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The Republic of Malawi Ministry of Health P.O BOX 30377 LILONGWE 3, MALAWI THE MALAWI COVID-19 VACCINE DEPLOYMENT PLAN The Expanded Programme of Immunization (EPI) 02 February 2021
Transcript

The Republic of Malawi

Ministry of Health

P.O BOX 30377

LILONGWE 3,

MALAWI

THE MALAWI COVID-19 VACCINE DEPLOYMENT PLAN

The Expanded Programme of Immunization (EPI)

02 February 2021

2 | Page

Executive Summary

The vaccine deployment plan remains a strategic document which helps with the roll out of

COVID19 vaccine and ensures a clear roadmap for resource mobilization which includes extra

doses of the COVID19 vaccines. The deployment plan will provide a stepwise approach to

building confidence to the COVAX team, WHO, UNICEF and Gavi including multilateral and

bilateral partners that vaccine doses and resources are being put to good use and more lives will

be saved from this pandemic. Malawi is a member of the COVAX facility arrangement.

Malawi has a population of 18,898,441 (NSO 2021) in which 58% are those above 15years of age.

The COVAX Facility arrangement will target 20% of the country’s population, which is 3,779688.

The MAITAG recommended that the target of 20% will comprise of health workers, social

workers, the elderly, and people with comorbid health conditions such as diabetes, hypertension

and those with HIV/ AIDS, mentally ill and disabled including the humanitarian groups like

refugees. The immunization program will adopt and modify the WHO micro planning tools for

covid-19 vaccination.

The Malawi Government will engage in bilateral and multilateral discussions with relevant

partners to lobby for additional vaccines beyond the 20% from the COVAX facility. The Pharmacy

Medicines and Regulatory Authority, a member of the WHO and AVAREF has already put in

place the mechanisms for expedited approvals of the new vaccine. It will also rely on stringent

regulatory authorities, the WHO Emergency Use Listing (EUL). The manufacturer

indemnification is already approved and submitted to the COVAX team

COVID-19 vaccine introduction will be planned and coordinated under the Ministry of Health new

vaccine introduction structures. The structures include The EPI Sub Technical Working Group

(EPI-TWG), the National Task Force (NTF), the Malawi Immunization Technical Advisory Group

(MAITAG) and the District Task Force at subnational level. The country will mobilize funds and

identify funding mechanisms to support the roll out of the vaccine at national and subnational

levels. The Ministry of Finance, MoH and partners will ensure availability of resources with

support from the Presidential Task force and the office of the COVID19 coordinator at the office

of President and Cabinet (OPC).

3 | Page

The country has cold chain capacity to as much as 45% volume space following the successful

Cold Chain Equipment Optimization from Gavi. We have an available transport and logistics

system across all districts such that vaccines will be deployed without delays.

A comprehensive Communication, Social Mobilization and Risk Communication Plan to increase

knowledge and positive attitudes, and ultimately demand for the COVID-19 Vaccine has been

developed. This will be coupled with community engagement so that misinformation is corrected

and myths dispelled. The target groups have been segmented to ensure that no group is left without

information that facilitates informed choice for equity and access. The country shall use multiple

channels of communication including Interpersonal Communication (Face to Face Orientation,

interactive SMS’s, and community dialogues), Mass media (radio/TV programs & spots) and

Community Mobilization (Theatre for Development).

The National Vaccine Deployment Plan is costed at MWK1, 224,265,790.08 ($1,654,413.23) in

order to be operationalized. The demand creation and Social Mobilization is going to cost

MWK1000000000.00 in the first one year including 20% target population by the COVAX

Facility. These resources will be mobilized through the Malawi Government in collaboration with

its partners and NGOs. This cost excludes procurement of vaccines doses for the remaining 60%

of the total target population

Finally a robust paper based monitoring and evaluation has been planned which includes registers

and vaccination cards with special identity marks will be designed to monitor performance and

impact. A vaccine safety committee at both National and district level will be engaged to monitor

Adverse Events Following Immunization. A toll free number will be used to communicate any

safety concerns.

4 | Page

5 | Page

Contents

Executive Summary 2

List of Figures 8

List of Tables 9

Acknowledgements 10

Abbreviations 12

1.0 Introduction 15

1.1 Background 15

1.2 Health care services in Malawi 15

1.3 COVID-19 disease burden in Malawi 16

1.5 COVID-19 vaccine introduction 20

1.6 Lessons learned from influenza A H1N1 and other relevant vaccines 20

1.7 Goal and Objectives of COVID-19 Vaccine Deployment and Vaccination Plan 21

1.7.1 Goal 21

1.7.2 Objectives 21

2.0 Regulatory Preparedness 22

2.1 Pharmacy and Medicine Regulatory Authority (PMRA) expedited review procedure 22

2.1.2 Importation 23

2.1.3 Lot release 23

2.1.4 Risk management plan and safety surveillance 23

3.0. Planning and Coordination of the vaccine introduction 24

3.1 Development of a COVID-19 vaccine deployment Plan (NDVP) 27

3.2 Meetings 27

3.3 Microplanning 27

Resource Mobilization and funding 28

5.0 Identifications of target groups 29

5.1 Priority groups for COVID-19 Vaccination 30

5.2 Vaccination of populations outside the 20% priority target group 34

6.0 Vaccine delivery strategies 34

6.1 Health and social workers 34

6.2 Comorbid patients 35

6.3 The elderly 35

6 | Page

6.4 Refugees, Asylum seekers and Internally Displaced Persons (IDPs) 35

6.5 Mapping of eligible persons 36

6.6 Vaccination Supervision. 36

6.7 Infection prevention 36

7.0 Preparation of Supply Chain and Management of Health Care Waste 36

7.1 Strengthening Supply chain and human resource capacity 39

7.1.1 Vaccine Procurement 39

7.1.2 Distribution 40

7.1.3 Effective Vaccine Management Assessment (EVMA) 41

7.1.4 Human Resource capacity for Vaccine handling 41

7.1.5 Vaccine Stock Control and Accountability 42

7.2 Waste Management and reverse logistics 42

8.0 Human resource management and training 43

8.1 Training 44

9.0 Vaccine acceptance and uptake (Demand creation) 45

9.1 community engagement 45

9.2 Demand creation 46

9.3 Participants groups/target audiences 49

9.3.1 The primary audience 49

9.3.2 The secondary audience 49

9.3.3 The tertiary audience 50

9.4 Channels of Communication 50

9.5 Risk Communication strategy 52

9.6 Campaign Positioning 59

9.7 Phased Implementation of Risk and Crisis Communication 60

9.8 Monitoring, Evaluation and Documentation 61

9.9 Coordination 61

10.0 Vaccine safety monitoring 62

11.0 Immunization monitoring systems 66

12.0 COVID-19 vaccination Surveillance 67

13.0 Post Introduction Evaluation (PIE) 68

14.0 Lessons Learnt 68

Annexes 70

7 | Page

Annex 1 Risk Communication and Crisis plan 70

Annex 2 Proposed Set of Core Indicators for Monitoring & Evaluation 73

Annex 3 Timeline of Activities 76

Annex 3 demand creation and social mobilization and community engagement budget 78

8 | Page

List of Figures

Figure 1Distribution of COVID19 cases over time ....................................................................18

Figure 2 Map showing distribution of COVID19 cases in Malawi .............................................19

Figure 3 Coordination Flow Diagram ........................................................................................25

Figure 4 Age and sex distribution of COVID-19 deaths in Malawi as of 17 Jan 2021 ................31

Figure 5 Proportion of Age Groups According to Malawi Population and Housing National

Census 2018 ..............................................................................................................................31

Figure 6 Figure 7Malawi AEFI reporting workflow and timelines .............................................65

9 | Page

List of Tables Table 1 Malawi COVID-19 Situation by 25th January, 2021.................................................................. 17

Table 2 Summary of target and priority group ........................................................................................ 33

Table 4 Demand creation objectives ...................................................................................................... 48

Table 5 Summary of the different media and platforms to be used. ......................................................... 51

Table 6 Summary of Risk Communication Strategy ............................................................................... 52

Table 7 Proposed Crisis Responses on Anticipated Issues ...................................................................... 54

Table 8 Table 6 Risk and crisis communication phased implementation table ........................................ 60

10 | Page

Acknowledgements

The development of a National Vaccine Deployment Plan had been a huge task where only

massive commitment could help. The COVID-19 situation has made it very difficult and the work

very tedious, however the EPI-Sub Technical Working Group deserves a pat on their back. We

would therefore acknowledge the following contributors individually but also at partnership level;

MOH: Dr Storn Kabuluzi (DPHS-Chair Sub-TWG), Dr. Mike Nenani Chisema (DDPHS-EPI),

Mrs. Temwa Mzengeza Phiri, Mrs. Brenda Mhone, Mr. Mphatso Mtenje, Mr. Dennis Mwagomba,

Mr. Evans Mwendo Phiri, Mrs. Rhoda Chado, Mrs. Doreen Ali, Mrs. Janet Guta, Dr Annie Mwale,

Dr Jones Kaponda Masiye, Mr Mabvuto Thomasi, Mr. Alvin Chidothi Phiri, Mrs Pakwanja Twea,

Mr. Humphreys Nsona, Mr. Williams Lapukeni, Dr. Lawrence Nazimera, Captain Regina

Chigona(MDF) PMRA: Mr. Mphatso Kawaye, Mrs. Cecilia Sambakunsi and Mr. Anderson

Ndalama. OPC: Dr. Bridon Mbaya (COVID-19 Coordinator) COM: Dr Atupele Kapito Tembo,

Dr Juliana Kanyengambeta Mubanga (DHSS, Mchinji) Mr Davie Kulemera (CMST) Dr Sandy

Chiume Kayuni (KCH)

Partners and their representatives include WHO: Dr Susan Kambale, Dr Boston Zimba and Dr

Randy Mungwira, UNICEF: Dr Ghanashyam Seth, Mr. Steve Macheso, Mr. Chancy Mauluka,

JSI: Mrs. Hannah Hausi, Mr. Patrick Omar Nicks MLW; Dr Donnie Mategula PATH; Mr.

Rouden Nkisi ONSE: Simon Ntopi, Village Reach: Matthew Ziba UNHCR: Dr Kingsley

Ojeikere MHEN: Mr George Jobe World Bank: Dr Collins Zamawe USAID: Mrs Chifundo

Kuyeli

Colleagues please receive our heart-felt thanks to the wonderful contributions made to the whole

process with a special mention of partners like JSI, WHO and UNICEF.

,

11 | Page

12 | Page

Abbreviations

AEFI Adverse Events Following

AESI Adverse Event of special Interest

CCPF Chipatala Cha Pa Foni

CHAM Christian Health Association of Malawi

cMYP Comprehensive Multi Year Plan

CCEOP Cold Chain Equipment Optimization platform

CSOs Civil society Organizations

DVS District Vaccine Store

EMA European Medical Agency

EU European Union

EHP Essential Health Care Package

EPI Expanded Programme on Immunization

EVMA Effective Vaccine Management Assessment

FDA Food and Drug Administration

GBV Gender Based Violence

GVAP Global Vaccine Action Plan

13 | Page

HES Health Education Services

HIV Human Immuno-deficient Virus

HSSP Health Sector Strategic Plan

HSIS Health System and immunization Strengthening

HPV Human Papilloma Virus

KAP Knowledge, Attitude and Practices

KCH Kamuzu Central Hospital

MAITAG Malawi Immunization Technical Advisory Group

M & E Monitoring and Evaluation

MISA

MOH

Media Institute of Southern Africa

Ministry of Health

MOU Memorandum of Understanding

NTF National Task Force

NDVP National Vaccine deployment Plan

NGO Non-Governmental Organizations

NVS National Vaccine Store

14 | Page

PLWHIV People Living With HIV

PPE Personal Protective Equipment

PMRA Pharmacy Medicine Regulatory Authority

PHIM Public Health Institute of Malawi

POE Point of Entry

PIE Post Introduction Evaluation

RVS Regional Vaccine Store

SMT Stock Management Tool

SOP’s Standard Operating Procedures

SLA’s Service Level Agreements

VAR Vaccine arrival Report

VVM Vaccine Viral Monitor

WHO World Health Organization

15 | Page

1.0 Introduction

1.1 Background

Malawi is a landlocked country, located in sub-Saharan Africa. It is bordering Tanzania to the

north, Mozambique to the east and south, and Zambia to the west. The country has an area of 118,

500 sq. km, of which one-fifth is water surface, largely dominated by Lake Malawi. According to

National Statistical Office (NSO) 2018 projections, the country’s population in 2021 is 18,898,441

and most people live in the rural areas (84%). The country is divided into 29 health districts located

in three geographical regions: Northern, Central and Southern regions. (Malawi COVID-19

contingency plan, 2020).

1.2 Health care services in Malawi

In Malawi health care services are delivered by both the public and the private sectors. The public

sector includes all facilities under the MoH, Ministry of Local Government and Rural

Development, the Ministry of Forestry, the Police, the Prisons, and the Army. The private sector

consists of private for profit and private not for profit providers, mainly Christian Health

Association of Malawi (CHAM). The public sector provides services free of charge while the

private sector charges user fees for its services. There are currently 977 health facilities in Malawi

comprising 113 hospitals, 466 health centers, 48 dispensaries, 327 clinics, and 23 health posts.

These health facilities are managed by the government (472), CHAM (163), Private (214), NGOs

(58) and company (69) {Malawi SPA- 2013-14}. CHAM is a not for profit health services provider

and is the biggest partner for the MoH. It provides health services and trains health workers through

its health training institutions. CHAM facilities charge user fees for other medical services.

However, the Government of Malawi established Service Level Agreements (SLAs) with CHAM

facilities regarding the government-funded provision of free maternal and child health services

(Health Sector Strategic Plan (HSSP), 2011-2016).

In line with the HSSP III, health services are delivered at different levels: namely: primary,

secondary, and tertiary. These different levels are linked to each other through an elaborate referral

system that has been established within the health system. At the primary level, services are

delivered through health posts, dispensaries, maternity, health centers and community and rural

16 | Page

hospitals. At community level, health services are provided by a community-based cadre, HSAs.

District hospitals constitute the secondary level of health care. They are referral facilit ies for both

health centers and rural hospitals. They also service the local town population offering both in-

patient and out-patient services. CHAM hospitals also provide secondary level health care. The

provision and management of health services has since been devolved to Local governments

following the Decentralization Act (1997). The tertiary level comprises central hospitals: these

provide specialist referral health services for their respective regions. Specialist hospitals offer

very specific services such as obstetrics and gynecology. There are currently 4 central hospitals in

the country.

1.3 COVID-19 disease burden in Malawi

The country registered its first COVID-19 case on 2nd April 2020 and is currently experiencing a

second wave of the COVID-19 pandemic. As of 25 January 2021, a total of 19, 987 confirmed

COVID-19 cases and 518 deaths were reported in Malawi. Of these cases 1,951 are imported and

18,036 are locally transmitted. The case fatality rate so far is at 2.6%. See Table 1 below for details

on 25th January and Figure 1 for distribution of cases since April 2020.

17 | Page

Table 1 Malawi COVID-19 Situation by 25th January, 2021

Parameter Statistic

Cumulative confirmed cases 19, 987

Number of active cases 12,479

New confirmed cases in the past 24 hours 592

Cumulative deaths 518

Cumulative recoveries 6, 780

Cases lost to follow-up 134

Cases still under investigation for the outcome 76

Cumulative samples tested 130, 006

18 | Page

Figure 1Distribution of COVID19 cases over time

The cases are spread across the whole country, but more in cities of Blantyre, Lilongwe and

Mzuzu, see map below.

19 | Page

Figure 2 Map showing distribution of COVID19 cases in Malawi

20 | Page

1.5 COVID-19 vaccine introduction

The introduction of COVID-19 vaccine is one of the preventive measures adopted by the

country to prevent and control COVID-19 pandemic. This has been the long-term management

and control of COVID-19 globally. It also aligns with the comprehensive Multi-Year Plan

(cMYP) for 2017-2021 which outlines the priorities of the immunization programme, which

includes new vaccine introduction. Globally the introduction aligns with the Global Vaccine

Action Plan (GVAP) goal number 4 “Develop and Introduce new and improved vaccines and

technologies”. The country was approved to participate in the COVAX facility arrangement

which is working on ensuring equitable distribution and access of COVID-19 vaccines

regardless of economic status among the countries across the globe. The facility will work to

procure and distribute vaccines targeting 20% of the total population with other support

launched in the Technical Assistance plan and the Cold Chain Equipment support. It is expected

that countries will work to provide for operational cost as well as looking for more resources to

procure more doses to Carter for the remaining 80% populace. The country is engaging other

potential donors to support with the procurement of more vaccines and funding the operational

costs.

1.6 Lessons learned from influenza A H1N1 and other relevant vaccines

The country has provided life course vaccines which targeted other populations besides infants

e.g., H1N1 in 2010, Cholera vaccine from 2013 and Human Papilloma Virus (HPV) vaccine from

2019. The following lessons were learnt which will be applied to the COVID-19 vaccine to reach

out to more targeted populations:

● Collaboration and coordination amongst key ministries and cooperating partners are key

for the successful vaccine delivery.

● Timely availability of data capturing tools is critical for data management and timely

reporting.

● Timely communication to the public via newspaper and radios press is key to creation of

high vaccine demand.

● Timely quantification, procurement and delivery of vaccines & injection devices contribute

to the successful implementation of HPV vaccination.

● Capacity building is key to quality service delivery.

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● Some high-risk individuals in the priority groups refused to get the vaccine, however, some

individuals demanded the vaccine even if they were not in the prioritized groups.

● Identification of eligible individuals, based on the set priority groups, is critical to avoid

vaccinating non eligible individuals to ensure adequacy of the already inadequate vaccines.

● The strategy deployed should ensure that more targeted individuals are reached.

1.7 Goal and Objectives of COVID-19 Vaccine Deployment and Vaccination Plan

1.7.1 Goal

To contribute to the reduction of COVID-19 morbidity and mortality in Malawi through an

efficient and effective vaccination program.

1.7.2 Objectives

1. To facilitate timely availability of COVID-19 vaccines in Malawi without compromising

proper regulatory decision-making.

2. To establish effective planning, monitoring and evaluation of COVID-19 vaccine

introduction readiness and deployment.

3. To identify and prioritize target populations for COVID-19.

4. To ensure available and efficient vaccination delivery strategies which ensures equity in

COVID-19 vaccine access and protects the vulnerable.

5. To procure and provide adequate quantities of COVID-19 vaccine and injection materials

of the right quality at the right time to all delivery points.

6. To create demand for COVID-19 vaccine through effective communication and

community engagement to increase acceptance and uptake for equitable vaccine access.

7. To provide for a clear plan for vaccine safety and monitoring of adverse events following

immunization and help to build and sustain public confidence in COVID-19 vaccination

and immunization in general.

8. To establish a monitoring and evaluation system to measure the performance of COVID-

19 vaccination including Post Introduction evaluation (PIE).

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9. To stand in as a tool that Identifies and mobilizes resources for the rolling out of COVID-

19 vaccination.

2.0 Regulatory Preparedness

The objective is to facilitate the timely access of COVID-19 vaccines in Malawi while adhering to

the existing regulatory structures. The Pharmacy and Medicines Regulatory Authority (PMRA) is

a designated institution in Malawi with a mandate to regulate medicines including vaccines.

PMRA licenses all medicines that are marketed in Malawi and vaccines that are provided both in

public and private facilities. The process is easier if the product has received authorization by a

WHO listed country’s NRA. (https://www.who.int/medicines/regulation/sras/en/). This also

applies to all the vaccines that have received WHO prequalification including those that have

received WHO Emergency Use Listing (EUL

2.1 Pharmacy and Medicine Regulatory Authority (PMRA) expedited review

procedure

2.1.1 Registration

PMRA is able to conduct expedited review of the products which include vaccines. The process

usually takes approximately 15 days especially in an emergency setting. For the product to undergo

expedited review, it depends on the registration of the product. For the vaccine that has received

approval from WHO listed country’s NRA PMRA requires; evidence of registration in the

manufacturing country, assessment report from the NRA that approved the vaccine and lot release

information from the manufacturing country. The same process occurs if the product that has

received WHO prequalification or WHO Emergency Use Listing.

While the product that has received authorization from NRA from the country that is not listed by

WHO, the PMRA endeavors to conduct a comprehensive review. This involves requesting for the

full dossier and conducting a full evaluation. In an emergency setting, they involve an expedited

process which takes approximately 90 days. If the product is approved in a country that has a

working agreement with MPRA, the PMRA will rely on the assessment report from that country’s

NRA.

23 | Page

There are times that PMRA participates in joint evaluation with other regional NRAs. For instance,

PMRA has ever participated in joint evaluation with AVAREF when they were evaluating RTS,

S vaccine for pilot use. There are no plans to have a joint review with AVAREF on COVID-

19 vaccines. Sometimes the country’s NRA conducts joint evaluation with ZAZIBONA, which is

the regulatory authority of a group of countries within the SADC region. PMRA has been invited

to participate in joint evaluation with ZAZIBONA on one of the COVID-19 vaccines.

2.1.2 Importation

When the product has been procured, it is the duty of the procuring institution to arrange with

the clearing agent. In most instances, the vaccines that have WHO PQ or WHO EUL, UNICEF

procures and ensures that they have identified the clearing agent. PMRA provides import licenses

to the procuring institution, in this case to UNICEF.

2.1.3 Lot release

The country does not have the capacity to conduct lot release. It relies on the lot release data from

the manufacturing country. This is documented in the import license that PMRA provides to the

procuring institution when they are importing the vaccine (the guideline is still in draft form but

this is the practice). The manufacturer of the COVID-19 candidate that the country will receive

will have to provide the lot release so that it is included in the import license to be issued by PMRA.

2.1.4 Risk management plan and safety surveillance

The PMRA put in place measures which ensure that all the activities that market authorization

holders planned as part of their risk management plans are implemented. Also, they continue

monitoring the safety of the vaccine in routine use. There is a medicines safety and quality

monitoring committee that works hand in hand with EPI when there are issues regarding the safety

of the vaccine.

No regulatory challenges are expected during authorization of COVID-19 vaccine?. Considering

the accelerated nature of the COVID-19 vaccine, an enhanced safety surveillance program will be

necessary. PMRA has now implemented a functional pharmacovigilance system. PMRA-Malawi

is now the 135th Member of the WHO International Drug Monitoring Program.

24 | Page

Using the Reliance approach, 15 working days are adequate for the Medicines Committee to meet

and consider the registration of the product. Please note that the Ministry of Health sits in this

committee of the Board of Directors. The national regulator or authority has clarified the

requirements and documents needed for regulatory approvals of COVID-19 vaccines which

include; Product Dossier from manufacturer and Product sample from manufacturer while the

requirements and documents needed to import COVID-19 vaccines include; Import permit from

PMRA and summary lot protocols for lot release from the manufacture. The current average time

to issue an import permit or reject is 2 days.

The waiver for lot release is available and, in that case, goods are immediately allowed entry into

the country if there is available a valid import permit (Max 1 day). The normal regulatory approach

to new vaccine registration before introduction is only through product dossier review (either

locally or relying on dossier review reports from stringent regulatory authorities such as USFDA

or EMA or WHO prequalification). For biological products e.g. vaccine, testing is a very

challenging venture and usually only done when a product quality problem is identified after

introduction (e.g. when severe AEFIs are observed). The capacity to test biological products is

also quite limited in this part of Africa

3.0. Planning and Coordination of the vaccine introduction

Planning and coordination are a critical element of COVID-19 vaccine introduction. This function

shall ensure that adequate support and funding for COVID-19 vaccine are secured and utilized

prudently. The objectives include ensuring strong linkages across all the stakeholders for resource

mobilization, efficient allocation and utilization of resources and robust governance and

coordination across all relevant stakeholders.

25 | Page

Figure 3 Coordination Flow Diagram

COVID-19 vaccine introduction will be planned and coordinated through existing immunization

structures of the EPI program. The structures include The EPI Sub Technical Working Group (EPI

TWG), National Task Force (NTF) and the Malawi Immunization Technical Advisory Group

(MAITAG). EPI TWG is the equivalent of the Immunization Coordinating Committee (ICC),

which ultimately reports to the Essential Health Care package (EHP) Technical Working Group

of the MoH. It is responsible for planning, coordination, implementation, and monitoring of the

roll out of the COVID-19 vaccine. The EPI sub-TWG is a multidisciplinary platform with

representation from the MOH, other sectors, development partners, implementing partners,

academia, and Civil Society Organizations (CSOs), Non-Governmental Organizations (NGOs),

among others. Decisions to introduce a vaccine are made by the sub TWG after discussing the

burden of the disease and advantages of the vaccine, which follows consultation of the Malawi

Immunization Technical Advisory Group (MAITAG) for advice to the Ministry. Based on

Ministry of Health

Malawi Immunization

Technical Advisory Group

EPI sub Technical Working

Group

EPI District Task Force

National Task Force

26 | Page

MAITAG advice, the senior management of the ministry approves or rejects the introduction of a

vaccine.

The EPI sub TWG discussed the introduction of COVID-19 vaccine in the country and it was

approved. Afterwards MAITAG was engaged for advice and they recommended the introduction

and proposed the priority target group for the vaccine based on the local and international data

which was available. Finally, the Ministry of Health approved the introduction of COVID-19

vaccine in the country.

As a way of operationalizing and integration into existing processes, the COVID-19 vaccine roll

out activities will be included in the COVID-19 response plan as one of the strategies to be used

for the prevention and control of the pandemic. The Presidential task force will provide oversight

to the implementation of the vaccine deployment plan aided by the Ministry of Health and the

COVID19 Coordinating office at the Office of the President and Cabinet.

The NTF under the EPI sub TWG has been established to coordinate the actual implementation of

COVID-19 vaccine introduction. This task force includes stakeholders from CSOs, the private

sector, development partners, and NGOs and Malawi government and public services departments.

The NTF will guide on issues of:

Service Delivery.

Vaccine, Cold Chain & Logistics

Demand Generation & Communication.

Monitoring and Evaluation.

Determination of eligibility and proof of Vaccination.

Monitoring Vaccination impact

Monitoring vaccine safety

At subnational level, a replica structure called the District Task Force (DTF) will be established to

coordinate and guide implementation of district level activities. See the diagram below:

Six key activities to strengthen planning and coordination for COVID-19 vaccination, include;

conduct meetings across EPI governance structures (Sub-TWG, MAITAG, NTF, DTF, SMT and

EHP), develop a National Vaccine Deployment Plan ( NDVP), prepare detailed budgets for all

27 | Page

preparatory activities and actual vaccination, mobilize resources for the operationalization of the

vaccination, develop micro plans, conduct supportive supervision (pre-introduction and during

introduction) and conduct post mortem meetings and documentation of lessons learnt.

3.1 Development of a COVID-19 vaccine deployment Plan (NDVP)

A COVID-19 vaccine introduction plan has been developed by the EPI program with support from

partners. This is in line with the guidelines provided by WHO and MAITAG. The EPI sub TWG

drafted the NDVP which has been approved by the senior management of the ministry before

submission to COVAX.

3.2 Meetings

The sub TWG meets frequently to make decisions on the way forward on the introduction of

COVID-19 vaccines. The frequency of MAITAG meetings also increased to assist with the

decisions on target groups and vaccine candidates to be used in the country, as evidence unfolds.

NTF and DTF meetings will also roll out to guide on the planning and implementation of

preparatory activities at zonal and district level respectively.

3.3 Microplanning

The microplanning will be done by adapting the existing micro planning tool for Supplementary

Immunization Activities (SIA). The variables will include facility catchment population, priority

target groups, supply chain and logistics requirements, and prevention materials items like masks,

handwashing facilities and sanitizers.

Estimation of frontline health care workers and the social workers will be done by using the Human

Resource staff return which will be made available by the public Human resources offices. These

target numbers will provide the basis for calculation of logistic and supply requirements for the

delivery of the vaccines. The elderly will be estimated by using the 5% estimate of the total

population. The adapted micro planning tool will be sent out to the districts for population by

health facility and then aggregated at district level. 4.0 Resources and Funding

The COVID-19 vaccine introduction will require resources which include human resource and

capacity building, vaccines, cold chain equipment and funds for operational activities. These

activities will include training of health workers, supervision, printing of guidelines, monitoring

28 | Page

tools, communication materials and incentives for vaccinators. The vaccine and CCE requests

were submitted to Gavi for support with the vaccines and cold chain equipment procurement.

Resource Mobilization and funding

The National Vaccine Deployment Plan is costed at MWK1, 224,265,790.08 ($1,654,413.23) in

order to be operationalized. The demand creation and Social Mobilization is going to cost

MWK1000000000.00 in the first year of rolling out COVID-19 vaccine including 20% of target

population by the COVAX Facility. The country will mobilize funds and identify funding

mechanisms to release and distribute funds to lowest levels for operations. This cost is with

exception of procurement of doses beyond the COVAX Facility. (See Annex 2 and 3)

WHO and UNICEF are providing both technical and budgetary support in planning and

preparing the delivery of the vaccines. Malawi is erecting additional two cold rooms at the national

vaccine store with support from UNICEF under Gavi HSIS funding. John Snow Inc. is equally a

core partner supporting with technical assistance to the preparatory activities. We have been

assured of more resource mobilization in the country to facilitate the introduction.

Other potential funding sources are:

Loans (WB, AU)

Donations

Government contribution

COVAX facility

COVID-19 response budget

Bilateral and multilateral organizations

While looking at issues of resources and funding, the following points have to be considered in

order to ensure a successful vaccine introduction;

Estimation of financial and human resources needed to conduct the deployment and

vaccination operations in the designated points and in the required number of days.

Identification of funding mechanisms in collaboration with relevant stakeholders.

29 | Page

Finalization of the cost micro-plans for vaccination including plans for other relevant

components such as demand generation, risk communications and safety surveillance and

establishing a mechanism to release and distribute funds to lowest levels for operations.

A deliberate resource mobilization strategy will be developed to facilitate the execution of the

deployment plan but also increase transparency and accountability to the Malawi citizenry. Both

the public and the private including the faith based organization will be reached out in order to

mobilize resources and reduce any inequalities in the distribution of the vaccines. Where possible,

revolving funds will be introduced to facilitate acquisition of extra doses for all the people in the

country at the earliest time possible and beyond COVAX arrangement.

The Malawi government through the Ministries of Health and Finance will be engaging the

Bilateral and Multilateral and development banks in discussion for the possibility of grants and

loans. The loans will focus both procurement of extra doses and providing for the operation costs

so that no vaccines sit idle without use.

The EPI program will ensure leveraging of resources from the existing Health Systems

Strengthening Grant Gavi support. The areas include vaccine collection and distribution,

conducting National and district Task force meetings since Malawi will conduct IPV and HPV

routinization around this year 2021. We will also be conducting the Measles Rubella

supplementary immunization activities in October 2021, all these will provide an opportunity for

resource leveraging.

5.0 Identifications of target groups

Target group identification is aimed at getting the eligible groups for COVID-19 vaccination in an

equitable manner through prioritizing the recipient groups. This is in anticipation that the initial

supply will not be adequate to reach the whole population. It is therefore important to prioritize

groups to receive the initial vaccine supply from COVAX facility as well as subsequent vaccines

that will be made available to the country. The identification and prioritization is based on COVID-

19 morbidity and mortality data as stipulated below.

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5.1 Priority groups for COVID-19 Vaccination

In the first phase, the COVAX Facility will target 20% of the country’s population, which is

3,779688 (NSO, 2021 population projection). The COVID_19 has hit every country in the world

and this has pressed a lot of demand than the suppliers would handle and prioritization becomes

key in protecting the high risk groups. The MAITAG agreed to prioritize health workers and social

workers, the elderly, and people with comorbid health conditions such as diabetes, hypertension

and HIV that increase the risk of developing severe COVID-19 disease and death. A buffer will

also be set aside for humanitarian deployment. The first 3% within the initial 20% phase will target

health workers. The decision was based on the WHO recommendation to target groups based on

local epidemiologic information and an assessment of risk factors but also vaccine supply situation

in the country. Health workers include all health professionals and supporting staff providing care

to the patients in hospitals, community health workers and other support staff within the hospital

settings in direct contact with clients during service provision. This will include all health workers

in both public and private facilities. These will comprise 3% of the population. However, in case

of short supply of the vaccine, the priority will be health workers who are in hospitals that are

treating COVID-19 patients. These will comprise 2% of the health workers.

The social workers to be targeted in the first phase will include the police, soldiers, and prison

warders, who according to their work, are always in direct contact with groups of people and

mostly difficult to keep social distance. These comprise 2.4% of the population.

Although all age groups are at risk of contracting COVID-19 disease, older people are at increased

risk of developing severe illness and even death, if they contract the disease due to physiological

changes that come with ageing and potential underlying health conditions. The elderly who will

be targeted are those above 60 years since COVID-19 data for the first wave, Figure 3 below, has

shown that this is the age category that has most of the deaths.

The other priority group to be considered will be those who are mentally ill and disabled as they

can hardly understand and follow the COVID19 preventive measures despite not falling into any

of the categories. The country NVDP will ensure that the prioritization and targeting processes

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will be ongoing as we continue to monitor the epidemiological trends of the disease and the

availability of the vaccine doses.

Figure 4 Age and sex distribution of COVID-19 deaths in Malawi as of 17 Jan 2021

The Projected population of >60yrs is 944,922, which is 5% of the population [1], see Figure 4

below. Additional age groups will be added as the vaccine supply situation improves.

Figure 5 Proportion of Age Groups According to Malawi Population and Housing National

Census 2018

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Regarding people with chronic conditions, Diabetes Mellitus, hypertension, chronic respiratory

diseases, and HIV, they have shown to increase the risk of severe disease and deaths. This is

according to a death audit conducted at one of the central hospitals in the country, since currently,

there is no routine data on comorbid conditions contributing to more COVID - 19 deaths but this

scenario is the same as the global trend. The estimated number of people with comorbid conditions

is 1,834,010, which is 9.6% of the population. This is data from the Non-Communicable Unit of

the Ministry of Health. The country is putting up the system to collect routine data on COVID -

19 patients` status on comorbid. An allocation will also be set aside for humanitarian deployment

mainly for the refugees, asylum seekers and Internally Displaced Persons (IDPs), since the country

is prone to disasters mainly floods and it has a refugee camp. These will be prioritized in the first

phase because people stay in overcrowded places where social distance is not possible, hence high

risk of getting COVID-19. As of December 2020, the population of refugees and asylum seekers

in Malawi was at 48,270[3]. By 2021, a total of 88 refugees had been confirmed to have been

infected with COVID-19. The country usually experiences flooding in some areas from the month

of December to March. The 2020/2021 Disaster Contingency Plan estimates about 200,000 people

to be displaced. The country plans to vaccinate adults from the age of 16 years and above (125,000)

as evidenced by the clinical trials showing that the vaccines were safe and efficacious beginning

this age group.

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Table 2 below summarizes the numbers, proportions and strategies for the priority target

populations in order of priority.

Table 2 Summary of target and priority group

Target population (in

order of priority)

Number of

additional

individuals to be

vaccinated

Priority targeted

delivery strategy for

this population

Total cumulative % of

vaccines as a

percentage of

population

1. Front line

Health care

workers

( bedside and

COVID19

attendants)

377969 (2%) Workplaces 2%

2. Other health

workers (other

wards,

vaccinators)

188,985 (1%) Workplace 3%

3. Social workers 302,375 (1.6 %) Workplaces 4.6%

4. Population with

Comorbid

conditions

1,814,250 (9.5%) Health facilities 14.1%

5. The Elderly

(>60 years)

944,922 (5%) Health facilities and

communities

19.1%

6. Humanitarian

deployment

173,270 (0.9%) In camps 20%

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5.2 Vaccination of populations outside the 20% priority target group

The Malawi Government is engaged in bilateral discussions with relevant groups to lobby for

additional vaccines beyond the 20% from the COVAX facility. As more and more vaccines

become available, the second phase, which will vaccinate beyond the 20%, will reach the

remaining priority groups such as essential workers (teachers/ lecturers), the new cohort of the

elderly from the age of 40 years, social employment groups unable to social distance (commercial

sex workers, vendors and individuals working at supermarkets, shops, financial institutions like

banks), people living in squatter areas, prisoners and travelers.

The third phase will include age groups of high risk to transmit disease (16 to 49 years). The

priority groups will continue to be assessed till everyone eligible is reached with the vaccine in the

subsequent phases.

The country is planning to introduce the COVID-19 vaccine in March 2021 for phase 1

implementation. The introduction will be countrywide since the COVID-19 cases are distributed

in all the districts in the country. The subsequent phases will be at a four months interval, with the

second phase coming in August 2021 and the third phase in January 2022. However the phases

will be determined as more vaccine doses become available on a daily basis.

6.0 Vaccine delivery strategies

This section outlines the delivery strategies that will ensure good accessibility and utilization of

the COVID-19 vaccine including the hard to reach areas. Table 2 above also shows the strategy to

be used for each priority group. This will highlight issues of access by each target group,

supervision, and infection prevention.

6.1 Health and social workers

These health workers shall be reached and vaccinated at their workplaces. At each health facility

a COVID-19 vaccination point shall be available for the entire day to enable all health workers at

the institution and social workers in that area access the service. This arrangement will enable

health workers to get vaccinated whilst ensuring that services are not disrupted. We have engaged

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the Human Resources Management offices to provide health and social workforce data through

stuff return aggregates and physical counting of the employees. This data will facilitate supply

chain and logistics including management of the delivery strategy so that each and every frontline

worker is reached with information and the actual vaccine. The health workers will be registered

on the day of actual immunization. A vaccine data card will be provided to each vaccinated

individual so they can produce when they come back for their second dose and for their record.

6.2 Comorbid patients

COVID-19 vaccination shall be integrated with the health services such as Non-Communicable

Diseases (NCD) clinics in both public and high volume private health facilities and immunization

outreach clinics will also be used to ensure that all persons with comorbid conditions are reached

and vaccinated. Health facilities will provide numbers of comorbid patients in their microplans

and these are expected to be vaccinated in health facilities (NCD clinics) where they normally

access their treatments and at outreach clinics where routine immunizations are conducted. Days

will be set aside for their vaccinations or integrated during their special clinics, where possible.

The vaccine carriers and cold boxes will be used to transport vaccines to the outreach sites while

the fridges will keep vaccines at the static clinic.

6.3 The elderly

Vaccination stations for COVID-19 vaccine shall be set up in hospitals, health centers, clinics both

public and private near the Outpatient Care department to ensure that all the elderly easily access

the services. In addition to existing immunization sites such as static and outreach clinics,

temporary sites will be used to reach out and vaccinate the elderly in areas that are far from the set

routine immunization sites. The number of elderly persons in each health facility will be estimated

by using a 5% percent estimate of the catchment population

6.4 Refugees, Asylum seekers and Internally Displaced Persons (IDPs)

In Malawi all documented refugees and Asylum seekers reside at Dzaleka refugee camp in Dowa.

COVID-19 vaccination sites shall be arranged and set up at Dzaleka refugee camp health center

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including outreach sites within the camp to reach out those that cannot easily make it to the health

center.

6.5 Mapping of eligible persons

We shall rely on available data to map out for the elderly and those that are handicapped otherwise

the majority will be expected to come for vaccination at the nearest static or outreach clinic.

6.6 Vaccination Supervision.

District and National supervisors will conduct supportive supervision during vaccination. This will

aim at ensuring quality service provision.

6.7 Infection prevention

All vaccination sites will follow immunization protocols (SOPs) for COVID-19 infection

prevention measures which are used in all immunization sessions to ensure continuation of

immunization services. These include use of PPEs by all vaccinators, social distance, hand

washing, and use of sanitizers. The EPI program with guidance from WHO has developed a

Standard Operating Procedure which is currently being used for routine Immunization amidst

COVID - 19 pandemic, as such COVID-19 vaccination will use the same SOPs. The overall

gazetted COVID-19 restrictions and IPC guidelines developed by the Quality Department of the

Ministry of Health will equally be used.

7.0 Preparation of Supply Chain and Management of Health Care Waste

The Malawi immunization supply chain is a constellation of four levels of vaccine and axillary

storage facilities, processes, transport, and human resource. National Vaccine Stores (NVS) is the

primary store for vaccine and injection materials. The country uses both pull and push strategies

to move vaccines from National Vaccine stores to service delivery points. The supply chain

arrangement is meant to ensure that all delivery points have reliable supply of vaccine and injection

materials at the right time and in adequate quantities.

In Malawi, Vaccines enter the country through the Kamuzu International Airport in Lilongwe and

are readily moved to NVS for inspection and storage. Injection materials are shipped by sea and

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enter the country through Malawi’s main entry borders of Mwanza and Dedza districts. The

injection materials are then transported to the NVS warehouse for inspection and storage. Vaccine

and injection materials are collected from the NVS to regional stores. Districts collect vaccines

and injection materials from the regional stores. The districts keep vaccines for a month, during

which vaccines are distributed to all the health centers where they are provided to beneficiaries.

The NVS has a net positive storage capacity of 57,144 liters and negative storage capacity of 10,

256 liters. The negative cold chain storage capacity requirement for routine vaccines at National

vaccine stores is at 5,691.42 liters and the positive storage is at 31,575.99 liters, representing 55%

occupancy proportion for both negative and positive storage. The regional stores in the North and

Southern Region, have positive storage volume of 19,048 liters and negative storage capacities of

10,256 liters and the central regional store has 9,524 liters. The cold chain capacity currently

available is adequate to accommodate and support roll out of new vaccines, including COVID-19

vaccine. The COVID-19 vaccine will require 36725 liters including a buffer of 5% should we

manage to get doses enough for the 20% population. The MoH is adding two Walk in Cold rooms

at the National Vaccine store equivalent to 19048litres. This is with support from UNICEF.

The country is implementing the 5-year GAVI supported Cold Chain Equipment Optimization

Platform (CCEOP), a strategy that supports countries to procure vaccine cold chain equipment.

Through the grant, the country has procured and installed 106 (69 replacements and 37 extension)

and 203 (105 replacements and 98 extension) Solar Directed Drive (SDD) refrigerators in 2018

and 2020 respectively, and in 2021, a total of 260 refrigerators will be procured and installed. The

2021 implementation will install equipment at District Vaccine Stores (DVS) and various health

facilities to increase the cold chain space, this is in addition to equipping facilities which have

never had any Cold Chain Equipment (CCE). It is anticipated that this effort will increase the cold

chain space at district level.

Table 3 Summary Table of Point of Entry, Cold Chain Capacity of in-country fallback facilities

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Storage

Condition

Airport of Entry (Kamuzu

International Airport) (L)

National

Vaccine Stores

(L)

Regional

Vaccine

Stores

District

Stores (L)

+2 to +8 16,900 57,144 47,620 26,759

-15 to -25 0 10, 256 20,512 1,604

Dry store

space

0 846 m3 108 m3

Existing vaccine cold chain equipment including the refrigerators at service delivery points shall

be used for storing COVID-19 vaccine. It is anticipated that the country shall obtain COVID-19

vaccine candidates that conform to current available cold chain conditions of +2-+8 degrees

Celsius. However, as more candidates become available, vaccines that can be kept at -15 to -25

degrees Celsius can also be accepted however we do not have negative storage beyond the National

Vaccine Store and makes it difficult to accommodate ultra-cold chain vaccines. Malawi has also

submitted a Cold Chain Equipment request to the COVAX facility for consideration. We would

like to expand our National vaccine stores and Regional vaccine stores with additional two Walk

in Cold Rooms and one WICR at the central and Northern Regional vaccine stores. We have also

asked for support for remote temperature control gadgets and extra cold boxes and vaccine carriers

to supplement our cold chain equipment. This will support us in the long-term should we have

COVID-19 vaccine routinized or any future pandemics of similar nature and magnitude.

The National Vaccine Store and the Regional Vaccine Stores uses remote temperature monitoring

devices as well as onsite monitoring mechanism using available Fridge Tag 2 and freeze Tag 2

while the districts and health centers use track through the use Fridge Tag 2 to record and monitor

temperatures. These have been very essential during transportation at all tier levels across the

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country. We expect to benefit from this temperature monitoring technologies even for the COVID-

19 vaccines which among others may be without Vaccine Vial Monitor.

7.1 Strengthening Supply chain and human resource capacity

7.1.1 Vaccine Procurement

Vaccine and injection materials are procured through UNICEF and documentation for the same is

shared with the Ministry of Health/EPI prior to delivery of vaccines and injection materials. A

local clearing agent, is responsible for receiving and clearing vaccines and injection materials at

the point of entry, and transportation to the NVS. There are no notable challenges with this

available contractor as such we are confident of the continuation of similar services for COVID-

19 vaccines. The current Memorandum of Understanding (MoU) between the Ministry of Health

and Allied Freight shall be used to clear and transport COVID-19 vaccines and injection materials

from port of entry to the NVS.

Like any other vaccines, it is expected that upon arrival of COVID-19 vaccines, the country will

ensure that:

Pre-advice is shared with all relevant stakeholders before the arrival of vaccines and

injection materials.

Clearing agent has arranged for customs clearing and transportation from point of entry to

NVS.

Staff at national vaccine stores are ready to inspect and receive the vaccines and injection

materials

Vaccine arrival report is prepared and submitted to the UNICEF country office within 3

days following receipt of vaccines and our recent assessment on VAR had been above 95%

on time.

The WHO Stock Management Tool is being adapted to include COVID-19 vaccine, an Excel

based tool, is used to manage vaccine and axillary stocks, including stock control, tracking and

issuing. The SMT is available and used at NVS, the regional stores and the district vaccine stores.

The health facilities use the vaccine/injection materials stock management books that have all the

elements to track vaccine/injection materials transaction, including stock management of the

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stocks. In addition, the system uses the requisition/request form, dispatch forms and the vaccine

arrival report. Accountability during distribution is all a critical element area that shall be

prioritized for the COVID-19 vaccine. During distribution, each batch of vaccine shall be

accompanied by the dispatch form, and upon arrival the receiving stores shall prepare and provide

the arrival report. The VAR is a tool that provides feedback on the status and quantities of vaccines

received. As the roll out continues, subsequent issues will depend on the requesting facilities to

provide the storage facility the requisition form of the vaccine and ancillaries

required.

7.1.2 Distribution

Vaccine cold boxes and carriers are used to maintain cold chains during distribution. Freeze tags

are placed in the vaccine box/carriers to enable vaccine handlers detect if vaccines are exposed to

freezing, so that necessary steps are taken to ensure that only potent vaccines are provided to

beneficiaries. The COVID-19 vaccine has no Vaccine Vial Monitors (VVM) to check vaccine

potency hence prudence in temperature monitoring.

The Malawi EPI, through the GAVI Health System and Immunization Strengthening (HSIS) grant

procured seven vaccine transportation trucks. The trucks are positioned at NVS and the regional

Stores and these help with distribution of vaccines and injection materials from the NVS to the

regional stores. Through the same grant, each district was provided with vehicles to assist vaccine

collection and distribution.

Vaccines and injection materials are transported using the trucks that the country with support

from GAVI procured for transportation of vaccine and injection materials. Vaccines are loaded in

cold boxes for transportation to different tier levels. The cold boxes are conditioned properly to

ensure that recommended conditions are maintained during transportation of the vaccines. Freeze

tags are put in the cold boxes to assist the officers to detect if the vaccines were exposed to freezing

during transportation.

COVID -19 vaccines shall be transported in cold boxes, freeze indicators shall also be placed in

the cold boxes to ensure that vaccine potent and we have enough quantities. The NVS and the

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regional stores have already prepared space for storing covid-19 vaccine. The same shall also be

prepared at DVS.

7.1.3 Effective Vaccine Management Assessment (EVMA)

Malawi conducted the last EVMA in 2016 of which the primary, district and regional levels scored

above 80% for all the nine criteria. The National level scored 98% for vaccine arrival, 86% on

temperature, 100% on capacity, 835 on equipment, 100% on maintenance, 98% on stock

management, 93% on distribution, 96% on vaccine management and 96% on information and

support functions. However, some gaps were identified including lack of periodic temperature

record reviews, lack of alarms for some of the cold rooms at NVS, absence of fire management

protocols and extinguishers at all levels.

The country has been implementing some activities in the EVMA improvement plan since 2016

including institutionalizing temperature record reviews and installation of voltage regulators for

cold rooms at NVS, Regional Vaccine Store (RVS) and refrigerators at DVS. The country has

delayed conducting EVMA, as the one planned in 2020 was postponed to 2021 due to COVID-19

restrictions.

7.1.4 Human Resource capacity for Vaccine handling

The national and regional stores have officers who are responsible for managing vaccines and

axillaries, the cold chain equipment and accounting for the commodities. The district EPI

coordinators oversee vaccination activities in the district including management of vaccines at

district vaccine stores. They are supported by the cold chain technicians who repair cold chain

equipment and distribute vaccines. Although these teams can manage routine vaccines, there is a

need to build their capacity to adequately manage COVID-19 vaccines.

Malawi is a beneficiary of the Gavi Health System Strengthening grant now in year 3. Despite the

COVID-19 Challenges, the EPI program continues to conduct Vaccine Management training

targeting 9000 HSAs. So far one-third of the target number has been reached with the training. We

believe the objectives of this training will extend to COVID-19 vaccines.

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We are expecting that the EPI team together with its partners will be responsible for training of

the health workers and the volunteers with regards to supply chain and logistics. These topics will

also be included in the facilitators manual and trainers slide deck for COVID-19 vaccines.

7.1.5 Vaccine Stock Control and Accountability

Stock control and accountability is one of the critical responsibilities of the immunization program.

There are several tools that help vaccine stock control and helps to account for the doses that the

country prepares and administers to the beneficiaries. The tools include the WHO Stock

Management Tool (SMT), vaccine and injection dispatch forms, the Vaccine Arrival Reports

(VAR), Vaccine Request forms and Vaccine and injection material stock books. The dispatch

forms are used during the shipping of vaccines and axillaries from one point to another in the

supply chain. Upon receipt of the commodities, documentation is done in the VAR, SMT (at NVS,

RVS and DVS) and Vaccine and injection materials stock books at health facilities. The batch

numbers and VVM status is documented in the tools to enable accountability and quality

monitoring. This process has been mainstreamed for all vaccines in the supply chain and it shall

also apply to COVID-19 vaccines, except for VVM.

Key elements to be addressed for successful COVID-19 deployment include:

Develop SOPs and share with all vaccine storage facilities.

Complete furnishment of the NVS to increase capacity.

Procure refrigerators to distribute to both districts and health facilities to increase storage

capacity, as the rolling out of the vaccine proceeds.

Develop new guidelines for management of COVID-19 wastes

Revise the distribution plan for vaccines, injection material to include COVID-19 vaccine

and axillaries and PPEs.

7.2 Waste Management and reverse logistics

Vaccination campaigns are known to generate wastes. Types of wastes include sharps, infectious

non-sharp wastes and IPC materials wastes e.g. gloves, masks, used syringes, and other injection

materials that have negative effects on communities and the health workers. The risk from wastes

generated during campaigns increases when temporary sites are opened in communities. Waste

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management ensures that we do not pose any risk to both humans and the environment while

vaccinating the people. It is important that wastes are properly and categorically managed. The

EPI through the supply chain coordination team will facilitate collection of different wastes from

the vaccination sites to the designated incineration and disposal sites.

The NVS generates significant quantities of wastes from secondary packaging and packs that help

maintain the right conditions during transportation of vaccine and injection materials. These wastes

are shipped to pharma grade environmentally friendly incinerators located at Kamuzu Central

Hospital (KCH) in the central region and Queen Elizabeth Central Hospital in the south where they

are properly incinerated and disposed of. In addition, all waste generated at service delivery points

including used syringes and vials are largely disposed of by incineration at the district hospital

level. We are planning to use the same structures to dispose of waste that will be generated during

the management of COVID-19 vaccine.

The EPI program will be responsible for ensuring that all vaccines and vaccine devices which have

been used are recalled back to the National Vaccine stores. These will be reallocated or should

they show signs of not being potent, then disposal will be planned with nearest incineration facility.

A budget has been set aside to support this process and it is a common practice even during

supplementary immunization activities SIA.

8.0 Human resource management and training

Availability of human resources is critical in the introduction of the new vaccine. The EPI

Programme is under the directorate of Preventive Health services in the Ministry of Health. At

National level, the programme is managed by the EPI Programme manager and assisted by his

deputy. In addition, there are officers responsible for Routine immunization, cold chain, supply

chain, surveillance for both diseases, and AEFI and Monitoring and Evaluation.

The country has five zones and in all the zones there are Routine immunization officers responsible

for the zone. In two zones where there are cold-rooms, we have Zonal Immunization Supply

Officers managing the cold rooms and supplies. There are 29 District EPI Coordinators managing

EPI services in districts and these are assisted by their deputies and district Cold Chain

Technicians.

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About 80% of vaccinations in Malawi are done by the cadre of Health Surveillance Assistants.

Few nurses mainly Community Health Nurses and some clinicians also provide immunization

services. During vaccination sessions, the vaccinators are assisted by volunteers who support with

crowd control, and other integrated interventions e.g. growth monitoring. The COVID-19

vaccination will be handled by Health surveillance Assistants as usual who will be supervised by

the Community Health nurses, Public Health Officers at district including other cadres who will

be designated to undertake the supervisory role depending on training and availability. At the

health facility level, Nurses will be expected to vaccinate all the health and social workers at their

health facilities. The EPI coordinator at district level will be expected to coordinate all the activities

including management of supply chain and logistics.

All Health Promotion Officers will be expected to carry out demand creation activities in the

districts with support from the Health Education services unit of the Ministry of health. They will

be assisted by the Community Health Coordinator at district level who will be responsible for

community engagement activities which includes reaching to opinion leaders in order to facilitate

demand creation and dispel myths and misconception as well as misinformation.

The volunteers will be responsible for supporting the vaccinator including document management

and filing. They will also ensure clients are observing COVID-19 preventive measures and do any

other duty as assigned but not technical work.

8.1 Training

Training of Health workers is key to the successful introduction of any new vaccine in the

country. The country will develop a training plan to prepare for COVID-19 vaccine introduction

that includes key groups of participants, number of participants, training materials required. The

dates of training and key training partners and allocation of resources and overall planning.

National facilitators will train the District trainers who will carry out cascade training for health

workers and volunteers in their respective districts and central hospitals. The training will be

both in-person and virtual depending on Internet and network connectivity challenges, budgetary

constraints, and technical know-how on the use of virtual platforms for conducting

meetings/workshops.

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Training materials are essential tools for successful implementation of every training in the

introduction of new vaccines. In preparation of the COVID-19 vaccine introduction, different

training materials such as field manual, operational manual and training decks will be developed,

printed, and distributed in all the districts to guide training and used as reference materials. These

guidelines are being developed by adapting the generic materials provided by WHO. National

supervisors will supervise the district training sessions and district trainers will supervise the

orientation of community health volunteers to ensure high quality of training at all levels.

It is expected that the COVID-19 training will be rolled out immediately as the National Vaccine

Deployment Plan is submitted which is the third week of February prior to arrival of the first

consignment of the COVID-19 vaccines. The WHO has provided training materials which have

already been adapted in readiness for the trainings. WHO will support the printing of the training

manuals and slide decks for both facilitators and vaccinators.

Other materials to be used during the training include, COVID-19 tally books, registers, ID cards

and AEFI forms. These documents are under development with support from JSI, WHO and

UNICEF.

9.0 Vaccine acceptance and uptake (Demand creation)

9.1 community engagement

Community engagement is very crucial when introducing interventions in the community. More

so when Malawi will be introducing the new COVID-19 vaccine, the communities should be

properly engaged for successful implementation. All stakeholders including leaders - political,

religious, and traditional and community structures should be involved at onset during the

planning, implementation and evaluation phases. Communities should be empowered to assist in

making decisions and to implement and manage the introduction of the vaccine.

Community engagement activities will be done countrywide and some to targeted communities.

The target populations for the vaccine includes the health workers, elderly, social workers and

persons with comorbidities. Community engagement is complex, hard work, and requires to be

done on a continuous basis. The following are the interventions to be carried out;

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1. Development of operational guide for community engagement on COVID-19 response

using COVID 19 vaccine

2. Orientation of HSAS and other community Health workers on the operational guide for

community engagement on COVID 19 vaccine

3. Engagement with community leaders, block leaders, religious leaders, political leaders

on COVID 19 vaccine introduction and implementation including their roles

4. Engagement with community structures (CHAGS, VHCs, HCMCs, HMCs, VDCs,

ADCs) on COVID 19 vaccine introduction and implementation including their roles

5. Engagement with the Civil Society on COVID 19 vaccine including their roles to

support implementation

6. Monitor COVID-19 vaccine implementation using the community Health register

7. Review meetings with communities on implementation of COVID 19 vaccine

8. Community dialogue meetings during implementation

The community structures and stakeholders will be utilized by;

Promotion messaging

Engaging in rumour and misinformation identification and mitigation Arranging

community dialogue meetings as appropriate

Mitigating social and psychosocial impact as well as stigma and discrimination associated

with COVID-19 vaccine

Normalizing reactions of fear and anxiety associated with the uncertainty

and eventuality of COVID-19 vaccine

Giving key messages on the necessity of supportive family/caregiver

networks

9.2 Demand creation

Introducing a new vaccine is always a challenge, often due to inadequate knowledge, prevalence

of false information and general fear around adoption of new ideas and information. Since early

2020, there has been general hesitancy around COVID-19 vaccine on social media. By end

December 2020, the overall tone of immunization content was trending negatively in the region,

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including Malawi. Around 40% of content had a negative tone, with only 8% of articles and posts

displaying positive sentiments.

There has been resistance from religious sectors and doubts/concerns in the general population

about effectiveness and safety of COVID-19 vaccines. These include false claims that the vaccine

will cause infertility and that its promotion and/or uptake is diabolical/sinful. Other fears relate

to the fact that the vaccine has been developed over a short period of time; thus, its safety has not

been scientifically proven outside clinical trials. On the other hand, some Anti-vaccine groups have

disseminated news that the vaccine is a political agenda by the West to wipe out the African

population.

Pandemic fatigue is increasing, as a result in part due to the stress caused by uncertainty, lower

risk perceptions and reduced trust in government responses. By September 2020, according to

rapid assessment activities conducted by UNICEF, HC4L and MEIRU, knowledge of COVID-19

was over 90% while self-efficacy to practice the recommended behaviors trailed over 70%.

However, risk perception was low at around 40%.

The College of Medicine, with support from UNICEF and FCDO, conducted a KAP survey in

November 2020. Qualitative results indicated that most participants highlighted that COVID-19 is

a threat to humankind because of its transmission through air, spreads fast, it is deadly more deadly

than other known diseases and it has no cure. However, some reported that they are not afraid

because they are following preventive measures. Others indicated that there is nothing to fear about

COVID-19 because God is bigger than COVID-19 (they trust God and they would not be at risk).

Participants highlighted several social problems being faced by communities due to COVID-19.

Some highlighted loss of business and decreased economic activities as major concerns. Other

participants reported closure of schools as a critical problem facing the youth, while others were

much concerned with isolation.

Majority of participants indicated that they get information from radio, TV, and health workers.

Others reported that they get information from church leaders and at funerals. Participants reported

48 | Page

getting trusted information regarding COVID-19 from health workers. However, it was also noted

that radio, television, and social media plays a critical role in informing people regarding COVID-

19.

Almost all participants had adequate knowledge regarding preventive measures of spread of

COVID-19 19. Participants highlighted hand washing, use of masks, sanitizers and observing

social distance as common preventive measures. Almost all participants understand the need to

keep preventive measures in place, participants highlighted that reduction in COVID-19 cases can

be the only reason to lift the measures that have been put in place.

In recommendation the team observed, among other processes, that there is need to strengthen

interpersonal communication and community engagement which should include engagement of

religious leaders, community leaders and health workers to raise risk perception and debunk

rumors. In addition, partners need concerted effort from all response pillars to respond to the

socioecological effects of COVID-19 e.g. missed employment, which has a bearing on reducing

risk perception and adoption of recommended practices. The recommendations have been utilized

to share the current risk and crisis communication, and social mobilization plan on COVID-19

vaccine, which includes risk communication.

The demand creation strategy intends to ensure a high level of COVID-19 vaccine acceptance and

uptake among most-at-risk populations and the public. Demand creation strategies will be drawn

under the objectives stipulated in the Table 4 below.

Table 3 Demand creation objectives

COVID-19 Vaccine COVID-19

49 | Page

By June 2021: Increase to >95%, knowledge of

COVID-19 vaccine benefits, schedule, side effects,

place, and time of vaccination among all individuals

in Malawi.

By June 2021: Increase to over 80%, positive

attitudes regarding COVID-19 Vaccine safety,

efficacy, and willingness/intention

By June 2021: Increase to > 80%, public demand for

COVID-19 Vaccine among eligible population.

By December 2021: Increase risk perception of

COVID-19 to >70% by 2021

By June 2021: Maintain preventive practices

(handwashing, distancing, and face-masking in

public) of COVID-19 among individuals to >

70%)

9.3 Participants groups/target audiences

Priority audiences addressed in this strategy are based on data from WHO guidelines, national

guidelines and studies which identified the priority and key populations for COVID-19

Vaccination. The target audience are the target population for the vaccination and their influencers.

9.3.1 The primary audience

Primary audiences include health workers in private and public health care facilities, older people

aged 60 and above, people that have chronic conditions and social workers who interact with many

people on a daily basis like the police officers and soldiers that this vaccine deployment and

vaccination plan has prioritized for COVID-19 vaccination

9.3.2 The secondary audience

The secondary audiences include the leadership of association of medical doctors, nurses,

public/environmental health, pharmacy, laboratory and other allied health associations,

associations on People Living with HIV (PLHIV), cancer, diabetics and others, nurses’ and

medical council of Malawi, and Teachers association of Malawi. The leadership of elderly people

50 | Page

in Malawi, pensioners’ association of Malawi, religious groupings, Malawi interfaith association,

Pentecostal churches of Malawi and traditional leaders

9.3.3 The tertiary audience

Members of parliament, health right activists, Malawi Health Equity Network, Media Institute of

Southern Africa (MISA) in Malawi and the media fraternity constitute the tertiary audience. These

will be reached to lobby for message dissemination through their bodies.

9.4 Channels of Communication

The media plays a significant role in ensuring significant public awareness. The country shall use

multiple media and platforms for better message consumption and coverage.

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Table 4 Summary of the different media and platforms to be used.

1.0 COVID-19 Vaccination

Primary target

audience

Audience description Proposed Approaches and Channels

Health workers All people engaged in actions whose

primary intent is to enhance health in

private and government facilities.

Health workers infected with COVID-19

may contribute to health care-associated

infection transmission to their patients

and people they care for, including those

at high risk for developing severe

COVID-19 disease and complications

Interpersonal Communication: Face to Face

Orientation, interactive SMS’s

Mass media: radio/TV programs & spots

Older people People aged 60 years and above as their

immunity is low due to aging and are at

high risk to many infections including

COVID-19

IPC: community dialogues

Community Mobilisation: Theatre for

Development

Mass Media: radio and TV spots/programs

Persons with

underlying

health

conditions

People of all ages that are diabetic, HIV

positive, High blood pressure, asthma

and other chronic conditions are at

significantly higher risk of severe disease

or death

IPC: community dialogues

Community Mobilisation: Theatre for

Development

Mass Media: radio and TV spots/programs

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9.5 Risk Communication strategy

Crisis communication for the COVID-19 vaccine has been designed to provide guidance and easy

to follow steps to support the community in preparation for, management of rumors,

misconceptions and other associated vaccine AEFI with some of the following scenarios:

Side effects: soreness at the site of injection, fatigue, headache, and muscle pain.

Suspicion about poor vaccine quality.

Actual event arising from vaccine: Loss of trust of the current and subsequent vaccines.

Vaccine replacement/recall.

Table 5 Summary of Risk Communication Strategy

COVAX scenario

Development of side

effects: soreness at the site

of injection, fatigue,

headache, and muscle pain:

COVAX scenario:

Other adverse effects e.g.

fainting or death

COVAX scenario

Developing COVID-19

symptoms after vaccination

Key message:

It is normal to experience side

effects within 24 to 48 hours

after immunization

Key message:

There can be other effects

not related to COVAX,

which can happen when one

has taken the vaccine

Key message:

COVAX reduces the risk of

getting infected. Always follow

recommendations to avoid

vaccination if you are already

infected

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1. Supporting message

Seek prompt medical

attention if side effects

continue or if you are

concerned about their severity

1. Supporting message

COVAX does not increase

people’s risk to other life

threatening conditions

1. Supporting message

It is rare for a person who is

vaccinated to develop COVID-

19 symptoms

COVAX scenario:

Suspect poor vaccine quality

COVAX scenario:

· Actual

event arising from vaccine:

Loss of trust of the current

and subsequent vaccines

COVAX scenario:

· Vaccine

replacement/recall:

Demand explanations,

apology and

compensations.

Key message:

All vaccines including COVAX

are tested and found to be safe for

use.

Key message:

Many children in Malawi

safely receive the vaccines.

There are times when a single

or few doses might have

problems. The good news is

that a large number of the

population is protected

Key message:

Government can

recall/replace a vaccine if

it is proven that it have

detrimental effect on the

lives of people.

54 | Page

1. Supporting message

To protect lives some vaccines

are developed quickly e.g. the

Ebola vaccine and COVAX.

These are still tested for safety

1. Supporting message

COVAX is safe. Government

can recall/replace a vaccine if it

is proven that it have

detrimental effect on the lives

of people.

1. Supporting

message

When you have issues with

our services seek advice

from the nearest health

facility.

Table 6 Proposed Crisis Responses on Anticipated Issues

Issue Scenario Serious-

ness

(low,

medium,

high)

Crisis activities Preventive

actions e.g.

training etc.

New study New findings

showing that

COVAX has lower

efficacy

High

Ministerial

statement

Panel discussion

by experts (live)

Health worker

trainings

Media

orientations

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Production and

dissemination of

fact sheets

Community

sensitizations

Vaccine

reaction

(AEFI/AE)

Development of

other side effects (

normal and

abnormal)

Medium

High

Investigation and

prompt feedback

Follow up/close

supervision

Holding statement

(MoH Hq)

Health worker

trainings

Community

sensitization

Surveillance

and supervision

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Vaccine

recall

(suspensio

n)

Product quality

related issues

Program related

immunization error

High

Review

communication

materials

(Question and

answers, fact

sheet, press

statement, holding

statement

Investigation

(within 24 hours

after an AESI

report)

Press statement

Holding

statement

Community

meeting

Press briefing

Training health

workers on

malaria vaccine

& related AESIs

Community

meetings

Media briefing

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(Question and

answers, fact

sheet)

Media

report and

rumour

AEFIs/AESIs High

Medium

Media briefing

Press release

Public

announcements

Community

awareness

meetings

Community

engagement

Media briefing

Training health

workers & PROs

Press conference

Community

awareness

meetings

Community

engagement

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Vaccine

replacemen

t

Suspect poor

vaccine quality-

affect uptake

Loss of trust of the

current and

subsequent

vaccines

Demand

explanations,

apology and

compensations.

High

Media briefing

Press release

Public

announcements-

holding statements

Press conference

Community

awareness

meetings

Community

engagement

Training of

health workers,

Media & PROs

Press conference

Community

awareness

meetings

Community

engagement

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9.6 Campaign Positioning

Communication and social mobilization interventions will be implemented in three phases with

different levels of intensity. Phase 1 will include inception activities, e.g., rapid assessment, and

accelerated high-intensity interventions on debunking rumors and providing accurate information

on the vaccination. In addition, RCCE interventions will intensify motivation to increase risk

perception of COVID-19. Phase 2 will continue with community engagement while taking into

consideration emerging issues, e.g. AEFIs and crisis communication, while continuing to collect

insights and conduct communication, community engagement and social mobilization. Finally

Phase 3 will mainly involve evaluation and replanning. The table below illustrates:

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9.7 Phased Implementation of Risk and Crisis Communication

Table 7 Table 6 Risk and crisis communication phased implementation table

Intervention Phase 1 Phase 2 Phase 3

Rapid Assessment √ √

Regular collection of

insights

√ √ √

Review crisis

communication plan √ √

Public risk

communication:

Awareness &

debunking rumours

√ √ √

Community

engagement and

social mobilization

√ √ √

Advocacy √ √

AEFI & regular

monitoring and

response

Crisis communication √

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Review and

replanning

9.8 Monitoring, Evaluation and Documentation

Monitoring tools will be adapted from the COVID-19 vaccination monitoring framework and be

utilized for data collection at national, district and community levels, see Annex 2 for the

indicators. An online dashboard will be created for i) District health Promotion Officers and ii)

national partners (CSOs, iNGOs and government partners) to fill data on reach and provide insights

collected from the field as well as recommendations that will be discussed in RCCE meetings. To

ensure that there is regular situation analysis, other digital platforms will be utilized e.g. U-report,

929 platform (Chipatala cha pa Foni). M&E tools/platforms will include:

o National-level data collection forms

o District-level data collection forms

o Community-level data collection forms

o Online dashboard ( national and district)

o U-report templates

o CCPF (Chipatala cha pa Foni)

o Formal Survey by academia

o Talk walker ( Online Social Listening)

9.9 Coordination

Coordination mechanisms through COVID-19 RCCE Committees will be strengthened at national,

district and community levels to increase participation of partners. The committees will be chaired

by the Deputy Director of HES, District Health Promotion Officer and facility Health promotion

focal person respectively, and the responsibilities at national and district will be:

● Mapping interventions

● Monitoring implementation

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● Coordinating monitoring and evaluation activities e.g. joint monitoring, coordinating

partners conducting rapid assessment

● Providing guidance for leveraging resources

● Providing guidance for strategic approaches

At community Level the committee will be responsible for:

o Mapping interventions

o Monitoring implementation by community agents

o Coordinating monitoring and evaluation activities e.g. joint monitoring, coordinating

partners, monitoring, and reporting AEFIs.

In order to ensure that all the above objectives have been achieved, the following will be

undertaken; Conduct baseline research and evaluation, development of COVID-19 vaccine social

mobilization and crisis communication strategy, develop communication products for various

groups (media briefs, IPC for frontline workers, print materials, community mobilization guides,

advocacy kits), conduct district level social mobilization community engagement and

interpersonal communication by frontline workers, conduct media briefings, produce and air

communication products on COVID-19 vaccine, conduct advocacy meetings on COVID-19

vaccine and monitor implementation of communication activities, rumors, myths and

misconceptions.

10.0 Vaccine safety monitoring

Quality vaccines and safe immunization practices are important to successful immunization

programmes. Vaccines are largely used to protect individuals from acquiring deadly infectious

diseases which are preventable. Vaccines are safe and effective. However, no vaccine is 100% safe

and adverse reactions may occur which are mostly mild and self-limiting. Vaccines rarely cause

serious reactions and most of these serious reactions are coincidental to vaccination.

Adverse events following immunization (AEFI) surveillance is important in monitoring safety of

vaccines. AEFIs, if not properly handled, may confuse the public to the extent of compromising

the success of immunization programmes. AEFIs occur during routine immunizations, campaigns

and/or when new vaccines are introduced.

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Another essential component of vaccine safety surveillance is the detection and reporting of

Adverse Events of Special Interests (AESIs). This is a list of conditions set by experts to pay

special attention. The conditions would come from the events that have been detected in the

product of similar characteristics or and potential signals that were detected in the clinical trials.

Malawi will utilize its experience and lessons learnt with RTS, S AESI surveillance to conduct

similar active surveillance for selected AESIs of covid-19 vaccines.

The broad objective is to ensure that there is adequate monitoring and appropriate management of

AEFIs during the introduction of Covid vaccination. Including training of health care workers on

identification, management and reporting of suspected anaphylaxis and ensuring availability of

adrenaline AEFI kits at all vaccination sites.

Pharmacovigilance during the implementation of this deployment and vaccination plan shall be

guided by the following specific objectives:

To ensure that health workers are adequately trained on both common and rare

AEFIs

To ensure that vaccinators and health workers can detect, manage and report AEFIs

including those that may be due to COVID-19 vaccine.

To strengthen the existing structures of AEFI review and causality assessments so

that there is capacity to timely identify and characterize all AEFIs including those

that may appear in patients that received COVID-19 vaccine.

Malawi has a functional AEFI surveillance system. Since 2019, Malawi has been reporting more

than 10/100,000 cases which is an indicator of a functional AEFI surveillance system according to

the Global Vaccine Action Plan (GVAP). All the districts have AEFI reporting forms and AEFI

investigation forms. Furthermore, 11 out of 29 administrative districts have district investigational

teams. The guidelines are in place, the reporting and investigational tools have been distributed,

and line-list is generated and shared every quarter. Roles and responsibilities are clearly identified,

and training have been conducted at all levels and also in progress. Also, the country has a well

established national AEFI committee with expertise from diverse backgrounds already trained in

generic causality assessment. The committee, in coordination with the Intercountry Support team

64 | Page

(IST) is also being trained to undergo Covid vaccine specific challenges on causality assessment.

This committee is called the Medicines Safety and Quality Monitoring Committee, under

Pharmacy Medicine Regulatory Authority.

The country will continue training more health care workers in AEFI surveillance. Also, it will

utilize lessons learnt from RTS, S vaccine implementation in training and strengthening district

investigation teams in all the districts. These teams will be able to conduct investigation of all

AEFIs that warrant investigations and be able to provide feedback to the concerned communities.

Equally important is the training of health promotion officers in vaccine safety and crisis

communication. This will form an essential component of vaccine safety surveillance.

In addition, EPI will work closely with PMRA to ensure that the activities mentioned by the

vaccine manufacturers as part of their risk management plan are successfully implemented. AEFI

reporting will use the already existing structures as shown in figures 7 below

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Figure 6 Figure 7Malawi AEFI reporting workflow and timelines

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11.0 Immunization monitoring systems

Monitoring of COVID-19 vaccine uptake will be integrated into the routine immunization system.

During the vaccination session, WHO recommended tally sheets will be adapted to record doses

given. Vaccination registers will be used for recording recipient details i.e. name, village, date of

birth, and doses given i.e. first and second doses. Every vaccinated person will be given an ID

card, which will also act as a reminder card for the second dose. Summary sheets will be used for

consolidating data at every vaccination point, and the facility summaries will be reported

immediately using specifically designed excel base tools At the district level, data will be

aggregated in the excel tool disaggregated by gender and priority group, and sent to the national

level immediately. The national level will have a command center which will receive and

aggregate the data, analyze, interpret for action and give feedback to districts. The data will also

be shared with local and external partners.

The country has designed and developed COVID-19 vaccine M&E tools to be used for recording,

aggregation, and reporting data. These are micro-planning tools, registers, vaccination ID cards,

tally sheets which will be segregated by gender, target group, etc. These tools have been developed

by the national level team through adaptation of the generic WHO COVID-19 materials and other

materials from previous vaccine introduction. Health workers will be oriented on the use of the

revised tools for them to be able to use them for data collection and timely reporting.

Monitoring framework with a set of recommended indicators among which will be on coverage,

acceptability, disease surveillance, AEFI surveillance. These indicators include; Percentage of

health workers vaccinated monthly with the first dose of COVID-19 vaccine by district, Sex and

age(<60 and >60); Monthly drop out of COVID-19 vaccine (dose 1- dose 2) by district; Proportion

of districts with stock out of COVID-19 vaccine in a month; COVID-19 vaccine wastage rate by

district by month; Number of cases with minor or serious AEFIs associated with COVID-19

vaccine reported by district by month and Number of COVID-19 reported cases in the vaccinated

target group with number of doses received and interval from first to second dose. After the

vaccination exercise, the district will review the tally sheets and aggregate the data by target group

and report to the national command center, where data will be aggregated by gender and priority

target groups in order to understand the successes or challenges within each group.

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12.0 COVID-19 vaccination Surveillance

Malawi has detailed guidelines on how to implement surveillance strategies for COVID-19. The

main aim is to ensure that public health authorities rapidly identify and manage cases whilst

preventing further spread of the virus, thereby limiting associated morbidity and mortality.

Surveillance data helps to guide COVID-19 interventions including vaccination by providing

evidence for prioritizing high risk groups such as the elderly and those with comorbidities,

including those to be targeted for COVID-19 vaccines beyond the initial 20%. The objectives of

covid-19 surveillance are; Enable rapid detection, isolation, testing and management of cases;

Identify, follow-up and quarantine contacts; Monitor trends of COVID-19; Identify risk factors

for infection and disease transmission and guide development and implementation of targeted

control measures and vaccine implementation. Specifically, the vaccine programme will conduct

surveillance for AEFI for COVID-19 vaccine, early detection of infection and severe disease in

the vaccinated population and virus transmission dynamics following infection post vaccination.

In order to achieve the above objectives, the following disease surveillance strategies will be

implemented as part of the already existing surveillance system: Community Active Case finding,

Health Facility Active Case Finding- for both health workers and clients, Testing all travelers on

entry into the country and conduct follow-up visits up to 14 days, Testing of all truck drivers

entering the country, Testing all entrant essential personnel , Routine screening and testing health

workers managing COVID-19 cases, Isolation of all confirmed cases and quarantine of their

contacts, Intensified Contact Tracing and testing of all primary contacts and Sentinel and Mortality

surveillance in select facilities.

Surveillance system is currently being conducted in all the health facilities and the same system

will be maintained during COVID-19 vaccine introduction. A generic case-based surveillance

form is available for use in the surveillance manual of all immediately notifiable priority diseases

including COVID-19. The form also collects information on vaccination status of individuals for

vaccine preventable conditions, see Annex 3. The Public Health Institute of Malawi (PHIM) and

EPI have adapted the case-based form to collect information on COVID-19 vaccination status and

will include the vaccination status variable in the line list reporting template.

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Effectiveness or impact studies for the new covid-19 vaccine will be conducted by PHIM and EPI

in collaboration with academia and research institutions and any other stakeholders assessed to

have the technical expertise to conduct such studies. A proposed study looking at sero-

immunology among individuals receiving COVID-19 vaccine in urban and rural cohorts of

Malawi with ongoing work with Malawi Epidemiology Intervention Research Unit, will assess the

immune response, in vitro neutralizing antibody properties and susceptibility post COVID-19

vaccination. Another study will be a quasi-experimental design and will be conducted to assess

differences in infection/re-infection rates and severity of COVID-19 disease between those

receiving the vaccine and those not vaccinated for COVID-19. These studies will follow the ethical

guidance of in-country IRB, the National Health Sciences Research Committee and will be

monitored by the National Regulatory Authority.

13.0 Post Introduction Evaluation (PIE)

Post introduction evaluation assesses the impact of a new vaccine introduction on the country's

immunization system, including the vaccination performance during introduction. The country has

been conducting PIEs for all the new vaccines it has introduced before. The evaluation is conducted

6 to 12 months after the introduction.

The PIE will also be conducted for COVID-19 vaccine after 1 month from the first phase of

introduction to get lessons that can inform the rest of the phases. Due to the travel restrictions, the

country team will conduct the PIE by adapting the generic WHO PIE materials. Districts will be

sampled for data collection on all components of immunization. The data will be analysed and a

report written with key findings and recommendations.

14.0 Lessons Learnt

COVID-19 vaccine has been introduced in the world in a unique way due to the short time taken

from trials to manufacturing up to the actual vaccination. There has been a lot of misinformation

in social media even before the vaccine is introduced in the country. The country will be getting

lessons during the introduction through supervisory visits, the PIE and general feedback from the

community. After the vaccination, the country will pull together all these in a documentation which

will guide the follow-on phases and even share the lessons with other countries.

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References

[1] Kanyuka MM. 2018 MALAWI POPULATION AND HOUSING CENSUS. 18.

[2] Malawi_2009_STEPS_Report.pdf,

https://www.who.int/ncds/surveillance/steps/Malawi_2009_STEPS_Report.pdf (accessed

31 January 2021).

[3] Country - Malawi, https://data2.unhcr.org/en/country/mwi (accessed 31 January 2021).

70 | Page

Annexes

Annex 1 Risk Communication and Crisis plan

Target audience Justification Channel of communication

Teachers, Police

officers, soldiers,

drivers, sex

workers,

hospitality staff

These are workers whose nature of their

job demands interaction with a lot of

people and most of the times cannot

adhere to physical distancing; social

employment groups.

Interpersonal Communication: Face to

Face Orientation, interactive SMS’s

Mass media: radio/TV programs & spots

People around

borders Point of

Entries (/POEs)

(general

populations)

They are at high risk as they get exposed

to travelers.

Mass communication: leaflets, banners,

radio programs/spots

Community Mobilisation: community

dialogues/meetings/theatre

Travelers They are highly exposed to COVID-19

during travel

Mass communication: leaflets, banners

General

population

They have low risk perception due to

misconceptions and myths

IPC: community dialogues

Community Mobilisation: Theatre for

Development

Mass Media: radio and TV spots/programs

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Children &

Young People

Children are particularly vulnerable to

the socio-economic impacts and, in some

cases, by pandemic

Mitigation measures e.g. school closures.

They may not be able to access

appropriate information or understand

the recommended behaviors and suffer

from the psychosocial impacts of the

pandemic. There may also be disruptions

in care due to the socio-economic

impacts

IPC: interactive guides

Mass Media: comic books, animations

The homeless They may live isolated from society and

not have a network of family and friends

to share information.

They may be more focused on surviving

and obtaining food than accessing

official public health information and

may be suspicious or fearful of

government services.

IPC: Guides for child protection frontline

workers

GBV Survivors Gender-based violence (GBV) increases

during every type of emergency,

including disease outbreaks. Care and

support for GBV survivors may be

disrupted, including safety, security, and

justice services.

IPC: Victim support materials (integrated

with COVID-19 messages)

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People with

disabilities

Youth

Even under normal circumstances,

people with disabilities are less likely to

access health care, education, and

employment and to participate in the

community. They are more likely to live

in poverty, experience higher rates of

violence, neglect, and abuse, and are

among the most marginalized in any

crisis-affected community. They are

often excluded from decision-making

spaces and have unequal access to

information on outbreaks and

availability of services, especially those

who have specific communication needs.

Act as influencers and help in

information dissemination. Some are

active drivers of the pandemic, therefore

need to participate in prevention and

control.

IPC: Special materials for PwDs e.g.

Braille, sign language

Entertainment education: TV/radio

programs

Community/social mobilisation:

utilisation of youth platforms e.g. National

Youth Council at national and district levels,

youth clubs

New media: WhatsApp, FB etc.

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Annex 2 Proposed Set of Core Indicators for Monitoring & Evaluation

Outcome (Impact) Indicators

1. % of fully immunized persons segregated by Sex and age.

2. % of individuals who believe that all eligible persons should take the COVID-19

vaccine

3. % of beneficiaries and/or their parents who are willing to be vaccinated (or give

consent to be vaccinated).

4. %age of individuals practicing recommended behaviors to prevent and control COVID-

19

Outputs and Interim Outcomes Indicators

Knowledge, Awareness, Perception of Risk, Acceptance and Trust

1. % of individuals who have heard about the COVID-19 vaccine and know what it is

meant for.

2. % of individuals who know what measures should be taken if they have been in

contact with someone who has COVID-19

3. % of persons who believe they are at high/low/no risk of getting COVID-19.

4. % of persons per eligible population group who agree to take the COVID-19 vaccine

for preventing COVID-19.

5. % of all eligible persons who intend to give consent for COVID-19 vaccination (in the

future)

6. % of people who agree that they would consent to their child/relative receiving the

COVID-19 vaccine

7. % of eligible persons who believe that the COVID-19 vaccines are safe

8. % of eligible persons who believe that the COVID-19 vaccine is effective in preventing

COVID-19

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Coverage with Equity

11. % of eligible persons who took their first dose/all doses of COVID-19 vaccine.

12. % of eligible persons segregated by gender who were fully immunized with all doses

of COVID-19 vaccine in hard to reach areas.

Vaccination Experience and Frontline Worker Commitment

13. % of beneficiaries and/or their parents who reported that the vaccination experience

was positive

14. % of beneficiaries and/or their parents who had, or agreed to, proactively promote

COVID-19 vaccination in their communities or among their peers.

15. % of front-liners who ensured that >90% of all eligible persons in their designated

catchment area were reached with messages/interventions

Establishing COVID-19 Vaccination as a Norm

16. % of beneficiaries and/or their parents who believe that their community or peer group

expects all eligible persons to take COVID-19 vaccination.

Media Support and Commitment

18. % of positive and supportive COVID-19 vaccine reports in the media compared to

negative reports.

Input and Process Indicators: Coordination, Planning, and Operations

National Level

1. # of Communication Sub-committee or Working Group meetings that took place

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2. # of communication and social mobilization activities or events planned compared to

# of activities or events implemented

3. # of planned communication materials/products produced on COVID-19 vaccine

4. # of planned communication materials/products disseminated on COVID-19 vaccine

(distributed or broadcast)

5. # of parents/guardians of eligible persons who had been reached by COVID-19 vaccine

key messages (heard on broadcast media or through interpersonal communication by

front-line workers, etc.)

6. # of community leaders (at village/community level) who had been reached by

COVID-19 vaccine key messages (heard on broadcast media or through interpersonal

communication by front-line workers, etc.)

District Level

7. # of districts with communication and community engagement micro-plans (including

specific plans for reaching all beneficiaries in the hotspots)

8. # of communication and social mobilization activities or events planned compared to

# of activities or events implemented

9. # of frontline health-workers trained or sensitized versus # planned

10. # of planned locations per district that received IEC materials in a timely manner.

11. # of districts who reported sufficiency of communication resources (funds, fuel, IEC

materials, front-liners)

12. # of districts who conducted sensitization and engagement activity in each of the

GHVs

13. # of reports of rumors, misinformation, or AEFIs

14. # of reports of rumors, misinformation, or AEFIs that were resolved within 72 hours.

15. % of individuals who know how to provide feedback about decision making processes

which affect them

76 | Page

Annex 3 Timeline of Activities

FUNDING

Start End 1 2 3 4 5 6

1 Development of NDVP, budgets and timelinesEPI-

TWG(NCC)DONE 20/12/2020 09/02/2021

WHO/UNICEF/JS

I3 National Task Force Meeting NTF CHAIR in progress 16/02/2021 ongoing GLOBAL FUND

4 Sub committees' meetings NTF in progress 16/02/2021 ongoing not secured

5 Development of IEC materials and Review of

communication strategy including Risk and Crisis HEU in progress 11/02/2021 28/02/2021 UNICEF

6 Development of publicity materials HEU in progress 11/02/2021 28/02/2021 UNICEF

7 Printing of social mobilization Materials HEU in progress 11/02/2021 28/02/2021 UNICEF

8 Press conference HEU TO BE DONE 01/03/2021 23/04/2021

9 Briefing of media personnel HEU in progress 02/03/2021 31/03/2021 TREASURY

10 Advance Publicity HEU TO BE DONE 01/03/2021 ongoing WORLD BANK

11 Development of operational guide and training deck EPI in progress 15/02/2021 28/02/2021 WHO

12Finalization of training guides, Data monitoring and

Microplanning toolsEPI

in progress01/03/2021 05/03/2021

WHO

13 Development of data monitoring tools (including

C0VID vaccine)EPI in progress 15/02/2021 19/02/2021 UNICEF

14 Procurement/ mobilization of PPE EPI In progress 01/02/2021 28/02/2021 MoF/MoH

15 Airing of Radio/ TV slots HEU 01/03/2021 on going UNICEF

16 Printing of training guides and data monitoring tools EPI 15/02/2021 05/03/2021 WHO/UNICEF

17 Distribution of logistics to districts EPI 05/03/2021 31/03/2021 GLOBAL FUND

18 Training of District Trainers on COVID vaccine

IntroductionNTF 01/03/2021 12/03/2021 MoF/MoH

19 Briefing of DEC/DDC members DTF 01/03/2021 03/03/2021 MoF/MoH

20 Briefing of District Taskforce Members NTF 01/03/2021 12/03/2021 MoF/MoH

21 DTF meetings DTF 14/03/2021 30/03/2020 MoF/MoH

22 Briefing of Supervisors EPI 03/03/2021 04/03/2021 MoF/MoH

23 Briefing of vaccinators DTF 03/03/2021 04/03/2021 GLOBAL FUND

24 NTF Supervision during briefing of vaccinators DTF 03/03/2021 03/03/2021 MoF/MoH

25 Distribution of logistics to health facilities DTF 10/03/2021 16/03/2021 GLOBAL FUND

26 Facility microplanning DTF 05/03/2021 13/03/2021 MoF/MoH

27 Briefing of local leaders DTF 05/03/2021 06/03/2021 MoF/MoH

28 Briefing of Volunteers DTF 05/03/2021 06/03/2021 not secured

29 Micro planning Meeting EPI 10/03/2021 21/03/2021 not secured

30 Forecasting and Establishment of Traceability of

VaccinesEPI 23/03/2021 on going not secured

31Operational Research EPI/PHIM/

COM/PAR 01/03/2021 on going not secured

32 National Launch of COVID-19 vaccine NTF 08/03/2021 0ne time off MoF/MoH

33 NTF supervision on actual days NTF 26/03/2021 ongoing MoF/MoH

34 District level supervision on actual days DTF 26/03/2021 ongoing MoF/MoH

35 Injection materials wastes incineration DTF 01/03/2021 ongoing MoF/MoH

36 Data analysis at district level DTF 10/05/2021 ongoing MoF/MoH

37 Report writing NTF 30/06/2021 05/08/2021 MoF/MoH

38 Post -Introduction Evaluation (PIE) NTF 01/10/2021 30/10/2021 WHO/UNICEF

COVID 19 VACCINATION TIMELINE2021

S/No Main ActivitiesResponsib

leStatus

77 | Page

Annex 4 Budget

Table 1: Budget Summary

Item Description COST (MWK) US$ Funding support

Development of training guides 10,943,344.00 14,788.30 WHO/UNICEF

Finalization of training guides 8,548,008.00 11,551.36 WHO

Development of data monitoring tools (including C0VID 13,888,344.00 18,768.03 UNICEF

Printing of training guides and procurement of other 15,156,600.00 20,481.89 WHO

Press conference 590,280.00 797.68 MIN. OF FINANCE

Micro planning Meeting 92,260,300.00 124,676.08 MIN. OF FINANCE

Review and Finalization of Microplanning Tools 31,532,447.20 42,611.42 MIN. OF FINANCE

Mapping of target population for COVID-19 vaccine 97,528,000.00 131,794.59 MIN. OF FINANCE

Training of District Trainers on COVID vaccine 64,166,440.00 86,711.41 MIN. OF FINANCE

Briefing of District Taskforce Members 73,371,280.00 99,150.38 MIN. OF FINANCE

Briefing of Supervisors 49,906,348.00 67,441.01 MIN. OF FINANCE

Briefing of DEC/DDC members 24,992,182.00 33,773.22 MIN. OF FINANCE

Briefing of Vaccinators 82,643,494.00 111,680.40 MIN. OF FINANCE

Briefing of Volunteers 19,680,000.00 26,594.59 MIN. OF FINANCE

Briefing of local leaders 59,040,000.00 79,783.78 MIN. OF FINANCE

NTF Supervision during briefing of vaccinators 39,891,840.00 53,907.89 MIN. OF FINANCE

Distribution of logistics to districts 8,010,000.00 10,824.32 GLOBAL FUND

Distribution of logistics to health facilities 29,310,000.00 39,608.11 GLOBAL FUND

Incentives for vaccinators during Actual days 120,000,000.00 162,162.16 MIN. OF FINANCE

Incentives for volunteers during Actual days 13,120,000.00 17,729.73 MIN. OF FINANCE

NTF supervision on actual days 13,100,000.00 17,702.70 MIN. OF FINANCE

District level supervision on actual days 79,760,952.00 107,785.07 MIN. OF FINANCE

National Taskforce meetings 24,065,360.00 32,520.76 GLOBAL FUND

District planning meetings 45,836,978.88 61,941.86 MIN. OF FINANCE

Injection materials wastes incineration 8,206,492.00 11,089.85 MIN. OF FINANCE

Report writing 14,479,100.00 19,566.35 MIN. OF FINANCE

Clearing costs of vaccine and injection materials 4,420,000.00 5,972.97 MIN. OF FINANCE

Post -Introduction Evaluation (PIE) 33,702,160.00 45,543.46 WHO/UNICEF

Procurement of PPE 146,115,840.00 197,453.84 MIN. OF FINANCE

Grand Total 1,224,265,790.08 1,654,413.23

COVID-19 VACCINE INTRODUCTION BUDGET, 2021-22

78 | Page

Annex 3 demand creation and social mobilization and community engagement budget

MK US$

1 Development of Risk Crisis and Communication Strategy 20,137,232

2 Development of COVID-19 vaccine communication materials 6,767,504

3 Pre-Testing of COVID-19 vaccine materials 15,700,032

4 Printing of Publicity materials 34,300,000

5 Conduct Regional Press Briefings 19,939,716

6 Conduct Regional Media Tours 24,009,732

7 Media press releases on COVID-19 Vaccine 126,000,000

8 Advance Publicity 178,585,120

9 Hoisting of banners in strategic places in cities and districts 79,800,000

10Production of Radio and TV, Radio Programs, PSAs and Jingles

in different languages

123,000,000

11Airing of Radio and TV, Radio Programs, PSAs, Jingles and Live

Panel Discussions

1,015,126,680

12 Briefing of local leaders 139,334,328

13 Briefing of religious leaders 209,334,328

14 Conduct Door to Door meetings by HWs in 29 districts 195,865,600

15 Engagement with Civil Society 13,293,144

16 Strengthen the online presence 143,600,000

17 Virtual National Launch of COVID-19 VACCINE by H.E. 500,000

18Monitoring of Communication interventions with district task

teams

33,716,184

Grand Total 2,379,009,600 3,050,012

DEMAND CREATION BUDGET FOR 2021-22 COVID-19 VACCINE


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