Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1694845936727.pdf (South Africa)
NATIONAL COUNCIL OF PROVINCES (NCOP) Ministerial Briefing to the NCOP Vaccine Rollout Plan 25 February 2021 Minister of Health Dr Zl Mkhize FRAMEWORK FOR VACCINE IMPLEMENTATION Governance Structures Communication, stakeholder guidance, training (provinces, districts, public sector and private sector) Prioritizing population Allocation of vaccine Distribution (Supplier to Point of Use) Administration Safety, Effectiveness, Uptake, Second dose Supply – Monitor, Track Report Vaccine Uptake, Use, and Coverage Data Adverse Events Following Immunization (AEFI) Vaccine Effectiveness Monitoring and Reporting Regulatory Considerations Budget & Finance Adapted: From The Factory To The Frontlines: US Department of Health and Human Services) 2 WHY ARE VACCINES IMPORTANT The aim of vaccination is to: • • To prevent morbidity and mortality.
To achieve herd immunity and prevent ongoing transmission.

When a person gets vaccinated against a disease, their risk of infection is also reduced – personal protection 'Herd immunity', also known as 'population immunity', is the indirect protection from an infectious disease that happens when immunity develops in a population either through vaccination or through previous infection.

Herd immunity does not mean unvaccinated or individuals who have not previously been infected are themselves immune.
Instead, herd immunity exists when individuals who are not immune, but live in a community with a high proportion of immunity, have a reduced risk of disease as compared to non-immune individuals living in a community with a small fraction of immunity.

Lowering the possibility for a pathogen to circulate in the community protects those who cannot be vaccinated (due to health conditions, like allergies, or their age) from the disease targeted by the vaccine.
3 IDENTIFICATION AND PRIORITISATION OF TARGET POPULATION Vaccines will not be available for everyone immediately, and a prioritization system will have to be applied.

Guided by the MAC on Vaccines.

Priority will be given to those: • in roles considered to be essential for societal functioning; • most at risk of infection and serious outcomes, for example, those over 60 years, those with comorbid conditions and those living in overcrowded settings, • most at risk of transmitting SARS-CoV-2 to others.
4 PHASED APPROACH BASED ON AVAILABILITY OF VACCINES Adapted: From the factory to the frontlines: US Department of Health and Human Services) Illustative and not to scale.
5 PHASED APPROACH FOR VACCINE INTRODUCTION Phase I Health care workers (HCW) All health sector workers Target population: 1,000,000 Phase III Other persons >18 years Phase II Essential workers Target population: 2,500,000 Persons in congregate settings Target population: 1,100,000 Persons >60 years Target population: 5,000,000 Persons >18 years with co- morbidities Target population: 8,000,000 6 PHASE I: SEQUENCING OF HEALTH CARE WORKERS Category 1gory 4 Category 2 Those in contact with patients Those not in contact with patients.
• • • • Phase 1a: All patient-facing workers in hospitals and Emergency Medical Services workers Phase 1b: All patient-facing workers in other health care facilities/establishments Phase 1c: All patient-facing workers working at community level Phase 1d: Non-patient facing workers in the health sector • Within facilities, start with settings associated with highest exposure.
7 PHASE 1: HEALTH CARE WORKER SERVICE DELIVERY PLATFORM Work-based vaccination programme: Public and private hospitals • Most suitable for hospital linked HCWs Outreach work-based vaccination programme: Mobile teams move from facility to facility • Most suitable for HCWs in PHC, CHC and private medical centres Vaccination Centres: Remote or facility-based vaccination centres e.g.
pharmacies or other settings • Suitable for independent HCWs 8 PHASE 2 AND 3: HIGH RISK PRIORITY GROUPS AND GENERAL PUBLIC SERVICE DELIVERY PLATFORMS Health facility vaccination: Suitable in rural settings for community access Vaccination Centres: Facility based or standalone vaccination centres e.g.

pharmacy practices, GPs or NGOs Outreach vaccination programme: Service provided by outreach teams Suitable for congregated settings e.g.
old age homes Work-based vaccination programme: Suitable for essential workers e.g.

mining sector, industry and departments 9 National COVID Vaccination Programme Status Paused Sunday 6 February • Following concerns regarding efficacy of the Oxford-AstraZeneca (CoviShield) vaccine against mild-moderate COVID caused by the 501.V2 variant.

• CoviShield may still play a role in the National Programme but more local research is needed.

• There is likely to be significant lag period (approx.
3 months) before another vaccine is registered in South Africa.

• We sought other more urgent but safe and effective options 10 Ensemble study • The ENSEMBLE study was conducted in multiple regions (North and South America, Africa) at a time when the incidence of SARS-CoV-2 infection was very high and new lineages of the virus were emerging.
• 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.

• The onset of efficacy was evident as of day 14, with efficacy increasing through day 56, especially against severe disease.

• In South Africa the vaccine was 57% effective, where nearly all of the cases were due to infection with the new variant.
11 Ad26.Cov2.S Vaccine (J&J) Protects Against Severe COVID-19 In South Africa- most robust clinical data against the variant of all vaccines globally Tested in 43 783 people from 4 continents including 6,576 people in South Africa 100% 100% 100% 57% protection 85% protection 100% protection 0% 0% 0% Moderate-severe COVID Severe COVID Death 12 Safety • The vaccine had an acceptable safety profile.

• Common reactogenicity events • No safety signals observed.
• No anaphylaxis • Ad26 vector given to more than 200 000 people What are the next steps for this vaccine?

• JNJ have applied for “Emergency Use” and have submitted a request for an EUA at the FDA.

• They are submitting EUAs to other regulators.

• There is a rolling submission with SAHPRA in South Africa.
Making The Safe Efficacious AD26.Cov.S Vaccine (JnJ) Available Immediately Safe No safety concerns from trial, past trials or rollout programmes Efficacious Excellent protection against severe disease Easy to rollout Shelf life of up to 2 years at -20°C Can be stored at fridge temperature for 3 months Single shot Not yet licensed 15 A programme to enable rapid protection of healthcare workers Why is the vaccine being introduced in a research setting • The product has been show to be effective and safe • • Through the Sisonke programme, South Africa’s valued healthcare workers were It takes time to have the product licensed which will likely happen in coming weeks offered priority vaccination and access to this effective and safe vaccine • Without this, we run the risk of healthcare workers being at risk as a third wave arrives in South Africa • SAPHRA has approved use of the JnJ vaccine and the Sisonke program is making the vaccine available while full licensing through SAPHRA will take a couple of months • Starting today means we can protect our front line workers • Register now : https://vaccine.enroll.health.gov.za/#/ 17 Phased Approach For Vaccine Introduction Phase I Phase II Phase III Health care workers (HCW) Essential workers Other persons >18 years All health sector workers Target population: 2,500,000 Target population: 22,500,000 Target population: 1,250,000 Persons in congregate settings Target population: 1,100,000 Persons >60 years Target population: 5,000,000 Persons >18 years with co-morbidities Target population: 8,000,000 Expansion through usual vaccination centres Full Licence Open label programme License for use in Open Label Programme 18 Phased approach based on availability of vaccines Adapted: From the factory to the frontlines: US Department of Health and Human Services) Illustative and not to scale.
19 The first tranche of 80 000 doses of vaccine is on its way… Make history and be vaccinated Belgiu m South Africa O.R.

Tambo 20 20 Sisonke rollout COVID-19 Vaccine Administration Centres 5 easy steps for healthcare workers: 1.

Register on EVDS 2.

Respond to SMS invite for early access 3.

Provide consent to take part 4.

Receive your vaccination voucher 5.
Attend vaccination centre for administration Healthcare managers: What you need to know       300 000 to 500 000 doses expected in next 2 months 80 000 doses expected next week 18 sites across the country initially Focus on large hospitals Research staff to help maintain cold chain and draw up doses Vaccinators to administer 21 Distance from Research Site (km) *Doses (public & private) Vials Kits (20 vials) Vaccinators Hospital Province Eastern Cape Eastern Cape Free State Free State Overview ec Livingstone Hospital ec Nelson Mandela Academic Hospital fs Universitas (C) Hospital fs Pelonomi Hospital gp Chris Hani Baragwanath Hospital Gauteng Gauteng gp Steve Biko Academic Hospital kz Inkosi Albert Luthuli Central Hospital kz Prince Mshiyeni Memorial Hospital lp Pietersburg Hospital lp Mankweng Hospital mp Rob Ferreira Hospital mp Witbank Hospital nw Klerksdorp-Tshepong Tertiary Hospital nw Job Shimankana Tabane Hospital North West nc Robert Mangaliso Sobukwe Hospital wc Groote Schuur Hospital Limpopo Limpopo Mpumalanga Mpumalanga North West Western Cape KwaZulu-Natal KwaZulu-Natal Northern Cape HCW Supply Research Site 2 135 PHOENIX Pharma (Pty) Ltd 3 314 Nelson Mandela Academic Research Unit 2 544 Josha Research CRS 2 061 Josha Research CRS 7 426 Soweto HVTN CRS 3 803 Synexus SA - Watermeyer 3 868 CAPRISA eThekwini CRS 3 380 Chatsworth CRS 2 747 Elandsdoorn CRS 2 055 Elandsdoorn CRS 1 326 Mzansi Ethical Research Centre 1 099 Mzansi Ethical Research Centre 3 856 Aurum Institute Klerksdorp CRS 1 762 Aurum Institute Rustenburg CRS 2 599 Clinical HIV Research Unit (CHRU) 3 847 Groote Schuur HIV CRS wc Tygerberg Hospital Western Cape 4 935 FAM-CRU (Family Clinical research Unit) *Please see assumptions on the next slide.
Indicative allocations only.

Confirmed allocations will be formally communicated with provincial HODs TOTAL 78 880 39 440 1 972 7 10 8 6 23 12 12 11 9 6 4 3 12 6 8 12 15 164 22 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 JnJ program 4.

Complete JnJ consent process 5.

Voucher issued 6.

Vaccinee arrives 7.

Screening Station 8.


Vacinnee screened for COVID-19 9.

Vaccinator confirms proof of registration, ID document and Voucher code previously provided Study team preps injection Mark vaccination as complete Recipient receives a confirmatory SMS 23 How do I get my vaccine?

https://vaccine.enroll.health.gov.za/#/ 24 25 Vaccinate and save lives!

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