SAHPRA on use of Ivermectin; Covid-19 Update and Vaccine plan: Gauteng

Health

03 February 2021

Documents: 

SAHPRA presentation

Gauteng Health - Covid-19 update

Meeting Summary

Video: Portfolio Committee on Health, 3 February 2021

Audio: 

SAHPRA on use of Ivermectin; Covid-19 Update and Vaccine plan: Gauteng 1

SAHPRA on use of Ivermectin; Covid-19 Update and Vaccine plan: Gauteng 2

On 27 January 2021, the South African Health Products Regulatory Authority (SAHPRA) approved the use of Ivermectin for humans under a controlled compassionate use programme. SAHPRA briefed the Committee on this and on the status of various Covid-19 vaccines.

Members questioned the controlled compassionate use programme as it was additional bureaucracy for strained doctors. SAHPRA maintained that its position on Ivermectin was that more testing was required. It spoke of the vaccines and said that the efficacy of the vaccines on the South African variant was being researched. SAHPRA reiterated its role as regulator and said that the safety of citizens was its priority.

Members asked multiple questions about Ivermectin and the vaccine, AstraZeneca, that would be used in the country. Some members felt that the regulator had been reactive instead proactive about Ivermectin. Members welcomed SAHPRA prioritising the safety of citizens and urged scientific principles be followed.

The Gauteng Department of Health presented on the status and challenges of its healthcare services in the face of Covid-19 and its vaccine rollout strategy. There had been a decline in infection cases in the province. As of 2 February it had 389 841 confirmed cases, with 8 614 active cases. It had a 95% recovery rate and a mortality rate of 2.1%. It affirmed that it had bed capacity, adequate oxygen levels and that psychosocial support was being provided to healthcare workers.

Gauteng DoH outlined its vaccine strategy and timeline to the Committee. It would be rolled out in three phases and aimed to vaccinate 67% of the total population in the province. Vaccines would be allocated to healthcare workers in both the public and private sector. The vaccination programme would be launched on 10 February with incremental increases in launches throughout the three phases. Cold chain monitoring in hospitals was a priority as vaccines had to be stored at precise temperatures to prevent spoiling.

The new Gauteng Health MEC was welcomed by the Committee and questioned on how she would turn around the situation in the province. Members asked questions about the Nasrec Field Hospital and its low occupancy, the vaccine rollout strategy, why cold chain supply, the groups that would be receiving vaccines and why healthcare workers in clinics would only receive vaccinations in March. The Committee asked the Gauteng MEC for the Department's response to the Ombudsman's report on Tembisa Hospital.

Meeting report

The Chairperson requested a moment of silence for the lives lost due to Covid-19 and offered condolences to the family of Ms Tozama Mantashe.

He introduced the new Committee Member Dr Xiaomei Havard and asked her to introduce herself. The Chairperson requested that all Members introduce themselves so the new Member could become acquainted.

Dr Havard (ANC) greeted those present and gave thanks.

The various Members introduced and welcomed Dr Havard.

Ms E Wilson (DA) raised concerns about the Portfolio Committee. Members were unhappy with how meetings were being managed and chaired. There were concerns about access to information and how the press received information ahead of the Committee. This was unacceptable as the Committee did not receive a chance to question issues that went to the press before the Committee. There were severe concerns about time frames of meetings, particularly notice of important events. This created a situation where the Committee was unable to hold the Department to account. She requested that on the completion of the presentation, Members stay behind for an urgent meeting with Members only to discuss these matters. A date had to be set for such a meeting to take place and if necessary the Chair of Chairs to attend that meeting and give clarity on the situation.

The Chairperson said that her point was noted. This meeting with SAHPRA had been requested as the Committee had been inundated with questions about the status of Ivermectin. Members had read the presentation document and therefore the presenter would present a summary only to provide more time for questions. Thereafter there would be a meeting with the Gauteng Department of Health.

Dr S Thembekwayo (EFF) said that she had received the SAHPRA presentation only that morning. Members were invited to the webinar with the Minister at 7am this morning. How could Members be expected to engage if the document was only received today?

The Chairperson said Members should have received it yesterday and asked who had not.

Mr P Van Staden (FF+) said that this was the problem being raised by Ms Wilson about the running of meetings, as he had also received the presentation on the morning of the meeting. The working strategy in the Committee had to be discussed. Members were in the dark as information was received through media reports, which was unacceptable. This was an important matter that had to be discussed and he requested there be a meeting on it before the Committee continued with the proceedings of the day.

The Chairperson said that this could not happen as SAHPRA had already logged in to present. The matter could be addressed in a house meeting afterwards as proposed by Ms Wilson. He requested that SAHPRA present without summarising as some Members had received the document only this morning.

Mr A Shaik Emam (NFP) said that matters about documents being sent late or being unsatisfactory could be discussed in the house meeting. He wanted the information gaps about vaccines in the presentation addressed.

The Chairperson noted what Mr Shaik Emam said. SAHPRA had not commented on the progress it was making on the registration of vaccines and this had to be added to the presentation.

Ms A Gela (ANC) supported the proposal to discuss house matters after the SAHPRA presentation.

Ms H Ismail (DA) was concerned that if SAHPRA presented in detail, question time would be restricted.

The Chairperson replied that if the document had not been poorly distributed, the presentation would have been summarised. He hoped that there would be two rounds of questions and no restrictions.

SAHPRA briefing
Prof Helen Rees, SAHPRA board chairperson, said she would make opening remarks about Ivermectin and vaccines after introductions were made.

Dr Boitumelo Semete, SAHPRA CEO, said that she was joined by the full executive team which included the Human Resources executive, Chief Operating Officer, Board Secretary, Chief Regulatory Officer and Chief Financial Officer. She was pleased to say that SAHPRA now had a full complement of the executive and hoped this would lead to good progress in terms of its mandate. She also introduced additional Board Members.

Prof Rees welcomed engaging on anything Covid-19 related not just Ivermectin and vaccines. If given the opportunity SAHPRA could return and present on overall progress in the regulatory authority. She wanted to provide a background before the presentation. The regulatory authority was tasked with ensuring the safety, quality and efficacy of health products in South Africa with the social and medical context being considered when making decisions and recommendations. Safety was paramount to what it did.

At the start of the global pandemic, it was recognised that there would not be enough time to develop brand new drugs to address all aspects of Covid-19 such as prevention, treatment of mild disease and serious disease. Instead there was a global effort to look at old medicines and to repurpose these if suitable for management of Covid-19. A lot of work went into looking at the molecules, how they perform and their characteristics. Artificial Intelligence (AI) has been used globally to sort through thousands of drugs to determine drugs what could possibly have an impact on Covid-19 prevention and treatment.

Right at the beginning there was excitement about Chloroquine and Hydroxychloroquine both for prevention and treatment but unfortunately in the large treatment trial it proved not to be effective; similarly with Interferon. Anti-retroviral drugs such Lopinavir-Ritonavir were not supported by large studies. For Remdesivir, also an anti-viral, larger studies have not confirmed what was hoped from smaller studies.

Against this background, was where Ivermectin had entered and it appeared in the laboratory that it might have anti-viral as well as anti-inflammatory activity. The spectrum of Covid disease starts with what the virus does, this is where anti-virals were needed. Later on when people became very ill an inflammatory process takes over and here drugs such as Dexamethasone, a steroid, are needed. Therefore two different approaches were needed and it was against this background the data on Ivermectin would be presented.

A number of very small studies had been done and larger studies had begun. The small studies either did not show anything or showed some hopeful impact but not sufficient to say that it definitely works. For this large properly designed studies were required. Without this, the data would not be able to be interpreted as seen with Chloroquine, Interferon, Remdesivir where small studies looked hopeful but big studies showed nothing. This was extremely important for the way that regulators did their business as there had to be really good evidence.

On vaccines, she would go into the registration timelines. The average 10 to 11 years to develop a vaccine had been concertinaed into less than a year. It was unprecedented and this was done by overlapping the way that business was done. Some vaccines were already on the shelf developed for example, for the original Severe Acute Respiratory Syndrome (SARS), and these were repurposed. Other vaccines developed for platforms, precisely for this scenario of a pandemic where there was an unknown virus. These platforms were being developed so that a new virus could be plugged on the platform. There were some vaccines already in the cupboard at the start of the pandemic that could be adapted quickly.

Different phases of clinical trials were overlapped so the timeline was consolidated into a year – although there was a lot of safety data from the clinical trials. These large trials had tens of thousands of people in them and safety was an important point to keep monitoring. With vaccines some serious side effects could occur once in a million not a thousand; therefore it had to be rolled out to millions of people while monitoring safety signals. Dr Samete would explain how SAHPRA was closely involved with monitoring as a World Health Organisation (WHO) global partner.

All the safety signals were consolidated globally because if anything serious was seen it is likely to be highly uncommon. This was the background to the vaccines. Dr Semete would go into detail. Prof Rees said she would be happy to explain this information in more detail in understanding the regulator's role when it came to Ivermectin and why there were two groups of doctors, one strongly believing and passionate that it was working and another saying it should not be used. Somewhere in the middle there had to be a regulatory decision that protected people’s safety and SAHPRA was very careful about not declaring something effective if it did not have the evidence.

Dr Boitumelo Semete, SAHPRA CEO, introduced and summarised the most advanced Covid-19 vaccines in development which have the status of regulatory approval in some countries.

SAHPRA had issued a Section 21 authorisation for the Oxford University AstraZeneca vaccine produced by the Serum Institute of India (SII) which was a viral vector administered in two doses. The AstraZeneca had landed in the country on Monday 1 February and it had emergency use listing in United Kingdom and India. All the advanced vaccines had not presented any severe side effects but were being continuously monitored.

Multiple vaccine applications had been submitted and SAHPRA was engaging with the manufacturers. These were outlined.

Dr Samete highlighted that while for safety, efficacy and quality considerations, it had ensured that the vaccine manufactured by SII was comparable with that manufactured by AstraZeneca. There had been a number of engagements with AstraZeneca and the SII and it worked closely with the manufacturers it had partnered with. The clinical data was the same submitted to all the other regulators .This was something that was agreed on as regulators that there would be a global dossier so that the same data was provided globally to allow expedited review as well as share reports and learning.

It had to be ensured that it was a quality product as it left India and landed in SA. Each country had a national control lab and the vaccine would be checked by these labs in India and SA.

It was important for SAHPRA to continuously monitor the safety of vaccines and their performance as they were being rolled out. The tiered mechanisms in place were outlined. SAHPRA was working with the National Department of Health (NDoH) and would be getting reports on any adverse events following immunisation on a two week basis. Serious adverse effects following immunisation would be reported to SAHPRA within 24 hours.

An online web application platform had been created where those who had vaccines could log on. There was also a manual process where indication could be made to healthcare practitioners about side effects. It was anticipating close to a thousand reports on a daily basis. It had strengthened its team and would be getting data analysts to support data mining to identifying serious adverse effects and communicate these locally and globally. There was a very stringent monitoring process in place for when these vaccines are rolled out.

SA had to be very proud that it was taking part in the global studies not only for vaccines but also therapeutics. SA was contributing to the global knowledge being generated. Dr Samete outlined the ongoing approved SAHPRA Covid-19 vaccine studies in the country.

She said one of the questions that might arise was how it would respond if someone had received a vaccine and became infected with Covid-19. The monitoring platforms in place as vaccines were rolled out would have individuals that would be able to follow up. The platform would be a linked to the Covid-19 testing database and there would be a monitoring of this.

Ivermectin
Ivermectin was a widely used drug for the treatment and control of parasites in animals and is used to treat several tropical diseases in humans not commonly seen in South Africa. A section 21 application had been released for topical Ivermectin for the treatment of scabies and head lice. It was registered for use under Fertilizers, Farm Feeds, Seeds and Remedies (Act 36 of 1947) as a veterinary product but has not been recently registered for human use. It was listed as a Schedule 3 product so that when an application for registration is received it has been scheduled already. A product being scheduled did not necessarily mean that it was registered.

An application for Ivermectin had been submitted in 1988 but this registration had lapsed. The possible reason for the lapse in registration was due to a low prevalence of tropical diseases in SA. Currently the product was not registered for human use. Ivermectin was registered for human use in some countries and it was then used off-label for Covid-19. In this case the medical practitioner took full accountability when using the product. As the product was not registered in SA the off-label mechanism was unavailable.

There was an increased interest in Ivermectin as lab based studies indicated that it was a product that could inhibit viral replication and there were several clinical studies ongoing. She would talk to some of the gaps in these clinical studies.

Data analysis for use of Ivermectin for management of Covid-19
There were a number of clinical studies in other countries but there were challenges with the studies. The studies were small in size and were not standardised and properly designed clinical trials. Due to these gaps in clinical studies and scientific information as highlighted by various authors, SAHPRA as regulator was unable to make a decision. It hoped that other clinical trials across the world released data that it could review. SAHPRA would review any data that emerged. SAHPRA had issued a statement in December which said that Ivermectin could not be utilised. The data that came through in January was reviewed and on 27 January 2021 SAHPRA announced it will implement a compassionate use access programme.

Reviews from a number of sources had been considered such as the National Essential Medicines List Committee (NEMLC) and WHO. The overall quality of the randomised trials for Ivermectin in COVIDÔÇÉ19 patients was currently extremely low. The overall trend was positive however the data was insufficient to enable a regulator to make a decision. SAHPRA encouraged that clinical trials be conducted in SA.

SAHPRA had a meeting with the scientific community in the previous week and three clinical trial studies were expected to be submitted. These would be from the University of the Free State and the Witwatersrand and Stellenbosch University could also submit possibly. It was excited to receive these studies and the reviews would be expedited.

Despite limited evidence for the clinical benefit of the drug, SAHPRA had listened to external stakeholders. Medical practitioners were saying that people were dying and here was a drug that could save lives. After extensive engagement and analysis, it noted that there was insufficient data to indicate a clinical benefit but nor did it indicate the drug caused harm. In the context of the second wave, SAHPRA had internal robust discussions about enabling access to the product that was controlled so it was known to whom the product went and how the patient was faring. SAHPRA resolved to make Ivermectin available under a Controlled Compassionate Use Access Programme.

There were three tiers of authorisation that have to be followed to use Ivermectin:
- Authorisation of a licensed manufacturer/wholesaler/distributor to ensure the quality of the drug
- Authorisation of the healthcare facility to keep stock to ensure compliance with good distribution practices and availability of stock
- Authorisation of the medical practitioner for named patient prescription where the medical practitioner assumes full responsibility.

SAHPRA had put this mechanism in place so that it could receive reports on the performance of the product – this was an important middle ground for the regulator’s mandate and being cognisant of the situation at hand.

Discussion
The Chairperson gave thanks. He noted that the presentation was sent late last night hence the complaints from Members. He wanted an improvement on this. Due to poor network connection, he asked to Dr Jacobs to talk on his behalf.

Dr K Jacobs (ANC) said that in a pandemic people clutched at many things to find answers but the Committee had to be informed by medical science. Medical science had evolved over many years and had mechanisms in place such as peer review to ensure safety amongst other clinical testing practices. He detailed the importance of clinical trials for drugs to be declared safe for human use. Members had a responsibility to familiarise themselves with the importance of what was put out to the public.

He agreed with what SAHPRA had done in following research methodology when releasing drugs to the public for consumption. SAHPRA had a responsibility to ensure that drugs were safe for use by communities. He congratulated SAHPRA on the manner it was dealing with this.

Mr Van Staden said there was a lot of uncertainty for the public and a lot of questions that needed to be answered for closure about the drugs and vaccines. He asked for clarity on the uncertainties in the public domain. If the vaccine is not effective against the virus, would SAHPRA then approve Ivermectin for human use and legalise it for the treatment of Covid-19? Why could SAHPRA not run tests and clinical trials itself to get evidence about Ivermectin being safe for human consumption? Why did it have to wait?

Did SAHPRA have the ability to process a lot of section 21 applications and if not, why not? If not, by what date would SAHPRA have systems in place for this? What was SAHPRA’s view on the Gauteng High Court order from the previous day between SAHPRA and other parties? What role would SAHPRA play in the distribution of a vaccine?

More than 34 000 healthcare workers had already registered on the app. How would SAHPRA monitor citizens that were unable to register via the application if it was going to play a role in the distribution of the vaccine? Most of the population did not have access to internet or the necessary tools to go online.

What role would SAHPRA play in the distribution of the vaccine to see that it was distributed effectively to the public? Some scientists said that the vaccine was efficient and some said it would not work at all, what was its view on this? Was it wise to import a lot of different vaccines and use a lot of vaccines instead of sticking to one product?

Ms Wilson appreciated the presentation. She hoped that clarity could be provided as the Committee had request a meeting with SAHPRA since the first week of January. It was perturbing that SAHPRA had a press conference with the Minister about the vaccine before appearing before the Committee despite several requests. She wanted clarity on why this was the case and why it had not appeared before the Committee sooner.

Ms Wilson cited a scenario in China where vaccine vials were filled with saline and given to people on the market. She asked what would be done to control disposal of vials to prevent this in SA.

What role was SAHPRA playing in tenders going out to companies for distribution? In Mpumalanga, there were stories of the Premier’s daughter having a tender for vaccine distribution. This was disturbing and it was confirmed that this company had only been registered this year. She was asking this question because vaccines had to be stored and distributed under very controlled environments. It was important that distributors had to adhere to regulations when handling the vaccines. What was it doing to confirm that those given tenders would handle vaccines in the correct manner?

She asked for an update on the electronic system to monitor people that were getting vaccines. The vaccination programme was starting but there was no indication that biometrics, data or the electronic system was in place to monitor and maintain the information.

Vaccines such as AstraZeneca and Sputnik V had already been used in high numbers in other countries and according to the presentation these vaccines were under review and trial. She was confused as trials had been completed in other countries and there was scientific data and vaccines were being used on millions of people – yet SA was still reviewing and having trials. Why are we so far behind if so many people are using the vaccines?

She asked where exactly the Ivermectin tablets seized at the airport were. The South African Police Services (SAPS) had a bad record of holding stolen stock. What controls were there to prevent this Ivermectin from entering the market? People on the ground were were not aware of the correct usage and that it was a weight-based product. There was potential for huge harm.

On the three authorisation tiers to use Ivermectin, there were desperate people, including doctors. Saving lives had to be a priority. Doctors said that when dealing with thousands of patients, applying for Section 21 for each patient was burdensome and terribly time consuming. SAHPRA said it would respond to applications within 24 hours, was it in the position to do this?

SAHPRA financial report and annual report had not been received yet and she requested an update on this. There was a lot of questions about its funding, where it was being used and what its financial status was.

Ms N Chirwa (EFF) said a million vaccines had arrived on Monday and for AstraZeneca two shots had to be administered. Did this mean there were a million vaccines or 500 000? NDoH had said that 1.5 million healthcare workers would be immunised in the first rollout stage yet there was only a million vaccines. She asked for clarity.

She believed SAHPRA had dropped the ball on Ivermectin as it had to be a forerunner and not reactive. The passivity shown was a cause for concern.

What were the confines of its mandate on clinical trials? Could SAHPRA facilitate its own trials or did it just facilitate application processes? If it could facilitate its own trials, why had this not happened? What was the way forward as this was not being answered? SAHPRA had to be dragged to court to get answers. It was embarrassing that it was so reactive. It had to be dragged to court to administer something that was its obligation especially during a global pandemic.

She asked for a summary on the number of Covid-19 vaccine trials in SA and at what stage these trials were.She asked if SA collaborated with vaccine manufacturers and what its contribution had been. She asked for a picture of the capacity for state owned storage and distribution facilities.

Ms Ismail gave thanks for the presentation. The Ivermectin issue had been going on for too long and the delay by SAHPRA had led to black market trading. She agreed that the proper trials had to occur but the reality was that people were dying. Social media and communities were saying that Ivermectin had assisted people. She asked how many Section 21 applications had been received for the use of Ivermectin. On what basis were vaccine suppliers chosen? She requested that SAHPRA provide a full breakdown of all Covid-19 vaccine data it had at present. The more there was a delay the more the black market would grow.

She asked for a full report of donors to SAHPRA for the past three years. Was it true that it received a R70 million donation from the Bill and Melinda Gates Foundation in 2019/20?

She asked how sure SAHPRA was that the procured vaccines were safe. There are already issues with admission of vaccines in SA. The country was purchasing vaccines from SII, which was a private company, at double the price compared to other African countries. Were there no other options available to SA and why could it not source it directly? She questioned why SA was not working on creating vaccines itself.

On Ivermectin sourcing, she asked where doctors should source Ivermectin and if there were SAHPRA approved facilities for its supply. Would there be a Guaranteed Maximum Price (GMP) for Ivermectin? Was a single set exit price being considered? Had applications been received by manufacturing facilities abroad? If yes, how long would it take for a certificate of analysis to be done? Would there be a delay for overseas countries not yet registered? She was concerned that delays would affect the availability of Ivermectin.

She requested a full report on all external donor-funded research and programmes funded outside the NDoH. She would discuss other issues when SAHPRA met with the Committee again.

Mr Shaik Emam express his disappointment with SAHPRA. Before he had decided to go the legal route, it was his responsibility to exhaust all internal processes but SAHPRA did not respond to communication. For this reason he had to go the legal route for Ivermectin.

He asked for the application dates for when the approval of vaccines to be purchased were made. How was it that vaccines had already been procured but not approved or registered by SAHPRA? The vaccines had been procured from a whole host of countries as announced by the President which were not approved by SAHPRA. There was a major difference in the efficiency of these vaccines. Why did SA procure from these companies when there are others with higher success rates? He was seriously concerned about this.

He noted that SAHPRA had conceded that there was no risk in the evidence on Ivermectin. Who had the responsibility to be at the forefront in dealing with Ivermectin – NDoH or SAHPRA? From his perspective, NDoH had to be at the forefront of accelerating the process working together. SAHPRA was not as independent as it thought it was. When did NDoH approach it to review the data on Ivermectin because prior to his attorney sending a letter, and others, there was no response or comments from SAHPRA or NDoH?

Mr Shaik Emam said that Ivermectin had been one of the safest drugs for the last forty years. It had to be admitted that it was not only used for animal use in SA as SAHPRA had conceded, but it had been used by 3.7 billion people worldwide without reports of serious side effects from all the research he had done.

SAHPRA had agreed for Ivermectin to be rolled out but in a controlled environment which the NFP did not have a problem with. His concern was about the measures put in place was the additional bureaucracy for doctors. What was the purpose of the application if medical practitioners could approve and dispense the drug and then send the application? If it was for data collection for side effects, he did not have a problem. He commended SAHPRA for this.

Ivermectin was approved for human use by health authorities elsewhere. There was not enough evidence that it worked for Covid-19 but what was the worst thing that could happen if Ivermectin was administered?

SAHPRA lacked consistency as it did not allow the Ivermectin but allowed the purchase of vaccines which were not approved. What could SAHPRA do to accelerate the Ivermectin process and take away the “red tape” and leave it in the hands of the medical practitioners with reporting in place so that data could be reviewed? Local manufacturing of drugs had to be allowed in a controlled environment.

He asked what authority SAHPRA had to state that Ivermectin was illegal as no such process for this appeared to have been followed. Since the use of Ivermectin was allowed, was it no longer illegal?

Lives were lost due to substandard Personal Protective Equipment (PPE) approved by SAHPRA. Would SAHPRA take responsibility for the death of healthcare workers?

On the vaccines coming into the country, what indemnity was available for people on the ground who took the vaccine? It appeared that SAHPRA conveniently did not mention deaths related to vaccines.

He requested that the process for Ivermectin be simplified as it sounded laborious. What did SAHPRA believe was the simplest process that protected lives and placed trust in medical practitioners to do the work they did best? Did it intend on conducting urgent trials for Ivermectin or rely on the evidence of doctors?

Mr Shaik Emam said vaccines were ordered from Johnson & Johnson which had a 51-57% efficacy rate and he requested the rationale.

On funding, he asked for a report on all SAHPRA funding and how it was utilised as well dates for when funds had been received. How did its funding impact its independence as a regulator given that some of its funders were promoters of certain drugs? Remdesivir had been approved by SAHPRA and it had admitted that it was not effective. How had it gone ahead and approved and registered this drug for Covid-19?

Dr Thembekwayo said that what SAHPRA had presented on TV was totally different to what it presented now. She questioned if this was why it failed to send the presentation before the time and why there was a difference in this content to that presented to the media.

There was an indication of mistrust, how far did it trust doctors' expertise? Prof Rees indicated in her introduction that there was not enough time to develop new medicine and Dr Samete reiterated that there was insufficient data and not enough time yet Ivermectin had been used by billions of people previously. This meant the information used by SAHPRA to influence people to accept that there was insufficient data was based on SAHPRAs negative attitude it had towards medical practitioners of SA. She asked when it would accept and trust that there were good medical practitioners in SA who could assist in the production of vaccine.

Are vaccines for Western countries different from vaccines for African countries? What stringent measures were in place to assure the public that vaccines were safe, efficient and of high quality?

All the information provided on Ivermectin access had not been included in slides. This needed to be added so that it could be referred to in future.

Mr T Munyai (ANC) appreciated the presentation. There was full confidence in SAHPRA whose mandate was to protect people. Ivermectin was not a panacea or solution for Covid-19. The efforts by SAHPRA were supported and it was not its mandate to procure drugs as it was the regulator. Questions about quantities was the realm of the Health Ministry. He proposed that the Minister of Health be called to brief the Committee on the vaccine roll out. He did not support operating as a representative of drug companies and said SAHPRA had to be trusted as the regulatory body. It would not be convinced by volumes of drug usage elsewhere, court cases, the black market, and rhetoric from the media but rather science and a scientific approach. SAHPRA had to be supported to continue following science. Some people were not speak as drug company representatives but as representatives of the country’s people.

Mr Shaik Emam raised a point of order.

Dr Thembekwayo raised point of order.

Mr Shaik Emam said that Mr Munyai had to withdraw his statement as Members were not taking legal action to promote drug manufacturers.

Dr Jacobs said that the point of order was noted.

Dr Thembekwayo said this was an opportunity to ask questions not to respond on the behalf of presenters or criticise other Members of Parliament.

Dr Jacobs asked if Mr Munyai had heard the request.

Mr Munyai replied that he had not heard some of it as his system was down. He said that the Members were representatives of the people and not of drug companies. There was insufficient scientific data for Ivermectin. Stating that a large number of people in the market used it did not mean SA had to approve it. That was rhetoric not science.

Ms Ismail called a point of order.

Ms Ismail wanted to put it on record that Mr Munyai was stating this out of context. Members were not talking about Ivermectin being used overseas in high numbers but about vaccines and their procurement and usage. Mr Munyai had to stop responding on the behalf of SAHPRA.

Mr Munyai said that he was being disrupted while others received time to speak. He agreed with Dr Jacobs’s proposal. SAHPRA had to be supported. It had not to be replaced by the judiciary or rhetoric. The standard and responsibility to protect people had to be higher than any other issue.

There was vaccine war in the global space but propaganda must not be used to undermine countries. A Member used media reports that were not based on facts and this had to be withdrawn. SAHPRA had to be supported and the ANC supported it. Some tried to belittle it but the ANC was behind SAHPRA.

Ms Wilson called a point of order and said that Mr Munyai could not make accusations that SAHPRA was being targeted. This was completely out of order. Members were present to get answers to questions and discuss issues. Mr Munyai could not misinterpret the facts and put his own assumptions forward. She requested that he withdraw.

Dr Jacobs said her point of order was noted and there would be a continuation of the meeting with Members only.

The Chairperson came online at this stage saying he had had connectivity issues.

The Chairperson said that SAHPRA kept to a particular principle that when there was a public outcry about matters there would be prioritisation of the medication. He wanted to check if this process was a SAHPRA principle. If there was a public outcry about a medication it did not mean it would be allowed [inaudible due to lost connectivity]. SAHPRA had said it would prioritise this medication and jump the queue and investigate its safety and efficacy first and this was what it did. Had there been a delay in this process and could it provide more information? It was a correct that the drug had never been for human use. If Members were claiming that there was a huge amount human use data then it had to be sent to SAHPRA. The South African Medical Association (SAMA) had said it welcomed the court judgement on Ivermectin and was cautious but wanted space as individual doctors to ensure its safety.

Dr Jacobs said to the Chairperson that it had been a vigorous discussion. He advised Members to be mindful of the requirements for the registration of drugs.

SAHPRA responses
Prof Rees said the dialogue was welcomed. She said that a regulator was like a referee and had a set of rules and it had to ensure, that medicine and health products were safe, of good quality and worked. This was SAHPRA’s mandate and procurement, pricing, purchasing and decisions about distribution and final administration fell under NDoH and clinical trials fell under researchers.

In response to questions about whether research had been done, she said that SA researchers under Covid-19 had to be congratulated for their work. SAHPRA’s work was not to do research as it received clinical trial applications and ensured its safety for participants and thereafter reviewed and monitored the clinical trials.

For Ivermectin, SAHPRA had encouraged local researchers to consider doing studies as it was a strongly felt issue and doctors were looking for other therapies. So far there had been at least three groups interested but big trials would come through internationally. SA researchers had seriously interacted with this issue at the request of the regulator. The regulator did not do trials but approve and monitor them.

An overarching point was that, it was important for the regulator to listen to the people as it had to not only ensure safety, quality and efficacy but also the questions people out there people asked. The regulator had prioritised anything that was Covid-19 related. The Board had watched closely and held any eye on the executive on this.

On the question of Ivermectin and whether the regulator was proactive enough and listening to what people said, she said that the answer was yes. SAHPRA recognised that heath care practitioners were desperate to look for better treatments but in terms of proven treatments and prevention there was very limited product available but what it did have was shown to have worked in large randomised control trials. SAHPRA heard that there was such strong views on Ivermectin but there were strong views on both sides for it working or that there was no sufficient evidence as well.

SAHPRA had been proactively looking at data, considering that two big review studies would be coming out, one was meta-analysis from Dr Andrew Hill and the other was the National Essential Medicines systemic review. Both studies came to the same conclusion that even if there was an indication of benefit in some of the smaller studies there was insufficient evidence for a regulatory authority to make a regulatory decision.

The current view on Ivermectin, was that while there are small signals from small studies that there might be benefit, no conclusion could be made that it was good for treatment nor that it was bad for treatment. Getting bigger well controlled studies would break this logjam. Well controlled studies would come out in February and March and in April hopefully there would be new data and this would hopefully break the logjam. In the meantime SAHPRA tried to find the middle ground as one of its mandate was safety.

The use of veterinary products or illegally imported products that was not guaranteed to be Ivermectin or the incorrect dosage. This situation was dangerous and therefore while there was a wait for bigger data to determine if Ivermectin worked or not SAHPRA wanted to ensure that doctors that felt strongly and wanted to access it could. There were doctors with different views on the drug but it wanted to ensure that those wanted to use it could do it with a product designed for human consumption at the correct dosage. This allowed doctors to take an independent clinical decision and this was called off the label use. Ivermectin was not registered for the treatment or prevention of Covid-19 anywhere in the world.

She said in response to the question about if none of the other vaccines worked that if it was unknown whether Ivermectin worked it could not replace something else. This was why there was a regulator and regulators sometimes had to make unpopular decisions where there were strong views held.

Prof Rees said that on the Ivermectin issue, she believed the middle ground on Ivermectin was wise and that it was important to note that the SAMA was supporting it on this position.

On vaccines, she said that SAHPRA was responsible for vaccine trials and SA had been outstanding with the number of trials it had contributed to and this data could be provided. SA had contributed to the trials for five different vaccines in development and there would be more trials. SAHPRA did not do trials but approved and monitored trials.

Prof Rees said that she wanted to share something important. She said that when the data for the vaccines were received, it did not stop when the figures were received. One reason it did not stop was because there was variant in SA and it was deeply concerned that the variant would affect the efficacy of some of the vaccines. There was currently work being done by researchers to determine the impact of the variant on efficacy. Manufacturers were also considering the impact of various variants and how products would have to be altered. The regulator received data constantly which had to be considered.

Ivermectin data would come in and it was being considered. SAHPRA had been thinking of Ivermectin for months and not just because of a court case. The data had been considered and there were multiple engagements about Ivermectin way before the court case. SAHPRA had concluded considering the demands made and the varying views and that for the safety of the public it had to go the middle route.

Dr Samete said Prof Rees had covered some questions.

On the question about if the vaccine was ineffective would Ivermectin be authorised, she said that there was insufficient data for Ivermectin’s use as a prophylaxis. It worked very differently to a vaccine. It was seen as two different strategies therefore a decision on vaccines would not affect a decision of Ivermectin. In terms of the range of vaccines being considered because there is emerging data and the variant, the vaccines have to be constantly evaluated for efficacy.

On people receiving saline, she said this was where regulator’s roles became important and therefore SAHPRA worked with the National Control Lab and the product that arrived in SA had to be tested. The public had to trust SAHPRA that these assessments were done and therefore every decision made had to be science based. The quantities that had arrived were currently being tested and once this was completed, a lot release certificate would be issued.

On why there were on going trials, she said Prof Rees had spoken to the matter and emerging variants.

On the volumes of the vaccines, she said a million does had arrived and the remainder was expected but the batch of 1.5 million had been authorised.

Dr Samete stressed the role of the regulator. It was not the one that conducted trials but monitored trials and made regulatory decisions as it could not be a referee and player.

SAHPRA had not been passive as a regulator. Its first statement was published in December and before then it had been engaging with other regulators on drugs. As regulators SAHPRA had been staying on top of matters.

On the application date, she said that the dates were included in the slides and that it had been updated on slides.

On the current clinic trials in SA, she said there were slides in the presentation that indicated all the current trials in SA and their related information.

On procurement, she said SAHPRA was working closely with NDoH and it was aware of the conversations it was having with manufacturers. It was a global approach taken by all regulators that no vaccine would be procured, even through the Covax Facility, if not authorised by the regulator. There was a lot engagement between the Department and manufacturers. SAHPRA was aware of the current discussions with manufacturers and there was alignment as it did engage with NDoH. No product would be finalised about procurement if not approved by the regulator.

On the variants and vaccine efficacy, she said that as Prof Rees had indicated clinical trials would continue. The WHO published minimum requirements for a vaccine to be determined as efficacious and this was something the regulatory body had accepted and those authorised would fall within this.

On the presentation differing, she clarified that the presentation given did not differ to what was presented with the Minister. She would share the presentation with the Minister if it was wanted.

On differences in vaccines, she said that there was not a difference between vaccines in western countries and African countries. The dossier that SAHPRA received was the same scientific and clinical information that had been submitted internationally. She said it could be said with confidence that SA was getting the same vaccine that manufacturers were making.

On Ivermectin and capacity, she said that SAHPRA was aware that capacity had to be strengthened when it put together the programme as large numbers of applications were expected. It did have the capacity and the Section 21 team had been supplemented. SAHPRA was coping and 27 applications had been received in January and seven had been received in the last three days.

On the High Court Decision, she said that SAHPRA held a press conference on 27th of January where it indicated the Compassionate Access Programme. The decision on this had started before this. SAHPRA was not influenced by court proceedings and it was a coincidence that the court application was received as SAHPRA was preparing to communicate about the programme to the public.

On confiscated products, she said that as part of its standard operating procedure (SOPs), the product was stored with the police services and analysis was done on the products. Regular inspections were done to ensure that the product was still at facilities.

On sources of Ivermectin, she said that it would be available through licences manufactures, distributors and wholesalers and she would be happy to make this information available.

On the issue of pricing, she said that as a regulator SAHPRA was not involved but there was a pricing committee that addressed such matters.

On international applications, she said that the ones authorised were local companies but because the product was not manufactured locally it would need to imported, therefore note was taken of where the product came from to ensure compliance.

On bureaucracy in the programme process, she said it was not bureaucracy but to ensure the safety of the public.

Dr Jacobs gave thanks and said he would hand over to the Chairperson.

Further Discussion
Dr Jacobs said it was a robust debate and Members had to be mindful of SAHPRA’s role and what was said and the information it put in the public space. Members had to be careful about putting forward fake news and false statements. On Premier of Mpumalanga and the tender, he said that it had come forward that it was fake news. Procurement was a national initiative that would be controlled nationally.

The role of SAHPRA had to not be confused with various entities that it had oversight over. The public had to not be confused, the role of SAHPRA was a regulatory. This was what SAHPRA did and what SAHPRA had reiterated in his response. Wrongful allegations and statements made towards SAHPRA had to be withdrawn and it had to be engaged with it in a fair way considering its given mandate.

Mr Emam Shaik gave thanks and said NDoH had a greater responsibility than SAHPRA. It was said nothing would be procured without authorisation but there was a public statement that 40 million doses had been procured and this was not authorised by SAHPRA. He requested a response on this matter.

He welcomed the review of some of the Ivermectin data. Many experts were saying that it could be used a preventative and had to be taken at early stages. He was concerned with how prevention would be dealt with and the time frame it given so that it was effective. He asked for guidance on this.

He said the public had to be made aware of approved manufacturers for Ivermectin so that fake products were not bought by the public.

He said that his question on how Ivermectin was made illegal had not been answered yet.

On the 57% efficacy of the Johnson and Johnson vaccine, he asked if SAHPRA had recommended it to NDoH despite its low efficacy rate. He asked for guidance on these points.

Ms Wilson said that should like to clarify some information. On the case of the Mpumalanga Premier, she said that she was well aware of the information being fake news. The crux of the question was in the light of tenders going out for vaccine distribution and considering that the product required proper storage and transportation, whether SAHPRA had been involved in the tender process. Had SAHPRA been tasked to create protocol for the tenders? She said she used the case of the Premier as an example.

On the use of saline, she gave thanks for the response. She asked if there was a process for proper treatment of used vials and it was ensured that it did not go simply to waste treatment. What would be done with vials and what would be done to ensure that the vials did not end up in the wrong hands? She was seriously concerned about this issue.

On vaccines, she asked if additional vaccines apart from AstraZeneca had procurement certification authorised. If so further details had to be provided about these vaccines and their origins.

On vaccine prices, she asked for an indication on the matter and requested assurance despite it being done by NDoH.

On the database for vaccines, she asked if SAHPRA was confident that the database system for the vaccine programme was running sufficiently.

Dr Jacobs said he raised a point of order. He said that it was noted that that Ms Wilson stated that she was aware that the matter about the Mpumalanga Premier was fake news. Members had to be clear about what it put in the public space and it was not honourable to put fake news out there without putting indicating that it was. He requested that she apologise for her statement.

Ms Wilson said that she had said “in light of the fact” when referring to the news of the Premier. She said she would not apologise. She did not accuse the Premier and only stated it as it was in the public domain and some believed it to be true therefore in light of that she asked SAHPRA to comment. She said that she had used it as an example and would not apologise.

The Chairperson put it on the record that the news about the Premier was fake news. SAHPRA was not involved with procurement as it was not relevant to it. He said the matter was not relevant to SAHPRA and was fake news.

Ms Ismail wanted it on record that the Committee worked with SAHPRA and transparency was a requirement. Members had to beg for meetings and questions need to be answered as Members had to provide responses to citizens.

Ivermectin needed to be processed and safety measures had to be adhered to, this was not being opposed. The reality was that health professionals were in the dark as where to source Ivermectin. People were dying and more information had to be made available.

SAHPRA had said it received reliable data from the SA National Control Laboratory, when could this be made available to the Committee? So that Members could answer to communities and citizens at large.

She gave thanks for the responses and said that the Chairperson had to ensure that there was a meeting with the Minister of Health so that questions that were relevant to the Department and not SAHPRA could be addressed. She requested that the information on who licenced wholesalers and distributors of Ivermectin were be provided. She also requested a breakdown of applications received with an indication of which entities been authorised and who had not been authorised with reasons.

On Ivermectin, she said that she was concerned about the cost factor of it and wanted SAHPRA to address the matter on the high cost of the application so that it was accessible.

Mr Munyai said he was pleased that issues were clarified… Mr Munyai was inaudible.

The Chairperson asked if Mr Munyai was still talking.

Mr Munyai said that he was happy that the fake news against the Premier was addressed. The claims against the People’s Republic of China were part of media propaganda… He had connectivity issues.

The Chairperson said that he heard that Sputnik vaccine from Russia would have the best efficacy and asked for further comment on this.

On the country not having a choice on the vaccine it bought and that applications were rather processed by SAHPRA had to be addressed by NDoH. He said that he would try and determine a time for a meeting with the Minister wherein an update on vaccines could be given. While Members were public representatives he cautioned being representatives for other bodies that had their own members.

He had phoned SAMA leadership to determine its view on the matter and court matter. He said that Prof Rees was correct that there was no unanimity amongst doctors but SAMA supported the approach taken by SAHPRA. Whatever happened SAHPRA would be responsible for the safety of citizens and it had to not be pushed into a corner.

SAHPRA response
Prof Rees said SAHPRA welcomed more discussions with the Committee both formally and informally. She said that SAHPRA had probably not done a good enough job explaining to the public what a regulator did. She outlined that the regulator was important pillar of an effective health system.

On finance, she said if SAHPRA was asked if it needed more funding, the answer was yes. It was doing a lot with the budget it had but it was important that it remained properly funded.

On Covid-19 as disease and why it was complicated, she outlined that the disease had five areas to consider where there could be intervention which were presentation, early treatment- patients who did not need to be hospitalised, those who needed oxygen and who did not need oxygen and those who needed ventilators. The interventions for these five areas differed therefore a lot of data was needed for the continuum of the disease. Just because a drug worked in one of the five areas did not mean it worked in another. Currently there was not enough information as it was an ongoing project.

SAHPRA was sympathetic to those desperate to find solutions. SAHPRA could not however, say that Ivermectin saves lives for any of those five categories as there was not enough data to say it did not work or worked. There had to be more clinical trial information for the drug as well as information on dosage. That information was not yet available therefore SAHPRA was trying to ensure safety while waiting for it.

On SAHPRA’s role in approving vaccines according to efficacy, she said that she said the Pfizer and Moderna vaccines were at about 95%, AstraZeneca at 70% and Sputnik was 90%, Novavax was 60% for HIV negative people and just below 50% for the whole population and the Johnson and Johnson vaccine was 66% overall. These figures were from clinical trials and the concern was the impact of the variant on these various vaccines and the impact on each of the vaccines were not expected to be the same. The data for this was being reviewed closely. There also a Ministerial advisory committee on vaccines for the Minster and a technical working group on this matter. This would be a critical area going forward where public representatives would be required as there would be changes.

Prof Rees said that SAHPRA was ring-fenced in what it did as it was a regulator. She gave thanks for the engagement.

Dr Samete asked if the other Board members wanted to comment.        

Prof Shabir Banoo, Chief Technical Specialist, SAHPRA, gave thanks for the questions.

On the approval of vaccines versus the procurement strategy, he said that most countries had submitted orders for vaccines many months ago whilst it was still under development. Global supply had to be considered as well as countries needs to have access as quickly as possible.

Globally many countries had put in orders for vaccines months ago while regulators were looking for measures to expedite the approval. It was the same in SA and SAHPRA would only allow the importation of a vaccine once it had been approved it but the strategy of NDoH to ensure access through putting in orders was in line with SAHPRAs engagement with it.

On the distribution of vaccines and SAHPRA’s role, he said that it was important to note that when the Department of health issued contracts to manufacturers or distributers that SAHPRA’s regulatory requirements were adhered to. SAHPRA had an oversight role over the entire supply chain and ensuring that regulations were adhered to. It would also ensure that medicines were disposed of appropriately.

On Ivermectin and its safety, he said that it had to be recognised that all medicines had side-effects and this included Ivermectin. The dialogue about Ivermectin’s safety was related to the dose it was used in parasitic diseases but within the context of Covid-19 there was no idea what the safe dosage was. It was known that when Ivermectin was used in larger doses the risk of side effects was quite high. High doses of Ivermectin could cause side effects such as neurological impairments and liver damage. The safety of a medication was the approved dose for a particular indication. It was also part of regulators mandate to ensure that drugs were safe, effective and of good quality. The current data on Ivermectin still needed to be confirmed by regulators.

Ms Mandisa Hela, Vice Chairperson, SAHPRA gave thanks. In response to the question about SAHPRA saying a medicine was illegal, she said in terms of the Medicines Act anything that was not registered in the country was not supposed to be on the market. There were two avenues for being on the market, one was through registration and the other through a dispensation like Section 21. Its primary mandate was to protect the people of SA.

She said that generally when SAHPRA had all the data up to phase three of a clinical trials there would be registration if there were no qualms but it would be monitored throughout its life cycle. In this case there had been a rush to get the vaccines on the market and work was being done on phase three trials and therefore it was impossible to say that the vaccines had been registered. This was why the vaccines were entering through a Section 21 dispensation and when robust data was released there would be full registration. This was done globally, other countries had emergency use authorisation but this was not in SA law therefore Section 21 was being used.

Dr Samete said that she would address questions which had not been addressed yet. She said that SAHPRA was not involved in the procurement of products as its role ended when the regulator decision was issued and once the product was procured and available it did post market surveillance to monitor safety and side-effects of products. NDoH in its tendering process did ensure that the requirements for a successful bidder included regulatory requirements.

On the National Control Lab, she said that it reported to SAHPRA and provided a report to it when it was generated. The Lab was busy with assessments currently and the lot release certificate would be released to SAHPRA. This certificate had to be issued before vaccines were released.

On the database for registration, she said that SAHPRA was not involved in this but its role was for the database it had in for the reporting of side-effects.

On Ivermectin and its purported indication for its use for the prevention of Covid-19, she said that the information was completely insufficient. This was why the Compassionate Usage Programme would enable SAHPRA to get the data hence the strict reporting mechanisms. Currently there was no data for its use for the prevention of Covid-19.

On who was authorised, she said that it had been communicated to applicants including information about wholesalers and distributers because it was not an over the counter drug. There were already applications through manufacturers that had been authorised.

On the disposal of the vials, she said that this would be included in the protocols and she said the Department had held a programme where those who would administer vaccines were trained. SOPs on disposal were in place typically.

On Ivermectin’s availability at healthcare facilities, she said an application had to be submitted due to controlled access. It would not be made available to all healthcare facilities as not all doctors wanted it. SAHPRA had already received applications from healthcare facilities that wanted it.

On the number of applications, she said that since the programme had been communicated, a handful of applications had been authorised. Seven applications had been received in February and 21 in January. The bulk of the applications in January was from before the compassionate access programme was finalised. These applications would have been rejected on the basis of insufficiency of data. Since the programme had been instituted there were 10 applications, which were processed. Of the 10, those for named patients were authorised but there were some applying through an unlicensed manufacturer. It had been communicated that the programme required application through a licensed manufacturer. A few were applications from healthcare facilities, some were authorised others required certificates of authorisation as per the National Health Act.

On costs, she said that it was still being discussed internally but in the long term as data and clinical trials was received it would either continue to be available under section 21 or be registered.

SAHPRA had not received communication to present its annual report but it welcomed this. It would always avail itself to engagement with the Committee.

The Chairperson thanked the SAHPRA team; they would be invited in future to present the Annual Report.

Ms Hela noted that the SAHPRA website had a list of authorised distributors and wholesalers.

Committee matters
The Chairperson said that the next meeting would start at 3.30 pm. He gave Ms Wilson a chance to say what she wanted but since it was going to be a difficult topic there were two options. One option is listen to Ms Wilson and then return at 2.00 pm to deliberate on the matter or take a break until 3.30 pm and schedule a meeting for a later time.

Dr Thembekwayo wanted engagement on how Members interacted with each other in front of visitors.

Mr Shaik Emam said that most of his questions were not adequately answered. The Committee needed to have a regular closed meeting where it discussed its own committee matters and oversight. A date had to be determined for when these matters could be discussed in detail.

Ms Wilson said that an in-house committee meeting was required on the matter. The Chair or Chairs needed to be present to explain how the committee had to function.

The concerns from the opposition which she believed other Members shared were: timeous notification of events and oversight; receiving presentations documents timeously; responses to correspondence by the Chairperson as various stakeholders had said correspondence was not received; insufficient time for engagement with presentations; reading of correspondence in the meeting; and issuing press releases released before discussed with the Committee.

There had to be a plan of action going forward and there had to be a programme. Members played a pivotal role in the crisis and she felt that it did not have sufficient time to deal with issues. The fact that SAHPRA had not been invited to present its annual report was an example of the issues the Committee had and it was very concerning. She concerned that the recommendations of the Committee were not visited before the entities appeared before it a year later. These were some of the concerns she raised and was sure that other Members would add to her concerns raised. These were the concerns of the Democratic Alliance that had to be addressed.

The Chairperson requested that Ms Wilson furnish her statement in writing so that these matters could be processed. He admitted that there might have been administrative oversights. He agreed that the House Chair had to be invited to that meeting. He noted that the Minister was available to make a presentation on 5 February on an update of the vaccine rollout plan.

Dr Thembekwayo said that the Chairperson had not responded to her on Members' conduct during the meeting. Mr Munyai had answered on behalf of the presenters during question time. Members were not expected to answer on the behalf of presenters. This was not an ANC committee.

Ms Gela said that it was never said that it was an ANC committee.

Dr Tembekwayo said she was not talking to Ms Gela.

The Chairperson said the Chair of Chair would orientate Members on matters.

The meeting was adjourned until 3.30 pm when it would meet with the Gauteng Health Department.

Gauteng Department of Health (GDoH) vaccine rollout programme
Dr Nomathemba Mokgethi, Gauteng MEC for Health, apologised in advance for submitting the presentation late. It had been presented yesterday to the Provincial Coordinating Committee (PCC) and to the Executive Committee (Exco) on that day and it had to be reworked and new statistics added for Covid-19 management.

Covid-19 in Gauteng
Ms Meisie Lerutla, GDoH Chief Director: District Health Services, presented on Gauteng's status of healthcare services for COVID-19 as of 2 February 2021 and the challenges. In Gauteng the numbers continued to decrease from 9 to 30 January. There had been a considerable decrease in the number of new cases. Cumulatively as a province there were 388 620 confirmed cases with 3.5% active cases, 94.4% recovered, with a mortality rate of 2.1%.

The Covid-19 data per district was outlined. The three metros – Johannesburg highest followed by Tshwane and Ekurhuleni – had the highest number of cases followed by the district councils with 12% of total cases. Screening and testing figures were outlined as well.

The bed occupancy rate in hospitals was outlined. There was capacity in all districts for managing Covid-19 patients, the figures excluded Nasrec which was a field hospital. On bed occupancy at Nasrec, there was a total of 1000 beds and at the moment the facility was underutilised with intermediate care low flow oxygen beds having an occupancy of 14% and isolation 6%.

The number of health workers across sectors in Gauteng with Covid-19 were outlined. The numbers in the GDoH was higher followed by the private sector and others.

Mortuary capacity at Forensic Pathology Services (FPS) was 1608 and provincial hospitals 1 813. FPS capacity was at 57% utilisation and 35% in provincial hospitals with a provincial average of 45%. There was plans for mobile mortuaries which would add 288 spaces and work was being done on the ICT if this capacity was needed.

The challenges included adherence in communities to Covid-19 protocols; multiple human resources challenges; insufficient functional beds in hospitals if there were an increase in cases; as well as slow completion of infrastructure projects. There was also an increased demand for public health services beyond Covid-19. Mitigating measures for these challenges were outlined.

Vaccine roll out
Mr Dumisani Malele, CEO Medical Supplies and Project Manager for Vaccine Rollout Programme, said that Gauteng intended to vaccinate 67% of its population and it would done in three phases. Phase one would vaccinate frontline healthcare workers, phase two for essential workers, persons who in congregate settings and persons over 60 years, and phase three was for the general population. Targets for vaccinations across the districts were outlined both in the public and private sector target. The vaccine allocation for the first dose was 130 000 for private sector and 85 500 for public sector employees. The public sector allocation excluded municipal healthcare workers and non-Persal employees.

The rollout project was a multi-sectoral project and the stakeholder mapping was outlined.

NDoH Covid-19 vaccine supply chain and vaccine rollout timelines for Phase 1 with dates were outlined. The vaccination programme would launch on 10 of February at the Chris Hani Baragwaneth Hospital.

The presentation outlined there were 224 vaccination sites and 808 vaccinators. From the first dose on 10 February, there would be an incremental launch at all 10 hospital sites, followed by the 23 other hospitals and then at the 191 Primary Healthcare (PHC) facilities in March.

There were additional readiness assessment activities such as monitoring of cold chain status. There were multiple measures in place to monitor fridges and storage capacity. There were minor challenges that would be addressed before the rollout.

On cold chain monitoring in hospitals, the vaccine had to be stored at a temperature between two and eight degrees Celsius therefore temperature measuring was critical. The majority of pharmacies were still using the old method of temperature measuring but this did not stop the rollout.

On vaccine security, vaccines would be transported by Biovac and escorted by security and SAPS. Pharmacies had security and GDoH was working with the Provincial Joint Operational and Intelligence Structure (PROVJOINTS) on a security plan.

A timeline was given for immediate to medium priorities, the progress by work groups and the steps for phase 2 and 3.

Discussion
The Chairperson thanked them and asked for progress on the Tembisa hospital matter. He still had to write the findings from the oversight visit to the GDoH.

Ms Ismail asked for a full report on oxygen supply in the province. On the Anglo Gold Ashanti hospital, she requested a full report and asked how much money was spent on the hospital as well as how many Covid-19 patients had been treated at it.

On infrastructure, she asked how the budgeted funds were used. She requested a report on all expenditure for healthcare infrastructure related to Covid-19.

She requested a full breakdown of where and which health facilities Cuban doctors were posted and asked if contracts had been signed by each doctor as well as the monthly cost for each doctor. She requested the full details of vaccination sites including names and addresses. What was the percentage of the current vacant posts in province?

In social media reports the former Chief Financial Officer of Gauteng Health claimed that she received instructions from the Office of the Premier and former Health MEC, Dr Bandile Masuku, and the former Head of Department, Prof Mkhululi Lukhele, to award PPE tenders to certain companies of their choice. She requested a report back on these investigations and tenders awarded by GDoH.

The damning report by the Health Ombudsman on the death of Mr Shonisani Lethole at Tembisa Hospital was shocking and revealed failure at every level. Denial of food for four days and poor record keeping, falsified information and negligence that contributed to the death. What was GDoH going to do to ensure that this did not happen again to any other patient at Tembisa Hospital or any other hospital? Who would be held accountable for what happened at Tembisa Hospital? On what basis was Tembisa Hospital identified and designated for Covid-19 patients?

Ms Ismail asked why municipal healthcare workers were not included in the vaccine rollout plan. How many people did the GDoH plan to vaccinate per day? What was the number of intern doctors working at each hospital and have these interns been paid?

Ms Gela welcomed the presentation and congratulated the newly appointed MEC. She said the previous speaker had raised many of her questions. She asked if the GDoH had received any donations and if this information could be shared.

On the shortage of staff, she welcomed the working relationship with the nursing agencies. Healthcare workers were exhausted, isolating or Covid-positive. Had it faced these challenges as shortage of staff was a serious challenge in other provinces?

She asked the GDoH to explain its prevention strategy as Gauteng was identified as a hotspot.

She welcomed its vaccine rollout strategy  and its communication strategy. The good work it had done with communication was appreciated as even in rural areas people received the information. She welcomed the response from GDoH and all the work it had done. The response time from the Emergency Medical Service (EMS) was noted and appreciated. She thanked the Gauteng team for its response to the flood in Leratong Hospital. She thanked the department for its good work and urged it to keep it up.

Mr Van Staden welcomed the new MEC. He said that Tembisa Hospital was not the only hospital with big problems and such problems were a long time coming. He asked what new plans the MEC was putting in place to address problems to ensure patients received the care they needed and were not neglected without food or chained to beds as had happened in the past year. There were constant challenges in the province and the previous MEC was charged with corruption and there was the Life Esidimeni tragedy as well. There were many investigations by the Gauteng government but nothing appeared to happen. What new plans would the MEC put on the table to eradicate all these challenges and turnaround the healthcare system in Gauteng?

The Chairperson said the former MEC had not been charged for corruption.

Mr Van Staden said he was referring to MEC Qedani Mahlangu and the Life Esidemeni case. On vaccines, he asked by which date GDoH expected to vaccinate the 10 million citizens and by what date was expected for healthcare worker vaccinations.

He requested a report per hospital with figures on total admissions, bed capacity for high care, ICU and general wards, oxygen and mortuary capacity. Why did it get rid of the other field hospitals when there would be further waves of Covid-19? Was there a backlog in issuing death certificates?

He requested a report on the shortages of doctors, nurses and healthcare workers per hospital in Gauteng as well as a report on the status of new interns in the province for 2021. What was the status of PPE per hospital in the province? Where there any backlogs in laboratory testing? If so, what was the latest figures and how many days was it behind?

Ms Chirwa said that it seemed that there was no sense of urgency from the province. The health system was collapsed from clinics to hospitals. There was no sense of urgency to at least devise plans around resolving these challenges. She asked why the Nasrec field hospital was not utilised. It was due to a lack of information distribution therefore people did not know they could be picked up to go to Nasrec to isolate. Every person in Gauteng did not know that isolation at home was unnecessary and that they could go to Nasrec. There were misconceptions about who could go to Nasrec and sufficient ground work was not done. How would it ensure that everyone was aware?

How many temporary workers had been employed since the beginning of the pandemic and when would these workers become permanently employed? What would be done to ensure more community healthcare workers were absorbed in the province as this area was a challenge?

She had raised with the Acting HoD about a young girl who was a radio presenter who had cancer. When it was at an advanced stage she was told to go from a public hospital to a private hospital. After intervention she was sent to another public hospital but it was too late. It appeared that GDoH wanted matters in the news before addressing them. Why did it have to be pushed and begged to do its job? Negligent cases were reported every day by constituents. People were dying instead of being healed at facilities in the province and it felt no shame that people were dying. She asked for the MEC to resolve these challenges. Why did the Gauteng Department always have to be begged? She could provide the details of the woman but she had been in contact with the Acting HoD about this for the past month.

Where were the vaccination stations across the province? There was no science in the rollout strategy for phase two and three. What criteria were used and how many doses would be rolled out in communities? Health justice had to be maintained with the involvement of science that considered socio-economic and other contributing factors. This had to inform the roll out strategy. There was no science. What was it planning to do and what was the response to taxi ranks? She wanted an update on the Gateway Clinic project.

There was misinformation about vaccines in the province – there were even posters offering vaccinations. What was the Gauteng's response to this? How would it regulate vaccinations to prevent fake vaccines and misinformation around vaccines as well as educating people about the importance of a vaccine and accessing it? GDoH had not done a good job informing people on the ground about vaccines.

Ms Gwarube congratulated the MEC on her appointment. The PPE corruption scandal was clearly an insidious culture within the Department that had been allowed to fester. This was a deeply worrying culture and billions of public money had been unaccounted for. What had she done since her appointment in cleaning out the rot of corruption in GDoH?

NDoH was handling the acquisition side of the vaccine programme and each province would fund the associated logistics. She had picked up a number logistical gaps. One was that the initial sites were seven hospitals and she assumed that these would be the nodes from which vaccination sites would be supplied. However, she was concerned that PHC facilities would only be on-boarded in March. If this was only happening in March this put healthcare workers at PHC facilities at a disadvantage. Why was this the case?

If it was due to infrastructure gaps as the challenge of cold storage, what assurance was there that cold storage and ICT infrastructure would be addressed by March? Was there a plan to capacitate PHC facilities and when would this happen and how far was it? This could have begun last year. How did these infrastructure gaps fit into the budget and from where would money be sourced? Who were the vaccinators, were thyy additional workers or existing staff members? On allocation to the public and private sector, how would it be rolled out considering that two doses had to be administered? What was the plan if the second batch of vaccines did not arrive in time for the second dose?

Ms Wilson welcomed the MEC who had joined at a chaotic time in the Department.

On EMS capacity and ambulances, according to a response to a written question to the Minister the ambulances in Gauteng were restricted to cover an area of between 14 000 and 41 000 square kilometres. This was a huge challenge and hundreds of complaints had been received about this. The time ambulances took to arrive was concerning and distressing to patients.

She needed clarity on bed occupancy as conflicting statements had been made about capacity during the presentation. A further 300 beds were being sourced for Jubilee when there were a lot of beds still available according to the presentation. Was this necessary considering strained finances?

She said there were retired healthcare workers that had volunteered but never got a response or were rejected. There was a shortage yet many who volunteered had been treated in this manner.

On vaccines, she said that 85 000 public healthcare workers would be vaccinated in the first phase and 130 000 in the private sector. Was there an equitable share for this rollout?

On the vaccine rollout, there were timelines and dates but ICT systems were not in place. ICT systems did not just happen overnight and its infrastructure was lacking. GDoH was being super over confident or trying to impress Members. She thought that the rollout plan was unlikely.

On the phases of the rollout, she said that the province had planned three phases and provided dates yet the Minister had not advised Members when the next vaccines would arrive and their details. She said it appeared that it was planning with more information than the Committee had. Why was this information not available to the Committee?

In light of what happened in Gauteng before, there had to be checks and balances on the tender process. The tender documents particularly for distribution had to be very clear on what was required as it could not have inexperienced or unqualified companies getting bids to move vaccines.

On the disposal of used vaccine vials, she requested assurance that proper protocols were in place for vaccine waste management to avoid the situation with fake vaccines that had occurred in China. She was not sure if the occurrence in China was fake news but she believed it was not.

The Chairperson asked for clarity the on the EMS challenges and distances she had mentioned.

Ms Wilson said in response to a written question she had submitted to the Minister, she was informed that the ambulances in some areas were expected to cover a distance of 4000 – 41 0000 square kilometres radius. The area was huge and this matter had to be dealt with.

Dr Thembekwayo asked what plans were there to ensure chronic patients received medical care.

On the status and the costs of upgrades in Gauteng, she requested that this information be made available. Could the increase in unclaimed bodies mentioned in the media be confirmed? What happened to unclaimed bodies?

She said that excess deaths were a serious concern. What was being done to ensure every death was recorded correctly?

She asked if there was a recovery plan for patients’ folders at the flooded Leratong Hospital.

She told the Gauteng Health MEC about the case of a patient who was operated on in 2016 and left the hospital with an open wound and was still struggling with the wound. She had contacted the CEO of Mamelodi Hospital to schedule an appointment for this patient. His appointment was confirmed but he left the hospital without being attended to by the CEO. She requested that the MEC intervene as her intervention had failed. She cited the case of an old woman who was suffering from cancer who had been sent away. This was another case that indicated the negligence and inhumane treatment from the hospitals in Gauteng. She asked for a way forward on these two cases.

There are long queues at clinics in Gauteng. She asked how people would be accommodated when there would be vaccination rollouts at these locations. She asked where vaccinations would be done. GDoH communication did not reach out to poor communities.

Dr Jacobs said that there was an impression that the vaccine would erase all the problems but an infection was still being dealt with and everything had to be done to manage cases until there was herd immunity. The decline in the case numbers in Gauteng and the continual opening of new wards was noted. What are the future plans for preparation for a new resurgence of infections? Was there preparation for a third wave especially consider winter? He asked that this be answered under three points: staff and new training programmes, increased clinical support to patients and people who would have chronic diseases after being infected. He requested a written response if the GDoH was unable to respond. He commended the Department on the rollout plan. He welcomed the MEC.

On slide 19 and 20 on the private sector target numbers, he saw 6000 more pharmacists than doctors. If this was correlated with slide 20, there was 50% more staff in the private sector and this was worrying.

He did not see mention of other healthcare students receiving vaccinations such as physiotherapists that worked in a clinical setting. Universities also had medical faculties and this was not mentioned which was concerning.

The Western Cape wanted to procure its own vaccine; what was Gauteng's view on alternative procurement? What was it strategy considering that the second dose of the vaccine was required within 21 days?

Mr Munyai welcomed the fantastic presentation and the decline o infections in Gauteng. He understood that the procurement of vaccinations was nationalised. The other key issue was that there was an intensive communicate strategy to indicate the availability of the field hospitals including Nasrec. To say that that there was a lack of communication could be misleading.

Ms Chirwa raised a point of order. She requested that she be respected and said that Mr Munyai was not the GDoH and he could not be respond on its behalf to her questions. These tendencies had to be addressed as the first meeting was almost collapsed by Mr Munyai. He did not respect his fellow co-workers as he tried his best to defend the ANC.  

Ms Gela said Ms Chirwa was out of order.

Ms Chirwa said she was not talking to Ms Gela.

The Chairperson requested that Members not respond to questions until there had been a response by the province. The Chairperson said it was wrong of Ms Thembekwayo to support Ms Chirwa in the background. Ms Gela was also wrong for coming in. Ms Gela and Ms Thembekwayo were out of order to speak when Ms Chirwa had been granted an opportunity. He requested that Mr Munyai not answer the questions of Members.

Ms Chirwa and Mr Munyai had an exchange.

The Chairperson asked Ms Chirwa to stop as she had made her point and requested that Mr Munyai reference the points of other Members.

Mr Munyai said he would continue to speak for his party. The ANC Gauteng province was the best in terms of its healthcare system. He asked if the MEC thought the procurement of the vaccine would happen centrally by national because in SA there was no federal government. He asked the MEC to raise the good points that had been made in healthcare services to patients during Covid-19. He praised the GDoH and its work.

The Chairperson welcomed the MEC. He asked what category of health professionals would be vaccinators. He was concerned that nursing agencies were being considered when people could be employed from communities. Two years ago all provinces were supported by a presidential…[inaudible 1.46.57]. Had this not had an impact on getting more healthcare workers?

He was concerned about the statement that three out of seven hospitals had the temperature monitoring system in place. It did not state when the other four would receive these systems. He requested a timeline for when these fridges would be repaired.

On Tembisa Hospital, he said that the biggest challenge was that the hospital was declared as a tertiary hospital. It serviced a large population but the resources were lacking to have it function properly. There had to be an improvement on infrastructure, human resources (HR), equipment and nurses on the ground. He requested comment on the matter but was open to engagement on it at a later stage.

GDoH response
Mr Lesiba Malotana, Acting Health HOD, replied that part of the challenges at Tembisa Hospital, as a tertiary hospital were systemic and the GDoH had taken a decision not to appeal the Ombudmans Report. The report recommendations would be used to deal with systemic matters that included systemic improvements in health technology, infrastructure and ICT. It had to ensure that Tembisa was adequately funded for tertiary services bearing in mind that it did not have a nearby referral facility therefore getting Kempton Park Hospital on board would alleviate that.

Mr Malotana confirmed that donations had been received and they totalled under half a billion. The donations contributed towards PPE and ventilators. He could avail a detailed report as submitted to Provincial Treasury.

He conceded that Covid-19 had taken a toll on staff. Since the beginning of Covid-19, 4000 staff had been brought on board. In terms of legacy there would be more beds and staff than before Covid-19. Gauteng’s approach was that it always intended to repurpose, reuse, renovate and renew infrastructure and then build within the current infrastructure where possible so that there was a legacy and then use alternative building technology (ABT) with field hospitals as it was not part of the legacy.

He noted that staff were fatigued and staff had a protracted recovery rate post infection. Psycho-social support had been extended to staff.

On EMS, he replied that geographically the distance to patients was not as far as in other provinces but there were challenges with concentrations and volumes. Over the past three years EMS had been recapitalised and over 3000 ambulances brought in to address population demand and ageing fleet. The provincialisation of EMS had also been completed. Based on statistics, call volume had increased by more than a 100% year on year. Service demands remained high.

Nasrec was intended to be a field hospital and also used for stable persons under investigation (PUIs). The province had communicated the admission criteria. During the first wave, there were multiple field hospitals but occupancy rate was always at less than 10%. From a resource view it made more sense to consolidate everything under Nasrec. The occupancy levels at Nasrec were low as patients required a higher level of care than it could offer. To date, from the previous year R204 million had been spent on beds and patients at Nasrec.

On staff vacancies, just over 4000 staff members now on board were not there before Covid-19. Those on Covid-19 contracts would be made permanent. There was currently a process to convert these contracts to permanent positions and engagements were happening on funding for this.

Ms Lerutla, GDoH Chief Director: District Health Services, replied that Gauteng was comfortable with oxygen supply in the province. It had weekly meetings with Afrox, the supplier. There was a system that once oxygen levels went below 50%, Afrox refilled. A report on this would be made available to Members.

On municipal healthcare worker exclusion, she replied that the workers had been included in all the districts in the numbers that would be immunised.

On testing, the turnaround time for Covid-19 tests was 48 hours and it did not have challenges with the National Health Laboratory Service (NHLS). Gauteng was the only province where community health workers had been absorbed as permanent staff.

On apparent discrepancy in hospital occupancy, she clarified that beds were not overflowing but occupancy was mentioned as a challenge in case the numbers went up in future beyond what it had. It wanted to be prepared. That is why it is continuing with the Jubilee Hospital ABT facility and the repurposing of beds could happen if needed.

Nursing agencies were being considered as an option if there was a critical challenge. However, as a province it had not taken from nursing agencies but employed directly.

Mr Malele, CEO Medical Supplies and Vaccine Rollout Project Manager, replied on the number of vaccinations per day that there would be learning from the first round at Chris Hani Baragwanath. If all the vaccinators were active, the plan was that one vaccinator would vaccinate 40 people per day but as more vaccinators were activated there would be an increase.

The plan was to do all the vaccinations over a period of 12 months – the dependency was the availability of vaccines. On the 85 500 doses that it received, healthcare workers would be vaccinated as a first dose and national had reserved a second dose. The second doses would be made after 28 days or so and the second doses had been reserved to prevent challenges.

On the vaccination of PHC workers, he explained that the first phase had four categories. The first category was people who dealt with intubation and intubation which normally happened at healthcare facilities. Therefore vaccinations would happen at hospitals first then clinics.

On digital connectivity challenges, Mr Malele replied that not all PHCs had connectivity problems and these would be addressed where necessary.

Medical waste would be managed properly as there was a contracted service provider.

On fridge temperature monitoring, he explained that the temperatures in the three facilities were being monitored it was just that automated electronic monitoring was not being used.

He replied about cold storage at clinics saying that it was not the first time that vaccinations would be done at PHC facilities therefore there was storage. During the second and third phases there would be collaboration with the private sector.

Gauteng Health MEC response
MEC Mokgethi replied that there were network challenges in some parts of Gauteng and she also had experienced network challenges. She apologised if not every question was answered and requested that unanswered questions be sent in writing. The points raised by Members would be considered and factored into their plans.

On Tembisa Hosptial, she said that a position had been taken that the report from the Health Ombudsman would not be challenged and it would be used as a tool to address gaps.

On the accreditation of Tembisa as a tertiary hospital, she said it was included in the recommendations. The Minister would look into the accreditation.

The Ombudsman's findings on structural matters had been considered and a task team had been created to address the matter. If ABT was extended it could be used to ensure more beds and equipment. It was acknowledged that Tembisa was servicing a large population. The maternity ward was challenged as it was overcrowded. Tembisa had a lot of foreign nationals and more than 50% of the babies born there were from foreign nationals. How other countries would pay if their citizens accessed our facilities had to be considered. The MEC committed that human resources were being considered and the recommendations of the Health Ombudsman would be implemented.

She had presented a report to Exco and the Hospital CEO had been given a letter of intention to suspend. The Ombudsman’s Report found that the CEO allowed himself to be misled. When it was reported to the Minister and the Ombudsman had started to investigate, the Hospital had to write a report to the then MEC and Ombudsman but when the investigators came on site they realised that the report had discrepancies. The investigator said that there was an opportunity to correct the matter when it was submitted to the Ombudsman and to notify the MEC. The CEO was supposed to have picked this up.

The Department would also be working with the family. When the HOD had gone to introduce the CEO of Charlotte Maxeke Hospital, who would be the acting CEO until the process of allowing people to clear their names was completed, some of the implicated had already apologised and wanted to have a session with the family.

Reports would be submitted to the Minister as the Ombudsman's recommendations were actioned which could be sent to the Committee as well.

On PPE accountability, she said Special Investigating Unit (SIU) investigations were currently underway.

The MEC said only National would procure. As needles, syringes and swabs would be used when doing vaccinations, a task team was created that would do close monitoring as the rollout happened. There would also be a technical team, and this included the CFO, who would report on costs of materials and expenditure would be monitored. She said that security was top secret to ensure that vaccines were not lost.

She asked Dr Thembekwayo to furnish her with the details of the two patients. There had been a number of letters of appreciation that was boosting the morale of the staff for risked their lives to save others. In one meeting doctors said that the doctors had to be supported with psychosocial and spiritual support as they were seeing people pass away on a daily basis. Support was put in place.

On what had been done well to manage Covid-19 in Gauteng, she replied that it was better prepared than at the first phase and it was more prepared at the second phase and hotspots were being managed much better. The extra capacity it had created would be utilised post Covid as it had invested in quality infrastructure. There was also a better collaboration between municipalities, the private sector and the province.

She requested that the unanswered questions be submitted in writing.

On the Anglo Gold Ashanti Hospital, she said that it was complete and it would be functional. It would be launched officially the week after next. It could be utilised post Covid-19 to close infrastructure gaps.

On Leratong Hospital, she said that most of damaged files were supposed to be destroyed as they were more than 10 years but she would have to provide a further report once she had more information.

Closing remarks
The Chairperson requested that Dr Thembekwayo follow up on the patient’s details with the MEC. Ms Ismail's question on infrastructure and Ms Chirwa's question about a patient were unanswered. Questions that required detailed information such as figures for interns and Cuban doctors could also be addressed in writing.

The Western Cape and Eastern Cape responses to outstanding questions would be forwarded to Members and it was appreciated that provinces had sent back responses.

Seven Committee Members resided in Gauteng and were therefore aware of matters. He wished the Gauteng Health Department well in its efforts and congratulated it for the progress it made one week after receiving the Ombudsman’s report. It had to assist Tembisa Hospital – it had to be supported so that it remained a tertiary hospital.

He was convinced that a session was required with the House Chairperson to address in-house matters.

The meeting was adjourned.