MRC on Johnson and Johnson Clinical Trials & 2019/20 Annual Report; South African TB Caucus Secretariat on activities to date


24 March 2021


South African Medical Research Council (SAMRC) presentation

South Africa’s TB Caucus presentation

Understanding the Sisonke phase 3B open label study

Meeting Summary

Video: Portfolio Committee on Health, 24 March 2021
Audio: MRC on Johnson and Johnson Clinical Trials & 2019/20 Annual Report; South African TB Caucus Secretariat on activities to date

The South African Medical Research Council (SAMRC) told Parliament on Wednesday that South Africans were well aware that the distribution of the Johnson & Johnson (J&J) COVID-19 vaccine to health workers was being done as part of a study and was not the actual roll-out. The Committee was concerned that the public was not fully aware that the Johnson & Johnson vaccine was part of a study, and a Member said that the SAMRC was covering things up. The SAMRC said that it was not covering up; it held press conferences, it went on television with the Minister. Its website shows the Electronic Vaccine Date System, where one will see the consent forms. It is very clear to the public that this was being done as part of a study and was not the actual rollout.

SAMRC gave an update on the J&J clinical trial (Sisonke Phase 3B open label study). There was a question from a Member on how many healthcare workers would be vaccinated in the trial, and the SAMRC said that the Sisonke study aimed to vaccinate 500 000 healthcare workers. As the roll-out began, SAMRC would work closely with the Department of Health to transition the sites to roll out vaccines which will either be J&J or Pfizer. As far as SAMRC understood, the J&J agreements have been signed. There is a schedule of vaccines available and it was sure that the Department of Health can indicate when these vaccines will come. The J&J presentation noted that the national vaccine programme was “paused” on February 9 after data was released showing that the AstraZeneca vaccine was not effective for mild and moderate infection from the dominant COVID-19 variant in South Africa. SAMRC moved rapidly to start the Phase 3B clinical trial to replace the national rollout, and the reason it did this was because healthcare workers are three to four times more likely to develop COVID-19.

Globally, one in seven COVID-19 cases are healthcare workers. To date in South Africa, more than 40 000 such workers had contracted the disease and just fewer than 6 500 had been hospitalised. Around 650 healthcare workers had died. To transition to the J&J study was seen as the best option. This is a single-dose vaccine and it can protect against severe disease; this included protection against the dominant variant in South Africa. SAMRC said that South Africa should not be alarmed if there was a shortage of vaccines in the next two months — because, afterwards, vaccines would flow because the global manufacturing would have taken place. From what SAMRC could see, according to the global reports, after July there will be massive access to the vaccines. The Department of Health would mostly likely announce the number of vaccines coming into the country in the next couple of months. SAMRC knows that there are issues of efficacy in Brazil with China’s vaccine, Sinovac, and again this points to the need for local data. One cannot extrapolate from other countries because South Africa is dealing with different variants. It was important to have local evidence that a particular vaccine worked before administering it to citizens. National Treasury had given R150 million to conduct the J&J study, which translated to about R500 or R600 per person — which was "incredibly cost effective". SAMRC had got up to half a million doses from J&J to conduct this Phase 3B clinical trial. When it knew that it could not go ahead with the AstraZeneca roll-out, it approached J&J for these vaccines. The last vaccines, which will be 200 000 doses, were in the USA. South Africa had to get approval from the FDA (US Food and Drug Administration) and had to get permission from the US government, to allow them to release these vaccines. There is a global shortage of vaccines, and 200 000 doses coming to SA from the US could cause diplomatic issues. SAMRC had to ensure that everyone understood that this was for the Phase 3B clinical trial and that the vaccines were not being taken away from US citizens. These things take time and a lot of negotiations and logistical operations, and so the last 200 000 doses will come in about two weeks’ time and that will conclude the doses SAMRC gets. The vaccines will be delivered and administered, and that will conclude the half a million Phase 3B clinical trial. SAMRC encouraged those who have been vaccinated and are showing side effects to report them immediately.

On a possible third wave, SAMRC expressed concern, particularly after the April weekend, Easter holidays, and as South Africa goes into winter, as people spend more time indoors, the third wave is imminent.

On the effect of banning alcohol, SAMRC said that South Africa saw the impact of alcohol on motor vehicle accidents, emergency rooms and violence. It noted that when there is alcohol control in South Africa, the emergency rooms are more manageable and unnatural deaths go down. More robust alcohol regulations are needed. SAMRC said that South Africa needs to increase the age of people who drink alcohol to 21. There is a need to empower tavern owners and bar owners to withhold alcohol from people who should not be drinking more.

The South African National Aids Council (SANAC) presented on the South African TB Caucus which will be the South African chapter of Parliamentarians and Members of Provincial Legislatures raising awareness about the TB epidemic and interventions to overcome it. The South African TB Caucus is supported by SANAC as the Secretariat. It did not achieve most of the goals set out by the United Nations High Level Meeting in 2019, but did come close to achieving some of the targets. In the presentation given by SANAC, there is “leakage” in the system of TB treatment, where not all who are diagnosed with TB are put on treatment, for example. Thus far, only the North West provincial legislature had established a TB Caucus. Parliament was about to launch the National TB Caucus in March 2020 when COVID-19 prevented this. SANAC as the TB Caucus Secretariat is funded by the Global Fund which gave R11 million over three years to support the work of the TB Caucus.

The Committee Chairperson was pleased with Members' response to the responsibility of the TB Caucus role.

Meeting report

South African Medical Research Council 2019/20 Annual Report
Prof Johnny Mahlangu, SAMRC Board Chairperson introduced the Board members: Prof Linda Skaal, Vice Chairperson, SAMRC; Dr Tim Tucker; Prof Ronelle Carolissen; Ms June Williams; Adv Dorothy Khosa; Prof William Rae; Prof Eunice Seekoe; and Prof Collet Dandara.

Prof Glenda Gray, SAMRC President and CEO, introduced the Executive Management Committee
Mr Nick Buick, Chief Financial Officer (CFO); Prof Jeffrey Mphahlele, Deputy CEO and Vice President; Dr Alfred Thutloa Head: Corporate and Marketing Communications; Prof Rachel Jewkes, Executive Director: Research Strategy; Mr Mzimhle Popo, Legal Counsel; Dr Michelle Mulder Senior Programme Manager: HIV Programme.

Prof Johnny Mahlangu, SAMRC Board Chairperson, introduced SAMRC as a Section 3A entity in terms of the MRC Act of 1991 and is here to improve the health and quality of life of South Africans. It does this through research, development and technology transfer. This organisation is 52 years old, having been established in 1969 with the mandate of conducting and funding health research and medical innovation. It focuses on the top ten causes of death and disability in South Africa and the associated risk factors. Once those have been identified, there will be downstream interventions for these. It provides policy makers with the most accurate health information to make informed health policy decisions that enhance the quality of life of South Africans.

Prof Gray spoke on Research and Innovation in a Time of COVID-19.
Responding to Emerging National Health Needs and Global Trends

• SAMRC has always shown a remarkable ability to be responsive to the current
issues that affect the health of our citizens or health on our continent.
• Responded to the Ebola epidemic and funded scientists to study the molecular
epidemiology of the Ebola Virus.
• Recent advancement of COVID-19 into South Africa, SAMRC:
• Rapidly allocated money to fund research of this epidemic.
• Allocated funding for surveillance: understanding molecular epidemiology and host shedding.
• Will contribute to funding clinical research and the search for preventative and treatment options.

COVID-19 Research Funding
• About R80 million ring-fenced by SAMRC and the Department of Science and Innovation (DSI) to propel research and innovation on COVID-19.
• R56 million committed to projects on epidemiology, disease surveillance,
treatment and diagnostics.
• R5 million contribution from the Technology Innovation Agency.
• R8 million towards hospital based disease surveillance.
• R5 million towards community surveillance and understanding immune
responses to COVID-19 in HIV infected and uninfected individuals.
• R7.5 million commitment to support two projects, led by KRISP/UKZN and Hyrax
BioSciences (SARS-Co-V-2 genome sequencing/surveillance/identify/ manage outbreak hotspots).
• R1 million contribution each to the SOLIDARITY and CORONATION trials for therapeutics.
• Investigate COVID 19 link/impact to GBV, mental health, livelihoods in population groups.
• Sexual and Reproductive Health (SRH) and Rights of Young Women in eThekwini.
• Femicide and child homicide and COVID-19 in South Africa.
• Community stakeholder knowledge, perceptions, beliefs, behaviour and responses to COVID-19.
• Prevalence, clinical characteristics, immunologic responses and outcomes of children with suspected or confirmed COVID-19.
• Impact of COVID-19 lockdown on access to SRH services, interventions and commodities.
• SAMRC and DSI: Epidemiological study on COVID-19 transmission and natural history in KZN.

COVID-19 Diagnostics and Testing Projects
• Support development of local capacity to supply reagents for gold standard COVID-19 testing.
• Offer rapid alternatives for the direct detection of the virus.
• Streamline laboratory testing, validation and registration of local diagnostics & serology tests.
• Waste Water Surveillance Sewage based early warning system for the coronavirus.
• Detect emerging COVID-19 hotspots through samples from 24 sewage plants across regions.
• The monitoring of SARS-Co-V-2 in wastewater is conducted at selected wastewater treatment plants in the Western Cape, Eastern Cape, Limpopo and Gauteng provinces.
• Wastewater based epidemiology to detect RNA levels a week before clinical symptoms detected.
• Potential for broader application of wastewater based surveillance in SA to similarly
develop a public health early warning system for hepatitis A, measles and norovirus.

A. Governance: Board Members are drawn from the health-related and academic sectors.

B. Financial Information
Mr Nick Buick, CFO: SAMRC, said looking at the Revenue, one could see that the numbers have not moved to any great degree, and were below inflation in most instances. Revenue in 2019/20 was 4% up to nearly R1.1 billion for the year. Other income grew by 16%, which is above inflation, mainly due to lease income, and foreign exchange gains. Much of the SAMRC contract revenue comes through in foreign currency, which means with the Rand weakening over that period of time, it saw substantial foreign exchange gains which boosted its income. The Operating Expense was flat, with a 1% growth of R1.1 billion. SAMRC has put a lot of effort into controlling its costs and improving its efficiencies. As the revenue has grown, it has not made significant investments on the cost side, so its cost efficiencies are generating results, where it has only seen a 1% growth in its operating costs for the year.

It had an operating surplus of R12 million, against its 2018/19 deficit of R37 million. Investment income has decreased by 6%, from R34 million to R32 million. That was mainly as a result of declining interest rates during this period in the country, so SAMRC earned less money on its invested cash. It had some negative fair value adjustments. It did a fair value review of its balance sheet at the end of March to ensure that the carrying value of its investments was correct. This was just at the time that COVID-19 hit, and it had to do some impairment of some of its assets in the balance sheet, which meant a R1.5 million negative adjustment to the balance sheet. That has since recovered, and SAMRC is back on the green on the balance sheet side. There were small amounts of finance costs which have shown a decrease.

• Revenue increased by 3.7% to R1.092 billion
• Baseline income increased by 9.8% to R597 million (baseline grant from National Treasury)
• Contract income decreased by 2.9% to R495 million
• Investment income decreased by 5.6% to R32 million
• Value of new research contracts signed R334 million
• Expenditure decreased by 0.7% to R1.1 billion
• Collaborative research costs decreased by 11.2% to R457 million
• Travel costs decreased by 0.1% to R46 million
• Staff costs increased by 8.8% to R402 million
• Laboratory Operating Costs increased by 2.2% to R53 million

Revenue Growth
Other non-tax revenue included lease income, where SAMRC has a number of tenants in its buildings across the country. It also included foreign exchange gains.

Revenue Vs Expenditure
(See page 22 for a line graph showing the revenue versus expenditure trends.)

Expenditure Trends
(See page 23 for a line graph showing the expenditure trends.)

Expenditure Trends Per Strategic Objective
Strategic objectives included administration, core research, innovation and technology, capacity development. Core research was the biggest contributor, followed by innovation and technology.

Expenditure Per Strategic Objective 2019/2020
Research spend accounted for about 50% of total expenditure, against a target of 56%. Innovation is at 24% of total costs, compared to a target of 18%. Capacity development was relatively low at 7%. Lastly, with corporate and support, the SAMRC objective is to maintain total support costs at about 20% of the total spend, and it managed to achieve that in 2019/20.

Budget to Actual
Actual revenue was slightly ahead of the SAMRC budget, but very close to it, as was expenditure. It managed to keep its costs within its budget. There was a R43 million surplus.

Variances to Budget
Most of the costs and income were on track with the SAMRC budget.
- Personnel costs – below budget at R403 million
- Depreciation – SAMRC extended the useful lives of some of its fixed assets for a positive impact.

Statement of Financial Position
• Total assets increased by 12.4% to R674 million
• Receivables from exchange transactions decreased by 28% to R63 million
• Vat receivable increased by 90% to R10 million
• Cash & cash equivalents decreased by 20% to R370 million

• Payables from exchange transactions decreased by 22% to R110 million
• Provisions decreased by 35% to R12 million
• Deferred income decreased by 33% to R198 million

Cumulative Reserves
• Increased by 14.4% to R341 million. National Treasury approved retaining cumulative reserves.

Baseline Allocation Trend
The baseline grant is the contribution from National Treasury through the Department of Health (DoH). It has increased below inflation, but has still increased up to 2021. The 2021 figure does not include the R150 million received in the last week or two from National Treasury for emergency funding for the vaccine study. The 2020/21 number is higher. For 2021/22, SAMRC has seen an additional R100 million adjustment in its baseline grant to allow it to invest in other COVID-19 initiatives. SAMRC hopes that that will not be a one-year injection but increase over the years.

In Summary
• Continued efficiencies and cost management initiatives contributed to surplus of R43 million.
• SAMRC continues to maintain strong reserves as assets exceed liabilities by R341 million.
• R33 million invested in improving SAMRC buildings and IT infrastructure.

C. Human Resources
Dr Mongezi Mdhluli, SAMRC Chief Research Operations Officer, noted that SAMRC used to have what is called promotions, but it has since replaced that with career progression, which looks at a longer period of time than a promotion, which is a once-off occurrence. Due to the moratorium, communicated to SAMRC over the last year, it has not been able to do career progression.

Transformation, Career Progression & Advancement
• 60 staff were successful in applications for career advancement or progression to a next level.
• 88% of CPA was Black, with 32% African and 70% female.
• The CPA process assist in developing a pipeline to have more specialist scientists on board.

Dr Mdhluli spoke to employee wellness programme and appointments by race and gender

Senior Management by Race
Dr Mdhluli said that SAMRC was “not proud” of this but was making strides in ensuring that it has both racial and gender equity in appointments. From 2017/2018 to 2019/2020, most senior staff were white. These are personnel who have been in SAMRC for a very long period and some are nearing retirement age. When SAMRC replaces them, they will be replaced with designated groups to ensure that SAMRC has racial equity. SAMRC has started the process of “step aside”, where some of its executive management already stepped aside to make an opening to appoint a new executive to address racial inequity. It also changed how it appoints unit directors; they used to be appointed for life, now they are appointed for a term of five years, which can be extended.

Senior Management by Gender
Most of the SAMRC senior management is male.

D. Transformation Plan for Science
Prof Jeffrey Mphahlele, Deputy CEO and Vice President, SAMRC, presented.

SAMRC Transformation Plan for Science
• Focus is both internal and external.
• An enabling environment that supports research execution.
• The Strategy aims to promote and support diversity.
• Attention to gender, disability and race is critical to address Transformation Plan.
• Where disability is concerned, SAMRC aims to develop guidelines pertaining to sick leave, key result areas and generally accommodating disability in the workplace.

Transforming the Next Generation of Researchers: Ten Programmes

1. Bongani Mayosi National Health Scholars Programme (BM-NHSP) - flagship
2. Clinician-Researcher Development Scholarship (MD/PhD) (CRP)
3. National Medical Scholars Programme* (under review)
4. Internship Scholarship Programme (ISP)
5. International Masters in Vaccinology (IMVACC)
6. Biostatistics Human Capacity Building Initiative (BAPED)
7. Research Capacity Development Initiative (RCDI or “HDIs”)
8. Mid-Career Scientist Programme (MCSP)
9. Intramural Postdoctoral Fellowship (Postdoc)
10. SAMRC Staff Development Grant (RDG)

Those who are given scholarships, their research must align with the top ten causes of death in South Africa. There has been a shift from infectious diseases to non-communicable diseases. SAMRC also covers research on injuries and funds research on maternal and child health.

Transformation Profile; Response to National Research Priorities; Extramural Research Units; Profile of Unit Directors and Transforming Self-Initiated Research Grants were covered.

Transformation: Implementation of the Deputy Directors Programme
What SAMRC has done in the last four to five years, is establish a programme of deputy directors to ensure that if a unit director retires, there is a succession. Even if deputy directors are not necessarily guaranteed a post, it is to ensure SAMRC “grew its own timber”. A total of seven Deputy Directors have been appointed across units since 2017, against a target of 10.

E. Annual Performance Plan 2019/20
Dr Mdhluli presented on the Performance Indicators and Target Achievements and noted SAMRC achieved a clean audit; budget spent on salaries and operations of corporate administrative functions was kept below 20% and appeared to meet all its targets for its four strategic goals.

F. Scientific Impact (see document.)

Understanding the Sisonke Phase 3B clinical trial of Johnson & Johnson vaccine
Prof Glenda Gray said this study was developed after evaluating the efficacy of the four COVID-19 vaccines. SAMRC only has data for three of the vaccines against the local variant. With the Johnson & Johnson or Janssen study, South Africa has an overall 64% vaccine efficacy, and 95% of the cases were from the current circulating variant (B.1.351). In the Novavax study, there was a reduction in vaccine efficacy to 48.6%, where 93% of the cases were from the B.1.351 variant. The AstraZeneca study showed a 10% vaccine efficacy against the B.1.351 variant.

When SAMRC learned about the vaccine efficacy of AstraZeneca, it rapidly moved forward with using the J&J vaccine because it had just had information that this vaccine was efficacious. It saw that that vaccine gave high protection in South Africa, where the variant is prevalent. It also saw a 72% vaccine efficacy in the USA. This vaccine efficacy was similar by comorbidity status, sex, race and ethnicity (see graph).

The J&J vaccine was logistically and practically advantageous. When the vaccine is licensed in South Africa, “we will be able to get five doses per vial”; one does not need any dilution for the vaccine; it can be stored for three months at normal refrigerator temperatures (such as a bar fridge); it can be stored for two years at -20°C; it is easy to scale up to large-scale manufacturing; 20 million doses are expected by 31 March 2021; 100 million doses have been given to the USA in the first half of 2021; and shipping fits into existing supply chain infrastructure.

A person gets the maximum effect 28 days after vaccination. Until it is 28 days after one has had a vaccine, one many not be protected. In South Africa, against severe or critical disease, the J&J vaccine is 81.7% efficacious.

National COVID Vaccination Programme Status
• The National COVID Vaccination Programme was paused on 9 February due to the data coming out of the Astra-Zeneca study in South Africa on the efficacy of the Oxford-AstraZeneca vaccine against mild-moderate COVID caused by the 501.V2 variant.
• SAMRC moved rapidly to start the J&J Phase 3B open label study to replace the national roll-out.
• Astra-Zeneca may still play a role in the National Programme but more local research is needed.
• There is a significant lag period before another vaccine is registered in South Africa.
• Vaccination must start without delay to protect health workers during a likely 3rd wave this winter.
• Health workers are 3 to 4 times more likely than the general population to develop COVID-19
• 1 in 7 cases of COVID-19 are in health workers globally
• 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.
• The ENSEMBLE trial showed excellent protection of a single-dose J&J vaccine against severe COVID-19 including in South Africa so to delay would be unethical.

Approach For Vaccine Introduction
• Phase 1 is healthcare workers with target population of 1 250 000. Started with Sisonke study.
• Phase 2 includes:
- Essential workers
Target population: 2,500,000
- Persons in congregate settings
Target population: 1,100,000
- Persons >60 years (more than 60 years)
Target population: 5,000,000
- Persons >18 years with co-morbidities
Target population: 8,000,000.
• Phase 3 is other persons older than 18 years, with a target population of 22 500 000.

Approach based on availability of vaccines
The Sisonke study is the first part of the national roll-out, and is part of phase 1A. This is the time where at a global level limited doses of vaccines are available with highly constrained supply.

Sisonke: Phase 3B open label study
5 easy steps for healthcare workers:
1. Register on the Electronic Vaccination Data System (EVDS)
2. Respond to SMS invite for early access
3. Provide consent to take part
4. Receive vaccination voucher
5. Attend vaccination centre for administration
• 300 000 to 500 000 doses expected in next 2 months
• 80 000 doses expected next week
• 47 sites across the country
• Focus on large hospitals then move to more rural sites
• Research staff to help maintain cold chain and draw up doses
• Vaccinators to administer.

Prof Gray said up to half a million vaccinations will be given to healthcare workers. The number of vaccinated healthcare workers was 195 000 as of 23 March 2021. South Africa has been getting 80 000 doses about every 14 days, and will get another shipment on 26 March 2021. It expects to get 200 000 doses in about 14 days’ time to complete the vaccination programme.

What is a Phase 3B open label study?
• It is a study conducted after efficacy of a drug or vaccine has been established
• Occurs before licensure or registration
• Does not have a placebo control arm
• Evaluates field effectiveness
• Builds on the safety profile of the compound
• Brings an effective vaccine or drug to populations in an accelerated fashion
• Under regulatory and ethical oversight

Prof Gray said it was known at the end of January 2021 that the J&J single dose study worked, after the ENSEMBLE 1 results became available. A Phase 3B open label study is conducted before a vaccine is licensed. SAMRC started this programme before the USA Food and Drug Administration (FDA), and before the World Health Organisation (WHO) gave emergency use authorisation. At this time, many regions around the world have given emergency use authorisation now for the J&J vaccine, and it is under a rolling evaluation at the South African Health Products Authority (SAHPRA). This is not experimental; SAMRC knows that this vaccine works. There is no need for a placebo control arm, because what SAMRC is testing is the field effectiveness of the vaccine. This study builds on the safety profile of the vaccine, and it brings an effective vaccine to populations in an accelerated fashion, while registration is ongoing at a global level. These trials are always executed under regulatory and ethical oversight, hence there has to be trained pharmacists and investigators and there have to be research sites, all at the vaccine sites. A research team has to work with the vaccines. At this time, SAMRC is in both urban and rural sites, and there are now 72 sites all over the country. There are 32 research centres supporting these 72 sites. Hopefully, the programme will be concluded by the end of April.

Prof Gray ended by saying, “We need to vaccinate to save lives in South Africa”.

Ms H Ismail (DA) said that COVID-19 exposed how quickly, with required focus and resources, a vaccine can actually be developed. How will SAMRC use this experience to develop vaccines for other critical diseases, such as HIV, tuberculosis (TB), malaria and others? Given the economic situation locally and globally, how is SAMRC adapting? What policy decisions have been made to mitigate the impact? Are there any retrenchments planned and has the compensation of employees been affected? What is the progress on an HIV vaccine, which commenced in 2016? She asked SAMRC to provide details on the irregular expenditure identified at the SAMRC. What is being done to prevent irregular expenditure in the future? Have there been any cases of fraud or corruption at the SAMRC, including personal protective equipment (PPE)-related corruption?

She asked SAMRC to provide the demographics of the Masters and PhD students who were awarded bursaries and scholarships. Are the conditions of the bursaries and scholarships structured to ensure that graduates go to the public health sector for two or three years? If not, what are the plans to alter the conditions of bursaries and scholarships? On the J&J trial, have there been any serious adverse reactions to the current trial? Has SAMRC, with the DoH, set aside for a possible adverse reaction? Has there been any interaction on the J&J trial? When will the J&J trial be concluded? When will South Africa be using a concluded vaccine? It is easy for the masses out there not to understand that SAMRC is doing a trial now; everybody just thinks that it is a vaccine. There were health workers who were refusing to take the J&J trial vaccine, simply because there are so many questions around it. When it comes to the manufacture of vaccines, should South Africa have not now started producing its own vaccines, and how far is it in this process? Are there clinical trials on Ivermectin in this country, and is SAMRC involved in this? SAMRC mentioned that there were entities assisting it with data – how is this being dealt with? SAMRC mentioned costs, but is it on a contractual basis, how is it correlating between all the provinces? Has SAMRC been dealing with the institutes such as the Aurum Institue for Health Research. How is it dealing with these institutes – what does the contract actually contain? How is the J&J trial being handled in the private healthcare sector? Who is overseeing it, and what are the challenges if any?

Mr T Munyai (ANC) noted the moratorium on advancement in SAMRC. That does not assist with transformation. But in the final analysis, he was very excited about the demographics breakdown, and of the progression of the development of a new generation of scientists. That is very exciting, and includes women and young people. The Committee was “very excited about the clean audit that SAMRC achieved”. It was not the first time; SAMRC had been doing well in handling finances. On data and vaccines, etc., he would not ask that as he had been asking it for almost six months.

Ms N Chirwa (EFF) said that SAMRC had done a “horrible” job of ensuring the public is aware that what is currently happening in South Africa is a trial, and not an approved vaccine programme. How does SAMRC plan on resolving this, and making it overtly public information, and not covering it with “vaccination programme”, but state that this is a trial? Interchanging the two words has been confusing. Who is the highest donor to SAMRC outside of National Treasury? She had raised the question of adverse effects in the J&J trial with SAHPRA, and it referred the Committee to the SAMRC; could it have a detailed scope of what this looks like throughout the Sisonke trial? Are there extreme or close-to-extreme cases?

She asked what SAMRC means that it hopes to conclude the Sisonke study by the end of April. What is the plan? What will stop the plan from being implemented? “We can’t be subjected to the hopes and aspirations of the SAMRC; we want details; we want a scientific plan, and if there are things that will stop the plan from manifesting, let us know”. It does not want hopes, it wants targets. It wants numbers, it wants dates. If the plan is to vaccinate 1.25 million healthcare workers, what then changes it to 700 000? What will then prevent the 700 000 from being vaccinated by end of April? She asked what the anticipated timelines are for the three phases of the vaccine programme. Those timelines also seem to be changing, and the lack of ensuring that the public is aware of the vaccine trial being a trial and not an actual programme; this is also another part that is very vague. There are no dates anymore, and the dates keep changing. What is the anticipated timeline? What is the planned timeline forf how these three phases of the vaccination programme will unfold? By the end of 2021, how many people will have been vaccinated? Is the plan still 67% of the population? The Minister of Health has said that not enough money has been made available, what then is the number by the end of 2021? How much did SAMRC receive from National Treasury to do the J&J vaccine trial? She asked for information on the vaccination trial programme for people with co-morbidities.

Ms Chirwa said that it was “back to the race issue”. In 2019, SAMRC came before the Committee, highlighted the race issue, and in 2021, it is still the same issue. How is SAMRC addressing employing a small number of black people? This is unacceptable, because it was raised in 2019, and even then, SAMRC said that it was addressing it. In 2021, SAMRC still addressing it. How has it addressed this if it has not changed? She asked SAMRC to give tangible evidence of how it will address the fact that it still employs a small number of black people, and yet in the same breath, it claims that it is addressing the issue since 2019. To address means to work towards correcting an issue. This is a public entity, and it is one of five DoH public entities. It cannot be that since 2019, SAMRC is still giving demographics where it admits that in a country with 80% black people, and 8% white people, it is funding 37% black people and 29% black people in the year 2020. She described this as “tragic”. This is presented as some sort of victory, but it is not.

SAMRC told the Committee about the step-aside programme, but how many people have stepped aside? Give the numbers, portfolios, positions that people held and who holds those positions now. SAMRC cannot present a step-aside programme, and then not inform who has stepped aside since 2019. How did COVID-19 prevent SAMRC from making more appointments in its promotion programme, specifically black people? What was it about the pandemic that prevented this programme from happening? There are ways of conducting interviews online. She asked for a detailed and tangible response to this particular question.

Ms G Tseke (ANC) acknowledged the work that SAMRC had done over the years in improving the country’s health, and providing quality service through innovation and research. She also appreciated how the entity got a clean audit over the years. Members of the Committee appreciated that, and SAMRC should continue to do the good work, and to continue flying the flag of the country very high, not only in South Africa, but globally. In 2019, SAMRC celebrated 50 years of existence. Could the entity share the highlights and the impact of those activities? On its communication strategy: How do South Africans perceive and understand the work of the SAMRC, especially in rural areas? Has the visibility of SAMRC improved compared to previous years, especially in disadvantaged areas? On gender inequity: As much as the entity has greater representation of women across the board, a lot still needs to be done, especially in top management. The case in point is the number of male presenters today. It turns out that a lot still needs to be done, and the Committee wants to see change. How many of the 120 graduates who received bursaries are employed in the public health sector? A number of indicators were overachieved. SAMRC noted that it will set the indicators higher in the next annual report. Is it setting targets to stretch itself to higher levels of performance?

Mr M Sokatsha (ANC) asked about personnel costs which were below budget. What is SAMRC doing to address this? On human resources: The presenter mentioned that there is an employee assistance programme. Is this programme only for SAMRC employees? What about family members of the employees? On the transformation plan for science: He asked for the plan on disabilities; and can it give percentages on how far it is with addressing disabilities? He congratulated SAMRC on a clean audit.

Ms A Gela (ANC) said the Committee welcomes a clean audit with no findings. This is a good achievement, and the Committee is proud of the good work that SAMRC is doing for the country. She asked how is SAMRC going to address the imbalance in senior positions. The Committee understands that SAMRC has inherited that problem, but it needs to be corrected. How has COVID-19 affected the way SAMRC operates? Can it get an update on the test TB research conducted so far? Could the Committee get report on whether there have there been any spoilt or damaged doses? It is hoped that SAMRC will sort out whatever challenges it has, to ensure that it corrects the mistakes of the past. The Committee does have confidence in SAMRC, so that it moves forward in serving the country. She thanked Prof Gray for the good work she was doing with her team. The Committee appreciates and supports the report SAMRC had tabled.

Dr S Thembekwayo (EFF) asked about transformation. How possible is it for SAMRC to apply the step-aside programme to the 29 white executives, rather than waiting for them to go into retirement? It needs to be applied to the first ranks of executives. If the SARMC agrees that it will apply the step-aside programme, how soon will it be? The Committee wants to see true transformation taking place. SAMRC said that it rapidly allocated money to fund research on the epidemic in South Africa. There has been a lot of research in hospitals and some clinics with COVID-19 vaccines. What is worrying is the respondents in the research receive R800 or R1000, and some get cellphones, because they were given a vaccination. Is SAMRC aware of this? How does it control this? Are people supposed to be paid money and why is it happening? These are not health workers, but ordinary South Africans. What is the SAMRC relationship to these parallel trials that are taking place? In the media, there was a recipient in Cape Town of the J&J vaccine who reported that she experienced headaches, severe muscle pain, and fatigue over a three-day period. She had to consult a doctor and pay from her own pocket. What is in place for those health workers who experience severe muscle pain etc. after receiving the vaccination? Is there clear communication of what people are supposed to do for adverse side effects, and who is supposed to help them without paying for a doctor?

Ms M Hlengwa (IFP) was very impressed with the overall performance of SAMRC. It achieved all of the performance targets, and remains financially strong with its accumulated reserve of R341.5 million. SAMRC should continue to receive a clean audit as it had received a clean audit seven times. Could SAMRC provide more detail on the pipeline it is developing to have more specialist scientists on board? What specific initiatives is SAMRC doing to attract specialist scientists, and what targets has it set for this? Will it consider setting the targets higher, and what additional performance targets will SAMRC include?

Ms E Wilson (DA) said that it was “on record” that SAMRC always does an outstanding job, particularly in its administration and finance. Its continued record of good governance and clean audits is good. Its continued levels of excellence must be commended. On the seven intramural units, are those all still open and functional? Anything that is indicative of irregular expenditure or fruitless and wasteful expenditure is always concerning; could SAMRC explain how its irregular expenditure arose? Her biggest concern was around vaccine availability.

It was mentioned in the press how Prof Gray had gone to great lengths to try and get access to vaccines for South Africa, and that she had a degree of success. However, the situation remains. She asked about the three months before another vaccine will be registered in South Africa; could SAMRC give an indication of why it is going to take another three months, how many are there, and what processes have to be followed? “I think we can safely say that the third wave is on its way, if it is not starting already”. In the last two days, Ms Wilson had three friends and two family members in various areas of South Africa who have tested positive for COVID-19. It is “absolutely alarming; we haven’t been faced with that on a personal basis before”.

On the daily statistics, one is seeing that South Africa was down to just over 500 positive cases a day, and yet the indications are that this is fast changing. This raises huge concerns about vaccine availability. As of 22 March 2021, South Africa had only vaccinated about 183 000 health workers. South Africa has 1.2 million health workers to vaccinate, and that is just the health workers. That is before it starts on the elderly and people with co-morbidities. Having done only 183 000 out of 1.2 million workers “is absolutely alarming”. SAMRC indicated that there is 3 000 and possibly another 5 000 expected to be vaccinated in the next couple of weeks. That still does not even take South Africa to a third of the number of health workers it needs to vaccinate. That is not including the average person on the street, or poor people in rural areas. “The third wave is here”. What is being done to accelerate the system, and what is the hold-up? It is on every person’s mind.

MPs are inundated with calls about vaccinations and why nothing has happened. She got calls from young people across the board who had been offered jobs overseas. Such young people cannot get work here; “there is no work here”; they have work offers and contracts for companies overseas. These young people cannot leave the country and take up these opportunities they need so desperately because they need to be vaccinated first. This is “an absolute crisis”; there must be a way. People cannot be denied opportunities. COVID-19 has done enough damage already, and so many millions have lost their work. Now there are opportunities for people who can actually get work who cannot leave the country, simply because they cannot get vaccinated.

Ms Wilson was not saying that SAMRC is entirely to blame. DoH in general was to blame for this. What is being done to accelerate this? The third wave is on its way. South Africa is going into winter. People are already suddenly testing positive for COVID-19. South Africa cannot, under any circumstances, afford another lockdown; it will “absolutely destroy a country that is teetering on the edge already”. There was a court ruling to say that people could order vaccines directly; South Africa has big companies who are prepared to do that, but the Committee does not know who to refer companies to.

Dr K Jacobs (ANC) commended SAMRC on its clean audit. He noted that the SAMRC revenue was up by 3.7% for 2019/20. Its revenue primarily through its baseline income from the DoH will be decreased for 2020/21 and 2022/23. Unfortunately, it is also the time when South Africa has experienced COVID-19. The SAMRC 2019/20 Annual Report had only one month of COVID-19. He did have a concern as he was certain that SAMRC had done some extrapolation, and had applied its mind as to how it would be affected in 2020/21, and what that would do to its revenue base. It would be helpful to hear if SAMRC had been considering where things could be going in the future considering COVID-19.

On expenditure trends, SAMRC had increased its expenditure trends towards 2017/18, and thereafter there had been a steady line. What are the current projections on expenditure trends? The 2019/20 expenditure was a little more than what SAMRC had anticipated. Where does it think it will be getting more funds from, because COVID-19 is surely here for a number of years? Surely there would be much more work that had to be done in the near future?

On the profile of unit directors his concern had been raised by many of the Members that transformation is slow. On the SAMRC Board, he wanted to raise concerns specifically. When the Committee talks in the present South Africa, it hoped that it would not be having this conversation on race, especially those who fought in the struggle and in the liberation movements. Unfortunately, that is what it is, that “we now talk about race”, and Dr Jacobs had to ask about that. He saw a very small representation by coloured people within SAMRC. He wanted to hear the SAMRC answer on that. If one looks at the demographics of South Africa, then that is surely a misrepresentation. When does SAMRC expect to get it right on demographics?

On the Sisonke project, the Committee understands that it is a phase three open label study, and it appreciates that it was brought to South Africa so it could start vaccinating its healthcare workers. South Africa has lost about 650 healthcare workers. He was very thankful for the project that had been rolled out. It does not matter what the name is; the point is that there is vaccination taking place, and that vaccination saves lives. With the SAMRC envisaged programme to reach population immunity, the Committee sees that the programme is very slow with vaccination. The Committee understands that it is also a case of supply and demand. What are the plans going forward to increase the receipt of vaccines so South Africa can speed up its vaccination programme? The SinoVac vaccine has been rolled out in other countries such as Brazil, and the Sinopharm vaccine is at a phase three study, and also that the Sputnik V vaccine has been rolled out in countries such as the UAE. Could the Committee get feedback on where South Africa is, and where it stands with those vaccines, and being able to acquire those vaccines?

The Chairperson joined other Members who had commended SAMRC for its excellent work in governance. The Committee should ask SAMRC to accelerate its programme of transformation of leadership. But the Committee does not often get institutions coming to present a clean audit for more than five years. DoH itself is on an unqualified audit for a number of years, but it has not been able to move to a clean audit. The Committee wanted to encourage SAMRC to accelerate this. When the Committee gets those who have qualified audits and disclaimers, then it has to “hammer them”. He would want Prof Gray to find the time to share SAMRC good practices with some of the institutions DoH is associated with on how it manages to do its work so well. If it is possible for SAMRC to have a clean audit, then it might be possible for others to do the same.

He noted that there were slides that SAMRC did not present because of time. It once came to present to the Committee on the impact alcohol has. The Committee now knows what the absence of alcohol did during COVID-19. There were certain benefits to the country. The Committee needs to have that discussion with SAMRC on alcohol and perhaps with other Portfolio Committees who might be worried about the economic impact of reducing use. He wished the Committee found time to bring back SAMRC to talk about its research work.

The Committee had a presentation from the DoH on the J&J vaccine. Members had said to get SAMRC, in particular Prof Gray, to explain some of the challenges. SAHPRA had briefed them on its contributions and some of the delays. SAMRC stated about the Sisonke clinical trial that based on the efficacy of J&J, this is the route it has taken. He was raising this as a concern because he did not know if Members had shared this information widely enough with their political parties, because as late as yesterday, an MP said that as there has been a delay in getting the J&J roll-out faster, why not give AstraZeneca to those at high-risk such as the elderly? However, AstraZeneca has only 10% efficacy. That is as useful as giving Smarties as a vaccination. He hoped that SAMRC would clarify that.

[Ms Wilson wrote in the chat box: Please can we get contact details for companies who are prepared to buy vaccines for their staff. Were 5 million vaccines offered to us by China, and if so, were they rejected?]
[Ms Ismail wrote in the chat box:]

Prof Gray replied on vaccine development: It is clear that South Africa has been involved in early vaccine development. This vaccine development started many years ago, but was expanded with HIV vaccines, where the South African Government and the DoH funded SAAVI, the South African Aids Vaccine Initiative. There has been work on an academic level on vaccine development at many of the universities. One of the challenges around vaccine development is that one needs to go from an academic entity into an ability to scale up and manufacture. This is where the relationship with Biovac and other vaccine developers is very important. SAMRC has a very close relationship with Biovac, and it is working with Biovac on some local COVID-19 vaccine-related developments. One of them is a second-generation adenovirus serotype 5 (Ad5) vector, that could possibly be a universal boost for all the COVID-19 vaccines that South Africa has. It is working on both a sublingual and oral formulation. Phase one studies have already started on subcutaneous administration, and it will move to the oral and sublingual later on. SAMRC is working with Biovac as a partner. With other vaccine manufacturing, Aspen is part of the tech transfer for the J&J vaccine. Aspen is one of seven global manufacturers to do "fill and finish", and hopefully it will come on board. Aspen has done quality assurance, and once it has been cleared, it will be producing J&J vaccines locally, both for local and global use.

COVID-19 has shown that there is an important need to develop vaccine manufacturing capabilities on the African continent. The Department of Science and Innovation (DSI) and DoH have set aside a programme, and SAMRC has been in talks with DSI and DoH also to expand its relationship with the Serum Institute, together with Biovac. That programme is led by the DSI Director General, Dr Phil Mjwara. There have been adaptations locally, and there is a need to work at a global level; South Africa needs to be globally competitive. There is a lot of work that is happening, both at academic centres and Biovac, to try and make South Africa more prominent in manufacturing.

On HIV vaccine development, on 25 March 2021 there will be a New England Journal of Medicine article where Prof Gray will be the first author, and the paper will announce the results of one of the HIV vaccine trials SAMRC was involved in. There are three Phase three HIV vaccine trials that have been conducted.
- Last week, the antibody mediated prevention (AMP) study was published, and this was using a monoclonal antibody, with VRC01, and this showed a proof of concept that a monoclonal antibody can prevent HIV acquisition. There will be further work to look at multivalent monoclonal antibodies. Of that, South Africa has CAP256, and that vaccine is being evaluated, and will probably be part of a multivalent monoclonal antibody infusions for the prevention of HIV acquisition. That is a very important and exciting area.
- The HVTN 702 vaccine trial (results) that will be announced tomorrow, was adapted from the Thai study, and SAMRC made it clade C specific. One cannot extrapolate results from one part of the world to another part of the world. In 2007, there was a study in Thailand that showed that this heterologous time boost using a pox protein prime boost vaccine had 33% efficacy in Thailand. SAMRC is very excited about that project, and it adapted it to be clade C specific, which is the clade of HIV that circulates in South Africa. SAMRC conducted this study, and the HVTN 702 trial did not work. One cannot translate results from one part of the world and think that the results will work in another part of the world. That is a useful lesson for COVID-19 as well – just because something works in one country, does not mean that it will work in other countries. There are different clades that are circulating, different variants, and different ports of infection, so SAMRC cannot infer anything. Local trials have to be done to understand if the vaccines work.
- There is a trial that is ongoing, called HVTN 706. This is an Ad26 HIV vaccine, and it is based on the same platform as the J&J Ad26 COVID-19 vaccine, and on the same platform as the Ebola vaccine that was developed. SAMRC does to its Data and Safety Monitoring Board (DSMB) in April, and either it gets told that it can continue with the trial, which means that the results are still looking good, or it is stopped because the HIV vaccine trial has not worked.
- SAMRC is busy doing other vaccine trials, where it is looking at [unclear 01:51:23] to induce neutralising antibodies. There is a trial that is ongoing in South Africa that is trying to prevent breast milk transmission, and where SAMRC is using an immunogen to induce antibodies to protect babies against HIV.

On J&J side effects: Like in ENSEMBLE 1 and ENSEMBLE 2, around 2% of all those vaccinated have had side effects, which is normal. The side effects coming out of the Sisonke study are no different to what was seen in ENSEMBLE 1 and 2, and these relate to allergies. Sometimes healthcare workers do not want to reveal that they have allergies. “If you have allergies, please work with us, so we can ensure that we have discussions about it”. There have been people who think that they are protected, and so there have been a number of COVID-19 cases, who were either infected at the time of vaccination, or got infected three or four days afterwards. There have been other side effects such as sore arms, but these are all part of the reactogenicity. This is what is expected; it is a reactogenic vaccine, and the side effect profile is exactly the same side effect profile that has been seen with other vaccines. SAMRC has a safety desk, pharmaco vigilance, and all its safety reports go to SAHPRA every two weeks. SAMRC is mandated by SAHPRA to report on all its safety. It has an electronic adverse event case reporting form (CRF), it has paper-based adverse event reports, a safety desk telephonic contact, and the moment somebody gets a vaccine, SAMRC SMSes them to remind them that if they have any side effects, to let SAMRC know of the side effects.

SAMRC can also look at the back end through the NICD and NHLS, to look at if there are other safety issues that have been flagged. If there are hospitalizations, SAMRC works closely with the healthcare worker who has been hospitalized and the team treating that person, to see if there is a causal relationship between the vaccine and the side effects. SAMRC does expect 2% of people to experience side effects, which is the same as what was seen in ENSEMBLE. SAMRC has already vaccinated around 200 000 people; so one can quickly work out how much side effects will be seen. This is a reactogenic vaccine like all COVID-19 vaccines, and SAMRC does expect a robust immune response, which will manifest. It also knows that people who have had COVID-19 before can have an exaggerated immune response, because they have had exposure. The immune system then recognises this; it is almost like a prime boost. The immune system has been primed with a natural COVID-19 infection, and then it is boosted with a vaccine. Thus, SAMRC does expect an exaggerated response. If a person has had severe COVID-19, SAMRC does expect them to speak to SAMRC, after which it will discuss that person’s vaccination programme. The most important thing is communication.

A lot of healthcare workers are desperate to get a vaccine, so sometimes they hide the fact that they have allergies, or that they have had severe COVID-19. SAMRC does want people to work with it, so that it can manage adverse reactions in a way that helps everybody, both the person vaccinated, and the health team around them. At the vaccination sites (which Prof Gray encouraged the Committee to visit), there is a lot of supervision and surveillance. The Department of Public Enterprises (DPE) has come to all the vaccination sites that oversee the programme, and monitors SAMRC. SAHPRA provides monitoring over SAMRC, as well as its ethics committees, providing regulatory oversight. It is important to recognise that SAMRC is a government entity, and it has to do everything under good clinical and pharmaceutical practice. There has to be good oversight, good vigilance, and the informed consent form has to be signed, so that people know what is going on.

SAMRC has not funded any trials of Ivermectin. There is a Section 21 SAHPRA registration that will oversee some of the clinical evaluations of Ivermectin. SAMRC is funding antiviral studies that are ongoing, and the moment that these results are available, it will share them.

On data sharing: Everything is on the Electronic Vaccine Data System (EVDS) which is a DoH platform; it is a very good platform, and SAMRC has a data sharing agreement. As this is public funding, data will be in the public domain once data sharing agreements have been sorted out.

On the private sector: There is a 70/30 split, where 70% of the vaccines go to the public sector, and 30% go to the private sector. SAMRC works very closely with everybody, because there are lots of people who need to be vaccinated. There are 10 000 GPs that require vaccination, there are 10 000 dentists, there are physio therapists; there are a lot of people who require vaccinations. SAMRC works very closely with the private sector, DoH, and the provinces. Every vaccine that SAMRC delivers is negotiated by DoH, the provinces, the sites, and hospital sites. Every vaccine and every allocation is worked through the EVDS, which has become quite strict, so one cannot abuse the system.

On the Sisonke study being a Phase 3B clinical trial: SAMRC is not covering up anything. It held press conferences, it went on television with the Minister. If one goes onto the SAMRC website, if one reads the EDVS, if one has signed informed consent; everywhere it is very public that this is a Phase 3B clinical trial. SAMRC continues to communicate that all the time.

On Treasury: For the 500 000 healthcare workers, SAMRC requires doctors, nurses, and pharmacists, and it has research sites operating. Treasury has given R150 million to SAMRC to conduct the study, which translates to just under R600 a person, which is cost-effective. Some of the tender processes came up much higher, even up to R2 000 a participant to execute a vaccination.

On extreme cases: A lot of the extreme cases from the vaccine are no different to what SAMRC saw in ENSEMBLE 1 and 2. Those cases were related to allergies. They also relate to people who had long COVID-19. SAMRC was seeing a lot of reactions from people who had long COVID-19, or who had COVID-19 infection.

SAMRC has about 500 000 doses from J&J to conduct the phase three open label study. When SAMRC knew that it could not go ahead with the AstraZeneca roll-out, it approached J&J. These vaccines were all over the world; started flying vaccines, at the company’s cost, back to Belgium, Germany and the USA. These vaccines (J&J) are flown, then put into a warehouse, and when there are enough doses, they get sent to South Africa, and that is why it has got up to 80 000 doses every 14 days, because these vaccines are being collected to be shipped back to South Africa. The last amount of vaccines, which were 200 000 doses, were in the USA. South Africa had to get approval from the FDA, and it had to get approval from the US government to allow them to release these vaccines. There is a global shortage of vaccines. 200 000 doses coming from the USA to South Africa “could cause diplomatic issues, so South Africa had to ensure that everyone understood that this is for the Phase 3B clinical trial, and these vaccines were not taking away from US citizens. These things take time, and take a lot of negotiation, and a lot of logistical operations. The last 200 000 doses will arrive in about two weeks’ time, and that will conclude the last amount of doses SAMRC gets. Those vaccines will be delivered to the sites, the vaccines will be administered, and that will conclude the half a million phase three open label study. There are lots of healthcare workers that have co-morbidities. SAMRC is watching those co- morbidities very carefully. It is very important for SAMRC to understand which co-morbidities have more side effects, and it is also very important for it to understand people who are elderly, and to understand the side effect profile in elderly healthcare workers.

On the highlight activities: SAMRC did a series of seminars, workshops and academic days. It also did a submission to the South African Medical Journal on its 50 years of academic work.

Prof Gray asked Dr Mdhluli to talk about knowledge translation as a new indicator. South Africa is very fortunate to have fine health research scientists. SAMRC is fortunate that a lot of the research that it funds, people are motivated to have that research published.

On the step-aside policy: Three positions at the Executive Committee level will be advertised. One is currently advertised, and one will be advertised over the weekend, and another one has just been advertised. These are three positions at the executive level which address transformation. The issue is that a lot of these people are permanently employed, and they are close to retirement. The white senior scientists that have been in SAMRC have been there for 30 to 50 years. Such people are permanent employees, so SAMRC cannot exactly fire them. What it has done with people who are nearing retirement is gotten them to step aside and mentor other people to address transformation.

On the study that used cellphones: This was ENSEMBLE 1, this was the single shot J&J study, and it was phase three. It was a global study – 43 000 people were enrolled in Latin America, South Africa and the USA. This was an electronic-based programme where the only way that SAMRC could engage in the ENSEMBLE 1 study (it was important because SAMRC knew that it works against South Africa’s variant) was that people had to have a cellphone platform to enter their side effect profile. These cellphones could only be used for the application for the electronic data; the phones could not be used for anything else. Some people’s grandchildren managed to hack into the phone and use the data. The data and cellphones could only be used for the ENSEMBLE electronic vaccination records, so it could track side effects in real time. This was critical for SAMRC, because it had to do the registration very quickly. The study started enrolling in late October. By the end of January, SAMRC had results that it could announce. The only way that one can do this is to have real-time data on safety and side effects. At the end of the study, the phones are given back, and are not for the use of the participants. To emphasise, both SAHPRA and the Ethical Research Committee would have to approve anything to do with reimbursement. Everybody was aware that these cellphones were only able to be used for reporting side effects and reactogenicity.

On the participant who had headaches and muscle pain: SAMRC knows that this vaccine is reactogenic; it is like a flu vaccine; it wanted it to be reactogenic, since it means that one’s immune system is responding, and that there will be side effects. If a person suspects that they are going to have reactogenicity, then SAMRC would like to speak to that person, because they can take Panado before they take the vaccine, which will reduce the reactogenicity. Prof Gray again expressed that she would like to invite Members to visit the vaccination sites. The DPE had come to the vaccination sites, had done its audit, had done its review, and looked at everything. For example, it looked at the cold chain, management, the informed consent processes, and it looked at how the participants had been managed. The Committee can request the DPE report. At every vaccine site that is opened, the DPE goes and does an in-depth report, and it spends days there to ensure that everything is going as required.

On the third wave: All are worried about the third wave, particularly after the Easter holidays and the start of winter (where people spend more time indoors). The third wave “is imminent”. SAMRC gives out a weekly mortality report; there is a slight uptick in mortality, and South Africa needs to ensure that it monitors the excess deaths. The Sisonke study vaccinates up to 500 000 healthcare workers. As the roll-out begins, SAMRC will work closely with DoH to transition the sites to the roll-out vaccines, which will either be J&J or Pfizer. As far as she understood, the J&J agreements have been signed, there is a schedule of vaccines available, and she was sure that the DoH could be asked to indicate when these vaccines will arrive. At a global level, vaccines have been allotted to South Africa, and in the next two months, there are shortages, but then afterwards vaccines will flow because the gear-up of the global manufacturing will have taken place. From the global reports, in July there will be massive access to vaccines. DoH will announce the number of vaccines that are coming into country in the next couple of months to take it up to July.

On other vaccines such as Sinovac and Sputnik: SAMRC knows that in Brazil, there are issues with Sinovac efficacy. That again points to the need for local data. One cannot extrapolate from one country to the next; countries have different variants. The issue with Sputnik, which is the Ad26 Prime and Ad5 boost is that it is a first-generation Ad5 vector. There was a vaccine trial that was executed in South Africa and the USA in the mid-2000s, called Step and Phambili, that investigated the Merck Ad5 [unclear 02:11:56] vaccine. In men who had previous exposure to Ad5, and who were uncircumcised, there was an increased susceptibility to HIV after vaccination. SAMRC had to be careful with the Sputnik vaccine; it needs local data, and it needs to be able to see if the Ad5 component of Sputnik will affect South Africa’s HIV pandemic.

On clean audits: “We are scientists, and so we love rules; we love the Public Finance Management Act (PFMA)”. Auditing is very important. When one is a scientist, the first part of being a scientist is to be creative; one has a hypothesis, and that is the first part of one’s creativity. But when one executes an experiment, it must be auditable, it must be reproducible, and it must stand up to rigour and scrutiny. That is what makes SAMRC good at the PFMA; it is because it understands the importance of reproducibility, scrutiny and audit. That works, even if sometimes Prof Gray’s scientists push back a little at her and management, the fact that they understand the importance of rules is important and for the PFMA.

On the impact of alcohol: SAMRC saw the impact of alcohol on motor vehicle accidents, on the emergency room, and it definitely notes that when there is alcohol control in the country, the emergency rooms are manageable, and the unnatural deaths do go down. Going forward, South Africa does need more robust alcohol regulations. South Africa needs to increase the age at which people can start drinking alcohol; Prof Gray thought it should be 21. There should be a limit on the volume and the quantity that people can buy at one time. South Africa also needs to empower tavern owners and bar people to withhold alcohol from people who are clearly inebriated and should not be drinking anymore. Alcohol needs to be regulated in South Africa, and it needs to get away from selling high volumes of alcohol without discrimination.

On the AstraZeneca vaccine: SAMRC did not see any efficacy in mild to moderate disease in South Africa. The vaccine was not evaluated against severe disease, so it cannot make a call. SAMRC is in a data-free zone; it has no evidence that the AstraZeneca vaccine will work against mild, moderate or severe disease in South Africa. The only way it can do that experiment is to do the study.

If it gives out a vaccine and it does not know if it works, there is therapeutic misconception. SAMRC already saw it with the J&J study; it had to keep telling healthcare workers that they were only protected 20 days after vaccination, and this is with a vaccine that it knows works. If it does not know if a vaccine works, then SAMRC worries about therapeutic misconception, where someone is given the vaccine and they believe that it works, and then they are exposed and the vaccine does not work. For all the vaccines, if it is Sputnik, AstraZeneca, or Sinovac, SAMRC needs local evidence that the vaccine works. Prof Gray had told the Committee about the HIV vaccine trial that worked in Thailand, it was brought to South Africa, it was optimised for its own epidemic, and it did not work. That is a clear example that one cannot deduce vaccine efficacy from anywhere in the world; South Africa needs its own local data. Whatever happens, SAMRC does not want therapeutic misconception, and it does not want to roll out vaccines where it does not know exactly if it works against its variant.

Prof Rachel Jewkes, Executive Scientist: Research Strategy and Intramural Units, SAMRC, responded to questions. She said that SAMRC was trying to stretch staff. It has added a new target on translation of research into impact on policy and practice. This is a very important area. SAMRC has put it in for the first time in the current Annual Performance Plan (APP), and it has set targets that are fairly low, not because it is an area it wants people to do little work in, but it is something where it has to learn about how easy it is to measure the work that is being done, since target achievement is audited. There is a considerable amount of work that goes on across SAMRC in translating research findings into policy and practice, as well as communicating key messages from research in formats where the general public can learn and understand more about their health and the society we live in through the findings of research. This is an area where she would say to Committee Members, “Please watch this space”, and SAMRC will be reporting more on what it is achieving in that area over the coming years.

A key headline from this year has been that with all the research on COVID-19, and Prof Gray’s position on the Ministerial Advisory Committee, and the work of SAMRC on vaccines and particularly driving Sisonke, there has been a tremendous impact on policy and practice. There has also been a tremendous amount of visibility of SAMRC in the media communicating the findings of research, and communicating with the public on COVID-19 in different ways. In the future, SAMRC will tell the Committee more when it reports to it about the work that SAMRC has been doing in funding organisations that are taking messages, particularly on COVID-19 and vaccines into communities to generate demand for the vaccine when South Africa is able to actually roll it out across the country.

Dr Mdhluli replied that SAMRC is collaborating with the Open Society Foundation in the USA, from which it has funding that it is leveraging in addressing vaccine hesitancy. Additionally, SAMRC, together with the African Union, and Centre for Disease Control and Prevention (CDC) has developed a framework for the fair allocation of vaccines across the continent. Most of the Western countries bought a lot of vaccines, which is referred to as vaccine nationalism. Hence countries such as Canada got enough vaccines to vaccinate their population two or three times. Prof Gray spoke about vaccines that have been collected from around the world; this could have been as a result of an instance of vaccine nationalism.

On fraud and corruption: SAMRC uses PPE for its clinical trials. It procured PPE using transversal contracts arranged by National Treasury. To his knowledge, there had not been any corruption. SAMRC also received a donation of PPE from the USA to allocate to researchers. Researchers are susceptible to COVID-19 in the clinical trials. Last week, SAMRC had an engagement with the Auditor General who will be auditing the Sisonke open label study. Once the AG is done with that, it will appear in the SAMRC 2020/21 Annual Report.

The moratorium only related to career progression. It was not a moratorium set by SAMRC; it was set by National Treasury in communication with DoH. It is similar to what is happening with the agreement government had that there were no salary increases. In that moratorium, there is an indication that there should not be any changes in the conditions of service for any staff, including board members. SAMRC implemented that moratorium, as an instruction from the executive authority, which affected career progression and advancement.

When he talked about senior management, Dr Mdhluli did indicate that SAMRC is not happy with what it has. This is a historic effect that it could not fire people, but it is addressing this issue. Ms Chirwa did point out that SAMRC came with this issue in 2019, but it would have a labour issue if it fired a person to address the demographics. SAMRC takes the point, and it will discuss with its Board how it can fast-track this process.

Mr Buick responded on irregular expenditure and fruitless and wasteful expenditure. On page 200 of the Annual Report, SAMRC irregular expenditure was R5 632 for the year, and its fruitless and wasteful expenditure was R873. SAMRC is encouraged that it is declining. To his knowledge, there had not been any irregular expenditure in the current financial year. Even R1 of irregular expenditure is too much, so SAMRC has a number of initiatives to curtail it, and it has training programmes. It also has its supply chain management (SCM) forum, which runs monthly, where it stresses this and takes people through the SCM policies. Permeating from the Board down to the EMC is a zero-tolerance approach to irregular and fruitless expenditure, as well as a rigorous consequence management programme in place.

Its highest funder outside of the National Treasury in the current financial year, was DSI with R128 million. There were US agencies such as the CDC and National Institute of Health (NIH).

On the personnel budget and why SAMRC is below budget: If one looks at the actual costs, one can see that the actual compared to last year went up by 8.8%. He had explained why that was the case. However, SAMRC is still below budget, and one needs to look at the mix of research expenditure between laboratory costs and staff costs as the type of research it does. The SAMRC budget was a little bit optimistic on the contract side with the number of staff it would be employing on projects.

On the Sisonke budget: The presentation states SAMRC received R134 million after accounting for VAT from National Treasury.

There was a question on how SAMRC weathered the COVID-19 storm in 2020/21, and the financial impact of COVID-19 on its baseline funding. SAMRC has not closed the books yet on the 2020/21 financial year. The situation is that it has seen a decline in its research activity in its traditional research, and its costs have shown a decline there. One example would be travel; nobody is travelling and SAMRC has seen a significant cost reduction in that area. It has seen a marked ramping up in funding for COVID-19 research. It managed to ring-fence R80 million of its own money, and it had various other funders such as the Solidarity Fund, which means that it has rapidly redirected R260 million to COVID-19 funding in 2020/21. It has been quite responsive to that. Together with its strong balance sheet, it has withstood COVID-19 remarkably well financially.

[Prof Gray wrote in the chat box: They need to be registered in country by SAHPRA – any donations need SAHPRA approval.]

Prof Mphahlele replied about the demographics of the recipients of scholarships. Even though he singled out the Bongani Mayosi National Health Scholars’ Programme as the flagship programme, he did indicate that SAMRC had quite a number of scholarship programmes. There is the Clinician-Researcher Development Scholarship (MD/PhD) (CRP); the National Medical Scholars
Programme; the Internship Scholarship Programme (ISP), etc. If one looks at demographics of the recipients, what it has presented for BM-NHSP and HSP is not different from what one sees in other programmes. In the CRP, 35% of recipients are white, 23% Indian, 10% coloured, 33% African. The trend is the same in other programmes. SAMRC is generally giving more scholarships to black students.

On employability of the recipients of scholarships, SAMRC is fortunate in that most of the people it funds in its scholarship programmes are clinicians. These are people with medical degrees, and they want to become researchers. Such people are already employed. SAMRC also has programmes where it is able to fund people to leave their day jobs and focus on research for four to five years. SAMRC puts more emphasis on the PhD. A number of people who take up the PhD scholarships; these are the people who are already very keen on research, and after getting their PhDs, they go on to do research. The Committee can rest assured that a number of SAMRC scholarship recipients are employed.

On the support SAMRC gives to staff with disabilities, it is running workshops to encourage staff to declare their disability. Some people do not like to declare this, so SAMRC tries to encourage people to declare, especially new staff, so that it can deal with that. It then accommodates staff depending on the nature of their disability so that it can provide a supportive work environment. SAMRC ensures that it caters for sick leave for staff with disabilities.

SAMRC has taken note of the profile of the unit directors, especially the coloured unit directors. When one addresses transformation, it is always a work in progress. SAMRC is not at a stage where everything is perfect, but it is constantly addressing this issue.

There was a question on communication about vaccination and its perception within disadvantaged communities. With the Open Society Foundation funding, SAMRC would be going into the communities. It engages with partners such as the Treatment Action Campaign (TAC) and Africa Alliance.

Dr Alfred Thutloa Head: Corporate and Marketing Communications, SAMRC, spoke about a programme it did in Worcester where SAMRC had schoolchildren come to an exhibition where they were taught about TB as a disease, how one can get it and TB prevention methods. There were various videos shown to the students. It was very experiential.

On research translation: SAMRC is working with DoH to work on COVID-19 vaccine hesitancy, and misinformation. SAMRC has developed a communication strategy that it has worked on with DoH and DSI. That strategy has been shared with the Solidarity Fund, and SAMRC is looking to have that programme funded. It will be rolled out under SAMRC and the African Alliance, which works in communities and once that funding is allocated, it will be able to roll out that programme.

Dr Mdhluli added that SAMRC formed no strategy on stopping appointments because of COVID-19. There were a few appointments during COVID-19.

On the employee wellness programme: This programme also involves direct family members. Family members can phone the call centre. Prof Mphahlele had touched on disabilities. In the SAMRC Annual Report, on page 189, six people declared their disability. SAMRC is encouraging people to declare their disabilities. There is a misconception that people think that disabilities are only visible disabilities. Perhaps SAMRC needed to educate people on declaring a disability.

Dr Dhlomo had suggested that SAMRC share their experience in good governance. It has done that; it has assisted SAHPRA quite a lot, such as with the appointment of the HR executive. With some of the procurement, it helped SAHPRA in creating transversal contracts for them. SAMRC has been assisting its sister organisations with good governance.

Prof Gray said that on a global level, SAMRC co-funders are the Newton Fund, which is the UK MRC and the USA’s NIH, which are both government entities. SAMRC gets some funding from Michael and Susan Dell Foundation, the ELMA Foundation, and the Gates Foundation.

Dr Michelle Mulder, Senior Programme Manager: HIV Programme, SAMRC, replied on funding that one thing that has happened with COVID-19 is that SAMRC had a number of non-traditional funders coming in, so in this financial year, it received funding from the Solidarity Fund.

SAMRC is funding a number of innovations in the TB space. It has been supporting a large TB drug discovery programme for a number of years now at UCT’s H3D facility, and this is co-funded with the Gates Foundation. This programme has become part of the global TB Drug Accelerator. One of the platform technologies SAMRC is funding at UCT School of Medicine is screening for biological activity against TB. These assays are now used internationally by the TB Drug Accelerator. SAMRC also has some projects in the TB diagnostic space, such as looking at non-sputum-based diagnostics for TB. It also has a project that has identified seven urinary biomarkers, which are now being developed into a point-of-care test. Linked to that, it also has a project where researchers have identified a number of markers that provide correlative risk of TB disease treatment success, and risk of recurring TB. These are now being validated and developed into point-of-care assays. SAMRC continues to find new ways and/or to fund the discovery of new diagnostics, particularly point-of-care, to extend the kind of screen diagnosis undertaken for TB.

[Prof Eunice Seekoe, SAMRC Board Member, wrote in the chat box: SAMRC puts a lot of emphasis on transformation. There is a specific programme which funds researchers from historically disadvantaged universities. This programme ensures participation and increased research output in these universities.]
[Dr Jeffrey Mphahlele wrote in the chat box: Correct, I did not highlight the programme for HDIs]

Prof Gray thanked the Chairperson and Members for their scrutiny. SAMRC appreciated this interrogation, because it is important for it as a public entity to be responsive, and to understand the concerns of parliamentarians. SAMRC hoped that it had answered Members’ questions, and that Members would use it as a resource. SAMRC is a “spectacular organisation”; it is very responsive, and Prof Gray was very proud of the work that it does.

Prof Mahlangu thanked the Committee for a very productive meeting. SAMRC remains at the Committee’s disposal in getting the necessary data it requires to be able to formulate policies. SAMRC is looking forward to the next meeting, hopefully it will be able to address most of the questions not addressed today. He thanked SAMRC Board and the Executive Management Committee for making themselves available in this meeting.

The Chairperson thanked SAMRC for the interaction. It will continue interacting with the SAMRC. There has been an expression of the Committee’s pride in SAMRC because of the good work that it continues to do, but Members were also not shy to point out some of the challenges SAMRC still faces, and it hopes that SAMRC continues working on those.

The Chairperson pointed out that 24 March is World TB Day. There are countries in the world that worry about TB. South Africa should be one of those countries, because for as long as one can remember, TB has been a problem in this country, perhaps since it started having mines. There is a saying that if there is TB in the Southern African Development Community (SADC), and one looks at TB as a snake, then the head of that snake is in South Africa. Unless one deals with the head of TB in South Africa, it does not matter what one does in Swaziland, Lesotho, Botswana, and Zimbabwe; one has not dealt with TB in SADC. It calls on the Members that this Government, and themselves as MPs, should be doing much more on TB awareness and leadership because it is on South Africa’s doorstep. The TB caucus was launched in Parliament just at the start of COVID-19; it did not manage to have a debate about it. So the TB Caucus has come back to present to the Committee. He hoped that within the presentation, the TB Caucus could create a programme for the Committee to lead the South Africa TB Caucus Chapter of Parliamentarians because parliamentarians are looking to the Committee on Health to lead and talk about TB.

TB Caucus: SA National Aids Council (SANAC) briefing
Ms Coceka Nogoduka, SANAC Acting CEO, presented, accompanied by Matsidiso Sopodi, SANAC Technical Lead: TB Programme, and Mr Sibusiso Hlatshwayo, TB Caucus Secretariat.

• The National Strategic Plan (NSP) 2017-2022 is a roadmap that enables thousands of organisations and individuals to pull together to overcome the HIV, TB and sexually transmitted infection (STI) epidemics by working towards one set of national goals and objectives.
SA has made great progress in the last 10 years but huge challenges still lie ahead, especially for prevention:
- The number of new HIV infections remains extremely high
- There is still a gap in terms of realising the full benefits of ‘treatment as prevention’ due to the treatment gap among men
- Progressive policies are not fully implemented
- Effective programmes are not adequately scaled up
- Ineffective and/or fragmented programmes continue to be implemented

TB in the NSP
• TB Care Cascade – 90-90-90 (where the TB Caucus is looking at how 90% of the population should be screened for TB, and 90% of those screened that require treatment should be initiated on treatment, and 90% of those on TB treatment should be successfully cured).
• TB investment case (where it is looking at what are the key critical interventions as a country).
• Key Populations for TB response in South Africa
• Parliament Caucus on TB
• Civil society response around responding to TB in South Africa

SA TB Progress: United Nations High-Level Meeting (UNHLM) 2019 six indicators with targets:
- Childhood TB diagnosis and treatment
- MDR-TB diagnosis and treatment
- TB Diagnosis and treatment
- Preventive therapy for under 5 years
- Preventive therapy (PT) in contacts more than 5 yrs of age
- Preventive therapy in people living with HIV (PLHIV)
There are four indicators where South Africa has not met the target, one indicator where South Africa is not collecting data, and it met one indicator target (Preventive therapy in PLHIV).

TB Treatment Cascade
The data shown was based on the recently published TB Survey in South Africa. In the cascade, there is leakage, and South Africa is missing patients as it implements the TB programme. There are 390 000 people who are infected with TB in South Africa. Of those who accessed a TB test, there were 335 428 people, with 54 572 people missing. 311 899 were diagnosed with TB. Of those diagnosed with TB, 235 652 were notified and started on treatment. Only 186 003 people were treated successfully for TB. Judging by the actual numbers, the TB programme is not doing well. There is much work that South Africa still needs to do on TB.

High Burden TB Districts
eThekwini and City of Johannesburg are two of the highest TB burden districts. There was 25% decline in notified cases in each district in 2020 compared to 2019.

Why TB Caucus?
Goal 6 of the NSP talks about “Promote leadership and shared accountability for a sustainable response to HIV, TB and STIs”, so the TB Caucus falls under Goal 6.

What is TB Caucus?
• Unique network of political representatives (it is apolitical, so all MPs in Parliament should be Members of the TB Caucus).
• Caucus members play a crucial role in holding government to account and ensuring that commitments are delivered so the TB epidemic can be eliminated.
• Members of the Caucus work collectively and individually to increase progress against the TB epidemic at sub-national, national, regional, & global level.
• Supported by SANAC Secretariat / Provincial AIDS Councils
• Members of the Caucus adhere to the principles of the Barcelona Declaration:
- Working across geographical and political divides in a non-partisan and inclusive fashion;
- Engaging with civil society and all other stakeholders involved in the fight against TB epidemic;
- To confront stigma and social isolation associated with the disease.

Global TB Caucus
The TB Caucus is a global movement. It is also available at regional level, and today the TB Caucus was presenting at a national level so that there can be a national structure, and the provincial legislatures are also working on establishing TB caucuses.

What Can the SA TB Caucus Do?
• Advocacy Agenda
- TB Financing
- Innovative Prevention & Treatment approaches
- Facilitating and advocating for integration of TB/HIV
- Leading a Human Rights agenda around TB
- Human Resources for Health – community workers
• Engaging communities / constituencies
• Build high-level political commitment to drive the TB agenda in South Africa
• Call for a stronger, louder voice legislating for a TB response in South Africa
• Advocate for TB multi-sectoral approach, ensuring government departments respond to TB
• Patient empowerment through engagements with communities and constituencies
• Draw from lessons of the HIV community

• In 2014, UK MP Nick Herbert and former South African Minister of Health, Dr Aaron Motsoaledi, co-founded the Global TB Caucus at the first Global TB Summit.
• May 2018 was the lead up to the UNHLM on TB
• 4 September 2018, SA TB Caucus was launched and debate on TB held in Parliament.
• Resolution of Parliament (12 September 2018)
• Chair of Portfolio Committee on Health (NA) and Chair of Social Services Select Committee (NCOP) would be Co-chairs of SA TB Caucus
• Coordinating body of SA TB Caucus would consist of 11 NA MPs and 9 NCOP MPs.

The Inaugural Inter Ministerial Committee (IMC) Meeting on 23 August 2019 resolved that:
a) SA TB Caucus be institutionalized as a SANAC programme
b) SANAC establish the SA TB Caucus Secretariat
c) Re-launch of the SA TB Caucus – 15 March 2020
d) Establish at least 3 x Provincial TB Caucus – 15 March 2020
As COVID-19 occurred, SANAC was unable to continue with the work on the TB Caucus. The re-launch of the TB Caucus had not yet taken place at a national level.

SA TB Caucus Activities to Date
In January 2021, the SA TB Caucus co-hosted an international webinar on TB Political Advocacy: Sustaining TB Services During the COVID-19 Pandemic
• Addressed by SA Minister of Health, Lord Nick Herbert – Co-chairperson of Global TB Caucus; Dr Eric Goosby – Member of President Joe Biden’s COVID-19 Advisory Committee; Ms Steve Letsike – SANAC co-chairperson; Ms Lizzie Nkosi - Minister of Health of Eswatini.
• Opinion Editorial in Bhekisisa by Health Portfolio Committee Chair Dr Dhlomo in March 2020.
• Opinion Editorial by Ms Steve Letsike: Addressing aftermath of COVID-19.
• Opinion Editorial in Bhekisisa by North West Health MEC Mr Madoda Sambatha.
• North West Provincial Legislature held a TB debate in February 2020 and a launch in March 2021 (North West is the only province to date that has launched a TB Caucus).

Proposed Next Steps
• TB debate at National Parliament
• Briefing of Speaker’s Forum on TB Caucus
• Launch of TB Caucus at National Parliament
• Members of Parliament to sign the SA version of the Barcelona Declaration
• Engagement involving MPs and representatives of Civil Society
• Induction of MPs on the work of the TB Caucus
• On-going awareness messages on TB.

Ms Gela welcomed the presentation. She asked about the responsibilities of Members of Parliament in the TB Caucus. The Committee welcomed SANAC’s proposed TB debate in the National Assembly, and Members are looking forward to working with SANAC. She was happy that one province had already launched a TB Caucus, and that other provinces will do the same. The provinces do have the PACs, the District Aids Council (DAC), and Local Aids Council (LAC), where TB issues are discussed. Maybe SANAC is coming with something different. Can there be an integrated relationship or have one structure? She wanted clarity because AIDS Councils were already there. To whom does the SA TB Caucus account? On funds: Does the SA TB Caucus get donations. Members welcome the Committee Chairperson being involved in the TB Caucus. There is a need to close the gaps, to ensure that as political leadership, MPs are at the forefront, because TB is also a pandemic, it is very serious, and it is killing. MPs need to ensure that they work together with SANAC on awareness campaigns to make South Africans aware of TB.

Ms Ismail asked who sets the agenda for the SA TB Caucus, and how often should it meet with stakeholders and public representatives? She was asking that question with the intention of oversight. As the Committee on Health, one of its main criteria is to do oversight. The SA TB Caucus is very new. What has it learnt from TB Caucuses elsewhere that could be implemented in South Africa? Are there audited financial statements of SA TB Caucus available to MPs and the public? Please explain the measures in place to counter the influence or abuse of party politics in execution of the SA TB Caucus’s activities? Have there been instances where the SA TB Caucus participated in political party gatherings for TB awareness? Are there prescribed practices for documenting the activities of the SA TB Caucus? Where does the TB Caucus get funding from? Please provide a report on management and measures to safeguard donations from corruption.

Ms Chirwa thanked SANAC for the presentation. She asked to whom the TB Caucus accounts and if it gets funding from Parliament or National Treasury and how much money. What is the relationship of the TB Caucus to the SAMRC? Where can the Committee access the TB Caucus research documentation? Please explain the measures in place to counter the influence or abuse of party politics. Had the Caucus participated in a political party gathering for TB awareness and education and, if so, which political party? How does it deal with infiltration of political party bias? What relationship does the TB Caucus have with activists and NGOs working on TB prevention, education and support? Where are these NGOs based, and what kind of work has the TB Caucus done with NGOs and activists on the ground? What are the systems in place in the TB Caucus to prevent corruption and to responding to corruption by personnel? Ms Chirwa asked if there have been instances of corruption to date. What programmes is the TB Caucus involved in with vulnerable groups such as miners in education, support and prevention, and general activism on compensation?

Mr Sokatsha noted four indicators could not be met, which is close to 60%, that is a huge number. Why could South Africa not meet those four indicators? He also asked about the role of local municipalities. There is a role for provincial legislatures and National Parliament but there was no clear indication about the role of local municipalities. There are also the mines. What programmes does TB Caucus have on the mines where TB is most prevalent?

The Chairperson spoke about the indicators. Where South Africa wanted to have TB diagnosis and treatment, it was targeting doing 221 600, and it did 167 471, which meant the target was "red".

On preventative therapy for those under five years, it targeted 23 900 and managed to get 22 689. It being red might affect those who are going to work on those indicators; who would think that they have to put more effort into TB diagnosis and treatment, than into preventative therapy for under five years. The latter was well-taken-care-of.

With the MDR-TB diagnosis and treatment, the target was 10 100, and the result was 8 815. To the Chairperson, that would be more "amber". More effort should be put into those targets that were definitely "red", and put a little bit less effort into those that were almost achieved. He thought that that slide might be a bit misleading if all the targets were marked red. He had known this programme from the other side, as a Member of Parliament. He had always been amazed at the uptake and interest of Members of Parliament of other countries, such as Uganda, Tanzania, in both HIV and TB. He had not been seeing a corresponding interest and availability of South Africa’s Members of Parliament who have seen clinics where there is not enough TB treatment.

The Global TB Caucus is Members of Parliament holding the government accountable and becoming advocates of TB in villages where Members come from, and say to government that it had not been seen this side; why is it not here? There have been people suffering on this side, who are not accessing clinics, and there have been clinics where there is not enough TB treatment. In other countries, that watchdog is Members of Parliament. In South Africa, there seems to be a sentiment of “Why do we worry, TB is very common in this country. Therefore you worry about common things that happen commonly”. So if a space could be found for Members to add their voices on these “very common things” that are happening, it will be of great assistance.

What are the districts with a TB burden? What are the figures? The World Health Organisation has got a particular figure that it uses to define that. Why did SANAC say that eThekwini has a high burden of disease compared to Harry Gwala or De Aar? What are the figures? What are the numbers that SANAC has? That will be important. Are these figures available to be shared with the Committee? SANAC is charging Members of Parliament to play a critical role. He was getting an indication from Members they would be willing to take those this role they are expected to play. There is a need to accelerate. Already, a province legislature has launched a TB Caucus. Those at a national level have not managed to do that, although not through a fault of their own.

Ms Coceka replied about the link between the provincial and district AIDS Councils and the TB Caucus. The AIDS Councils are coordinating the HIV and TB response from the government side. There are Members of Executive Councils (MECs) sitting on the committee to be able to respond to what their departments are doing. Committees are also working with multiple sectors, with both civil society and the private sector. The TB Caucus is then placed at the legislature, looking at Members of the Provincial Legislature, and looking at Members of Parliament, and not necessarily looking at the Members of the Executive Committee that are deployed to government departments. This is work that is supposed to be done by the political leadership in their capacity as politicians, and working with their constituencies and their communities to be able to drive the awareness of TB in the community. This work also includes holding government departments accountable in the work they need to do on TB, and also as legislators, to drive legislation and policies on TB.

Currently, SANAC/TB Caucus Secretariat is funded by the Global Fund. The Global Fund gave an amount of R11 million over three years to support the work of the TB Caucus. With this money, there can be a TB Caucus Secretariat responsible for driving the work of supporting the TB Caucus. The work that SANAC is doing in supporting the launch of the national as well as provincial TB Caucuses will be coming from that budget, as well as the awareness work. This will be information and communication work, that it will be doing with the Members, ensuring that MPs are able to talk on radio, making sure MPs write pieces of information that will go out either electronically or in social media spaces, as well as in print media.

SANAC has not been allocated any budget for the TB Caucus from National Treasury and Parliament. The first TB Caucus was launched in 2018, towards the end of the Fifth Administration. SANAC has not gone to Treasury to request funding. That is probably the kind of work where the Committee Chairperson can guide SANAC as it goes forward with the work, and when it has tangible activities for the TB Caucus, then it can work with Treasury to see how much budget can be allocated to it.

On local municipalities: SANAC had thought that in these two years, which was 2020/21, it would start by ensuring that the TB Caucus is functional at a national level and at a provincial level, and it would then go ahead and work with the municipalities. Provinces such as Mpumalanga have already coordinated their Speakers’ Forum, which includes the district municipality speakers. SANAC has already presented to the district municipalities on the TB Caucuses. Other provinces are already engaging at a district level, and other provinces have not. In SANAC’s work plan for the next year, it will also start engaging with district municipalities, because that is where services are implemented.

Members asked about engaging in political gatherings. To date, SANAC has not been invited by any political party to support a political gathering in ensuring that there will be TB messaging and TB services at a political gathering. When Members invite the TB services support within party functions, SANAC will work with the DoH, as well as NGOs that provide services in the communities, to ensure that in that gathering, there will be activities around TB messaging, and SANAC will be doing screening for TB, as well as ensuring that those who are positive access treatment.

On Lessons from other countries: In countries that have made progress around the TB Caucus, especially in the region, SANAC has seen Members of Parliament being vocal in ensuring that most government departments that have a key role to play in TB, for example the Department of Transport, and ensure that there is proper communication and awareness around infection control and ventilation in public transport. The Department of Housing (the Department of Human Settlements, Water and Sanitation in South Africa) is critical in the types of housing that are being built, to ensure that houses adhere to TB ventilation. The Department of Basic Education can ensure that within the classrooms, learners are aware of infection control and ventilation, and that there is screening of learners when they get into the education sector. With the Department of Employment and Labour, Members were asking about mining and construction as key industries that drive infections for men. Those are the different departments that SANAC needs on board to be able to drive the agenda around TB prevention, so that the DoH [audio cut out 03:30:21-03:30:48] needs to also ensure that it mainstreams TB in the work that it is doing. That is the work that Members in other countries have done. Also, in political gatherings and constituency gatherings, Members will be making sure that they are able to articulate what drives TB infections, what measures community members can take to protect themselves around TB, what are the signs and symptoms of TB, and when one sees those signs and symptoms, then what are the next steps that one needs to take.

On oversight for the TB Caucus: Ms Nogoduka hoped that the Committee Chairperson would be guiding the TB Caucus in that work. The work of the TB Caucus is the advocacy and activism of the Members of Parliament to ensure there is visible political leadership around the response for TB. The Chairperson of the Committee on Health, and the NCOP Committee Chairperson are co-chairing the TB Caucus. It would follow the same route of accountability with other activities that the Committee is engaged with. The Chairperson could best guide the TB Caucus in ensuring that there is oversight on its Members.

On key activities: In the workshop that the TB Caucus will be having with Members, it will give Members information, and share some of the activities that they can undertake. It will also share with Members on how they can talk about TB as a disease confidently, and how TB affects communities, and the socioeconomic status of the country. Members will also be sharing information on TB stigma, so that they can address stigma and discrimination in communities that are affected by TB. It is hoped that after this workshop, Members have the information that they require, and materials that Members can use when they continue to talk about TB.

One of the challenges that South Africa has is that it only talks about TB in March when the world is commemorating TB. Through TB Caucus work, Members of Parliament will ensure that there will be continuous conversation on TB, and continue to raise the flag about the challenges that South Africa has with TB.

The Deputy President, in his capacity as Chairperson of SANAC, is this morning in Ehlanzeni where the TB Day commemoration is held. He accepted a memorandum from the TAC, whose members marched to hand over a memorandum requesting the Deputy President to declare TB as a crisis in South Africa. That is the work that the TB Caucus will be contributing to – Members of Parliament will be leading those conversations on how best to respond to TB as a crisis in South Africa. Members will be showing that political leadership and that political activism ensuring that TB remains a key priority in the country.

There was a question on the current NGOs that are implementing and supporting work in South Africa, as well as work happening around miners on TB prevention, which Mr Hlatshwayo would answer.

Mr Hlatshwayo said that the TB Caucus is an apolitical initiative. All political parties are part of it, and there is no favouritism with whom it interacts. On what MPs can do: The workshop had already been mentioned. That is one area that MPs can support. The TB Caucus would like to work with all Members of Parliament, especially the leaders of the different parties, on writing open editorials, as it was done with Dr Dhlomo and the North West province. It is also hoping to have an induction and presentation to the Speakers' Forum. The TB Caucus is also looking to work with Parliament on debates.

The TB Caucus work with the mines is focused on working with politicians, legislatures at national level and at provincial level. It will need to have a work plan that will help it identify where it can work with miners. TB in mines is a big problem. If there are political voices that the TB Caucus can work with for mines to take more accountability in their TB response, then he thought that is something that the Caucus Secretariat can do.

Ms Nogoduka noted the question on numbers and she would share information on the districts that have the highest TB burden and aligning that with the WHO criteria. The TB Caucus has those numbers and it will share that with the Committee. The TB Caucus noted the Chairperson’s comments on the targets that it reached and did not reach. It will correct that slide before it shares that with Members.

The Chairperson said that it was encouraging to hear the questions Members had posed on this process, and he requested that Members take it up even more. Members could volunteer to work with Members assigned to the Portfolio Committee on Justice and Correctional Services to visit prisons to check on the programmes focusing on treating prisoners with TB.

The Committee could work with the Department of Mineral Resources and Energy (DMRE) to visit the Chamber of Mines and get to speak to the owners of the mines to ask what they are doing about TB progammes on their turf, how well they look after people who contract TB. While the Committee could probably say that there is a duty on the DoH, the Committee on Health should then be able to hold stakeholders accountable if miners have TB. TB is so common – one will find it in prisons, villages, schools, and everywhere. The Committee may be able to add on to create its programmes that can “beef up” this process. He was encouraged by some of SANAC’s comments, that the Committee is going to probably be able to work out a plan such as when to put a debate in Parliament, when to launch as a TB Caucus, and when to start going around and advocating for TB treatment and prevention in society. He thanked the team for providing insight to the Committee, and it did look like Members were highly motivated to take up this additional contribution.

Ms Nogoduka thanked the Committee for this opportunity to present. This is a historical day, because the World TB Day commemoration event is taking place in Ehlanzeni. It is significant that on this important day, “we will also be having TB conversations with the Committee”. The TB Caucus is looking forward to hearing back from the Committee on the proposed activities that the TB Caucus had tabled, and it looks forward to supporting the Committee with the work that it will be undertaking to contribute to eradicating TB in South Africa.

The Chairperson thanked the TB Caucus team. With the Members’ permission, the Chairperson would be writing to either the Chair of Chairs or to the Speaker requesting that this TB Caucus programme be fast-tracked in the second term. He would also speak to the NCOP Chairperson. He would communicate responses to the Members.

Committee business
Mr T Munyai (ANC) requested that the discussion on the plan of action to work during the constituency period be taken off the agenda.

Dr S Thembekwayo (EFF) agreed. It is a constituency period, and Members need to work with their political parties in preparation for the municipal elections.

The Committee adopted the 17 March 2021 minutes. The minutes stated that the Committee would hold meetings in the constituency period.

Members indicated their unwillingness to work in the constituency period until Parliament reconvenes on 3 May. This would include the planned fortnightly briefings with the Minister.

Ms Gela said that is was very important for the Committee to have those briefing meetings with the Minister so that the Committee is on board, “especially as we know that we are still facing COVID-19 and a lot of challenges”. There are many things that are happening, and the Committee needs to be updated. She was also pleased as the minutes reflected that the Committee had a discussion on the National Health Insurance (NHI) and the request that was forwarded to the Committee to consider having one and a half days to continue with the 121 submissions, because the Committee has a lot of work it must do. Although the Committee understands that it is faces local government elections, she was asking if Committee Members would also consider having the briefing meeting with the Minister.

The Chairperson agreed that despite the Committee being on a constituency period, it would be able to take the briefing from the Minister. He had an additional request, which was about the NHI, so the Committee would keep discussing that and see if permission comes through. The Committee agreed that the Minister can brief the Committee fortnightly. That briefing would happen sometime this week. If there any Member who would have a challenge if it respects its fortnightly engagements with the Minister in light of this pandemic?

Ms Ismail agreed that the Committee should continue with fortnightly meetings with the Minister.

The meeting was adjourned.