among infants in rural areas, the IMR for males and females is 65 and 53 deaths

per 1,000 live births, respectively, compared with urban male and female IMRs of 60 and 49 deaths

per 1,000 live births, respectively. It is estimated that there are over three times as many infants dying

per 1,000 live births in the poorest wealth quintile compared to the richest.16 There is also substantial

variation in IMR among regions, with Greater Accra recording the lowest IMR of 48 deaths per 1,000

live births, in comparison to the Upper West that recorded the highest IMR of 81 deaths per 1,000 live

births.

A number of contributory factors such as increased socioeconomic development and immunization of

children against vaccine-preventable diseases (VPDs) as outlined in the Child Health Policy account

for much of the progress made in reducing morbidity and mortality. The country has not recorded any

documented death from measles since 2003, and since November 2008 there have not been any

reports of wild poliovirus (WPV).

Immunization against VPDs delineates the one key intervention to be scaled up alongside the

continuum of care. This focuses on improving access and quality, as well as increasing the demand

for essential services. This strategy identifies the recent new technologies such as low osmolarity oral

rehydration solution (ORS) and zinc for the management of diarrhea in children, the introduction of

new vaccines such as the second dose measles, pneumococcal, and rotavirus vaccines through the

national EPI.

An estimated 40% of all deaths that occur before the age of five years have been found to be

associated directly and indirectly with undernutrition, making it the single most important cause of

child mortality. In response, a number of initiatives have been implemented since 2007. The MOH in

its five-year programme of work (5YPOW III 2007–2011) and Ghana Health Sector Medium-Term

Development Plan (HSMTDP 2010–2013),22 in conjunction with the Ghana Health Service,

spearheaded the launch of the ‘Imagine Ghana Free of Malnutrition’ initiative. This was a multi-

sectoral strategy that sought to address malnutrition as a developmental problem in the context of the

Ghana Poverty Reduction Strategy (GPRS). The health sector has expanded its child health

interventions specifically in nutrition services, immunization, vitamin A supplementation, and

deworming that affect child nutritional and health status, primarily through the rapid delivery

approach.

Many challenges still beset child survival in Ghana, despite these efforts. These include the inability

to sustain funding to support programs under the EPI, therefore requiring a significant amount of

resource mobilization. There is the need for more innovative and efficient use of resources, as well as

sustainable measures for resource mobilization and allocation to the child health program.

The inadequacy of human resources and skills within the health system poses a major obstacle to

quality of care, especially in the area of neonatal, postnatal and child illnesses. Also underreporting of

child deaths and inadequate national data to provide complete and reliable information on child health

are major contributors to challenges in delivering child health interventions.


1.5 Overview of the National Immunization Programme

The 27th World Health Assembly (WHA), held in May 1974, established the Expanded Programme on

Immunization to ensure that all children, in all countries, benefited from life-saving and efficacious

vaccines.23 This decision was arrived at based on the success of the smallpox eradication program.24

The purpose for establishing the EPI Programme was to protect against the then six killer diseases

namely tuberculosis, diphtheria, tetanus, pertussis, measles and poliomyelitis. For infectious diseases

that can only be transmitted from person to person, immunization results in the elimination of the

disease and, eventually, can achieve the eradication of the organism that causes it.25 This was the case

with smallpox and may be the case with two other diseases—polio and measles.26

Immunization has contributed significantly in reducing the number of hospitalizations and treatment

costs through the prevention of infectious diseases.27 Thus, apart from the provision of clean water and

sanitation, immunization against VPDs has saved more lives than any other public health

intervention.25 It is estimated by WHO that immunization prevents about 2 to 3 million deaths every

year from VPDs.28 In the developing world where health care services can be hard to come by,

vaccinations are a child’s best chance of survival against life-threatening and debilitating diseases.

Routine immunization, an ongoing system that provides timely protection through vaccination to all

children, is at the center of these immunization efforts. The continued discovery, research, and the

development of new and improved vaccines has made immunization more effective in combating

major causes of childhood illness and death.

1.5.1 Historical overview of immunization

The EPI was established in Ghana in June 1978 with six antigens—Bacillus Calmette-Guérin (BCG),

measles, diphtheria-pertussis-tetanus (DPT), and oral polio vaccine for infants. Tetanus toxoid (TT)

vaccination was also introduced to protect against maternal and neonatal tetanus.29 The establishment

of the immunization program was in response to the National Health Policy to reduce morbidity and

mortality of VPDs, which then contributed significantly to both infant and child mortality in the

country.30

Ghana has a good legal framework backing immunization in the country. The Children’s Act of 1998

(Act 560) provides for a child’s right to education and wellbeing and explicitly mentions

immunization. “No person shall deprive a child access to education, immunization, adequate diet,

clothing, shelter, medical attention, or any other thing required for his development.’’31 The Public

Health Act of Ghana also details the regulation framework for who can give vaccination, the

responsibilities of the health professionals and the general public, and the sanctions to be applied for

any infractions of this law.32

The EPI Programme is implemented by GHS which is the largest public health service delivery

agency of the MOH. The program is situated within the Diseases Control and Prevention Department

(DCD) of the Public Health Division (PHD) of GHS. The mandate of the EPI Programme is to

contribute to the overall poverty reduction goal of the government through the reduction in child

morbidity and mortality. This is done by controlling, eliminating, or eradicating VPDs through

immunization; as an essential component of Primary Health Care (PHC).

Immunization services in Ghana are integrated into the public health system and form part of overall

child health care services at the regional, district, and sub-district levels. The policy of

decentralization allows for autonomy at these levels in planning and budgeting for service delivery,

including immunization services. Immunization performance is an integral part of the performance

assessment of health managers at all levels.


The EPI Programme has been strong in two key areas since its establishment. The first is the

remarkable improvement in the quality and coverage of the antigens on the national immunization

schedule. Quality-wise, the program has introduced innovative technologies to ensure the safety of all

vaccines, such as auto-disable syringes, safety boxes, and continuous temperature-loggers.29 The

coverage rates of antigens have increased from about 6% in the late 1970s to over 90% in recent

years.33 This has resulted in a corresponding decrease in the incidence of diseases. Tables 2 and 3

show the progress made in the control of VPDs.

The second is the expansion in the number of antigens on the national immunization schedule. The

EPI Programme was originally established with vaccines for what were then six killer diseases:

tuberculosis; diphtheria; tetanus; pertussis; measles; and poliomyelitis. The country added yellow

fever vaccine to the immunization schedule in 1992. Ten years later, hepatitis B (hepB) and

haemophilus influenza type b (Hib) vaccines were introduced. These vaccines were combined with

the already existing DPT into a DPT+hepB+ Hib pentavalent vaccine. In 2012, vaccines for

pneumonia and diarrhea were again added to the immunization schedule. In 2013, vaccination against

rubella was introduced in a bivalent measles-rubella (MR) vaccine. The EPI Programme is currently

providing vaccination against 12 VPDs. This is illustrated in Figure 4 and the vaccination schedule is

illustrated in Table 4.

Figure 4: Chronology of vaccine introductions in Ghana.34


1.5.2 EPI-related Health Indicators

Table 2. Summary of EPI-related Health Indicators, 2004–2014.33

Indicator

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

20

14

Infant mortality rate/1,000

live births 64 64 64 64 50 50 50 50 53 53 53

Under-five mortality

rate/1,000 live births 111 111 111 111 80 80 80 80 82 82 82

Maternal mortality

ratio/100,000 live births 214 214 214 214 451 451 451 451 350 350 350

Penta-3 vaccination

coverage (%) 76 85 84 88 87 89 87 87 88 86 90

Measles @ 9-month

vaccination coverage (%) 78 83 85 89 86 89 88 88 89 84 88

BCG vaccination coverage

(%) 92 100 100 102 103 104 102 105 104 98 103

OPV-3 vaccination

coverage (%) 76 85 84 88 86 89 87 87 87 86 90

Yellow Fever vaccination

coverage (%) 76 82 84 88 86 89 88 87 88 84 87

TT2+ vaccination coverage

(%) 62 71 68 71 76 79 76 76 74 71 62

Non polio AFP rate (%) 1.5 1.8 1.7 1.7 2.4 2.5 1.8 2.2 1.6 2.7 3.0

*All coverage rates calculated using birth cohort

Table 3. Trends in incidence of vaccine preventable diseases, 2005–2014.33

Year /Diseases 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Suspected Measles 439 420 588 1305 686 692 1744 1613 1081 1044

Confirmed Measles 66 81 8 81 101 36 109 330 319 124

Confirmed Rubella 32 32 175 459 135 160 552 372 168 26

NNT Cases 30 29 12 8 8 1 5 9 1 1

NNT Death NA 14 10 4 5 1 3 4 1 1

Suspected YF 2 7 0 174 210 321 575 327 428 546

Confirmed YF 1 3 6 0 0 0 31 3 7 4*

Pertussis 277 21 628 4 0 0 0 0 0 0

AFP 171 168 167 254 309 216 277 199 334 379

Confirmed polio 0 0 0 8 0 0 0 0 0 0

*Probable cases (No confirmatory test results available)


Figure 5 illustrates the association between increased MCV coverage and the reduction in suspected

measles cases, in addition to highlighting when supplementary immunization activities (SIAs) took

place.

Figure 5. Graphical relationship between suspected cases of measles and immunization coverage.33

Table 4. National Immunization and Vitamin A Supplementation Schedule.35

Age Vaccines Doses Route and Site of Injection

At birth BCG OPV0

0.05ml 2 drops

Intra-dermal, right upper arm Oral

6 weeks

DPT-HepB-Hib1 OPV1 Pneumo 1 Rota 1

0.5ml 2drops 0.5 ml 1.5 ml vial

Intra-muscular, lateral aspect of left thigh Oral Intra-muscular, lateral aspect of right thigh Oral

10 weeks




14 weeks

DPT-HepB-Hib3 Pneumo 3 OPV3 IPV

0.5ml 0.5 ml 2 drops 0.5ml

Intra-muscular, lateral aspect of left thigh Intra-muscular, lateral aspect of right thigh Oral Intra-muscular, lateral aspect of right thigh

6 months Vitamin A 100,000 IU Oral

9 months Measles-Rubella Yellow Fever

0.5ml 0.5ml

Subcutaneous, left upper arm Subcutaneous, right upper arm


18 months Measles-rubella Men A Vitamin A

0.5ml 0.5ml 200,000 IU

Subcutaneous, left upper arm Intra-muscular, right upper arm Oral

After 18 months Vitamin A is given every 6 months till child is 5 years’ old 18 months – Give long-lasting insecticide-treated nets (LLINs) to the child

0

10

20

30

40

50

60

70

80

90

100

0

5000

10000

15000

20000

25000

30000

35000

40000

45000

50000

19

94

19

95

19

96

19

97

19

98

19

99

20

00

20

01

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

20

14

Suspected Measles Cases MCV Coverage%

SIA

SIAMRSIA


1.5.3 Considerations for deciding to introduce a New Vaccine

EPI remains committed to its goal of universal access to all relevant vaccines for at risk populations.

The program aims to expand the targeted groups to include older children, adolescents, and adults and

work in synergy with other public health programs in order to control diseases and achieve better

health for all populations, particularly the underserved populations.

Vaccine introduction in Ghana depends on a number of factors. The first of these factors is to

establish the burden of the disease. There is the need to demonstrate with data the morbidity and

mortality caused by the disease as well as hospitalizations associated with the disease. It is also

important to assess available control strategies and establish that immunization is the best and feasible

option in terms of cost-effectiveness. The efficacy, safety, acceptability, and cost of available vaccines

have to be considered as well.

The country has to prioritize the disease as a public health problem and also assess the financial

implications. Programmatic issues such as the immunization schedule, cold chain, change in recording

and reporting forms, human resources, as well as service delivery must be considered.

1.5.4 Planned New Vaccine Introductions

A key strategy of the comprehensive multi-year plan (cMYP 2015–2019) of EPI is to ensure effective

and sustainable introduction of new vaccines and technologies to improve the health status of the

population.29 The following are vaccines planned for introduction, with committed donor support.

Meningitis A vaccine—GHS has received approval from Gavi, the Vaccine Alliance (Gavi) to

nationally introduce Meningococcal A Conjugate Vaccine into routine immunization in

November 2016, to be administered at 18 months of age. It is expected that the introduction of

this vaccine will help maintain population immunity and consolidate the gains in preventing

meningitis made after the Meningococcal Conjugate Vaccine type A (Men A) campaign in 2012.

It will also help eliminate meningitis outbreaks due to Meningococcal serotype A. A catch-up

campaign was conducted in August 2016 in preparation for the national introduction.

Inactivated Polio vaccine—As part of the Global Polio Eradication Initiative (GPEI), Gavi is also

supporting the country to introduce inactivated polio vaccine (IPV) into routine immunization.

The vaccine is expected to be introduced by the third quarter of 2017. The introduction of the

vaccine is in line with the polio end-game strategy.

The structures that will be put in place before the introduction will help strengthen the routine

immunization and the overall health system in-country.

1.5.5 Candidate vaccines under consideration for introduction

The country has successfully completed the Human papillomavirus (HPV) demonstration vaccination

project. The country is currently putting together an application to Gavi for support to introduce the

vaccine nationally.

Other potential vaccines that may be introduced are RTS,S (depending on the outcome of the pilot

implementation programme) and hepB for newborns.

1.6 Overview of National Malaria Control Programme

Globally, malaria is estimated to impose an economic growth penalty of over 1.2% of the Gross

Domestic Product (GDP) on endemic countries. WHO estimated that the total cost of malaria to

Africa was US$ 1.8 billion in 1995 and US$ 2 billion in 1997.36 In Ghana, malaria has been hyper-

endemic and accounts for a considerable disease burden. Malaria persists as the leading cause of

mortality and morbidity in Ghana, especially among children under five years and pregnant women


(see Figure 3). Intensive government efforts at controlling malaria in Ghana dates back to 1957 when

a malaria control unit within the MOH was established in the Volta Region in collaboration with

WHO to train personnel in geographical reconnaissance, malariometric and entomological surveys,

and to conduct trials of indoor residual insecticide application in the control of adult mosquito

populations. Ghana followed this up in 1961 with the creation of a National Malaria Service when the

country adopted the global Malaria Eradication Programme, which used residual spraying and

larvicides to control malaria vectors. The program had to be discontinued in 1967 for technical and

financial reasons. In 1992, the country launched a 5-year (1993–1997) National Malaria Control

Action Plan with the focus on capacity building for improved disease management in health facilities.

Drawing on past experiences and lessons, an accelerated malaria control program piloted in 30

districts was launched in 1997, again with a focus on case management.

In 1998 Ghana committed itself to the Roll Back Malaria (RBM) Initiative, which builds on the

Global Malaria Strategy with a focus on Africa. The goal of the RBM Initiative was to halve the

world's malaria burden by 2010. Consequently, the country drew a Medium-Term Strategic Plan for

Malaria Control in Ghana (1998-2002), which sought to improve the coverage of malaria control

activity by adopting an inter-sectoral approach, involving other government sectors and partnership

with the private sector and the community. It also committed itself to the Abuja Declaration on RBM

in Africa, which similarly sought to achieve specific targets on malaria prevention and control with

time limits.37

Unfortunately, the various control measures undertaken over the years met with limited success

mainly due to factors including a focus on single strategies, lack of funding, poor human resource

capacity, and non-involvement of NGOs, civil society and other stakeholders. A new national

strategic malaria control plan was therefore developed (2000-2008) in 2001 based on RBM principles

of multiple interventions, involvement of all stakeholders, and evidence-based interventions. Key

interventions promoted in the new RBM Plan included promoting home-based care, use of

insecticide-treated bed nets (ITN)/ long-lasting insecticide-treated nets (LLIN), improving case

management in health facilities, and use of appropriate chemoprophylaxis in pregnancy. Initially,

implementation of most of these interventions was limited in scale due to lack of funds and capacity

to scale up. Some funds were therefore mobilized in 2002 from the Global Fund to implement some

of these interventions in 20 selected districts initially with the view of scaling up to the remaining 90

districts over the next 5 years. In 2004, additional funding was mobilized from the Global Fund and

other partners to scale up most of the interventions countrywide.

The 2008-2015 National Strategic Plan (NSP) was revised to produce the 2014-2020 NSP after a

comprehensive program review in 2013 building on the gains made and the lessons learned over the

years. The key intervention areas of the seven-year strategic plan are: integrated vector management;

malaria case management including malaria in pregnancy; integrated community case management;

seasonal malaria chemoprevention; the private sector co-payment mechanism to expand access to

quality-assured, affordable artemisinin-based combination therapy (ACT); and monitoring and

evaluation.

Integrated support systems include advocacy, behavior change communication, procurement, supply

management, health systems strengthening, governance and programme management, partnerships,

and resource mobilization.

The Government of Ghana remains the main responsible entity for financing the health sector through

the development and maintenance of health infrastructure and human resources. Other major sources

of funding and technical support for malaria control have been the Global Fund, the US Agency for

International Development (USAID)/President’s Malaria Initiative (PMI), Department for

International Development (DFID), and WHO, among others. With the dwindling of external

financial resources, there is an increasing move to mobilize internal resources to support the

implementation of the NSP so as to sustain the gains achieved over the years. For example, the Ghana

Malaria Foundation, which was launched in August 2016, is a private sector collaboration to assemble


funds through domestic resources for malaria control and intended to support work toward malaria

elimination.

Currently all the malaria prevention interventions are deployed nationwide except indoor residual

spraying (IRS) and seasonal malaria chemoprevention (SMC), which have subnational

implementation. IRS is implemented in the Upper West Region, Northern Region (5 districts) and

Ashanti Region (3 districts) whereas SMC is implanted in the Upper West and Upper East regions.

2. Epidemiology of Malaria

2.1 Population at risk

The entire population of Ghana (approximately 27 million) is at risk of malaria but the most

vulnerable groups are children under five years of age, pregnant women and persons with immune-

compromised conditions. Most of the population have a naturally acquired partial immunity which

wanes after six months if a person moves to a non-malaria region.2

2.2 Malaria parasite endemicity

In Ghana, Plasmodium falciparum is the predominant malaria parasite (about 80-90%) causing severe

morbidity and mortality particularly in children under five years of age and pregnant women. The

other parasites found in Ghana are the Plasmodium malariae (about 10-20%) and Plasmodium ovale

(about 1%). Plasmodium vivax has not been reported from health facilities or identified in any part of

the country because historically more than 90% of the population in West Africa have negative Duffy

antigens on red blood cells, making them relatively unsusceptible to infections with P.vivax.

Mara modelling in 2002 classified Ghana as being mainly hyperendemic (75%).38 However, malaria

is generally stable in Ghana and recent studies in 2011(MICS) and 2014 (GDHS) have shown

endemicity ranging from hypoendemicity in the Greater Accra Region to hyperendemicity in the

Upper West Region and mesoendemicity in the rest of the country (Figures 6 and 7).

2.3 Morbidity and Mortality

Malaria is a major cause of hospital attendance contributing to about 30% of OPD, 28% of

admissions. Severe forms of the disease is characterised by high body temperatures, passage of cola

coloured urine, anaemia, lethargy, prostration and eventual death due to complications. Diagnosis is

confirmed by the presence of parasite in a blood smear for microscopy or the detection of the parasite

antigens in a resample capillary blood on a rapid diagnostic test kit. The presence of fever for two to

three days is a cardinal sign for the suspicion of malaria in highly endemic regions.

In 2015, the country recorded about 10.1 million suspected cases and of these 4,315,379 (42.4%) were

confirmed malaria cases. The total number of deaths attributable to malaria in 2015 was 2,133 and of

these 1033 (48.4%) were in children under five years of age. Under-five case fatality rates however

have been declining over the past 5 years as shown in Figure 8.


Figure 6. Parasite prevalence in children 6 to 59 months of age according to microscopy in 2011 and

2014.39

*Both surveys were implemented during the peak transmission season: mid-September–mid-

December.

Figure 7. Parasite prevalence in children 6 to 59 months of age according to microscopy in 2011 and

2014.39

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Parasite prevalence (MICS 2011) Parasite prevalence (GDHS 2014)


Figure 8. Malaria case fatality rates for children under five years of age in Ghana, 2010–2015.2

2.4 Coverage of Key Malaria Interventions

Currently malaria case management, including malaria in pregnancy, and all the malaria prevention

interventions are deployed nationally except IRS and SMC, which have subnational implementation.

IRS is implemented on a small scale in the Upper West Region, Northern Region (5 districts), and

Ashanti Region (3 districts) and has challenges with sustained funding.39 SMC is currently

implemented in the Upper West region annually—July to October—with funding from 2015 to 2018.

At the regional and district levels malaria control is integrated into the broad health service delivery

system.40 In communities where CHPS is not present, community-based agents or volunteers are

trained to address cases of malaria, pneumonia, and diarrhea. The capacity of the staff at lower levels,

especially CHPS zones, to execute malaria control activities is limited and the system is not optimally

utilizing the potentials of the CHPS concept for scaling up malaria control interventions.40

Figure 10 illustrates that analysis of Ghana DHS surveys from 2003 to 2014 there has been a

substantial increase in net ownership and usage. Further analysis in Figure 11 shows that while

households (HH) with ownership of at least one net has increased; however, children <5 years of age

sleeping under the net is still sub-optimal. Meanwhile, children <5 years of age ill within two weeks

preceding the survey and had an anti-malarial varies across the indicators shown in Figure 12, and

remains relatively stagnant.

1.32

1.20

0.60 0.57 0.54 0.51

0.00

0.20

0.40

0.60

0.80

1.00

1.20

1.40

2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 2 0 1 4 2 0 1 5

MA

LAR

IA U

ND

ER F

IVE

CFR

YEAR


Figure 9. Number of OPD malaria cases (suspected and tested) put on ACT in Ghana, 2011–2015.2

Figure 10. Mosquito net ownership and usage in Ghana, 2003–2014. 3, 17, 20

9,7

19

10

,67

8

11

,05

9

7,5

31

10

,18

0

4,3

92

4,0

16 5

,38

5

5,5

90

7,4

98

3,8

47

6,1

42

9,5

36

6,1

94

5,8

42

2 0 1 1 2 0 1 2 2 0 1 3 2 0 1 4 2 0 1 5

NU

MB

ER O

F M

ALA

RIA

CA

SES

(1,0

00

)

YEAROPD Malaria Cases (Suspected) Opd Malaria Cases (Tested) Opd Malaria Cases Put on Acts

0

10

20

30

40

50

60

70

80

90

100

GDHS, 2003 GDHS, 2008 GDHS, 2014

Per

cen

tage

Year of Ghana Demographic and Health Survey

% of children <5 who slept under a treated net the previous night

% of households that own at least one treat net

% of households that own at least one net (treated or untreated)


Figure 11. Use and ownership of mosquito nets in Ghana, 2003–2014. 3, 16, 17, 20

Figure 12. Malaria treatment in children under the age of 5 in Ghana, 2003–2014. 3, 16, 17, 20

GDHS 2003 MICS 2006 GDHS 2008 MICS 2011 GDHS 2014

% of HH with at least one net 18 30 45 51 70

% of HH with at least one ITN 3 19 33 49 68

% of children <5 years who sleptunder a bednet the previous night

15 33 41 42 48

% of children <5 years who sleptunder and ITN the previous night

4 22 28 39 47

0

10

20

30

40

50

60

70

80

90

100

Per

cen

tage

GDHS 2003 MICS 2006 GDHS 2008 MICS 2011 GDHS 2014

% of children <5 years who were illwith fever the last 2 weeks precedingthe survey and had an anti-malarial

63 61 43 53 55

% of children <5 years who were illwith fever the last 2 weeks precedingthe survey and had an anti-malarial

within 24hrs

44 48 24 35 39

% of children <5 years who were illwith fever the last 2 weeks preceding

the survey and had an ACT4 22 18 31

0

10

20

30

40

50

60

70

80

90

100

Per

cen

tage


Figure 13. Proportion of pregnant women put on intermittent preventive treatment in pregnancy (IPT)

in Ghana, 2011–2015.2

3. RTS,S vaccine

3.1 RTS,S vaccine history, characteristics, and technical

specifications

The RTS,S malaria vaccine was developed over a 30-year period and tested for the active

immunization of children aged 6 weeks to 17 months against malaria caused by the Plasmodium

falciparum parasite. The vaccine confers partial protection against malaria in young children. It was

developed through a partnership between GSK and the PATH Malaria Vaccine Initiative (MVI), with

support from the Bill & Melinda Gates Foundation, and from a network of African research centers

that performed the studies. The clinical testing of RTS,S is at least 5 to 10 years ahead of other

candidate malaria vaccines.

RTS,S is a vaccine against Plasmodium falciparum, the most deadly malaria parasite globally, and the

most prevalent in Africa. The vaccine is being assessed as a complementary malaria control tool that

could potentially be added to—but not replace—the core package of proven malaria preventive,

diagnostic, and treatment procedures.

RTS,S completed a phase 3 clinical trial of approximately 15,000 infants and young children in 7 sub-

Saharan African countries (overview of the trial is summarized in Appendix 2). In Ghana, the trials

were conducted in Kintampo (Brong Ahafo Region) and in Agogo (Ashanti Region). The RTS,S

vaccine was tested in two age groups—infants 6-12 weeks and children 5-17 months—and assessed

as a 0/1/2 month schedule with a fourth dose 18 months after the third dose.41 The available evidence

suggests that the schedule must be a three-dose primary series with a minimum interval between doses

of four weeks, followed by a later fourth dose. The primary three doses are recommended to be

initiated as close as possible to 5 months of age and completed by 9 months of age, using the

measles/yellow fever contact. A fourth dose should be administered 15-18 months following the last

67.569.8

61.2

54.1

69.0

53.757.8

51.0

38.7

58.0

37.441.4

37.2

24.6

41.3

4.1

15.7

1.25.8

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

2011 2012 2013 2014 2015

PR

OP

OR

TIO

N O

F IP

T 1

-5

UP

TAK

E

YEAR

IPT 1 IPT 2 IPT 3 IPT 4 IPT 5


dose of the primary series. Because the vaccine efficacy was notably lower in the 6-12 weeks age

group, RTS,S has been recommended by WHO only to be used in the 5-17 month age group.

3.1.1 RTS,S vaccine technical specifications

RTS,S is a pre-erythrocytic stage hybrid recombinant protein vaccine. It is comprised of the P.

falciparum circumsporozoite protein fused to the hepatitis B surface antigen, co-expressed in yeast

with non-fused hepatitis B surface antigen with its adjuvant system AS01E. In the pivotal phase 3

trial, the reconstituted 0.5mL vaccine was administered via the intramuscular route among the 6-12

weeks age group, and 5-17 months using a 0/1/2 month schedule with a fourth RTS,S dose given 18

months after the third dose. The WHO Programmatic Suitability for Prequalification (PSPQ) Standing

Committee confirmed the suitability of the proposed two-dose vial presentation. The vaccine is stored

at 2–8 degrees Celsius (Appendix 3).41

3.2 RTS,S Vaccine safety

The safety and efficacy of RTS,S was evaluated in a randomized, controlled, multi-center, participant-

and observer-blinded phase 3 clinical trial. Two age categories (5-17 months and 6-12 weeks at first

vaccination) were enrolled between May 2009 and February 2011. A total of 6,537 6-12 weeks old

and 8,922 5-17 months-old were randomized in the trial.6

Vaccine reactogenicity: In both age categories, drowsiness, irritability, loss of appetite, and fever

(>37.5⁰C) were most frequently reported. The incidence of fever in the week after vaccination was

higher in children who received RTS,S than in those receiving the control vaccine. Grade 3 reactions

were rare, with the highest report being for Grade 3 fever (>39⁰C) among children who received the

RTS,S vaccine.42 In some children who experienced fever, the febrile reaction was accompanied by

generalized convulsions, but all those affected fully recovered within seven days.

Serious adverse events (SAEs): In the 5-17 month age group, from the first dose to the trial end (M0-

SE), SAEs were slightly less frequent in the RTS,S groups compared to the control group and this

remained so when malaria was excluded as an SAE. Twelve of the 1,472 reported SAEs in the RTS,S

groups (with and without the fourth dose), were considered related to the vaccine by the investigator,

(seven seizures, three episodes of pyrexia, one episode of myositis, and one injection-site reaction). In

the 6-12 week age category, from M0-SE, the frequency of SAEs reported in RTS,S groups and the

control group were similar and this remained so when malaria was excluded. Of the 1,182 reported

SAEs in the RTS,S groups, seven were considered related to the vaccine by the investigator (one

injection site reaction, two episodes of pyrexia, and four episodes febrile convulsions).43

There was an imbalance in the occurrence of meningitis among children 5–17 months in the study

cohort—more among the children who received RTS,S than those who did not. This could be a

chance finding, because comparisons were made across groups for many different diseases: the cases

of meningitis had a variety of aetiologies; some of these cases happened years after vaccination

without any obvious relationship to vaccination; and most of the cases were clustered in two sites. The

occurrence of meningitis will be followed closely during phase 4 studies, if RTS,S is licensed.

An increased number of cerebral malaria cases were documented in children in the older age category

malaria vaccine groups compared to the control group. This finding was in a subgroup analysis and its

significance in relation to vaccination is unclear. An excess of cerebral malaria was not seen in

children vaccinated in the younger age group. A planned post-authorization safety study (EPI-

MALARIA-003 VS AME) will continue to monitor these signals and other adverse events following

immunization (AEFI) and adverse events of special interest (AESI), during early implementation of

RTS,S as part of the phase 4 studies. A current baseline safety study is ongoing (MAL-EPI-002) prior


to RTS,S implementation to establish baseline rates of adverse events in the first three years of life.

Ghana is participating in this study through the Kintampo and Navrango research centres.

3.3 RTS,S Vaccine efficacy

Vaccine efficacy (VE) is described for the following time points: 12 months, 18 months (pre-fourth

dose) and study end (four doses) in the two age categories of children—5–17 months and 6–12

weeks—at the time of first vaccinations. Summary details can be found in Appendices 3, 4, and 5.

3.3.1 Vaccine efficacy against clinical malaria

Vaccine efficacy against all episodes of clinical malaria in the 5–17 month age group 12 months

following the first three doses was 51% across all sites, which declined to 46% by 18 months

following the first three doses and then to 26% by the end of the trial among participants who did not

receive a fourth dose. The addition of a fourth dose 18 months following the first three doses

increased the overall efficacy to 39%. The vaccine efficacy of three primary doses and the fourth

dose was 31.1% and 25.9% in Agogo and Kintampo, respectively. Up to the end of the study, vaccine

efficacy at each study site was higher among those who received a fourth dose, although the

confidence intervals are wide. Vaccine efficacy declined similarly across transmission sites over

time.5, 6

Vaccine efficacy against all episodes of clinical malaria in the 6–12 weeks age group 12 months

following the first three doses was 33% across all sites, which declined to 27% by 18 months

following the first three doses and then to 18% among participants not receiving a fourth dose of

RTS,S. The addition of a fourth dose 18 months following the first three doses increased overall

efficacy to 27%.5 In Ghana, the vaccine efficacy of a three-dose primary series with a fourth dose was

34.6%, but no vaccine efficacy was demonstrated in Kintampo. No plausible explanations have been

found for this finding, as the data quality in Kintampo was as good as all other participating research

sites. 5, 6

3.3.2 Vaccine efficacy against severe malaria

Vaccine efficacy against all episodes of severe malaria in the first 12 months was 45%, then estimated

at 36% up to 18 months and by the trial end (in the group without a fourth dose of RTS,S), the overall

efficacy was estimated at -6%, suggesting that three doses alone had no effect on the overall incidence

of severe malaria in high transmission settings (Appendix 7). The apparent protective effect in the

first 18 months was balanced by an age shift of cases in the period from 18 months to the end of the

trial. Among trial participants who received a fourth dose, the vaccine efficacy against severe malaria

was 32% by trial end.5, 6

3.3.3 Other outcomes

In the 5–17 month age category, there was a 42% reduction in hospitalization due to malaria 18

months following the first three doses, which fell to 12% among those receiving three doses by the

trial end and 40% among those receiving four doses during the full observation period. 5, 6

Overall, RTS,S prevented a substantial number of cases of clinical malaria over a three- to four- year

period in children and in young infants when administered with or without a booster dose, especially

in areas with higher malaria transmission. Efficacy against severe malaria over the entire study

period until study end was only observed in the older group of children who received a fourth dose of

RTS,S. An increased risk for severe malaria cannot be excluded in children not receiving a fourth

dose.5, 6


Duration of protectiona

A smaller phase II study was conducted in Kenya looking at the duration of protection. The study

followed 312 of the original 447 participants enrolled and showed that a three-dose vaccination regimen

with RTS,S was initially protective, but the benefits were offset by a rebound or age shift in the fifth

year of follow-up among children on the coast of Kenya (a fairly low-transmission area) who were at

higher-than-average exposure to malaria parasites.

This follow-up study was conducted with the three-dose regimen, rather than the four doses, which has

been recommended by WHO and is the dosing that will be used in the RTS,S pilot implementation

programme. A large-phase III trial of the vaccine conducted at eleven sites in seven countries showed

that children who received four doses of RTS,S were protected against malaria for at least four years.

Three of the eleven sites that participated in the phase III trial are undertaking extended surveillance of

the vaccine beyond year four that may help us better understand the duration of efficacy of a four-dose

schedule of the vaccine.

3.4 Co-administration with other vaccines

RTS,S was evaluated together with EPI vaccines in a randomized, open-label, phase 2 trial in Ghana,

Tanzania, and Gabon. Diptheria toxoid, tetanus, and pertussis (DTwP),/HepB/Hib+oral (penta), oral

polio vaccine (OPV) was co-administered at visits 0/1/2, and measles and yellow fever was

administered at month 7.

The safety results were consistent with other phase 2 trials. Among the serious events reported, none

were judged to be related to vaccination.44 The antibody response of all EPI antigens (hepatitis B,

diphtheria, tetanus, pertussis, polio [types 1 and 2], measles, yellow fever) when administered with

RTS,S was similar to when the EPI vaccines are administered alone with the exception of polio 3, for

which antibody titres were lower.45

In another co-administration trial in Ghana, RTS,S was co-administered with EPI antigens, including

pneumococcal conjugate vaccine (PCV10) and rotavirus vaccine. Antibody response to major

pneumococcal antigens (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 19F and 23F) were similar when the

vaccine was administered with or without RTS,S. Similarly, rota vaccine antigen response was also

demonstrated when administered with or without RTS,S. There was no evidence of interference by

RTS,S/ASO1E on the immune responses of the already licensed and in use vaccines.5

3.5 Special risk groups

A trial in Kenya evaluated safety and immunogenicity of three doses of RTS,S (administered on a

0/1/2 month schedule) in 200 HIV-infected children from 6 to 17 months of age (80% in 5–17 month

range; HIV stage I and II) randomized 1:1 to receive RTS,S or a control vaccine (rabies). EPI

vaccines were given at least 7 days apart from RTS,S.46 At the time of the first vaccine dose, 92% of

participants were taking co-trimoxazole; and by one month following dose 3, 97% were on anti-

retroviral therapy (up from 73% at the initiation of the trial).

RTS,S was immunogenic among the 99 participants who received the experimental vaccine (anti-

Chondroitin Sulfate antibody geometric mean concentration (GMC) of 329 EU/mL at 1 month post

dose 3). Vaccine efficacy against clinical malaria was estimated over 12 months post-dose 3 and was

37.2% (95% CI: -26.5%, 68.8%, According-to-Protocol (ATP) cohort). During this observation

a Ally Olotu, Ph.D. et al. Seven-year Efficacy of RTS,S/AS01 Malaria Vaccine among Young African Children. The New England

Journal of Medicine. 2016; 374:2519-2529.


period, one episode of severe malaria occurred in the RTS,S group compared to eight episodes in the

rabies vaccine group. 46

During 14 months following the first dose, the proportion of participants reporting at least one SAE

was similar in the RTS,S and control groups at 41.4% (95% CI: 31.6, 51.8) in the RTS,S group and

36.6% (95% CI: 27.3, 46.8) in the rabies vaccine group. The most common SAEs reported were

pneumonia, gastroenteritis, and febrile convulsions. Of nine fatal SAEs, five occurred in the RTS,S

group and 4 in the rabies vaccine group, none of which were judged to be related to vaccination.

Unsolicited adverse events occurred in a similar proportion of subjects in both groups in the 30 days

post-vaccination (99%). There was no significant difference between growth parameters.46

There was also no significant difference between the RTS,S and rabies vaccine groups on CD4+ T-

cell %age, CD4 + T-cell absolute counts and WHO AIDS clinical classification. There was no

difference in HIV viral load reduction between the two groups by 12 months post dose 3, though there

was a trend for a more marked reduction in HIV viral load at 1 and 6 months post dose 3 in the rabies

group (not statistically significant). 46

The results, therefore, provide a level of confidence that RTS,S is safe to administer to HIV-positive

children, without requiring HIV screening. Additionally, the study findings suggested that RTS,S may

help to reduce the risk of malaria in young children already burdened with early-stage HIV.

4. Status of other malaria vaccines in development

More than 30 P. falciparum malaria-vaccine projects are at either advanced preclinical or clinical

stages of evaluation (Appendix 8).47 Approaches that target all parts of the parasite’s lifecycle are

being developed, but only RTS,S (a liver-stage vaccine) has completed pivotal phase 3 evaluation and

been approved by regulators. Other vaccine trials are ongoing and described in Appendix 8, or on

WHO website. It is unlikely that a next-generation malaria vaccine will be available in 5 to 10 years’

time.

5. Economic and Financial considerations

5.1 Economic burden of disease

The Economic cost of malaria to businesses in Ghana in 2014 was US$6,588,729.09 (i.e. GHS20,

088,310.23). About 90% of the total cost was direct costs, and 10% was indirect cost i.e. productivity

losses due to worker absenteeism. In 2015 a study of firms in Ashanti, Greater Accra and Western

regions showed that businesses lose 30 productive working days per employee each year due to

malaria related illness.48

It is documented that a mean amount of US$2.76 and US$11.84 were incurred by household as direct

and indirect costs respectively and on average a household incurred a total cost of US$14.61 per

patient per episode.49

In Ghana, estimates of the economic burden of malaria on households and the economy abound.

Asante and Asenso-Okyere (2003) estimated that in Ghana, a 1% increase in malaria morbidity

reduces economic growth by about 0.41%, and that an episode of malaria costs households US$15.79

(in 2003 dollars). Abotsi (2012) estimated that an episode of malaria costs households between

US$10.20 (uncomplicated malaria) and US$46.62 (severe malaria) (in 2007 dollars). Furthermore,


Sicuri, Vieta, Lindner, Constenla, and Sauboin (2013) found that households spent between US$5.70

(uncomplicated malaria) and US$48.73 (severe) in Ghana.50

5.2 Public health impact and cost-effectiveness of the RTS,S malaria vaccine

A WHO-led project worked with four modelling groupsc to generate and summarize public health

impact (PHI) and cost-effectiveness (CE) estimates for the use of RTS,S in different malaria

transmission settings.8 The modelling predictions indicate a significant public health impact and high

level of cost-effectiveness of RTS,S in moderate to high transmission settings, if implemented after

achieving high LLIN usage, and high coverage of SMC (where this intervention is appropriate).8

Using the RTS,S phase 3 clinical trial data, all models assumed:

A 3- and 4-dose schedule, with the first three doses given at 6, 7.5 and 9 months and a 4th dose at

27 months.

Vaccination coverage of 90% for the first 3 doses and 72% for the fourth dose.

A cost of $5 (USD) per dose (range of $2–10 per dose).

Parasite prevalence in 2 to 10 year olds (PfPR2-10), across a range of 3 to 65 %.

Access to ACT treatment at 45%.51

Implementation of RTS,S is in the context of other malaria control interventions (e.g., LLINs,

IRS) and treatment.

Outputs are cumulative over a 15 year horizon across the entire population and for children under

5 years of age.

The models generated estimated outputs for:

Clinical malaria cases averted per 100,000 fully vaccinated children.

Severe malaria cases averted per 100,000 fully vaccinated children.

Deaths and disability-adjusted life years (DALYs, primarily driven by mortality) averted per

100,000 fully vaccinated children (defined by three doses given).

Key limitations:

The phase 3 clinical trials were not powered to show impact on mortality, and due to the excellent

clinical care received, there was a marked reduction in mortality among all trial participants,52

minimizing the ability to measure impact.

The model projections assume that 72% of children received the fourth dose, compared to near

100% coverage in the trial.

5.2.1 Estimated public health impact

All modelling groups predict a positive public health impact over a 15-year time horizon with the

introduction of RTS,S in parasite prevalence (PfPR2-10) settings between 10% and 65%. Depending on

malaria transmission settings, it is estimated that 6 to 29% of deaths in children under 5 years of age

could be averted with the addition of RTS,S to existing LLIN coverage (68%)52,53 and with access to

c The four modeling groups are: Imperial College of London (Imperial); Institute of Disease Modeling in Bellevue, Washington (IDM); Swiss

Tropical and Public health Institute of Basel, Switzerland (Swiss TPH); and Glaxo-Smith Kline of Belgium (GSK).


malaria treatment (see Appendix 11 for a summary of limitations). For areas where PfPR2-10 > 10%,

RTS,S is predicted to be cost-effective compared to standard norms and thresholds. In the context of

Ghana, the entire country has a PfPR2-10 greater than 10%, and 7 out of the 10 regions are above

20%. Based on the modelled estimates and Ghana’s burden of disease, Ghana could potentially see a

significant public health impact with the use of RTS,S alongside other malaria control interventions.3

The estimated absolute impact of RTS,S for clinical cases and malaria deaths in children under the

age of 5 was shown to be greater in areas of higher malaria transmission settings. The vaccine impact

is estimated to avert 116,500 (30,900-160,000) cases of clinical malaria and 484 (195-838) deaths per

100,000 vaccinated children under a 4-dose schedule for PfPR2-10 between 10% and 65% (Appendix

9). This translates to approximately one malaria death prevented for every 200 children fully

vaccinated. Table 6 summarizes the estimated median deaths that could be averted per 100,000

vaccinated children under the age of five in different parasite prevalence settings by region in Ghana.

Table 5. Estimated malaria cases and deaths averted in children under 5 years of age receiving 4

doses of RTS,S in malaria transmission settings with PfPR2-10 between 10 to 65 %.

%age of events averted in PfPR2-10

settings of 10 to 65% (children

under 5 years of age)

Impact per 100,000 vaccinated

children (entire population)

Malaria clinical cases 21% (8-31%) 116,500 (31,500 to 160,500)

Malaria deaths 18% (6-29%) 484 (190 to 860)


Table 6. Estimated median deaths averted per 100,000 vaccinated based on subnational parasite

prevalence settings.

Region Parasite prevalence

PfPR2-10 (2014)3

Surviving infants

(2017)54

Annual modelled

malaria deaths for

children <5 yrs old55

Estimated median

deaths averted per

100,000 range (min

to max) based on

PfPR2-108

Northern 40% 76,500 4,200 523 (486-831)

Western 39% 73,000 4,200 523 (486-831)

Upper West 38% 21,100 1,300 523 (486-831)

Central 38% 66,700 3,700 523 (486-831)

Eastern 30% 82,500 4,300 459 (406-715)

Brong-Ahafo 27% 71,200 4,000 459 (406-715)

Volta 25% 67,100 2,800 420 (372-650)

Ashanti 17% 154,500 6,900 400 (336-616)

Upper East 12% 31,700 1,800 229 (189-344)

Greater Accra 11% 129,800 3,500 229 (189 -344)

Total 774,100 36,700 (malaria)

54,000 (all-cause)56

Estimated global malaria-related deaths averted per 100,000 children vaccinated with 3 doses of RTS,S,

by PfPR2-10 8

Median deaths

averted range

(min to max)

229

(189-344)

353

(250-511)

400

(336-616)

420

(372-650)

459

(406-715)

519

(465-831)

523

(486-831)

546

(507-854)

PfPR2-10 10 15 20 25 30 35 40 45

In all models, RTS,S vaccination is predicted to lead to an age shift in malaria incidence with children

of older ages becoming more affected by disease where enhanced prevention measures are

implemented, although the overall benefit is predicted to be positive. In high prevalence settings this

shift is predicted to occur sooner than in moderate or low transmission settings. The age-shift is

predicted to occur sooner for more severe disease than for uncomplicated malaria cases. The predicted

age shift is common to any preventive malaria intervention, and indeed a more pronounced age shift is

predicted for SMC.1

5.2.3 Estimated cost-effectiveness

The median of the 4 model predictions for the costs of routine RTS,S vaccination in a 4-dose schedule

is US$ 87 per DALY averted (assuming US$ 5 vaccine cost per dose) in settings with PfPR2-10

between 10% and 65% and increases as transmission decreases below a PfPR2-10 of 10%. These

estimates are consistent with the cost per DALY averted for other vaccines in a broad range of

developing countries.1,57,58,61 The cost-effectiveness estimates for RTS,S are below the national GDPs

per capita (median $842, interquartile range: 531-1668 across 43 malaria endemic African countries


with PfPR2-10 >10% in 2014).59 Furthermore, in settings with levels of 20% or greater, estimated

incremental cost-effectiveness ratios (ICERs) at a vaccine price of $5 are below $100 per DALY

averted.

The average incremental costs per DALY averted summarized in a 2011 review shows RTS,S as

slightly less cost-effective than LLINs, which are currently considered one of the most cost-effective

interventions available for malaria control (Table 7).60

Table 7. Summarized average incremental costs per DALY averted (2009 prices) for other malaria

prevention interventions.61

Intervention Incremental cost per DALY averted

LLINs $27 (range of $8.15 to 110)

Insecticide residual spraying (IRS) $143 (range of $135-150)

Intermittent preventative treatment (IPT) $24 ($1·08-44·24)

There was wide variation in the costing methodologies employed and economies of scale captured by

these studies and hence these figures should be interpreted as indicative ranges rather than directly

corresponding to the RTS,S estimates.

The RTS,S ICERs were lowest at intermediate levels of PfPR2-10 (Table 8, Appendix 10), however in

PfPR2-10>10%, they are generally below a threshold of $100 per DALY averted for a vaccine price of

$5 per dose. At PfPR2-10<10% the vaccine is estimated to be less cost-effective due to fewer cases and

deaths being averted for the same overall cost of a vaccine program. There is also less consensus

between the models at PfPR2-10<10%. The predicted ICER of a 4-dose schedule varied between the

models due to the different public health impact projections of the fourth dose. However, overall we

estimated the ICERs (compared to no vaccination) for the 4-dose schedule to be similar to those

estimated for 3-dose schedule (see Table 8). 8

Table 8. Summary predictions of public health impact and cost-effectiveness of RTS,S in areas of

PfPR2-10 between 10% and 65% for the 6-9 month immunization schedule under 3- and 4-dose schedules

at 15 years follow-up. Estimates are presented as median and ranges across the models’ medians.8

Outcome 6-9 months with three doses 6-9 months with fourth dose

at 24 months

Proportion of clinical cases under 5 averted 16.2% (7.3-24.1) 21.1% (7.9-30.6)

Proportion of deaths under 5 averted 13.8% (5.3-21.4) 18.0% (6.0-29.1)

Clinical cases averted per 100,000 fully

vaccinated

93,940 (20,490-126,540) 116,500 (31,500 to 160,500)

Deaths averted per 100,000 fully vaccinated 394 (127-708) 484 (189-859)

Incremental benefit (% of additional events averted of boosting schedule compared to non-boosting)

Clinical cases - 22% (3-49)

Deaths - 31% (-1-53)

ICER per clinical case averted:

$2 a dose $13 ($7-88) $10 ($6-93)

$5 a dose $30 ($18-211) $25 ($16-222)

$10 a dose $61 ($31-415) $51 ($28-437)

ICER per DALY averted:

$2 a dose $35 ($16-112) $38 ($18-97)

$5 a dose $80 ($44-279) $87 ($48-244)

$10 a dose $147 ($90-556) $154 ($99-487)


5.3 Vaccine price, donor subsidy, and national affordability

Currently, Ghana is exploring participation in the large scale RTS,S pilot implementations programme

that will be coordinated by WHO, in partnership with PATH and GSK. The pilot implementations are

expected to include up to 240,000 eligible children in Ghana for 3 to 5 years (approximately 2018 to

2022). It is expected that the RTS,S vaccine for pilot implementations will be donated; therefore,

there will be no cost for the vaccine during this period. GSK, the manufacturer of RTS,S, has

committed to selling the vaccine at a not-for-profit price.

Ghana currently purchases all of its traditional routine vaccines. For recently introduced vaccines

(e.g., PCV, rotavirus, MR), Ghana pays a pre-determined co-financing percentage of the cost, and

Gavi provides support for the balance. Gavi also provides support for health system strengthening.

However, Ghana has recently become a middle-income country, exceeding the current gross national

income (GNI) eligibility for Gavi support and has therefore entered into a preparatory graduation

transition out of Gavi support. As a result, Ghana’s vaccine co-payment to Gavi is gradually

increasing and eligibility for support will cease by 2022. The government will pay 20% of all co-

financed vaccines in 2016 to 2018. This will rise to 40% in 2019, 60% in 2020, 80% in 2021 and by

2022 will begin making the full payment (100%).62

In the context of the Ghana transition out of Gavi support for vaccines and the evidence generated

through the RTS,S pilot implementation programme, it will be appropriate for the country to use this

evidence to assess vaccine affordability and sustainability through the next updating of the cMYP in

2020.

6. Programmatic considerations

6.1 Proposed Immunization Schedule for RTS,S

The current National Immunization Schedule prescribes six visits for immunization services. The

visits begin from ‘at birth’ for BCG and OPV birth dose to ‘18 months’ for Measles Second Dose.

The six visits do not include the visits at 6 months and 12 months for vitamin A only.

The proposed schedule for RTS,S vaccination is a four-dose regimen: 6 months, 7 months, 9 months

and 24 months (Table 9). This schedule has been proposed after careful consideration of the

immunogenicity of the vaccine by age, the starting visit in particular and the existing visits on the

schedule as a whole.

The proposed schedule starts at 6 months where vitamin A supplementation is already an established

visit on the immunization schedule with about 70% coverage.9 The second dose of RTS,S introduces a

new visit at 7 months. The third dose has been planned to coincide with Measles-Rubella/Yellow

Fever vaccination at 9 months which has over 90% coverage.9 The final RTS,S dose is scheduled for

24 months. Vitamin A is provided to children aged 24 months, however, the coverage is not

encouraging. Efforts will be made to improve attendance at these proposed schedules to ensure a good

coverage in order to achieve the needed epidemiological impact.


Table 9. Proposed National Immunization and Vitamin A Supplementation Schedule with RTS,S.35

Age Vaccines Doses Route and Site of Injection

At birth BCG OPV0

0.05ml 2 drops

Intra-dermal, right upper arm Oral

6 weeks




10 weeks




14 weeks

DPT-HepB-Hib3 Pneumo 3 OPV3 IPV

0.5ml 0.5 ml 2 drops 0.5ml

Intra-muscular, lateral aspect of left thigh Intra-muscular, lateral aspect of right thigh Oral Intra-muscular, lateral aspect of right thigh

6 months Vitamin A RTS,S 1

100,000 IU 0.5 ml

Oral Intra-muscular, lateral aspect of left thigh

7 months RTS,S 2 0.5 ml Intra-muscular, lateral aspect of left thigh

9 months Measles-Rubella Yellow Fever RTS,S 2

0.5ml 0.5ml 0.5 ml

Subcutaneous, left upper arm Subcutaneous, right upper arm Intra-muscular, lateral aspect of left thigh


18 months Measles-rubella Men A Vitamin A

0.5ml 0.5ml 200,000 IU

Subcutaneous, left upper arm Intra-muscular, right upper arm Oral

24 months RTS,S 2 0.5 ml Intra-muscular, lateral aspect of left thigh

After 18 months Vitamin A is given every 6 months till child is 5 years’ old

18 months – Give long-lasting insecticide-treated nets (LLINs) to the child

6.2 Cold chain capacity

Cold chain is a critical component of every immunization system. Adequate cold storage capacity is

required for the successful implementation of any immunization program. The Government of Ghana,

with the support of partners, expanding the cold storage capacity at all levels prior to the simultaneous

introduction of vaccines for pneumonia and rotavirus diarrhea as well as the introduction of a second

dose for measles containing vaccine. The expansion was informed by the findings of the Effective

Vaccine Management Assessment (EVMA) which was conducted in 2010.

The country again conducted EVMA in 2014. Though this assessment showed marked improvements

over the 2010 assessment, both from process as well as structural perspective, cold chain gaps

especially at the National and peripheral levels were identified. Level-specific issues including

planned improvements are discussed below. All projections, unless otherwise stated, were done using

WHO-UNICEF Logistics Forecasting Tool.

6.2.1 Cold chain capacity at national level

The net cold chain capacity for positive storage at the national level currently stand at 56,250 litres

(Table 10). This capacity is just enough for accommodating the current vaccines on the immunization

schedule. With the planned vaccine introductions including Meningococcal Conjugate Vaccine type A


(Men A); IPV; and RTS,S between 2016-2020, there is need to expand the positive cold chain capacity

at the national level.

With Men A and IPV planned for 2016 and 2017 respectively, the Ghana Health Service will install

two units of 12,500 litres walk-in cold rooms (totalling 25,000 litres) at the National Level in 2016/2017.

This will increase the net storage at the National level to 81,250 litres. Funding for the procurement and

the installation of the two units have been secured from Gavi.

The planned introduction of RTS,S will have a huge effect on the cold storage capacity. The candidate

malaria vaccine, RTS,S has a cold chain volume of 9.7 cc/dose on a four-dose schedule. The increase

in the net cold chain capacity from 56,250 litres to 81,250 litres by 2017 will not be adequate to

accommodate the malaria vaccine when introduced. One-unit of 25,000 litres walk-in cold room would

have to be installed at the National Level prior to the introduction of this vaccine.

The existing positive cold storage space available at the National level as well as the additional space

needed to accommodate the proposed vaccine introductions are shown in Table 10. The negative cold

storage capacity however is adequate as the planned vaccines to be introduced are not stored in negative

temperatures.

Table 10. Capacity and cost for positive cold storage at the national level.

Formula 2015 2016 2017 2018 2019

A

Annual positive volume requirement, including new vaccine (specify:__________) (litres)

Sum-product of total vaccine doses

multiplied by packed volume per

dose

112,435 litr

118,283 litr

162,427 litr

174,906 litr

180,428 litr

B Existing net positive cold chain capacity (litres)

Capacity currently available

56,250 litr

56,250 litr

56,250 litr

56,250 litr

56,250 litr

C

Estimated minimum number of shipments per year required for the actual cold chain capacity

A/B 2.00 2.10 2.89 3.11 3.21

D Number of consignments / shipments per year

Based on national vaccine shipment

plan 4 4 4 4 4

E Gap in litres ((A*(1/D+Buffer/12)

- B) - 32

litr 2,892

litr 24,964

litr 31,203

litr 33,964

litr

F Estimated additional cost of cold chain

US $ $0 $123,472 $123,472 $0 $0

6.2.2 Cold chain capacity at regional level

The results of the 2010 EVMA showed that the available cold storage capacity at the regional level

was inadequate for the introduction of vaccines for pneumonia and rotavirus diarrhoea (Table 11). As

part of the improvement plan developed after the assessment, the country embarked on a major cold

chain infrastructure expansion at all levels. Walk-in cold rooms of 40m3 capacity were installed in

Ashanti, Brong-Ahafo and Central regions. Greater Accra Region was provided with 80m3 capacity

WICR, while all other regions had 30m3 WICR installed in the their respective vaccine store.


With the planned introduction of Men A followed by IPV, the cold storage capacity in Ashanti Region

will not be adequate and therefore has to be expanded. A 20m3 walk-in-cold-room will have to be

installed in the region prior to the introduction of these vaccines by 2017. The installation of this

walk-in cold room will adequately increase the cold storage capacity of the region to accommodate

the RTS,S vaccine when introduced.

The existing positive cold storage space available at the regional level as well as the additional space

needed to accommodate the proposed vaccine introductions are shown in Table 11.

Table 11. Capacity and cost for positive storage at the Regional Level.

6.2.3 Cold chain capacity at district and health facility levels

Prior to the simultaneous introduction of Pneumococcal and Rotavirus diarrhoea vaccines, the cold

storage capacity of districts, sub-districts and health facilities were expanded. In 2014, the

Government of Ghana, with the support of Gavi, procured 100 TCW 3000 refrigerators and 50TCW

2000 refrigerators. These refrigerators have been distributed to districts and facilities.

With the proposed introduction of Men A, IPV and RTS,S, about 67 districts will need cold chain

expansion. Additionally, the storage capacity of health facilities will also have to be expanded to

ensure the smooth introduction of these vaccines.

6.3 Service delivery

Service delivery within the health sector is at five main levels, as shown in Figure 14. The lowest

Ash

anti

Bro

ng

Ah

afo

Ce

ntr

al

East

ern

Gre

at

Acc

ra

No

rth

ern

Up

pe

r

East

Up

pe

r

We

st

Vo

lta

We

ste

rn

A

Annual positive

volume requirement,

including new

vaccine

(specify:__________

) (litres)

35,177 16,190 16,458 18,929 29,970 18,390 7,262 5,010 15,467 17,014

B

Existing net positive

cold chain capacity

(litres)

12,500 12,500 12,500 9,375 25,000 25,000 9,375 9,375 9,375 9,375

C

Estimated minimum

number of

shipments per year

required for the

actual cold chain

capacity

2.81 1.30 1.32 2.02 1.20 0.74 0.77 0.53 1.65 1.81

D

Number of

consignments /

shipments per year

4 4 4 4 4 4 4 4 4 4

E Gap in litres 3912 -4945 -4821 -543 -11017 -16420 -5986 -7037 -2158 -1437

FEstimated additional

cost of cold chain$46,389 $0 $0 $0 $0 $0 $0 $0 $0 $0


level in the health care delivery is the community level. Services are provided at the community

level through the CHPS strategy. The structure at the community level is the CHPS Zone. A Zone is

a geographical area covering a population of about 5000. It is made up of about 5-8 communities

and is managed by two Community Health Officers. Integrated services during immunization days

include: Growth monitoring, LLINs, Vitamin A, and health promotion.

The sub-district level is the next operational

level responsible for supporting service

delivery at the community level providing

supervision and oversight. The sub-district is a

management level with a Sub-District Health

Management Team (SDHMT) with

representation from other decentralised MDAs

including the head of the health centres in the

sub-district and the Local Government

representative. There is an average of 5 CHPS

Zones in each sub-district.

The District Health Directorate oversees health

service delivery at the district level. It is

government internally by the District Health

Management Team (DHMT) and the head is the District Director of health Services. On average,

each district has been demarcated to about 6 sub-districts. There are currently 216 districts. The

district health directorate works with the District Assembly (DA) of the Local Government and is a

member of the Social Committee of the DA.

There are ten regions in the country. The regional health service is responsible for monitoring

service delivery and provides technical guidance to the district level. The Regional Health

Directorate (RHD) has three units (Public Health, Clinical Care, Administration and) with the

Regional Director of Health Services as head of the RHD and Regional Health Services. The RDHS

is a member of the Social Service Committee of the Regional Coordinating Council (political office

at the region).

The regional health services provision embraces the establishment of effective mechanisms for

disease surveillance, prevention and control. There a r e 1 0 regional hospitals in the ten regions

which serve as referral centres. The country has 216 administrative districts with 109 district

hospitals and 1005 health administrative sub-districts. Additionally, there are 969 clinics, 1,676

CHPS zones, 789 health centres, 263 hospitals, 348 maternity homes, 3 psychiatry hospitals, 20

polyclinics, 4 teaching hospitals and two university hospitals.

The Teaching Hospitals serve as referral centres for the lower levels and provides specialized

medical services. The Ghana Health Service is the major service provider in the country. It operates

at the national, regional, district, sub-district and community level. Services provided include public

health and clinical services at all primary and secondary levels.

The private health sector in Ghana is a large and important actor in the health industry for health-

related goods and services. The private self-financing sector is concentrated in the urban and peri-

urban areas, with low rural penetration. Private self-financing health providers in rural areas face

more challenges given the higher poverty rate of the population.

Christian Health Association of Ghana (CHAG) represents nearly all non-profit health care service

provision in the country and targets hard-to reach rural communities.

CSOs also play a considerable role in delivering health services to communities. It is documented

that minority and marginalized groups represent the last 15-20% of the population that most often

Figure 14: Types of service delivery levels in Ghana.

Teaching hospitals

Regional hospitals

District hospitals

Health centres

Community health preventive services (CHPS)


eluded from immunization campaigns and other preventive services. CSOs are often the most

effective medium for delivering vaccines and services to the hard-to reach.

6.4 Human resource capacity

Delivery of immunization services is principally done by the Community Health Nurses and Disease

Control Officers. They are supported by the Public Health Nurses, Midwifes and District Directors of

Health Services. Whenever a new vaccine is introduced into the national immunization program, all

managers, supervisors and vaccinators at all levels are trained on the new vaccine. The national EPI

guideline will be revised to include RTS,S vaccine. Based on this revised guideline, training materials

(e.g. training manual, fact sheets, training pre-test and post-test forms) will be developed.

The Training and Service Delivery Subcommittee will plan and develop training programs relevant to

the various levels of the service, develop training manuals and guidelines for the introduction of the

malaria vaccine, review child health records, field guide and all reporting formats to include the new

vaccine, based on guidance from WHO.

Depending on guidance from WHO for preparation of the pilot implementations, it is likely the

training for malaria vaccine introduction will be cascaded. National level Trainer of Trainers (TOT)

for National and Regional training will be conducted at the central level. Participants will include the

Deputy Directors Public Health, Deputy Directors Clinical Care, EPI Coordinators, Public Health

Nurses, WHO/UNICEF EPI Focal points. The National Master trainers will in turn facilitate training

in their respective regions and districts. After completion of the district TOT, training of the

vaccinators & supervisors will be conducted.

The major topics that are most likely to be covered (though may differ depending on requirements and

needs for the pilot implementations) are: rationale for introduction of malaria vaccine, vaccination

schedule, injection site and technique with special focus on multiple injections at the same

immunization session, injection safety and waste management, AEFI surveillance, vaccine storage

and management, cold chain maintenance, communication, supervision, record keeping and reporting.

The methodology used for the training will be presentations, plenary discussion, question & answer

sessions, role play, group work, demonstration, practice sessions. Supervisors from national, regional,

districts and sub-district will supervise and monitor the implementation of all activities at all levels

using a checklist.

6.5 Current routine data monitoring (immunization and

malaria) and ability to evaluate rollout of vaccine

The District Health Information Management System (DHIMS), a web-based system, is used for the

management of health service data including immunization data. Data entry is done at the peripheral

level. Aggregated data as well as facility-specific data could then be accessed at all levels. Timeliness

and completeness of data is monitored at all levels to ensure immunization data in the DHIMS is

complete and also reported in a timely manner. At all levels, EPI managers monitor the performance

of all antigens using key indicators and graphs displayed on the EPI dashboard.

In addition to this, the EPI Programme also uses the District Vaccination Data Management Tool

(DVDMT) to monitor immunization performance from district level and above. With this system, data

is transferred from the DHIMS to the DVDMT which then generates key outputs that guide program

implementation.


The following tools are used for recording and reporting of immunization data; 1. Tally sheet, 2.

Monthly Vaccination Report, 3. Monthly Vaccine Store Report, 4. Vaccine Ledger and 5.

Immunization Monitor Chart. The malaria vaccine will be incorporated into these recording and

reporting tools.

Depending on guidance from WHO for pilot introductions, a Post-introduction Evaluation (PIE) will

be conducted to assess the vaccine introduction processes and document best practices, strengths and

weaknesses. Evaluation of performance will be done as part of the annual coverage surveys conducted

by the country as well as other surveys, such as the DHS and MICS.

6.6 Waste management infrastructure

In response to equipping all districts with at least one incinerator, provisions have been made within

the current HSS support from Gavi to construct 50 new incinerators in newly created districts.

Additionally, existing but non-functional ones in old districts will be rehabilitated with same support.

The remaining 13 districts will be catered for with funds from the malaria and other new vaccine

introduction grants (VIG) and supprted as the case may be (Figure 15).

Auto Disable syringes and safety boxes are used for all vaccinations in Ghana. There will be adequate

quantities of these safe injection equipment at all vaccination sites. At facilities/district with an

incinerator, injection waste are incinerated as per the national policy.

Currently, districts without incinerators cart

injection waste to nearby districts which have

functional incinerators for disposal. Until new

incinerators are fully built and functional, this

arrangement will continue and districts will be

supported with disinfectants and clothing kits for

waste managers including boots, heavy-duty (utility)

gloves, coverall gown, goggles, etc using funds from

Gavi. The Protective materials for the attendants will

regularly be supplied and they will be oriented to use

the materials at all times to avoid other health

hazards. Health care workers and waste managers

will be updated on infection prevention and injection

safety. The major component of the training will

focus on disaggregation of waste under the principle

of “DO NO HARM” to self and others. The training

will also include the use and safe disposal of

injection waste

Regular inspection of disposal sites will continue in

all districts to ensure effective management of the

waste.

6.7 Surveillance and pharmacovigilance

VPD surveillance is under the Department of Surveillance but it is a weak system with poor

monitoring and supervision. AEFI surveillance is managed by the EPI and reports to the Department

of Surveillance within the Food and Drug Authority (FDA).

Figure 15. Districts in Ghana with at least

one functional incinerator.


6.7.1 Malaria disease surveillance

Malaria data is collected through the routine reporting system (DHIMS). Malaria morbidity and

mortality data is captured for all age groups, with specificity for children under five years of age and

pregnant women. Data also captures severe and uncomplicated malaria and malaria-related mortality.

6.7.2 AEFI surveillance

There is a policy on Adverse Events Following Immunization as part of the National Policy on

Immunizations. There is also a Guideline for Surveillance of Adverse Events Following Immunization

in Ghana. This guideline would have to be adapted to Malaria vaccine AEFI reporting and to align

with recommendations and guidance from WHO.

There is an expert committee for AEFI monitoring. The AEFI committee is made up of experts from

diverse medical and social disciplines which includes but not limited to: general medical practice,

clinical pharmacy, clinical pharmacology, toxicology, epidemiology, pathology, industrial pharmacy,

dermatology, and child health. There are also co-opted members as and when required.

Additionally, there is complementary reporting between the FDA and EPI as post-marketing

surveillance is the responsibility of the FDA. At sub-national level, AEFI monitoring is done by the

EPI staff and district coordinators. When an AEFI is reported, it is investigated by the district

coordination, then reported to the regional coordinator, who sends to the national EPI, and the EPI

send to the FDA, where it goes to the Vaccine and Biologicals Safety Committee, composed of

diverse expertise (including EPI).

The capacity to conduct investigations into AEFI is available but needs reinforcement. For example,

training and more regular supervision with feedback are needed to improve monitoring and strengthen

the system, in addition to addressing cultural barriers (e.g., fear of reporting by the health workers).

Furthermore, there is not regular availability of reporting forms at all levels. Health-care providers

who administer vaccines maintain permanent vaccination records and are required to report

occurrences of certain adverse events to a central point. Reporting by parents or guardians of all

adverse events after vaccine administration will be encouraged. There is also an existing system for

addressing rumours. This however needs to be enhanced at all levels.

Adverse events following immunization with RTS,S will be reported by health-care providers to the

Food and Drugs Authority (FDA) through and existing structure of District, Region and National EPI-

FDA focal persons. Reporting forms and information about reporting requirements or completion of

the forms will be discussed as part of the RTS,S pre-implementation training of Health care Providers.

The existing Guidelines for Surveillance of Adverse Events Following Immunization in Ghana will

need to be updated and adapted for RTS,S AEFI reporting. A separate detailed AEFI Monitoring Plan

will be developed for AEFI monitoring, based on guidelines from WHO to align with the pilot

implementation protocol. Printed guidelines will be provided to all health facilities.

The following activities will need to be implemented to ensure effective surveillance measures at all

levels:

Sensitization of clinicians and other health staff on surveillance measures, particularly AEFI

surveillance and the need for adequate reporting and documentation.

Update AEFI recording and reporting forms, guidelines and investigation forms.

Strengthening routine surveillance and monitoring of AEFI.

Monitoring of monthly reports and feedback to districts and regions.


6.8 Strengths and weaknesses of the immunization program

A full analysis of the EPI strengths and weaknesses can be found in Appendix 12; the following

section highlights some key aspects that could be relevant for RTS,S.

6.8.1 Vaccine supply and quality

Procurement and distribution

Ghana has timely forecasting and procurement of vaccine supply and injection safety materials

through UNICEF. Additionally, the government pays 100% for BCG, OPV, Measles-rubella and

tetanus-diptheria booster (Td) vaccines and injection safety materials and is co-financing DTwP-

HepB-Hib, PCV13, Rotavirus, and Yellow Fever vaccines and injection materials through Gavi.

Vaccines are distributed quarterly from national to regional level and monthly from regions to

districts to sub-districts; however, while cold vans have been recently procured for all regions,

transportation for vaccines from district to service delivery level is still strained and there is limited

vaccine storage capacity in some districts.

Vaccine management

Electronic and manual stock control tools are available at all levels; however, there is poor

documentation on vaccine usage at the district and sub-district levels.

6.8.2 Logistics

Cold chain

Additional cold chain equipment has been installed in Ghana, including the existence of cold chain

corrective maintenance teams at national level with regional managers supporting regions and

districts; however, there are still challenges, particularly at the operational level with frequent

breakdowns of WICRs in the regions. There is regular central procurement of spare parts for

equipment maintenance and repairs; however, there is inadequate supply of spare parts (especially for

solar powered refrigerators) and weak technical capacity at sub-national level to respond to

maintenance and repairs.

Injection safety and waste management

Construction of 65 new incinerators is on-going; however, not all districts have functional

incinerators.

6.8.3 Service delivery

While 26% (5/216) of districts in Ghana had Penta3 coverage below 80% in 2013, overall, Ghana

consistently has high vaccination coverage, resulting in reduced morbidity and mortality caused by

VPDs. Additionally, all new vaccine introductions have been completed without interruption to

routine service delivery. Ghana also has a well-established integrated delivery structure of EPI with

other child survival strategies (e.g., Vit A supplementation, deworming, growth monitoring) through

supplemental immunization activities (SIAs), Child Health Promotion Week (CHPW), etc. Despite a

strong program, Ghana still struggles with high health worker attrition, poor utilization of data for

decision making at lower levels, and high and negative dropout rate in some districts.


6.8.4 Advocacy and communication

High community awareness about immunization has resulted in sustained demand for services. While

there are a lot of pieces in place to support communication and information, education and

communication (IEC) around vaccination, there are still challenges at the sub-national level: health

workers still lack adequate interpersonal communication skills; not enough IEC materials (that are not

always translated into the local language), and communication is not always integrated into district

level plans.

6.8.5 Surveillance

Currently, there is a weak community surveillance system in place and volunteer fatigue. There are

also inadequate supplies, like specimen containers, available for sample collections.

Surveillance for acute flaccid paralysis (AFP), measles, neo-natal tetanus (NNT), pediatric bacterial

meningitis (PBM), yellow fever, and rotavirus is being implemented within the Integrated Disease

Surveillance and Response framework (IDSR), which is updated to include other diseases of public

health importance. There are disease-specific surveillance committees (e.g., polio, congenital rubella

syndrome).

6.8.6 Program management

Policy, planning and management

EPI policy documents and updated field guide are available at national level; however, the EPI policy,

standards, guidelines, and field guides are not printed or available at all levels, though is currently in

the process of being updated. There is a strong national level partner coordination structure, which is

not reflected at district and operational levels where there is limited coordination.

Districts manage the coordination of their activities and there is a bottom-up planning approach,

which is functional; however, not all planned activities are implemented.

Supervision

An integrated supervision plan and checklist is available, and some technical assistance is provided by

partners for specific areas. However, supportive supervision is not conducted regularly at all levels,

particularly operational level, and there is a lack of feedback from supervision and monitoring.

6.8.7 Human and institutional resources

The human resource, staffing structure, pre- and in-service training is in place, but staff knowledge

and skills in logistics needs strengthening.

6.8.8 Sustainable financing

Ghana has a financial stability plan (FSP) and the government renewed its commitment to Gavi

through signing the Partnership Framework Agreement (PFA). Challenges persist with the

disbursement of funds to districts, and delayed accountability of funds advanced for implementation

of activities at all levels.


7. Sociocultural environment

7.1 Community perceptions of malaria, malaria interventions,

and vaccines

It was recognized early on by policy makers that understanding community perceptions of a malaria

vaccine would be important to aid in development of a communications strategy, should a vaccine be

licensed. Ghana was selected as one of four countries in a study to explore community-level factors

that could affect malaria vaccine acceptance in Ghana. The data was intended to inform

recommendations for a malaria vaccine communications strategy. The study was conducted in two

purposively selected regions of Ghana—the Ashanti Region (Ejisu-Juaben) and Upper East Region

(Bolga) of Ghana.

This study identified several factors that may facilitate the introduction of a malaria vaccine. These

factors include the highly accepted and well-established routines of the Child Welfare Clinics

(CWCs), the high value placed on vaccination by communities despite their limited knowledge of

vaccines, and the shared understanding that malaria prevention requires a comprehensive approach.

Communities appearing to be open to using a combination of methods to fight diseases suggests that a

partially efficacious malaria vaccine could be accepted as part of a tool kit of malaria control

strategies.

A summary of other key findings published in the study titled Factors Likely to Affect Community

Acceptance of a Malaria Vaccine in Two Districts of Ghana: A Qualitative Study,10 can be found in

Appendix 13.

7.2 Communications strategies and frameworks

The EPI and malaria programs have communication strategies for social mobilization, messaging and

education activities. A malaria vaccine-specific communication strategy was developed in anticipation

of a potential introduction of a malaria vaccine.

The sociocultural community perceptions study, which was also conducted in three other countries,

provided data that could inform country communications planning for possible implementation of a

malaria vaccine candidate. To support the communications planning in countries like Ghana, the

international NGO, PATH, used data from the community perceptions studies to develop a generic

malaria vaccine communications strategy, which Ghana used as a basis to develop a draft strategy.

The process of developing a Ghana-specific communication strategy was led by the National Malaria

Communication Committee (NMCC)b, which is a committee set up by the National Malaria Control

Program to deliberate on matters relating to malaria communication and advocacy. Through a nine-

month process involving several relevant stakeholders (see footnote), the generic communication

strategy was adapted and a Ghana-specific malaria vaccine communication strategy was developed.63

The UNICEF Communication for Development (C4D)64 approach was also used to inform the Ghana-

specific communication strategy.

b The committee is made up stakeholders from GHS (NMCP, EPI, HPD, FHD), GES and representatives from several NGOs and international

development agencies working in Malaria control, including UNICEF, S4H, PATH and JHU-CCP


7.2.1 Goals and objectives of the communication strategy

The communication strategy was developed around three overarching goals in the context of vaccine

implementation:

1. Foster accurate understanding of the potential risks and benefits of the RTS,S malaria vaccine

candidate and the need for continued use of other malaria control measures among caregivers of

young children.

2. Ensure that all relevant health care personnel have strong technical knowledge on how to handle,

prepare, safely and appropriately administer the RTS,S malaria vaccine candidate to children.

3. Facilitate widespread awareness of RTS,S, particularly among caregivers of young children,

family, and community members whose opinions inform parents’ health care decisions.

Since RTS,S is to be used first in the context of post-approval phase 4 studies and pilot

implementations, country-specific communication strategies, including tailored work plans and

materials, would enable proactive planning for effective communication on the vaccine.

7.2.2 Overall strategic approach

The communications strategy outlines various target audiences, appropriate messaging for specific

audiences, and identification of trusted, familiar, and reliable communication channels for delivering

these messages. Coordination of messages currently being delivered in relation to malaria control and

childhood immunization should be considered in the final communications and messaging plans.

The strategy summarizes the following elements:

Identification and prioritization of target audiences.

Use of multiple and diverse channels to deliver information.

Evidence-based messaging tailored to audience needs.

Integrated malaria vaccine communication including information about other childhood

vaccinations and malaria interventions.

Pretesting of malaria vaccine messages with target audiences.

7.2.3 Target audiences

In developing this communication strategy, audiences were identified on three main levels using

UNICEF’s C4D approach:

1. Micro level–immediate family, representatives of locally relevant institutions: village headman,

religious leaders, traditional leaders, local opinion leaders.

2. Meso level–those implementing activities: health workers, decentralized administrative authority,

decentralized health/education departments, local authority, NGOs, community radio, community

theater, etc.

3. Macro level–national politicians, international donors: those who will endorse policies/ strategies

and allocate resources.

7.2.4 Informational materials and methods

To identify key messages and determine appropriate channels of communication and types of

materials for different target audiences, it was considered best to focus first on familiar and reliable

(tried and true) communication channels, and providing information in local languages. While mass

media and printed materials can be useful, interpersonal communication by health staff is the most


common and accessible communication channel, particularly in addressing community needs, doubts,

and concerns.

Prior to implementation, IEC materials should be ready for dissemination in the community at least

one month before vaccination sessions begin. Materials should be in the national (or local) language,

as well as in English. The following types of IEC materials were identified and recommended in the

communications strategy, each bearing the logo of the Ministry of Health to legitimize the program:

Visual aids for illiterate and flyers for literate audiences to be used by vaccinators and health

educators to explain key concepts, including the need for continued use of other malaria

prevention methods and to seek care when a child exhibits symptoms of malaria.

Booklets for more educated audiences including teachers and development workers based in the

community.

Posters for the clinic to remind parents of the number of doses of the vaccine needed to protect

the child.

T-shirts given to vaccinators and other staff as “moving posters”.

Web pages to provide information to caregivers and stakeholders at national and other levels who

are likely to look for information about RTS,S online.

Text (SMS) and voice messaging to serve as reminders of upcoming at vaccination sessions.

The above materials are a list as options to be considered between the national health promotion

unit, malaria, and immunization programs in the final implementation planning and

communications strategy.

7.2.5 Management of information and communication

Some types of communication, such as giving leaflets to parents prior to vaccination may be carried

out only once. Other types of communication, such as community announcements about the number of

doses needed for vaccination, will be repeated. After the first year of vaccination, when the vaccine is

better known to communities, the education and communication frequency should be re-visited.

As part of the overall planning and coordination of the RTS,S vaccination pilot implementations, It is

likely that an advocacy, communication, social mobilization subcommittee will be established to

coordinate and organize the RTS,S communications planning for directly and indirectly

communications with communities and stakeholders.

Managers need to have in place a crisis communication plan for situations related to the RTS,S. It is

important for the communication team to develop plans to address any reports of adverse events

associated with the new vaccine, to deal with community concerns, and to respond promptly to rumors

and negative publicity. It is recommended that an early alert system be in place to advise program

managers when there is a need for a crisis communication intervention.


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Appendices

Appendix 1: Malaria vaccine TWG terms of reference

Facilitate periodic updates of national stakeholders on progress and results of the vaccine trials in

two sites (Kintampo and Agogo).

Identify data requirements and provide assistance to fill gaps through periodic reviews of the

Decision-Making Framework (DMF).

Gather, compile and package evidence for decision making on introduction of the malaria vaccine

in the health system and ensure that processes are in place for use of a malaria vaccine in Ghana.

Continue to feedback to the broader Inter-agency coordinating committee (ICC) on outcome of

processes.

Organize annual meetings to brief the broader stakeholder’s community on progress of the malaria

vaccine trial and status of the DMF implementation.

Prepare and/or review advocacy and communication materials for vaccine introduction through

media engagement.

Recommend and support studies on the socioeconomic benefits of the vaccine to inform policy.

Facilitate technical supportive missions and carry out field visits as when required.

Support the NRA in ensuring that regulatory requirements are met satisfactorily.

The team in addition will be expected to support any further essential actions that may arise during

the pre- introduction period.


Appendix 2: Overview of pivotal phase 3 trial findings1

Ages included in trial Two age categories: children at the age of 6-12 weeks (infants) and 5-17

months (children) at first vaccination.

Trial sites 11 centres in Burkina Faso (Nanoro), Gabon (Lambarene), Ghana

(Kintampo and Agogo), Kenya (Kilifi, Kombewa and Siaya), Malawi

(Lilongwe), Mozambique (Manhica) and Tanzania (Bagamoyo and

Korogwe).

Treatment groups Three treatment groups per age (1:1:1 randomization):

R3R received RTS,SE for four vaccinations

R3C received RTS,SE for three vaccinations and the control

(MCC) for fourth vaccination

C3C received the control (Rabies for 5-17 month children and

MCC for 6-12 week infants) for the first three vaccinations and the

fourth (MCC for both age groups) vaccination

Dosing schedule Doses are given on a 0, 1 and 2 months schedule, the fourth dose at 18

months after the 3rd dose.

Other vaccines

administered

Infants receive Tritanrix HepB/Hib + OPV concomitantly with the first

three doses and OPV concomitantly with the fourth dose. Additional

vaccination with BCG, OPV birth dose, measles and Yellow Fever were

given according to local EPI practice.

Follow up time Vaccine efficacy and immunogenicity are measured over a median of 38

(6-12 week younger age category) or 48 (5-17 month older age category)

months after the 3rd dose.

Primary objectives Efficacy co-primary objectives:

To evaluate the protective efficacy of RTS,SE against clinical

malaria disease caused by Plasmodium falciparum in African

children whose age at first dose will be from 5-17 months.

To evaluate the protective efficacy of RTS,SE against clinical

malaria disease caused by Plasmodium falciparum in African

children whose age at first dose will be from 6-12 weeks and will

receive vaccine in co-administration with DTwP/HepB/Hib

antigens (Tritanrix HepB/Hib) and OPV.

For the co-primary objectives, duration of follow-up was 12 months after

completion of the first three doses.


Appendix 3: RTS,S vaccine characteristics and presentation

The malaria vaccine, RTS,S is a 2-dose vial lyophilized (freeze-dried powder) vaccine. The RTS,S

antigen is clipped to a 2-dose vial of liquid AS01 adjuvant suspension to be used for reconstitution. The

“clip” presentation, which keeps the vaccine together with the correct reconstitution vial. This

“bundled” presentation avoids the possibility of the wrong diluent being used and simplifies the

inventory management processes at the country level.

The vaccine requires storage at 2-8˚C. There is a vaccine vial monitor (VVM) label to warn staff of

exposure to heat and subsequent deterioration of vaccine potency. There is no preservative, hence

once reconstituted the RTS,S vaccine must be discarded after six hours, or at the end of an

immunization session, whichever comes first. The pack is a 100-vial pack, which is the standard GSK

pack for vaccines in 3 mL vials supplied through UNICEF.

Formulation: Lyophilized (freeze dried powder).

Preservative: No preservative.

Storage temperature: 2-8˚C.

Effect of freezing: Freeze sensitive; Must not be frozen.

VVM type: To be confirmed (but will have VVM) on the side of diluent ASO1 vial.

Presentation: 2-dose vial.

How vials and diluents are packaged: Vaccine and diluent vials clipped together.

Packed volume per dose: 9.7 cc.

The pack is a 100-vial pack, which is the standard GSK pack for vaccines in 3 mL vials supplied

through UNICEF.

In line with WHO’s Multi-Dose Vial Policy (MDVP)65, because there is no preservative, once

reconstituted the RTS,S vaccine must be discarded after six hours, or at the end of the session,

whichever comes first.

Number of vials

per carton

Number of doses

per carton

Dimensions of

carton (cm)

Cold chain

volume (cc) per

dose in carton

Doses (and

cartons) per

insulated

shipping boxd

2 x 50 100 17.8 x 14.7 x 3.7 9.7 2400 (24)

d GSK insulated shipping boxes are of dimension 34 x 25 x 43 cm.


Appendix 4: RTS,S Vaccine efficacy in children aged 5-17

months and 6-12 weeks at first dose5,6

Vaccine efficacy

against clinical

malaria

(95% CI)

Vaccine efficacy

against severe malaria

(95% CI)

Vaccine efficacy

against hospitalisation

caused by malaria

(95% CI)

5-17 month

Over 12 months follow-up from dose 3

(ATP* cohort, N=6880) 51%

(47; 55)

45%

(22; 60)

48%

(35; 59)



(42; 49)

36%

(15; 51)

42%

(29; 52)

5 – 17 month:

3 doses only

(ATP* cohort, N=6918)

Over 30 months follow-up from dose 3 34%

(29; 39)

2%

(-28; 25)

18%

(1; 32)

Over 46 months follow-up** from

dose 3

26%

(21; 31)

-6%

(-35; 17)

12%

(-5; 26)

5 – 17 month

3 doses + 4th dose; (ATP* cohort, N=6918)

Over 30 months follow-up from dose 3 46%

(42; 50)

32%

(10; 50)

40%

(26; 52)

Over 46 months follow-up** from

dose 3

39%

(34; 43)

29%

(6; 46)

37%

(24; 49)

6-12 weeks



(26; 39)

37%

(5; 58)

32%

(7; 50)



(20; 32)

15%

(-20; 39)

17%

(-7; 36)

6 -12 weeks:

3 doses only; (ATP* cohort, N=5997)

Over 30 months follow-up

from dose 3

20%

(13; 27)

11%

(-22; 35)

10%

(-15; 30)

Over 36 months follow-up**

from dose 3

18%

(11; 25)

13%

(-17; 35)

13%

(-9; 31)

6 -12 weeks:

3 doses + 4th dose; (ATP* cohort, N=5997)

Over 30 months follow-up

from dose 3

28%

(22; 34)

17%

(-14; 40)

25%

(3; 42)

Over 36 months follow-up**

from dose 3

27%

(21; 32)

21%

(-7; 42)

27%

(7; 43)

*According-to-protocol (ATP) cohort: all infants immunised according to schedule, N= total number

in all 3 study groups

** The follow-up period from dose 3 to study end was not the same for all subjects because the study

ended on a fixed date. The median length for this follow-up period is 36 months.


Appendix 5: Vaccine efficacy against clinical and severe malaria by study site in the 5-17 months age category6


Appendix 6: Vaccine efficacy against clinical and severe malaria by study site in the 6-12 weeks age category6


Appendix 7: Cases of clinical and severe malaria averted at each site during 48 months follow-up in the 5-17 months age category6


Appendix 8: Global malaria vaccine pipeline47


Appendix 9: Model predictions of clinical cases and deaths averted per 100,000 fully vaccinated children8

The figure below illustrates model predictions of clinical malaria cases and deaths averted per

100,000 fully vaccinated children under a three-dose or four-dose immunization schedule and for a

range of baseline PfPR2-10 (parasite prevalence in 2-10 year olds, expressed as a percentage).

Results are broken down by model and are cumulative following 15 years of routine use of RTS,S.

Bars show median estimates and whiskers show 95% credible intervals.


Appendix 10: Cost in USD per clinical case or DALY averted as a function of baseline endemicity. 8

Results assume $2, $5 or $10 per dose. Colours indicate models (orange GSK, green EMOD-DTK,

blue Imperial and purple OpenMalaria). Solid lines represent a three-dose immunization schedule,

dashed lines a four-dose immunization schedule. Similar ICER estimates were obtained for the three-

dose and four-dose schedules because the additional public health benefit of the boosted schedule is

offset by the incremental cost of implementing the additional dose. Uncertainty estimates that

surround the models’ predictions are omitted for readability but overlap.


Appendix 11: Cost-effectiveness and public health impact limitations8

There was no statistically significant impact against severe disease measured in the trial for the 3-dose

schedule (4·5% ,-20·6 to 24·5%)90 at 32 months follow-up in the 5-17 month group, although there

was sustained significant efficacy with the 4-dose schedule (32·2%, 95% CI 13·7 to 46·9%). There

was additionally no measured impact on malaria- and all-cause mortality, although numbers of deaths

were small and the trial was not powered to assess this outcome.76 In contrast, we predicted a net

positive impact on severe disease cases and hence deaths averted with the 3-dose schedule, with an

incremental benefit of the fourth dose of 22% (3-49%) extra deaths averted depending on setting.

There are several possible reasons for this apparent discrepancy.

There are a number of limitations to the RTS,S cost-effectiveness and public health impact analyses.

Firstly, whilst the estimated vaccine efficacy and waning profile was similar across the models, these

profiles diverged after 18 month of follow-up. The predicted longer-term impact of the vaccine will

inevitably depend on this and hence it is important that these are updated with extended follow-up

data. Secondly, while the models reproduce vaccine efficacy estimates from the trial, the projections

of impact on disease and mortality are based on previous model fits to historical data relating clinical

and severe incidence to mortality, under the assumption that similar relationships hold in settings with

more limited access to health care. Unlike the trials of ITNs which demonstrated statistically

significant reductions in malaria mortality,52 there was no significant impact on malaria mortality or

all-cause mortality in the RTS,S trial. This is likely to be due to the significantly lower levels of

overall mortality observed in trial participants with high access to care. Nevertheless, the modelled

estimates of RTS, S impact on mortality require further validation and future studies following

implementation should include monitoring of impact on mortality. Thirdly, we assumed vaccination

would be implemented at 6-9 months with 3 or 4 doses whilst actual implementation schedules and

coverage may differ (including more than 4 doses). Over this age range naturally-acquired immunity

will be developing rapidly and physiological effects may also affect the maturity of the vaccine-

induced antibody response.67 Fourthly, only two of the models allowed for possible indirect effects on

transmission with one model predicting indirect effects in settings with low malaria prevalence.

Although the primary aim of the vaccine is to provide direct protection, it will be important to assess

any indirect effects in the post licensure phase. Finally, we did not include productivity losses to

households, and costs of immunization and disease management were considered from health system

perspective in our economic analysis. According to WHO guidelines the societal perspective is

generally preferred however in practice this is rarely done, as not all costs are available. In general,

adding costs beyond the health system would increase the cost-effectiveness of vaccination, making

our estimates lower. Despite these limitations, our results can help inform decisions about where to

implement RTS,S to have the greatest impact.


Appendix 12: EPI strengths and weaknesses summary (2015-2019 comprehensive multi-year

plan)29

SYSTEM

COMPONENT STRENGTHS WEAKNESSES

Vaccine supply

and quality

Procurement and distribution

Timely forecast and procurement of vaccines and injection safety

materials through UNICEF

Government of Ghana paying 100% for BCG, OPV, Measles-

Rubella and Td vaccines, and their injection safety materials

Ghana Government is co-financing the procurement of DPT-

HepB-Hib PCV13, Rotavirus, and Yellow fever vaccines and

injection materials with GAVI

Quarterly distribution plan from national to regions established

Monthly delivery of vaccines and other EPI logistics from regions

to districts and sub-districts

Cold vans for vaccine distribution procured for all ten regions

New cold van of higher capacity procured to improve vaccine

distribution from the national level

Bundling concept adequately practiced in the country

Stock control system for vaccines and other EPI logistics fully

functional at national level

Vaccine management

Stock Control Tools (electronic and manual) available at all levels

VVM on all vaccines for routine immunization; Multi-Dose Vial

Policy (MDVP) and Open Vail Policy (OVP) practiced at all

service delivery level.

Vaccine wastage sentinel monitoring being piloted in 20 districts

from all the ten regions

FDA, NRA, is charged with the responsibility of ensuring

registration, lot release, quality, safety and efficacy of vaccines

- Constrained transport situation especially at district and service

delivery levels.

- Inadequate storage capacity for vaccines in some districts

especially the new ones

- Vaccine potency testing for different levels not being carried out.

- Poor documentation on vaccine usage at the district and sub-

district levels


SYSTEM


used in the country. It also works closely with the National Ethics

Committee which oversees all clinical trials.

Logistics Cold Chain

- Increased in cold chain equipment through support from Unicef and

other partners.

- Existence of cold chain corrective and maintenance teams at

national level with regional equipment managers supporting

regions and districts.

- Cold chain equipment spare parts are procured centrally to support

the Maintenance activities.

Injection safety and waste management

- Policy, standards and guidelines on injection safety and waste

management available and being implemented.

- Committee in place to coordinate injection safety within GHS.

- All health facilities (100%) are using AD syringes for

immunizations.

- Construction of 65 new incinerators is on-going through the

support of WHO and Unicef.

- Regular breakdown of EPI equipment at the lower level.

- Frequent breakdown of WICR’s in the regions.

- Inadequate supply of spare parts especially for solar powered

refrigerators.

- Weak technical capacity in the regions for cold chain

maintenance teams.

- Not all districts have functional incinerators.

Service delivery - Reduction in morbidity and mortality due to VPDs especially

measles, polio and Hib (Hib meningitis in infants).

- Maternal and Neonatal tetanus eliminated in the country.

- New vaccines introduced into EPI routine without interruption of

services i.e. PCV13, Rotavirus and Measles/Rubella.

- Plans underway to introduce IPV.

- HPV vaccine piloted in the country.

- Integration of EPI with other child survival strategies e.g. Vitamin

A supplementation, deworming, growth monitoring through

strategies such as SIAs, CHPW and IMCH campaigns etc.

- 26% (5/216) of the districts have Penta3 coverage less than

80% in 2013.

- High attrition rate of health workers at service delivery level.

- Minimal involvement of the private sector and community in

planning and implementation of services especially outreaches.

- Poor utilization of data for decision making at the lower levels.

- High and Negative dropout rate remain a problem in some

districts.

Advocacy and

communication

- High community awareness about immunization which has resulted

in increased demand for services.

- High level of political involvement.

- Communication strategic plan in place.

- Inadequate interpersonal communication (IPC) skills among

health workers.

- Lack of IEC materials for routine immunization.

- Some of the existing IEC materials are not in local languages.


SYSTEM


- Assigned Personnel for communication at national and regional

levels.

- Involvement of traditional and Opinion leaders in advocacy.

- CSOs, Coalition of NGOs in health and other NGOs involved in

social mobilization and communication.

- Community-based volunteers are mobilized for NIDs.

- Not all districts have communication focal persons.

- Most districts do not have EPI communication included in their

district work plans.

Surveillance - Surveillance for AFP, measles, NNT, Pediatrics Bacterial Meningitis

(PBM), yellow fever and rotavirus is being implemented within the

Integrated Disease Surveillance and response (IDSR) framework.

- IDSR document updated to include other diseases of public health

importance.

- Plans to expand CRS sentinel sites.

- No wild polio virus has been report in the country since November

2008.

- Case based measles/rubella surveillance implemented in all districts.

- Functional national polio certification committee (NCC), national

polio expert committee (NPEC) and National Polio Laboratory

Containment Task Force (NTF).

- Case definition guidelines for MOH priority diseases have been

updated.

- Diphtheria not on MOH priority diseases list for surveillance.

- Weak community based surveillance system.

- Inadequate specimen containers for sample collection.

- Weak AFP surveillance.

- Volunteer fatigue.

Program

management

Policy, planning and management

- EPI policy document updated.

- EPI field guide updated.

- Structures for partner coordination are in place: ICC, NCC, technical

committees with strong collaboration with partners.

- Integrated bottom up planning within the districts.

- Review meetings held at all levels.

- Strong managerial skills at national and regional levels.

Supervision

- Integrated supervision plan and checklist at all levels

- Feedback provided to all levels on a regular basis

- Technical assistance provided by partners for specific areas.

- EPI policy, standards, guidelines are not available at all levels.

- Updated EPI field guide not printed.

- Adhoc activities disrupt planned activities at all levels.

- Poor coordination of partners at district level.

- Districts not implementing all planned activities.

- Irregular technical support supervision from all levels especially

to the operational level.

- Lack of feedback from supervision and monitoring.


SYSTEM


Strengthening

human and

institutional

resources

- Human Resource structure/staffing norms available at all levels with

skilled manpower at the implementation level

- Mid-level managers (MLM) training for National, regional and

districts officers planned

- Training conducted for pre-service health institutions on EPI

- Improvement in the number of technical staff at the service delivery

levels

- Weak staff knowledge and skills in logistics

- Planned training in MLM not often implemented

Sustainable

financing

- Financial Sustainability Plan (FSP) developed at national level with

involvement of all stakeholders.

- Government renewed its commitment to GAVI through signing

- of the Partnership Framework Agreement (PFA).

- Delays and inadequate disbursement of funds to districts.

- Delayed accountability of funds advanced for implementation of

activities at all levels.

Accelerated

Disease Control

Polio Eradication

- Increasing trends in OPV3 coverage at national level with current

coverage above 85%

- No case of Wild Poliovirus has been detected since November 2008

- Ghana maintains polio free status.

Maternal & Neonatal Tetanus Elimination

- Td vaccine introduced to replace TT

- Maternal/neonatal tetanus (MNT) eliminated in the country

Measles Control

- Measles coverage at national level is above 80%.

- Measles second dose introduced into routine

- Measles-Rubella vaccine also introduced into routine.

- Case based measles/rubella surveillance sustained nationwide.

- Negative measles cases tested for rubella

- No Recorded death due to measles since 2003

- 26% (56/216) of districts have OPV3 coverage less than 80%.

- Not all districts suspect AFP cases.

- National Td2+ coverage among pregnant women still less than

80%.

- Documentation of Td coverage results still a challenge

- MNT elimination sustainability strategic plan yet to be drafted

- Not all districts are reporting suspected measles cases

- Measles/rubella elimination strategic plans yet to be drafted


Appendix 13: Summary findings from the Ghana malaria vaccine community perceptions research10

Perceptions of malaria

1. Study participants considered malaria to be one of the most common health problems among

children.

2. Participants differentiated between mild and severe episodes of malaria and described malaria as a

very serious disease that could lead to death.

3. Children, followed by pregnant women and the elderly, were considered to be the groups most at

risk of contracting malaria.

4. Mosquitoes were considered to be the main cause of malaria, with dirt and stagnant water

associated with mosquito breeding seen as indirect causes.

Perceptions of interventions

1. There was consensus that no single preventive measure stopped malaria transmission completely.

In both regions studied, bed nets were the most cited preventive tool.

2. Communities did not find a contradiction between being vaccinated and getting a disease. Some

cited the measles vaccine to explain both the benefits and limits of vaccination (i.e., parents see

measles has been prevented, but that there are still outbreaks at times).

3. Participants explained that they already combine different preventive strategies and were unlikely

to stop using other malaria preventive measures, since—in addition to malaria prevention—bed

nets prevent the nuisance of mosquito bites and good hygiene prevents other diseases as well as

malaria.

4. Participants said bed nets were not distributed for free as frequently as they would have liked. In

some houses, three or more people shared the same net, making it very hot inside.

5. Participants also cited general hygienic measures, whether indirectly associated with mosquito

breeding or not, illustrating the wide range of measures taken for general prevention of sickness.

6. While participants occasionally mentioned other strategies for malaria prevention such as the use

of sprays and coils, price was said to be a major factor limiting the use of sprays, while coils were

seen as a fire hazard and linked to some discomfort.

7. In most interviews, it was only when prompted (and not in all cases) that people remembered the

preventive use of sulfadoxine-pyrimethamine (SP) in pregnant women and the intermittent

preventive treatment of malaria in children (IPTi and IPTc) in trial areas.

Perceptions of Vaccines

The understanding of what vaccines do ranged from references to “fighting diseases” in general to

partial knowledge of the diseases they protected against. When discussing the concept of ‘efficacy’,

some participants understood that vaccines had helped to eliminate some diseases from the

community, whereas other participants saw vaccines as diminishing the severity of the disease. While

most mothers did not know the specific illnesses the vaccines were intended to prevent, they could

distinguish them through the mode of administration, injection site, or the age of the child at

vaccination.

1. Study participants universally acknowledged vaccination as the main activity conducted within

the health system to promote child health. However, the perception of vaccination was closely

related to two other concepts: injections of medication and the package of activities at CWCs. The


issue was especially evident when people talked about malaria, as treatment in hospital for severe

malaria often includes injections of treatment highly valued by community participants.

2. The perception was that both vaccines and injections for treatment fought children’s diseases; that

injections fought diseases that were already “visible,” while vaccines either fought diseases that

were “hidden,” or prepared the body to fight in case the disease was coming.

3. Study participants acknowledged that vaccines had minor side effects, which were considered a

negative aspect of an intervention that otherwise had important benefits. Minor side effects cited

included: general discomfort, temperature, and swelling of the injection site.

4. Narratives also suggest that when families associate a vaccine with the occurrence of a serious

health problem, they may choose not to have their children vaccinated. In some cases, an issue of

trust in the health workers were cited as some families seemed to link more serious side effects

with questions about the expertise of nurses.

5. Most participants in the Ashanti Region generally preferred the oral method of delivery of

vaccines. Others, including traditional leaders in the Upper East Region, saw injections to be

more efficacious as they go “straight to the blood” and cannot be vomited up, as sometimes

happened with “malaria drugs” and the rotavirus vaccine.

Communication Preferences

Community members highlighted four main avenues for receiving health information: via radio,

information vans, health talks, and trusted people in the community. The communication tools least

mentioned were posters and television. In urban areas, people preferred radio and information vans,

whereas in rural areas, people preferred community durbars (gatherings of chiefs and people of the

community), and they trusted their leaders and community health volunteers to provide the relevant

information.

CWCs were observed to be relevant avenues for communication; however, direct counseling for

mothers was brief and irregular, and women tended not to ask many questions.

The study has also confirmed the existence of an active and flexible national health communication

structure and processes that enable dissemination and local coordination of messages and activities.

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