Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1698832129516.pdf (South Africa)
J&J EARLY ACCESS VACCINE STUDY UPDATE 25 FEBRUARY 2021 CONTEXT • • In light of efforts to register the Johnson & Johnson vaccine in the country, the vaccine roll out plan has changed to an Early Access Study conducted by MRC (Medical Research council) in partnership with the National and Provincial Departments of Health 80 000 doses of the J&J vaccine were received by the country on the 16th of February 2021 In Gauteng the study will be implemented in 2 sites namely; Chris Hani Baragwanath and Steve Biko Academic Hospitals • Gauteng received 16 800 (21%) of the 80 000 doses of the J&J vaccines allocated as follows to the two study sites - 5571 of these are allocated to Private Sector (5030 hospital Groups and 541 to GPs: o Steve Biko Academic Hospital 5 720 doses o Chris Hani Baragwanath Hospital 11 080 doses 2 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(public and private sector) 63 000 as 21% of 300 000 doses 105 000 as 21% of 500 000 doses Open label programme License for use in Open Label Programme 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 Total: 16 600 000 Expansion through usual vaccination centres Full Licence 3 TARGET POPULATION – PHASE • In each Health Facility, a risk based Category 1 Those conducting aerosol-generating procedures i.e.
intubation, ventilation, taking Covid-19 specimens classification of employees will be in 4 Categories 1-4 • The prioritisation of Health workers to be vaccinated will be based on: o Those with highest occupational risk, who have contact with patient first.

(Categories 1-4) o Those responsible for strategic programmes e.g.

Maternal and Child Health, HIV&AIDS and TB will also be prioritised • PERSAL based classification of these categories will be developed per facility and vaccination site.
Category 2 Those in direct contact with known or suspected Covid-19 patients Category 3 Those in contact with patients (who are not known or suspected to have Covid-19) Category 4 Those not in contact with patients 4 PROVINCIAL ALLOCATIONS Hospital Province HCW Supply Research Site Livingstone Hospital Eastern Cape Nelson Mandela Academic Hospital Eastern Cape Universitas (C) Hospital Free State Pelonomi Hospital Chris Hani Baragwanath Hospital Gauteng Free State Steve Biko Academic Hospital Inkosi Albert Luthuli Central Hospital KwaZulu-Natal KwaZulu-Natal Prince Mshiyeni Memorial Hospital Limpopo Pietersburg Hospital Limpopo Mankweng Hospital Gauteng 2 135 3 314 2 544 2 061 7 426 3 803 3 868 3 380 2 747 2 055 PHOENIX Pharma (Pty) Ltd Nelson Mandela Academic Research Unit Josha Research CRS Josha Research CRS Soweto HVTN CRS Synexus SA - Watermeyer CAPRISA eThekwini CRS Chatsworth CRS Elandsdoorn CRS Elandsdoorn CRS Rob Ferreira Hospital Witbank Hospital Klerksdorp-Tshepong Tertiary Hospital Job Shimankana Tabane Hospital Mpumalanga Mpumalanga 1 326 Mzansi Ethical Research Centre 1 099 Mzansi Ethical Research Centre North West 3 856 Aurum Institute Klerksdorp CRS North West 1 762 2 599 Aurum Institute Rustenburg CRS Clinical HIV Research Unit (CHRU) Robert Mangaliso Sobukwe Hospital Northern Cape Groote Schuur Hospital Western Cape 3 847 Groote Schuur HIV CRS Tygerberg Hospital Western Cape 4 935 FAM-CRU (Family Clinical research Unit) Distance from Research Site (km) *Doses (public & private) Vials Kits (20 vials) Vaccinators TOTAL 78 880 39 440 1 972 164 5 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  6 ASSUMPTIONS • Public sector HCW numbers were used as the base to calculated the total number of public and private sector HCWs (public : private = 2 : 1) • Vials were rounded up to accommodate the 20 vial kits or multiples thereof • Vaccinators were calculated using the following assumptions: o All doses to be administered within 14 days o Working days = 10 days o Working hours = 8 hours o Number of vaccinations per hour per vaccinator = 6 o Number of vaccinations per vaccinator per day = 48 • Private sector HCW and GPs will be vaccinated on weekends 7 GCR EARLY ACCESS VACCINE ROLL OUT PLAN 25 FEBRUARY 2021 ROLES AND RESPONSIBILITIES AMONG THE STAKEHOLDERS STAKEHOLDERS National Department of Health (NDoH) South African Medical Research Council (SAMRC) ROLES AND RESPONSIBILITIES • • Lead communication with stakeholders including labour and healthcare workers regarding the change in the vaccine roll out strategy Lead the communication with healthcare workers to clarify the new roll out process (vaccine implementation study) • Develop a vaccine study implementation plan • • To champion communication on the implementation study roll out as the implementing agent To recruit staff members to be involved in the vaccine implementation study phase Provide vaccinators for the vaccination implementation study roll out • Manage the entire vaccine implementation study phase • • Where Gauteng Health vaccinators are used SAMRC must provide indemnity • Manage clinical adverse events with support from GDoH Gauteng Department of Health (GDoH) • Provide a platform for the vaccination to take place in the department of Health with our staff members • Create the demand for the uptake of the vaccine • Encourage our staff members to be involved in the vaccine implementation study.
• Monitor the progress of the study together with MRC • reporting on a daily basis and provide update to the principals.
9 Dose allocations per sector Vaccination Site Allocation for the public sector Allocations for the private sector Allocations for Private Hospital Groups Allocation for Private GP”s Chris Hani Baragwanath Hospital Steve Biko Academic Hospital 7426 3654 3430 224 3803 1917 1600 317 Total 11229 5571 5030 541 Vaccination numbers per vaccinating site as at 23 February 2021 Name of Hospital Target number of End date Current vaccinations Balance of vaccines 03/03/2021 3064 8016 doses 11080 Chris Hani Baragwanath Hospital Steve Biko Academic Hospital 5720 24/02/2021 4337 Total 16800 03/03/2021 7401 0 9399 1st 16800 doses received by Gauteng on the 16th of February 2021-17th February -03/03/2021 District Name Level of Care Hospital Name Total no of registered patient facing health care workers-as of the 20th February 2021 753 Tshwane Health District Central Hospitals Dr George Mukhari Steve Biko 3803 Tertiary Hospital Kalafong Hospital 465 Regional hospital Mamelodi Hospital 242 Johannesburg Health District Central Hospitals Charlotte Maxeke 1503 Chris Hani Bara 2654 Ekurhuleni Health District Tertiary Hospital Helen Joseph Tertiary Hospital Tembisa District Hospital Bertha Xowa West Rand Regional Hospital Leratong Sedibeng Regional Hospital Sebokeng TOTAL 517 248 170 179 225 10759 Dedicated vaccinators 20 30 3 6 20 30 5 3 3 2 4 116 12 2nd 16800 doses to be received by Gauteng 04/03/2021-18th March 2021 District Name Regional Hospital Total no of registered patient facing health care workers Dedicated vaccinators Ekurhuleni Health District Pholosong Hospital Tambo Memorial Hospital Thelle Mogoerane Regional Hospital Johannesburg Health District Far East Rand Hospital Edenvale Hospital Rahima Moosa 145 477 270 253 223 322 3 3 3 3 10 3 Specialised Hospitals COVID-19 Vaccine Site 1 – Compliant status (Yes/No) COVID-19 Vaccine Site 1 – Estimated Number of Vaccinators Johannesburg Health District Sizwe Tropical Diseases Hospital 296 Tshwane Health District Cullinan Rehabilitation Hospital 28 Tshwane Rehabilitation Hospital 4 4 5 13 REMAINING HOSPITALS CONT… District Hospitals Total no of registered patient facing health care workers Dedicated vaccinators Odi Hospital Tshwane District Hospital Pretoria West Hospital Jubilee Hospital South Rand Hospital Bheki Mlangeni District Hospital Heidelberg Hospital Dr Yusuf Dadoo Hospital Carletonville Hospital Kopanong Hospital 134 108 134 58 64 51 121 5 5 10 5 8 3 6 5 5 10 14 VACCINATION PROCESS • Determine and set operating hours (07H30 -17H00) • Make provision for overtime (private sector, MRC, development partners) • Set daily target based on number of doses and provincial allocation • Book HCWs (Registered, SMS, Consent, Voucher number, invitation to vaccinate) • Allocate vaccinators based on numbers booked and operating hours (cluster support to augment shortage) CHRIS HANI BARAGWANATH HOSPITAL VACCINATING PROCESS/…1 • 640 people per day • Divided into 4 main groups: A, B, C, D, • Pre-Vaccination Day: Staff member will receive confirmation of the Group, i.e.
A and a timeslot • On Registration: Proof of Identity and booking needs to be presented at the registration desk 16 CHBAH VACCINATION PROCESS/…2 (Report to the information tent if unscheduled) • Your date/time will be scheduled • Arrival at venue (no cars / parking) • • Assembly area organised by time zones (by colour and time) • Registration (A-D) and issue number card • Waiting blocks (1m spaces) • Entry into hall • Vaccination in groups of 16 • Exit hall to Observation area • Monitoring zones • Final Exit 17 CHRIS HANI VACCINATION SITE LAYOUT Veranda Area for 15 minute post vaccination screening E x i t G a t e Lapa area 18 PRIVATE SECTOR TARGET POPULATION STAFF CATEGORY TOTAL NO OF STAFF MEMBERS NAME OF DISTRICT NO OF VACCINATION SITES Hospitals Specialists GPs Pathologists Radiologists Pharmacy Allied Dentists Optometrists Other Staff Members 61 638 9 003 10 818 8 391 3 062 16 482 8 789 5 941 1 156 4 217 Total 129 496 JOHANNESBURG EKURHULENI TSHWANE SEDIBENG WESTRAND TOTAL UNALLOCATED 30 16 20 4 5 75 79 TOTAL NO OF PRIVATE SECTOR VACCINATION SITES 154 * Data provided by Dr Barry Child appointed by B4SA to define the target population for the private sector.
19 PRIVATE SECTOR VACCINATORS - CHBAH HOSPITAL GROUP VACCINATORS WITH EVDS ACCOUNT ADMINISTRATOR WITH EVDS ACCOUNT Mediclinic Netcare Linmed Life Clinix 10 15 6 5 5 Vaccinators available per day = 41 Administrators available = 20 5 10 0 5 0 PRIVATE SECTOR VACCINATORS - SBAH HOSPITAL GROUP VACCINATORS WITH EVDS ACCOUNT ADMINISTRATOR WITH EVDS ACCOUNT Mediclinic Netcare Life 10 9 7 Vaccinators available per day = 26 Administrators available = 15 5 6 4 Increasing the number of vaccinations per day • Enrol more vaccinators into the vaccination sites • Involve vaccinators from the cluster in order to increase capacity of vaccinators in the province and reduce the level of fatigue from vaccinators and also reduce the waiting times during vaccination.
Increase the vaccination hours based on the working hours of the vaccinators including weekends.

• • Use vaccinators from the private sector over the weekends and public holidays and during the week.

• Use vaccinators from other hospitals to assist with the vaccinations in order increase the number of vaccinations.. • Register all the vaccinators in the cluster to be linked to Chris Hani or Steve Biko Academic Hospital.
• Rationale for increasing the number of vaccinations Initially, institutions were selected on the basis of a) proximity to the research sites (MRC) for logistical purposes b) cohort study clinical considerations • On the basis of managing the scheduled follow-up visits post-enrolment i.e.
at month 3, month 6 • The proposal then is that HCWs of the relevant risk category group across some of our institutions be allocated to and report to the 2 centres (SBAH & CHBAH) • That transport (and time off) is managed and provided for via the CEO’s Offices to and from SBAH/CHBAH.

A group from the same institution would need to be attended on the same day.

Each CEO would need to take charge and profile the numbers as well as ensure they are registered on EVDS and have consented.
DEMAND CREATION 25 FEBRUARY 2021 ELEMENTS OF THE COMMUNICATION STRATEGY/…1 Advocacy Advocacy efforts will aim to engage the maximum number of people by promoting the benefits of COVID-19 vaccine and support in building an enabling environment for rollout.

The following actions will be implemented: • Weekly Provincial Command Council media briefings to provide information and update on the vaccination process.
• Strategic meetings with members of the Provincial Command Council, academia, health fraternity, faith-based leaders and organised labour to reinforce vaccine key messages.

• Development of orientation leaflets for community mobilisation by different stakeholders.

ELEMENTS OF THE COMMUNICATION STRATEGY/…2 Mass media and digital • The media and digital platforms will play a key role in creating and influencing perceptions across the GCR.
• Approved key messages and FAQs to guide talking points for appointed spokespeople, marketing collateral and digital media toolkits.

• Regular media briefings, interviews and press kits to create and drive a positive narrative of the COVID-19 vaccine.

• Development and dissemination of positive opinion pieces, and articles by experts to the media.

• Development of positive stories and testimonials from recipients on the vaccine for GPG digital assets.
• Pitch positive stories of the success of the success of the vaccination process during each phase.

• Arrange media interviews with healthcare workers involved in the success of the vaccination programme.

• Host Educational webinars with epidemiologists and vaccine experts on the science,,, safety and efficacy of the various COVID-19 vaccines.
ELEMENTS OF THE COMMUNICATION STRATEGY /…3 Marketing and Advertising There will be digital billboards and marketing materials incorporated on Transit TV in the following train stations and taxi ranks: • Germiston Train Station, Ekurhuleni • Park Station, Johannesburg • Stratford Train Station, Sedibeng • Mabopane Train Station, Tshwane • Bosman Train Station, Tshwane • Denneboom Taxi Rank, Tshwane, • Bara Taxi Rank, Johannesburg • Bree Taxi Rank, Johannesburg • Noord Taxi Rank, Johannesburg • Vereeniging Taxi Rank Update on Vaccination at the two (2) sites • • • • • • • The vaccination is progressing very well although it started very slow.
Steve Biko (SBAH) has used all vaccines allocated to them.

All GPs and Private Sector HCWs eligible for vaccination during this period have been vaccinated.

CHBAH and SBAH currently have 24 and 42 vaccination points respectively.

The private sector has deployed vaccinators to the 2 sites to augment the numbers allocated.

Furthermore, they will erect a marque at CHBAH to increase the number of vaccinations done daily to ensure that the set targets are met.
Gauteng will be able to use all the allocated 16 800 doses by the 03/03/2021 and may receive additional doses from Johnson and Johnson.

Health care workers from the private sector are vaccinated from 4pm to 8pm at CHBAH and over the coming weekend.

Health care workers from the public sector facilities are vaccinated during the day.

GP”s are vaccinated in the morning and in the afternoon.
At Steve Biko,the private sector HCWs are vaccinated during the day together with health care workers from surrounding public sector facilities.

There has been no serious adverse events reported during this phase of the vaccination process.
STEVE BIKO ACADEMIC HOSPITAL INCIDENT (21.02.2021) • Saturday 20.02.21 – vaccinated Private Hospital Groups • Planned to vaccinate GPs from Pretoria on 21.02.2021 • Unexpected large number of unscheduled people turned up from GPs from the South Gauteng and some as far as Limpopo and Mpumalanga (~ 2000) • • • • Social distancing impossible as a result of non cooperation.

Situation getting put of control Took pictures and sent to media CEO, Police called and intervened.
MEC Health released media statement to allay fears and concerns of HCWs 1020 vaccinated by 17h30 with additional support from 20 Netcare vaccinators • No side effects/adverse events reported Matters arising from implementation of the study • At start of the vaccination programme EVDS not functioning optimally creating backlogs/ delays leading to manual capturing – potential to undermine process.

This has since improved and paper based system has ended.
• Arrival of unregistered & registered but unscheduled people demanding vaccination – increasing numbers allocated for the day and crating delays in vaccination flow and processes.

CEOs of the 2 sites, the private sector as well as MRC have addressed the matter and agreed that no unregistered and unscheduled health workers will be allowed at the vaccination.
• Communication has been strengthened to allay HCWs fears and concerns of missing vaccination • Labour has supported the vaccination process and encouraged their members to register on the EVDS.

CONCLUSION • Vaccine roll out got off to a slow start on the 17th Feb; however has gaining momentum.
• Gauteng will use all doses allocated with a possibility of moving the vaccination process to DGMAH and CMAH • As at the 23.02.2021, a total number 29 867 HCWs have being vaccinated, (6 558) of whom are from Gauteng • • The are several dependencies that affects detailed roll out planning (i.e.

number of vaccines for the next phase etc) The EVDS and IT systems MUST have been addressed by MRC and the province to enable smooth running of the process • COVID 19 is still with us.
We are not out of the woods yet ….. • Adherence to NPIs.

• Avoiding the 3Cs THANK YOU Vaccinate and save lives!