Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1694846109502.pdf (South Africa)
DEPARTMENT OF HEALTH LDOH COVID-19 VACCINE MINISTREIAL BRIEFING SESSION PROVINCIAL VACCINE ROLLOUT PLAN STATE OF READINESS PRESENTATION TO NCOP 25 FEBRUARY 2021 ZOOM MEETING Wednesday, February 24, 2021 1 Plan Outline Introduction 1.

2.

Purpose 3.

Overview of planning framework 4.

Governance Leadership and coordination 5.

Target Population 6.

Vaccine delivery platforms 7.

Human resources requirements 8.

Vaccine, cold chain, logistics and infrastructure 9.

Social mobilisation and Demand Creation 10.


Monitoring and evaluation 2 Outline continue 11.Johnson and Johnson Vaccine Implementation study 11.1.

Study aims and objectives 11.2 Methods – Study design – Study site – Target population – Study procedure – Ethic al consideration 12.
Critical implementation factors 3 Introduction • Since the declaration of COVID-19 –caused by a novel coronavirus as a public health emergency of international concern (PHEIC) by the WHO on 30 January 2020, every sector of society has been impacted.

• COVID-19 has since spread to all countries causing devastation in all sectors.
• In the absence of pharmacological treatment, except for supportive measures, public health interventions became the only hope of limiting the impact of COVID-19 on the health of communities.

• These public health interventions entail social, behavioural and environmental measures such as: universal making, hand hygiene, social distancing and avoiding poorly ventilated areas.

• Vaccination is the latest pharmacological public health intervention to be deployed to control the pandemic.
4 Aim and Objectives of Vaccination Overall Aim • To protect the population against the SARS-Cov-2 virus by interrupting transmission through achievement of herd immunity Objectives • To reduce the morbidity and mortality caused by the COVID-19 disease through prioritization of high risk and vulnerable population • To ensure readiness of the health service delivery platform for vaccination • To ensure safe and efficiency delivery of Vaccine to target population in the public and private sector • To empower the people of Limpopo with correct information with regard to Covid-19 vaccination • To monitor and evaluate the implementation of the COVID-19 vaccination programs 5 Functional Areas A.
Governance, Co-ordination and planning B.
Vaccine delivery platform  Human resources C. Vaccine, cold chain, logistics and infrastructure D. Communication and Demand creation E. Vaccine Safety monitoring and management F. Monitoring and evaluation , Information management System 6 Overview Worstream Planning and co ordination Focus Area COVID-19 Vaccination planning and coordination COVID-19 Vaccine governance and co-ordination structures Vaccine delivery platform Vaccine logistics and cold chain Budgeting and financing Monitoring and evaluation of vaccine plan Identification of target population Selection and accreditation of vaccination site Training and supervision of Vaccinators Development of vaccine protocols and guidelines Infection Prevention and control Healthcare Waste management Cold chain management Procurement and supply of vaccines Procurement and supply of vaccine related supplies Vaccine Quality control Stock monitoring 7 Overview Functional Area Focus Area Vaccine safety monitoring AEFI identification and reporting AEFI Surveillance Systems AEFI management Vaccine demand creation and communication Appropriate vaccine uptake communication Vaccine Safety communication Monitoring and evaluation Health Professional Vaccines communication Monitoring of vaccine knowledge, attitudes and practice (readiness) Monitoring and Evaluation framework Vaccine Plan indicators National Vaccine data management system 8 Governance, Co-ordination and planning 9 Governance, Co-ordination and Planning PROVINCIAL EXECUTIVE MANAGEMENT COVID - 19 SURGE CHAIRPERSON DR DOMBO COMMITTEE DEPUTY CHAIR DR NDWAMATO VACCINE TECHNICAL WORKING WORKGROUP DR MALATJI DEPUTY CAHIRPERSON MR KRUGER CHAIRPERSON COVID - 19 DITRICT VACCINATION TASK TEAM DISTRICT EXECUTIVE MANAGEMENT CHAIRPERSON OUTBREAK RESPONSE COMMITTEE - 10 Governance, Co-ordination and Planning • The vaccine rollout strategy will be coordinated by NDOH with Provincial Health Department and the private sector • In LDoH will coordinate the process through deployment two committees – The COVID-19 Surge Committee – responsible for oversight and coordination of the COVID-19 response – Vaccine Technical Working Group (TWG) which will report to the COVID-19 Surge Committee • The Vaccine technical Working Group comprises of representative from the various units at the Provincial Department of health The Vaccine Technical working group will categorized according the functional areas 11 Governance and Coordination Action plan Workstream Focus Area Activities Planning and co ordination • • Vaccination COVID-19 coordination COVID-19 Vaccine ordination structures Budgeting and financing • • Monitoring and evaluation of vaccine plan planning and Submit COVID-19 plan to Surge and executive for approval governance and co- Confirm appointment of technical working group Conduct Stakeholder engagements ( district and province) and briefings Ensure development of districts to develop micro plans Finalise the budget for the vaccination plan 12 Target Population Identification 13 Target Population Identification • Vaccines will not be available for everyone immediately and a prioritization system will have to be applied.
• Priority will be given to those: – in roles considered to be essential for societal functioning – most at risk of infection and serious outcomes, age above 60 those with comorbid conditions – hose living in overcrowded settings, – most at risk of transmitting SARS CoV 2 to others 14 Target Population • The vaccine will be introduced through a phased approach – Phase 1: All front line health workers in both public and private sector will be targeted for vaccination – Phase 2: High risk groups including: Persons in congregate settings, >60 years old, >18 yrs with co-morbidities; Other essential workers including: Teachers, Police, Security, Retail Food, Funeral Parlour, Banking, Services Sectors (local govt, port health, DHA, etc), Miners – Phase 3: Open vaccination to all The following groups have not been studied for vaccine efficacy and will thus be excluded • – Pregnant women and Children (less than 18 years) 15 Phase 1 Target Population • LDOH staff members (Persal) = 44 526 – Facility based hospital staff – PHC staff ( including mobile team) – Community based services CHWs – EMS – Depot – Provincial and district office staff – Malaria institute • NGO/ Non-Persal Staff = 6838 • Learnerships • Contractors: Social Workers • Outsourcing Contractors: SITA • Outsourcing Contractors: ANOVA • Periodic Appointments: Spraymen • Outsourcing Contractors: Red Cross staff • Lay Counsellors & Others 16 Target Population Phase 1 Risk Category Risk assessment Classification Category 1 Category 2 Category 3 Those conducting aerosol-generating procedures i.e.
intubation, ventilation, taking Covid-19 specimens Those in contact with patients Those in direct contact with known or suspected Covid-19 patients Those in contact with patients (who are not known or suspected to have Covid-19) Category 4 Those with some (limited) in contact with patients Category 5 Those not in contact with patients Those not in contact with patients Phase 1 Target Population • As part of enrolment for the vaccines, all health workers will complete an online registration • This will also be part of the consent procedures and risk assessment • The vaccination can be conducted in waves ( sequencing of vaccine clients) 18 Vaccine Delivery Platform 19 Vaccine Delivery Platform • Hub and spoke method – Primary site in hospital 37 (specialised hospital excluded) • Hospital Staff • EMS – Outreach team to be attached to each hospital • PHC staff • Mobile teams will at the fixed PHC facility • Phase 2 and 3 – PHC Facilities – Possibly augmented venues will be in the community • schools, churches, community halls, traditional authority • Tents can be utilised 20 Phase 1 Vaccination Platform Hospital Based Vaccination sites • Hospital staff • EMS • Forensic pathology staff Mobile Vaccination Outreach teams • PHC Staff • Mobile clinic • Nursing colleges • Malaria institute • District and provincial office • DEPOT 21 Vaccine Service Platform Phase 1 Vaccination Provision Platform Hospital vaccination setting Target Group Approach Hospital employee EMS Hospital Clinics Gateway – The vaccination of hospital-based health care workers will be provided through the Occupational Health Care Services/Units.
– Vaccine delivered to the hospital –stored in hospital pharmacy in accordance with manufacturer’s cold chain instructions – Vaccinators may be occupational health workers, IPC or other staff members with experience in vaccination.
– Virtual training will be conducted with vaccination team – Resources: Vaccinators (current and recruited), ancillary supplies, emergency equipment, waste disposal, 22 Vaccination Provision Platform Primary Health Care Vaccination outreach teams Vaccine Service platform Phase 1 Target Group Approach – Each hospital will partner with PHC to establish vaccination outreach teams which will cover each **geographical service area.
– These teams will develop a schedule and move from facility to facility vaccinating all eligible health care workers.
– Vaccine will be distributed to hospital for collection daily stored in accordance with cold chain requirements Primary healthcare Employees Community Health care workers Administrative offices Nursing College Malaria Offices 23 Vaccine Service platform Phase 2 and 3 Vaccination Provision Platform PHC OUTREACH Occupational Health Target Group Approach PHASE 2 AND 3 in Population public sector Occupational setting/ other essential workers Mining sectors – – PHC TEAMS attached to hospital will vaccinate population in each geographical service areas in phase 1 and phase 2 LDOH will liaise with other sectors with essential/frontline workers eligible for vaccination – Using the current multi-sectoral forums, sectors will be engaged and plans made – – to rollout vaccination in the sectors.
The model to be used will be determined by the dynamics in each sector, resource availability in LDOH, vaccine allocation, etc.
The group will vaccination centers in strategic places likely benefit from either mobile teams model or set up of 24 Vaccine Site Readiness • For phase 1 , all hospital excluding specialised hospitals will used as vaccination sites for phase 1 • All hospital will also be vaccination training centres for all the clinics in the catchment areas • Provincial EPI will develop a vaccination site readiness tool • Districts will conduct vaccination readiness assessment using a standardised criteria • Each district will establish mobile vaccination teams attached hospital in each geographical area • District will ensure that all vaccination mobile teams are equipped to conduct phase 1 vaccination • Is some areas depending on number of vaccine recipients hospitals maybe complexed as vaccination sites 25 Vaccine Site Readiness Criteria Focus Space Vaccine supply Criteria Items  Well ventilated dedicated room  Vaccine Fridge  Hand washing facilities  Bed and tables chairs  Vaccine vials  Surgical supplies  Relevant PPE  Pre packaged Emergency box  Waste management Human resources  Fully trained Vaccination team comprising of  Professional nurse  Enrolled Nurse  Admin clerk Data Management  Computer with internet connectivity  Phones  Vaccine register and paper tools AEFI reporting  AEFI reporting form  AEFI Case investigation forms Other  IEC material  Vaccination Sign Posts 26 Human Resources Planning 27 Human Resources Assumptions Key assuptions Assumptions Number of vaccinators available • Number of mobile clinics = 96 mobiles (50% of the mobile clinics with two vaccinators and then the other 50% have one vaccinator) , Therefore, number of vaccinators from mobile clinic are 144 Integrated School Health Programme (ISHP), approximately, there are 40 teams.
However, programme functionality need to be maintained.
Therefore, the assumption is that only 25 vaccinators maybe sacrificed towards the Covid19 vaccination Number of vaccinators available = 144 +25 169 • • Vaccination capacity Assuming one person can vaccinate 50 people 50 persons per vaccinator X total number of vaccinators (169) = 8450 per day = 8450 * 5 = 42250 per week = 42 250 X 4 = 169 000 per month =169 000 X 12 = 2, 028 000 Target Population Additional vaccinators are required for phase 2 and phase 3 of the vaccination to cover estimated target population Implementation risk • We need to factor-in leaves of absence (including quarantine and Isolation leaves), therefore, a buffer arbitrary human resource factor of 30% In conclusion, In summary, we need additional 300 vaccinators a day (Hired of six or 12 months’ contracts).
• 28 Phase 1 Scenario Scenario 1 Scenario 2 Scenario 3 Scenario 4 Total population 50 000 50 000 50 000 50 000 Target per day Number of vaccinators Vaccination period 2500 50 5000 100 7500 150 10 000 200 20 days 10 days 7 days 5 days • This shows that the province has capacity to vaccinate phase 1 population within a period of 2-3 week with current vaccinators 29 Scenario Analysis Phase 2 and 3 Target population Estimated population Scenario 1 3 month Scenario 2 6 months Scenario 3 12 months Targetper day Vaccinators per day Targetper day Vaccinators per day Target per day Vaccinator Per day Essential workers 250 000 : 2 e s a h P Persons in congregate settings Persons > 60 years Persons > 18 years with co- morbidities 4167 1833 110 000 500 000 8333 800 000 13333 Subtotal >18 years 3 without co- morbidities e s a h P 2 250 000 37500 750 18750 375 9375 188 For 6 months scenario the province would require an additional 276 – 169 =109 vaccinators for phase 2 375 – 169 = 206 vaccinators for phase 3 ***The procurement of vaccines and allocation to provinces will determine implementation 30 Training, Support and Supervision • The Vaccine TWG in collaboration with the provincial and district Resource Training centres will conduct training for the vaccinators and data capturers • Training will use virtual platforms and non-virtual platforms at district level • Train the trainer model will be used to train district trainers who will cascade training to vaccinator teams • Hospital Vaccination sites will be become training centres for vaccinators in their catchment area • Training plan including the items below is being developed – Training population – Training schedules – Trainers – Monitoring of training • Preparation for training is scheduled for 2021/01/28 31 Vaccine, Cold Chain Logistics and Infrastructure 32 Vaccine, cold chain, logistics and infrastructure • NDOH has committed to procure vaccines on behalf of provinces • Provinces will have to be allocated with each batch that is procured • The delivery points will be determined by the vaccine cold chain requirement vs the cold chain capacity in the province • Depending on the type and packaging of the vaccine, LDOH will procure consumables (needles and syringes), incl.
PPE • The current Health Care Risk Waste Disposal Contract will cater for the vaccination project (there may be extra costs due to increased vaccination) 33 COVID-19 Vaccine Profiles Phase 1 Vaccine name Pfizer/BioNTech Moderna Efficacy Administration Cold chain Important attributes 95% 95% IM IM -700C 2-80C 34 Vaccine, cold chain, logistics and infrastructure Functional Area Focus Area Activities Vaccine Logistics Cold chain management Warehousing and facility storage Cold Chain Maintenance • Audit additional capacity requirements • Ancillary supplies • Conduct Cold Chain Audit • Purchase additional cold chain capacity where necessary (phase 2 and 3) • Refresher Cold chain master training Logistics and distribution • Direct delivery from NDOH to hospital vaccination sites • Depot to be activated in phase 2 and 3 Forecasting and Supply planning • Stock monitoring • Prevention of stock wastage • Reverse logistics Risk Management • Prevention of theft during storage, distribution and vaccination 35 Vaccine Safety Monitoring 36 Vaccine Safety Monitoring • Safety monitoring is an important aspect on Vaccination program • The COVID-19 vaccine although it has been through phase 3 Trial, it will requires close monitoring and reporting of Adverse event critical especially in phase 1 • The plan proposes to use both active and passive methods for surveillance of vaccine safety • Active surveillance is recommended for Phase 1 of the COVID- 19 vaccine, because population is accessible • Passive surveillance for Phase 2 is recommended Vaccine Safety Monitoring Functional Area Objectives Activities Vaccine safety Monitoring To ensure early detection and management of AEFI • Develop COVID-19 Vaccination safety protocols and SOP • Compile a list of vaccine safety per district • Conduct training on COVID-19 vaccine safety monitoring to safety champions Implement and monitor district safety training • To ensure adequate reporting of AEFI using standardised tools and methods To ensure appropriate investigation of reported COVID-19 AEFI • Develop protocol for AEFI reporting • Develop and disseminate tools for AEFI • Liaise with Communication to develop communications on vaccine safety communication material • Develop guidelines and standardised tools for AEFI investigation 38 Social Mobilisation and Demand Creation 39 Social Mobilisation and Demand Creation Aim of social mobilization To empower the people of Limpopo with correct information with regard to Covid-19 vaccination.
Objectives  To support and encourage appropriate uptake of the vaccines by providing correct and timely information COVID-19 in terms of safety, availability and efficacy  Addressing vaccine fears, myths and misconceptions to ensure uptake of the vaccine  Managing and mitigating any potential disappointment resulting from unmet demand of the vaccine  Ensure continued adherence to non-pharmaceutical measure as an important prevention strategy  Generate awareness and understanding of the phased approach of prioritizing target groups 40 Social Mobilisation and Demand Creation • Vaccine education will encompass – General information on benefits of vaccination – Specific information on COVID-19 vaccine communication including vaccine safety – Communication on frequent asked questions, myths and concerns • Digital platform monitoring (to gather intelligence on community perceptions, ongoing myths and generally what drives local behaviour) – Importance of non-pharmaceutical measures – Communication of Roll out of each phase 41 Target Audiences ‒ All citizens; vaccine eager and vaccine hesitant groups.
‒ A focus on priority for people to be vaccinated in the first phase: health care workers, frontline functionaries, people over 50 years of age and people under 50 years with co-morbidities.

‒ Civil society organisations, professional bodies, advocacy groups, organised labour including hesitant groups, medical fraternity, social influencers and youth platforms & networks.
‒ Elected and non-elected representatives: MPs, MPLs, Councillors, traditional and faith leaders ‒ Academia, alternative medicine practitioners, traditional healers, naturopaths, homeopaths etc.

‒ National and community media including traditional and digital media, which will disseminate correct/factual information by proactively addressing any mis/disinformation or incorrect messaging.
‒ Government employees (including Department of Health employees) to serve as conduits for messages to their communities.
42 Platforms • The department will then share educational resources and messages with myth busters through all platforms: – Electronic and digital media, – Community engagements to traditional leaders, – religious leaders and traditional healers using existing platforms 43 Demand Creation Approach Political Leadership High level political support through the OTP and MEC Heath to provide information and improve acceptance and uptake Vaccinators Support Optimal support for the implementers with training and resources with clear messages, including ability to sell vaccination to clients Vaccine Dashboard Communication Use of up-to-date data to monitor implementation, to encourage the implementers and update the public Social Mobilisation Use of leaders, influencers and mobilisers in different communities and settings to create demand and improve acceptance and uptake 44 Social Intelligence Driven Response • The drivers of vaccination are complex, context-specific and change over time.
– Regular and timely data collection, analysis and use of data on the behavioural and social drivers of vaccination uptake will inform evidence-based planning and guide interventions and responsive messaging – Management of crisis communication: Content guidance, detection and response to rumors, misinformation with real-time rapid response – Emphasizing the importance of continued universal masking, social distancing, hand hygiene and avoidance of large gatherings – Rapid and open sharing of information about the vaccination programme 45 Monitoring and Evaluation Health Information Systems and ICT 46 Monitoring & Evaluation Workstream Focus area Activities Monitoring and Evaluation Monitoring and evaluation framework Develop monitoring and evaluation framework for the project Develop monitoring & evaluation tools for non-NIDS indicators Vaccine plan indicators Provision of ICT infrastructure to vaccination sites Provide technical assistance to vaccination sites ICT National Vaccine data management system Conduct training on EVDS 47 Monitoring & Evaluation The Draft National Indicator Data Set for COVID-19 Vaccination has been produced with definitions, means of calculations and data sources for each indicator and data element.
The selected priority indicators are: Population a) Vaccine uptake rate b) Vaccine coverage (dose 1 & 2 & fully immunised) (>18 yrs &<60 yrs) c) Vaccine coverage for vulnerable groups (60+ ages and those with co-morbidities) d) Vaccine drop-out rate between dose 1 & 2 e) % of vaccine beneficiaries reporting adverse events Health Systems a) Vaccine availability levels b) Vaccine stock out levels c) Number of vaccines sites/facilities d) % of vaccine sites ready for vaccine administration e) Number of vaccinators in each district f) % of vaccinators trained 48 Proposed NDOH Health Information Systems and ICT • Data needed for monitoring vaccine uptake and coverage, prioritization, planning, safety monitoring and vaccine effectiveness studies.
• An electronic vaccination data system (EVDS) is in the process of being developed by NDOH • EVDS to support collection and provision of the following information • Patient information (including demographics, number of doses, etc.)

• Health establishment where service is accessible (name and type, e.g.

clinic) • Vaccine administered (manufacturer, batch number, etc.)
• Safety information as part of a pharmacovigilance plan (Adverse Events Following Immunization – AEFI) • A record of vaccination to be issued to individuals where appropriate and required • Provinces should have access to the system and be able to export relevant reports from the system 49 NDOH EDVS Attributes • Pre-registration of HCWs during Phase 1, other recipients during Phase 2 in order to receive vaccination appointment.
• The system will be prepopulated with existing databases (Persal, HPRS,SASSA database).

• Digitized Consent form (for vaccination, to use personal data and location data).

• Vaccinators to be able to see whether it is an individual’s first or second dose and which vaccine has been administered.

(Dose alerts - vaccine dependent) • To be Linked to NHLS / NICD to determine effectiveness of vaccine i.e.
if patient later tests positive • Includes Adverse events following immunization (AEFI) monitoring • The system will send reminders or notifications for subsequent doses including date and facility 50 SUMMARY OF FUNDING REQUIREMENTS: VACCINATION COSTING .
Wednesday, February 24, 2021 51 Vaccination campaign costingCATEGORY2020/212021/22RandsCompensation of Employees 124 086 589 Goods and Services 21 619 000 108 393 000 Cooler boxes (mobile teams) 630 000 Cold Chain Monitors (eq<5000) 1 400 000 2ml Syringes 4 164 000 23G Needles 1 652 000 Cotton Wool balls 1 023 000 Security services (special) 9 664 000 106 304 000 Stationeryand other consumables 440 000 Loudhailers 425 000 Data/airtime/wifi 100 000 2 089 000 Flexible tables and chairs 515 000 Protective clothing 300 000 Covid branded Ambrellas 170 000 Community& SABC airtime 966 000 Social media & advertising 170 000 Machinery and Equipment14 485 000 2 900 000 Vaccine Fridges 14 000 000 Cold Rooms (5 Dist hospitals) 2 500 000 Gazebos400 000 Industrial Printer (Colour)280 000 Heavy duty shredder200 000 Heavy duty paper trimmer5 000 Total Budget Required36 104 000 235 379 589 LIMPOPO DEPARTMENT OF HEALTH COVID-19 THE SINGLE-DOSE AD26.COV2.S COVID-19 JOHNSON AND JOHNSON (JNJ) VACCINE IMPLEMENTATION (SISONKE) STUDY 15 FEBRUARY 2021 52 Introduction and background to JnJ vaccine • • • COVID Vaccination Programme Status has been paused since Sunday 6 February following concerns regarding efficacy of the Oxford-AstraZeneca (Covi-19 Shield) vaccine against mild & moderate COVID caused by the 501.V2 variant.
The single-dose Ad26.COV2.S COVID-19 Johnson and Johnson (JnJ) vaccine has been tested in RSA through the ENSEMBLE study as part of a global study in multiple regions (North and South America, Africa) In RSA the ENSEMBLE clinical trial is currently implemented in 31 research sites.

In South Africa and across world the vaccine was found to be: • 57% effective against moderate to severe disease, where nearly all of the cases were due to infection with the new variant.
85% High vaccine efficacy (overall, after Day 28) was noted against severe/critical COVID-19 with efficacy observed as early as Day 7 (77% as of Day 14).

100% protection against COVID-19-related deaths.
• • • 53 Ad26.Cov2.S Vaccine (J&J) Protects Against Severe COVID-19 In South Africa Tested in 43 783 people from 4 continents including 6,576 people in South Africa 100% 100% 100% 85% protecti on 57% protecti on 100% protecti on 0% 0% 0% Moderate- severe COVID Severe COVID Death 54 Single-arm phase 3B JnJ research study • NDOH is partnering with The ENSEMBLE, JnJ and SAMRC to implement the single dose Ad26:Cov-SAR2 implementation study • The SAMRC, JnJ and ENSEMBLE research sites will make the vaccine available to health workers through an early access open-label, single-arm phase 3B implementation study called Sisonke.
• The purpose of the briefing is to share the details of the implementation study 55 Single-arm phase 3B JnJ research study (2) • That this is a single-arm phase 3B research study, called Sisonke • The vaccine being researched in the study is called Ad26.COV2.S COVID-19 Johnson and Johnson (JnJ) vaccine • That this vaccine is not registered in South Africa and is unlicensed – It is only approved for research purposes – It is only available through the study.
– It may take up to 3 months to finalise the expedited registration the vaccine • The research protocol has been approved by the South African Health Products Regulatory Authority (SAHPRA) and the study will be conducted under the auspices of SAHPRA.

• Ethics approval has been obtained from the SAMRC and the UKZN Human Research Ethics Committees.

• Approval from other Ethics Committees to which the ENSEMBLE sites are accountable is outstanding.
Rationale for extension of the vaccine implementation study to health setting • • To date 40 000 South African health workers have developed COVID-19, 6 473 have been hospitalised and 663 of our colleagues have passed on.

As at 17 February 2021, 3288 HCWs in Limpopo have contracted COVID-19, with 35 deaths.
The proposed implementation study aims to o Fast track the development of more evidence for the effectiveness of the Johnson and Johnson vaccine through expanding the target population to HCWs o Make available the single dose J&J vaccine to HCWs on a voluntary basis under research conditions o Health care workers can volunteer to participate in a more detailed study to monitor vaccine effectiveness in a real-life setting • Benefits of participating in the phase 3B study as a HCW: o Assist in getting more evidence on the vaccine i.e.
benevolence/ altruism o Early access to the vaccine where would otherwise have to wait for all the studies to be completed to access approved and licensed product as part of vaccination campaign (which would take a minimum of three months from now) o NB: THIS IS NOT A VACCINATION CAMPAIGN 57 Study approach • Study Title – Open-label, single-arm phase 3B implementation study to monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa • Study design – Phase 3b Vaccine implementation study • Phase 3b defined – Phase 1 and 2 of the study has been conducted a safety of the vaccine has been established – Phase 3 aims to accumulate additional findings which may required as a condition for regulatory approval.
– To test effectiveness of vaccine – Usually performed near/after the applicant has filed for regulatory approval 58 59 Study aims and objective • The aim: – to determine the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) as compared to the general unvaccinated population in South Africa.
• Primary Objective: – To assess the effectiveness of Ad26.COV2.S vaccine on severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa.

60 Who will can be included in the Vaccination?
• Any health worker working the public of private sector can participate in the study • Inclusion of a health worker in the study is on voluntary basis • No health worker will be coerced to participate in the study • Informed consent procedure as per study protocol will be strictly adhered in on a voluntary basis • Priority for enrolment will first be given to patient facing HCWS versus non patient facing healthcare workers • Inclusion criteria • Age 18 and older • Health care worker in the private or public service • Willingness and ability to comply with vaccination plan and other procedures.
• Capable of giving electronic or personal signed informed consent 61 Exclusion criteria • Any significant acute or unstable chronic medical condition detected during eligibility assessment this includes acute COVID-19 infection • Participant reports being pregnant at time of enrolment or planning to be pregnant within 3 months.

• Current participation in any other research studies that would interfere with the objectives of this study.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

• Current signs and symptoms of COVID-19 (PUI) or confirmed COVID (need to be sent for testing or isolation).
The MAC is currently working on an advisory to guide on how long after a severe bout of COVID-19, is one eligible for vaccination 62 Vaccine profile • Vaccine safety • The vaccine has been reported as having an acceptable safety profile, with few reported side effects • Vaccine Efficacy • A single dose of Ad26.COV2.S vaccine was efficacious in the prevention of moderate to severe/critical COVID-19 with VE of 67% and 66% post Day 14 and post Day 28 post vaccination.
• Vaccine storage and administration – It is administered on the deltoid arm as a single dose • Stable at 2-8 degrees Celsius and reported that it can be stored for 3 months at temperature of -20 degrees Celsius 63 How will the study be implemented?
• Vaccination study planned to be implemented in phases as the vaccines becomes available • A total 300 000 to 500 000 doses expected in next 2 months according to NDOH • A total of 80 000 doses expected in South Africa week of 15 February2021 • Study sites: 20 public sector hospital across the country initially focussing on large hospitals  LDOH study sites are two: namely Pietersburg and Mankweng hospital  Sites were selected by the researchers in consultation with NDOH based on the number of healthcare workers and the COVID-19 caseload  ENSEMBLE research site in Limpopo Province: Ndlovu Research Center, Elandsdoorn CRS  Responsible for vaccine receipt and distribution to LDOH study sites  Research study support including cold chain management  The province is currently working on the expansion plan given the vastness of our province 64 Where are the clinical trial research sites in South Africa?
• Twenty (20) public sector hospitals have been identified for the first two-week period.

• Sixteen (16) of the ENSEMBLE Research sites have been identified as Primary Distribution Sites receiving product from Biovac.

• • The ENSEMBLE Research sites were chosen based on proximity to the identified public sectors hospitals.
Six (6) of these ENSEMBLE Research sites are either within the grounds of the public sector hospital complex or within 1km Research Sites Aurum Institute Klerksdorp CRS Aurum Institute Rustenburg CRS CAPRISA eThekwini CRS Chatsworth CRS Province North West North West KwaZulu-Natal KwaZulu-Natal Clinical HIV Research Unit (CHRU) Gauteng Elandsdoorn CRS Limpopo FAM-CRU (Family Clinical research Unit) Western Cape Groote Schuur HIV CRS Josha Research CRS Western Cape Free State Mzansi Ethical Research Centre Mpumalanga Nelson Mandela Academic Research Unit Eastern Cape Phoenix Pharma Eastern Cape Qhakaza Mbokodo Research Clinic CRS KwaZulu-Natal Soweto HVTN CRS Synexus SA – Watermeyer Gauteng Gauteng Wits RHI Shandukani Research Centre Gauteng 65 Doses allocated and target population Pietersburg Mankweng Doses allocated Number of vials 4080 2040 3080 1540 Study sites Number of HCWs Pietersburg Hospital Mankweng Hospital Private sector & other Public sector facilities Total 2747 2055 2358 7160 66 HCW Study participant enrolment procedure • Recruitment – Healthcare workers will be informed of the implementation study through information leaflet and stakeholder engagement • Study Enrolment – Interested Healthcare workers can self enrol on the EVDS system using NDOH link • Informed Consent – An sms will be sent to healthcare workers who have enrolled on EVDS – Healthcare workers go through the information provided and provide digital consent – Receive your vaccination voucher • Schedule appointment – The EVDS system will schedule appointments for healthcare workers at the allocated vaccination sites 67 HCW Study participant vaccination procedure • Vaccination Procedure – Registration desk to confirm eligibility of the participants – Research (or any government GCP trained) pharmacists to prepare all the doses and ensure cold chain requirement – A trained Vaccinator to administer the vaccine on the left deltoid arm as per protocol – Vaccinator to capture vaccine on EVDS – Vaccine recipient to be monitored for 15 minutes post vaccination • Vaccine safety Monitoring – The vaccine recipient will be given a vaccine safety card – Side effects to be reported to research team as directed – Vaccine adverse event reporting will be followed – Each sites to have health professionals trained on vaccine safety monitoring • Reporting and monitoring Implementation – All reporting will be done through EVDS – Paper tools are available as back up 68 Implemnation Reseach proposed procedure 4A S D V E J & J t n e s n o C n o i t a n i c c a V ) S D V E ( y a d EVDS to inform supply chain management throughout Out 1.
HCW self registers 2.

Notification sent to all beneficiaries to confirm registration, vaccination site and registration code 3.

Eligible beneficiary within catchment area receives SMS to opt in to J&J program END 4.

Complete J&J consent process 5.

Voucher issued Refer J&J consent module for detail Record the Vaccination Code from the Vaccinee SMS receive a message that they received the 1st dose of the Vaccine and schedules the dose for the 2nd dose appointment 6.
HCW vacinee receives SMS to present to Vaccine site administration desk (details in SMS) 7.

Eligibility confirmed 8.

Vaccinator completes consent and questionnaire on system 9.Vaccinator administers vaccine Relevant information captured on EVDS END 69 Uncertainties/unknown factors • The following aspects are awaiting clarification/ more information from NDOH following their communique to LDOH • Study governance Principal Investigator not indicated in NDOH letter.
Important as overall responsible for the study.

– – Names, roles and contacts of research team members assigned to Limpopo Province (Pharmacists, vaccinators, senior and assistant researchers, M&E and data managers etc. )
The study protocol outlining processes to be followed during the planning and implementation of the research study by the research team not yet available to the department Responsibilities of the province vs the research team – –  financial, human, vaccination resources  Obtaining consent  Vaccine safety monitoring • Study details – – Length of the study not indicated study information leaflet to target study participants that articulates pertinent study issues usually addressed in such leaflets including but not limited to:  Detailed definition and explanation of a phase 3B study  Pros and cons of participating in the study  Pre and post vaccination examinations, tests etc  Pre and post study obligations  Compensation to study participants including incidental / subsistence and travelling costs  Manner and length of follow up 70 Uncertainties/unknown factors • Study recruitment and participation – Can HCWs in other health facilities participate – The sequencing and prioritisation of the HCW participants  aerosolizing activities vs non-patient contact – Can non-PERSAL health care workers can participate in the study – whether other health facilities in the province will be enrolled in the study and if yes process of enrollment to be followed – Private sector HCW involvement including enrolment and study site – Informed consent form including translated versions  HCW not able to do electronic consent form – Enrolment through EVDS:  HCW with no access to smart phone  HCW that are computer/ web illiterate • Indemnity – For adverse events following immunizations provided by and to the research team – If LDOH personnel used: are they provided indemnity cover by the research study • Quarantine and QA JnJ study vaccine – Requirements for quarantine and QA – Period after arrival in country before release from national holding site 71 Implementation Progress • COVID-19 Vaccination started on the 19 February 2021 at both Polokwane and Mankweng hospitals • The hospitals has manged to vaccinate a total 1304 health care workers as @ 22/02/2021 • The vaccinated healthcare workers included – Polokwane and Mankweng healthcare workers – Private hospitals frontline workers – Independent health professionals • Challenge – EVDS enrolment and delay with obtaining vouchers which was the main challenges Date Number of clients vaccinated Pietersburg Mankweng 2021/02/19 2021/02/20 2021/02/21 20 236 524 60 194 270 72 Conclusion • The LDOH is committed to ensuring that the population is protected from COVID-19 infection through improving access to the COVID-19 vaccine • The province is partnering with relevant stakeholders to ensure efficient implementation of vaccination for all phases • Currently engaging stakeholders and district to facilitate rapid implementation and expansion of this study • Rapid review of resource requirement indicates that the province has capacity to implement phase 1 of the vaccination with support support from stakeholders and partners • The COVID-19 Vaccination plan, including the Implementation study, is flexible and will be updated as further information becomes available 73 Thank You 74