SAHPRA on Covid-19 vaccine licensing, vaccine efficacy rates and on latest vaccine research; Report on oversight to KZN & Gauteng to assess recent unrest
01 September 2021
In this virtual meeting the Committee received a briefing from the South African Health Products Regulatory Authority on the COVID-19 vaccines and adopted the reports of the Committee’s oversight visits to KwaZulu-Natal and Gauteng, that assessed the impact of the unrest on health infrastructure and the vaccine roll-out in the provinces.
The South African Health Products Regulatory Authority presented an update on the COVID-19 vaccines. The presentation focused on the vaccine approval process, vaccine effectiveness and vaccine trials as well as overall safety monitoring and causality assessments. The Regulatory Authority took the Committee through the approval process in detail. The approval process included the assessment of applicants, manufacturing sites, the production process, non-clinical data, safety and efficacy, amongst others. The Regulatory Authority outlined the process of monitoring the vaccines and the various tools for reporting adverse effects. A number of statistics and graphs were presented on the effectiveness of the vaccines and vaccine trials that were taking place globally.
Members of the Committee asked various questions about the presentation by the South African Health Products Regulatory Authority and related matters. Clarity was sought about the efficacy of the vaccines in South Africa against the new C.1.2 variant. Various questions were asked about the approval of the AstraZeneca vaccine. Clarity was sought about how long it took for a Section 21 approval, of the Medicines Act, and the amount of data required for emergency use to be granted. Members requested more clarity about the vaccine approval process and approval of vaccines for persons under the age of 18 years.
A request was made for engagement to take place between the Regulatory Authority and scientific experts to engage on the issues of the vaccines and Ivermectin to inform the public. Clarity was sought about the potential need to get tested for COVID-19 prior to getting vaccinated. Members requested clarity about various statistics and claims made in the media and amongst communities. The Chairperson requested that Members be mindful of the questions they asked in light of the potential concerns and confusion this could create amongst the public. The positive impact of the vaccine amongst health workers was highlighted.
The issue of surgical mesh was highlighted as well as the lack of acknowledgement by the Regulatory Authority and Department of Health about the issue on various other occasions. It was suggested that the Chief Executive Officer had’‘lied’and ‘mislead’the Committee on previous occasions in stating that ‘no grievances’were received by the Regulatory Authority on the matter. The issue of forced sterilisations was highlighted as an issue that needed to be followed up by the Committee in future engagements.
The Committee then considered the oversight visit reports from KwaZulu-Natal and Gauteng. The challenges experienced at the various hospitals and healthcare facilities were outlined, which included understaffing and negative impacts from the unrest on infrastructure, food supply and workers and patients. It was noted that discussions had taken place with both MECs in KwaZulu-Natal and Gauteng. It was noted that a report was requested from the MEC for Health in Gauteng on the Tembisa Provincial Tertiary Hospital as well as the status of the Kempton Park Hospital. Both reports were adopted with minor amendments made to the Oversight Report for the KwaZulu-Natal visit.
The Chairperson made brief opening remarks. He stated that there were two items on the agenda for the meeting, namely the briefing by the South African Health Products Regulatory Authority (SAHPRA) and the adoption of the oversight visit reports from KwaZulu-Natal (KZN) and Gauteng. He noted that there would be an Acting Secretary, as the Committee Secretary was absent as she was unwell. He wished her a speedy recovery in absentia. The Members in attendance were noted. There were no apologies.
SAHPRA COVID-19 Vaccine Update Presentation
Prof Helen Rees, Chairperson of the SAHPRA Board, made brief opening remarks.
Dr Boitumelo Semete-Makokotlela, Chief Executive Officer (CEO), SAHPRA, presented the update on COVID-19 vaccines to the Committee.
Key steps of COVID-19 vaccine assessment
● Applicant: verify that the applicant is licensed, SAHPRA compliant and has the capacity for control, vigilance and safety reporting.
● Place: Ensure each production site complies with Good Manufacturing Practice. Evaluate drug substances, product, packaging and testing. Note: Inspections performed at sites that are not GMP certified must be executed by an authority SAHPRA aligns with.
● Production: Ensure that the production process adheres to best practice – assess Chemistry, Manufacturing and Control (CMC)
● Non-clinical data assessment: Evaluate pre-clinical data to ensure that the vaccine trial meets all regulatory requirements for vaccines
● Safety, efficacy and quality testing: phase 1 to phase 3 clinical trials on human recipients to assess safety data and provide evidence of the vaccine’s ability to prevent COVID-19.
● Vaccine approval: Ensure that the vaccines schedule is aligned to the clinical data, product labelling and patient information leaflet.
● Appeal: Rejected applicants can appeal to the CEO within 20 days. They can further appeal to the Health Minister
● Traceability and surveillance: Verify lot release requirements to ensure easy accessibility of test reports, lot summary protocol, transportation and cold chain verification.
Assessment of CMC
Focus on how DS and DP are:
● Impurities are controlled
● Control tests and limits are justified
● Test methods are used
● Tests are validated
● Standards are referenced and used
● Packaged – packing materials and stability
Clinical studies assessment
Assessment of safety data: Requires an adequate number of vaccine recipients and monitoring for a sufficiently long time.
Assessment of efficacy data: Requires robust evidence of the vaccine's ability to prevent COVID-19 infection from well-conducted phase 3 clinical trials in humans.
Assessment of risk management plan: Applicant ability to record and report side effects. Assessment of efficacy against variants of concerns is critical.
The presentation outlined statistics and graphs on vaccine effectiveness and vaccine trials globally. See presentation for further information.
The overall safety monitoring of vaccines – reporting
● Tools for reporting
● Med Safety App
● E-Reporting portal on SAHPRA Website
● Paper-Based system
● Captured into Vigilance Hub – Back office of Med Safety App
● Captured at district, provincial, National or SAHPRA
● Vigilance Hub is accessible by both SAHPRA and NDoH
● Data on Vigilance Hub feeds directly into VigiFlow system
● In 2017, The National Immunisation Safety Expert Committee (NISEC) was appointed
● NISEC is a non-statutory standing Ministerial appointed Expert Committee responsible for:
● Review and assessment of all reported serious and severe adverse events following immunisation (AEFIs)
● Review of individual serious and unusual AEFIs
● Perform causality assessment of AEFIs
● Provide feedback on the causality assessment outcome to relevant stakeholders e.g. SAHPRA
● Submit recommendations to National Department of Health who also engages with the serious AEFIs reporters
NISEC Causality Assessment
● Outcome of death cases
● 30 cases are co-incidental
● 2 insufficient information provided
Other cases under assessment
● Capillary leak syndrome
● Guillain-Barre Syndrome
● Vascular disorders
Closing remarks of presentation by Chairperson of the Board
Prof Rees made brief closing remarks to the presentation. She stated that in the Act that governed SAHPRA, the CEO was the person who was responsible for decisions. Like all good governance structures there was a separation between the CEO, Secretariat and staff and the governance role that the Board played. The CEO was responsible, with her team, for making decisions. It was not the role of the Board to take those decisions, however in the event that the Board was concerned that SAHPRA was not doing its job as it should – the Board would then talk with the CEO and get an understanding from her to see if the Board could assist in solving any problems.
Mr P Van Staden (FF Plus) asked what the effectiveness was of the current vaccines against the new C.1.2 variant that had broken out in South Africa.
Ms H Ismail (DA) asked how long it took for a Section 21 approval, of the Medicines Act, to be given for the approval of the AstraZeneca vaccine. Which vaccines were approved for persons under the age of 18 years? Were there different vaccine concerns per age group? Would age have an impact on which vaccine was used? How much data was needed before an emergency use or an emergency vaccine was approved? What was the latest update about the vaccines that were approved for urgent roll-out – what was their efficacy against the latest variant?
Mr A Shaik Emam (NFP) asked exactly when SAHPRA received a Section 21 application for the roll-out of the AstraZeneca vaccine and when it was approved?
He communicated his condolences to the family of Mr K Maphatsoe (ANC), who had passed away the day before. He was under the impression that his passing happened a few days ‘after getting the COVID-19 vaccine’.
He stated that there was a ‘whole lot of evidence on the ground,’both for and against the vaccines and Ivermectin’. The public was not convinced about what was going on. He stated that even though he had got the vaccine, based on the advice he was given, particularly from the Committee and the experts. He wanted to know if SHAPRA would be willing to engage in a deliberation with other experts and scientists, who were ‘qualified people’, to discuss the issues around vaccines and Ivermectin. This would allow the ‘correct message’ to go out to the people about what was in the best interests of their health.
He noted what SAHPRA had said about the application process. He brought up the issue of Sputnik. Two or three weeks before he was advised that ‘seven months into an application not one piece of correspondence’ was received from SAHPRA acknowledging a receipt of the application from the applicants of Sputnik. He requested a comment on this. Why was the Johnson and Johnson (J&J) vaccine chosen, when there were other vaccines available? Who exactly negotiated the J&J vaccine?
He asked that the deaths that occurred after vaccination, coincidental or not—he did not believe that SAHPRA or the Department of Health were in a position to give the public an ‘absolute response’ about what the situation was. It called for ‘independent investigations’ so that the Committee could get a ‘clear picture’ of the deaths. He stated that ‘71 percent’ of those who took the vaccine had ‘not tested positive for COVID-19 before the vaccine’ and then ‘tested positive for COVID-19 after the vaccine.’ 27 Percent of the 71 percent had tested positive previously and two percent unknown’. He requested that he not be misunderstood, he was ‘not an anti-vaxxer’.’Even SAHPRA had admitted that this was a trial’. Where was the ‘convincing evidence’ that indeed the vaccines worked?
At the moment to a large extent, the ‘fact of the matter’ was that after taking the vaccination, people were still testing positive and ‘were still dying’.’ If one looked at the case of Mr Maphatsoe, was it ‘coincidental’ that he tested positive after the vaccine? What would be done about an independent investigation? The current investigations were being done after the person had died and was buried. He did not know what processes were being followed to establish exactly what the cause of death was. He requested clarity on that.
He went back to the issue of AstraZeneca. He stated that SAHPRA had approved it and conducted trials in the Country. How was it that SAHPRA approved the AstraZeneca vaccine when there was not enough information available? ‘No trials were done’ to assure SAHPRA. SAHPRA was likely aware of all the negative publicity about vaccines all over the world and all the ‘positive information’’that was unfolding about Ivermectin.
Ms M Sukers (ACDP) echoed what was previously stated by Ms Ismail. She asked for more clarity about the ‘minimum requirements’ applied and’‘stringent measures’ taken on approvals by SAHPRA. She asked that this process be explained to the Committee. Her assumption was that the minimum requirements needed to be met by the manufacturers, thus she requested clarity about how the stringent measures were applied, specifically in that context. This applied specifically to the case of the AstraZeneca vaccine. She asked that SAHPRA provide the Committee with examples of vaccines that did not meet the required standards, in SAHPRA’s assessments. She asked who had used the appeals process. She asked that SAHPRA provide more information about the 30 cases mentioned. As a lay person, did this mean that the person would have died regardless of the vaccine due to an underlying condition? Could assurance be given about the use of vaccines, when there was an underlying condition and how it would affect the mortality of individuals? There was a lot of pressure being applied on people to vaccinate, yet in all the awareness campaigns, there was limited emphasis on people needing to seek medical attention before they got vaccinated in order to ascertain their individual risk. She asked for SAHPRA’s view on that.
Was there enough awareness and information about where people could report adverse effects? She had seen a week before on News24 that there were instructions of how to go about reporting adverse effects. She had served in Committees where Members of Parliament did not receive any counselling or have any knowledge of where to go if they had adverse effects from vaccination. There were a number of cases in constituencies where people were spreading and saying that ‘this person received the vaccine and they died within a week.’ She served in the Central Karoo area where two health professionals had received the J&J vaccine right at the beginning of the roll-out programme. They had played a pivotal role in the fight against COVID-19. Their deaths, the previous month, caused a big concern for people because ‘both of them were vaccinated and had died’.There was a need for SAHPRA and the Department of Health to work together to provide explanations of coincidental deaths and that people should be’‘tested for COVID-19 prior to getting vaccinated’.’There were even public office bearers, that were ‘vaccinated on a Monday and died two weeks later’ from COVID-19. As a lay person she did not know what the correlation was between someone having COVID-19 and receiving the vaccine and how that impacted their health outcomes. She requested clarity on that.
Ms N Chirwa (EFF) stated that there was a lack of understanding about the processes that were followed in the approval of AstraZeneca - it had not been clarified properly. The issue had been raised countless times in meetings between the Portfolio Committee and SAHPRA. The response received in the past, sadly no longer sufficed, especially in the interests of accountability and the Committee’s mandate to conduct oversight. What was it that AstraZeneca had submitted that prompted the emergency approval from SAHPRA that Sputnik and Sinopharm had not submitted? She requested that the information be provided in detail. The review process was taking longer for other vaccines. She asked that SAHPRA not give the response that was given on previous occasions, that the ‘information could not be shared with the Committee for reasons of confidentiality’. This would prevent the Committee from carrying out its duties, especially when different narratives were arising, countering the process that SAHPRA was following as if there was some kind of ‘integrity crisis ‘at SAHPRA.
She asked for a proper appraisal of who had conducted the investigations of the reported adverse effects and fatalities. How were the investigations conducted? How was conclusive evidence gathered? She asked that the Chairperson consider having another meeting with SAHPRA so that a proper presentation could be given on the 30 cases. This would allow the Committee to understand what was meant by ‘coincidental’—all 30 cases could not be coincidental in the same manner.
She highlighted the issue of surgical mesh and the matter of Phindile Mncube. When SAHPRA was before the Committee previously, she had asked the CEO if SAHPRA had ever dealt with complications or issues about surgical mesh. SAHPRA’s CEO was ‘very confident’ in responding to state that SAHPRA ‘had never’ received a grievance about the use of surgical mesh in South Africa. If SAHPRA was influenced by other health regulatory bodies globally, why had SAHPRA not picked up that there was a crisis with the use of surgical mesh? Australia, New Zealand and other countries were conducting free surgeries to remove surgical mesh. There were cases in South Africa that required the removal of surgical mesh, where complications had arisen, especially for women. SAHPRA had not done anything. The CEO had said that they had ‘not investigated’ because they had ‘not received a grievance’. This was a ‘blatant lie’. There was ‘email proof’ of communication between SAHPRA and Phindile Mncube on the use of surgical mesh and the complications that she experienced. What kind of accountability did the CEO have if she stated that ‘SAHPRA had not received any grievance’? The CEO had not stated that she was ‘unaware of any grievances’. She stated that SAHPRA ‘had not received any grievance pertaining to the use of surgical mesh’. On top of that to have stated that this was the ‘reason why no investigations into cases of surgical mesh had taken place’. Why did the CEO ‘lie’ to the Portfolio Committee? This influenced the integrity of everything said by the CEO to the Committee, if the CEO could ‘mislead’ the entire Portfolio Committee on Health.
She asked that the Ministerial Committee, that was established by the former Minister on the forced sterilisations, provide an update to the Portfolio Committee on the process of forced sterilisations. There was a group of women who were unable to access healthcare, who were being turned away from hospitals. There were eight women she had personally met at the Steve Biko Academic Hospital. She had spoken with the CEO of the Hospital, and the CEO could not intervene in their healthcare because the case was being handled by the Ministerial Committee. This was something that the Portfolio Committee should be concerned about. There was a group of women who were forcibly sterilised, who experienced complications resulting from that – who could not access healthcare because it was ‘under investigation.’ The Ministerial Committee was not even ensuring that those women were at least able to access healthcare’. Their cases were ‘gruesome’; she would hate to even divulge the information about how gruesome and complex the cases were.
Ms A Gela (ANC) stated that she was not a scientist, she was a Member deployed by the African National Congress (ANC) to serve on the Committee. She thought that SAHPRA had been doing a very good job. SAHPRA had come to the Committee to brief Members and were doing their work as expected. She did not think that SAHPRA would mislead the country; SAHPRA was doing its best as required. As politicians, they needed to understand that. Not ‘attack’ SAHPRA. She stated that some Members of the Committee had come and ‘lambasted’ SAHPRA unnecessarily. Everyone was dealing with the COVID-19 pandemic - it was had not been anticipated. With all SAHPRA’s efforts, it had done very well. She knew that there was an issue that was raised by Members to ‘force’ SAHPRA to ‘take a wrong decision ’and she was happy that SAHPRA had not done that. As Members of the Portfolio Committee, they should lead society. Members should not come to the Committee with ‘wrong information’ and ‘mislead’ the country. It was very important. SAHPRA was under ‘attack by other people’, which was not right. She knew that SAHPRA would address all the queries and challenges that were raised.
She asked if SAHPRA had received any application from Cuba for vaccine registration so far. She noted that other Members had raised various points about Sputnik, she was not sure if they were trying to make a point.
Mr Shaik Emam raised a point of order. He stated that it was not fair; Members were all equal in the Committee. The Members had equal opportunity to ask SAHPRA to get clarity. The Member had spent ‘more time attacking other Members of the Committee’. Members were looking for clarity. These were issues that were raised by the community and organisations. If the Member was ‘out of touch with reality’, it was not their fault. She could not come to the Committee and spend three quarters of her time ‘attacking Members’, rather than dealing with the matter on hand. He stated that he thought the Chairperson needed to ‘protect’ the Members from this.
The Chairperson addressed Ms Gela. He stated that she had heard what Mr Shaik Emam had said, he asked her to continue.
Ms Gela apologised if she had offended Mr Shaik Emam. She stated that she had asked her questions.
Mr T Munyai (ANC) stated that COVID-19 had brought unprecedented consequences for the country. There had been disruptions and the healthcare system had been overwhelmed. The South African government had taken appropriate action, such as seeking vaccines on an emergency basis. It was an ‘objective reality’ that vaccines would protect people against severe illness and death. As Members of the Committee, they needed to be ambassadors of healthcare. It was imperative to become ambassadors of vaccinations. It was imperative that the Committee build a broader front of being vaccine champions. This ‘broad front’ should include the State-Owned Entities (SOEs), faith-based organisations, community organisations as well as non-governmental organisations and the private sector to make sure that people got vaccinated.
He communicated his condolences to the family of Mr Maphatsoe. Mr Maphatsoe’s passing should not be used as a basis for vaccine hesitancy/challenges. If that was found to be untrue that would have consequences to all Members. Allow the family time to mourn and not use the public space.
He pleaded that in the Committee’s next meeting, space be found to have a discussion about the threat posed against SAHPRA. The Committee should have a joint meeting with Members of the Security Cluster so that those that were taking decisions were protected. He had no problem with debate to make people aware of matters of science, so as to empower them – that was welcomed. It was important to ensure the autonomy and independence of SAHPRA to do its work without fear of favour based on science. It was important that the Committee be educated through the responses given by SAHPRA. If there were areas of support that were required at a high level, the Committee should do so without fear or favour.
When the Committee visited KZN, it was found that certain hospitals were not reporting some negative outcomes or side effects to SAHPRA. The Hospitals communicated it to the Centre for Communicable Diseases alone. The Committee advised the hospitals that they had an obligation to report to the Regulator. He would communicate those contact details to SAHPRA ‘via text’ after the meeting.
Ms Ismail asked if SAHPRA took any medical information (i.e. medication people were taking) from people when they went to get vaccinated. Did SAHPRA look into if the vaccine could be administered with such medicines? She stated that people tended not to get vaccinated if they did not know the potential reactions of the vaccine in relation to the chronic medications that they were on. She asked if SAHPRA followed up on people’s experiences after they got vaccinated.
Mr M Sokatsha (ANC) noted that SAHPRA was respected worldwide. He suggested that SAHPRA should not allow anyone to ‘play’ with their credibility. SAHPRA was doing a very good job. He asked how scientifically correct the information was, that was going around, that when people were infected with COVID-19 and went for vaccination ‘they died’. This was the rumour in the small towns and villages. People were afraid to go and get vaccinated due to the understanding that they ‘would die’ if they might be infected already with COVID-19.
The Chairperson stated that the Committee needed to be absolutely mindful of their roles as Members of the Portfolio Committee. He emphasised that the meetings were broadcast on national television. He was not suggesting that Members were doing anything wrong. He was concerned that the health of the people was determined by the messages that went out, this included anti-vaxxers and negative messages on social media. It also included the message that was going around on social media about the death of Mr Maphatsoe. It was not known at this point in time if there was any truth in it. He was also referring to members of the health fraternity who put anti-vaccine messages out there on social media.
Initially there were many media articles on COVID-19 and speculations about vaccines. There was at least a turnaround now where there was a positive approach to the messages that were sent out in digital and printed media. A question that Members needed to ask themselves, as South Africans, was ‘what would they do to save live in South Africa?’ If that question could be answered, then the questions that Members raised would be based and aimed at supporting that answer. That was the most important answer – the trajectory on which the country was currently and where the trajectory was taking them.
He outlined the positive impact of the vaccines on health workers. There had initially been a lot of deaths amongst healthcare workers due to COVID-19. Since the healthcare workers had been vaccinated, one hardly heard of severe cases of COVID-19 amongst that group. The healthcare workers received the J&J vaccine. Many people had received the Pfizer vaccine. Now one heard of 30 coincidental deaths. He understood that the Committee needed a better understanding of ‘coincidental’ at the level at which the Committee was engaging. He asked that SAHPRA share that information with the Committee. There were two deaths that had not yet been confirmed. There were many questions about the studies and interventions being carried out in order to find the causes of death and if there was a cause and effect relationship. From what he understood from Members, the Committee simply required more information about that.
He asked that Members of the Committee be mindful of what they said on a public platform which was televised. He asked that Member be mindful of the effects of their own words on the lives of South Africans.
Mr Munyai supported that the concrete proposal made by Mr Shaik Emam to have a scientific discussion.
Mr Shaik Emam stated that on the ground, people were confused, the Chairperson was correct about all the social media reports etc. Everyone had grown up with vaccines but there were now questions about vaccines. He thought that the proposed discussion between SAHPRA and ‘experts’ would help convince people that they were in the right hands.
Prof Rees agreed that many of the things being raised deserved a more in-depth debate with other role players. She agreed that that the kinds of questions being asked deserved clarification and evidence-based answers. She did not think SAHPRA would have time to do it justice in the meeting. Some of what was happening was that the mandate of SAHPRA was being confused with the mandate of other entities. There were other ministerial entities and statutory bodies who had very significant mandates in the context of the pandemic. SAHPRA could only do what was within its mandate and contribute to the public debate.
SAHPRA was a drug regulatory authority. Pretty much every country in the world had a drug regulatory authority. Over the past 20 years, many countries that had either no drug regulatory authority or quite weak drug regulatory authorities had recognised how important the structure was. One could see from the questions asked by the Members that everyone recognised how important the structure was. Before the pandemic, SAHPRA was regarded as one of the top regulatory authorities in the African region and in low-middle income countries. SAHPRA was recognised by the World Health Organisation (WHO). It was so well-recognised, that in the next week it would be announced that the Country had been awarded a vaccine manufacturing hub, which included a WHO assessment. One of the reasons the country was listed, was because the country had a strong, independent drug regulatory authority. Before the pandemic, hopefully most of the Members would have recognised that SAHPRA was a good and diligent drug regulatory authority. Was it perfect? Certainly not. There had been a backlog, that was discussed with Parliament, and they were trying to rectify that. It meant that the citizens of South Africa were able to go into a pharmacy, a clinic, an operation, to get their child treated and know that the drugs, vaccines and health products were safe, monitored and did what they claimed to do. This was not true of all countries today. If one could not rely on the safety of medicines, when one needed an anesthetic, for example, one would not be able to rely on the safety of the drips or the products given to put one to sleep. That was how critical a drug regulatory authority was. It was a silent but critical pillar of the healthcare system.
During the pandemic, SAHPRA had to roll up its sleeves, like every other entity, including government and do things differently and rapidly. Special committees were setup to advise the CEO on the decisions that were taken. These committees looked at clinical trials, vaccines, products and medical devices, all dedicated to COVID-19 and advised the CEO. It was the CEO who took the decisions and she got advice from the best experts that could be summoned in the country. It was not just the CEO alone, or with her very competent staff. It was the CEO, the staff and a lot of first-class academic experts.
The Board had oversight. The Board had also rolled up its sleeves and provided as much support as possible to the CEO, who she wanted to put on record, had done an ‘incredible job during the pandemic, particularly given that she was new and was plunged into this.’ SAHPRA had to do things differently and speedily but it was the same SAHPRA that the country recognised gave it safe health products, medicines and vaccines before the pandemic. The mode of operation had not changed. SAHPRA remained an independent authority. As Parliament, they had approved the legislation that made the drug regulator an independent authority. It was important that it was independent because it should not be influenced by any consideration other than the safety, quality and the effectiveness of the medicines and health products that were made available to South Africans. This was all done with the public good and public health in mind. SAHPRA was an evidence-based authority.
She listed some of the other entities, such as ministerial and statutory entities that were also working in the COVID-19 space. The National Immunisation Safety Expert Committee (NISAC) was a ministerial committee that looked independently at the safety of vaccines. There was a National Essential Medicines List Committee, which looked at all medicines and vaccines that were put into the public sector and independently evaluated them for their effectiveness and cost-effectiveness. There was a National Advisory Group on Immunisation (NAGI) that looked at all matters to do with vaccines and advised the Minister – the Group did not look at the COVID-19 vaccines currently as there was a Vaccine Ministerial Advisory Committee to supplement and complement the NAGI. There was a Vaccine Advisory Committee and Ministerial Advisory Committee. There was the Medical Research Council (MRC), which was a statutory body and a Health Sciences Research Council (HSRC), which was similarly a statutory body who were given a huge responsibility in coordinating research.
There were first class academics in the country. The variants that had emerged spoke to the quality of the academics. There were first-class ‘vaccinologists’, clinical trialists – she assumed everyone was familiar with the Head of the MRC, Prof Glenda Gray. There was the Department of Health who had to take all of this and make the decisions about which vaccines they would purchase, how they would roll it out and how it would be prioritised, with all input and background. In the event that people were not happy, there was also an Ombudsman. SAHPRA was just one part of this. SAHPRA would be very happy to come and have a further in-depth dialogue, to really go into the science and have a robust debate – that would not be a problem. The problem was that one could not say to the drug regulatory authority ‘answer everything, fix everything, do everything’, when in fact the Department of Health and the Minister of Health were the doers outside of all of the bodies she had just outlined.
There were very few vaccines in the world that were 100 percent effective. Many vaccines were partially effective and many vaccines acted by reducing the severity of disease or preventing symptoms developing, even if one had a low-grade infection. One hundred percent effective vaccines were a rare thing indeed. None of the COVID-19 vaccines were 100 percent effective. The different vaccines that SAHPRA looked at would have different levels of efficacy. With all of the early clinical trials, all of the vaccines showed that they reduced severe disease, hospitalisation and death. Due to the emergence of the variants, the efficacy of those vaccines - the variants were learning ways to resist people’s immune responses, both from natural and vaccine immunity. All of these variants were learning ways to resist. The effectiveness of all the vaccines had dropped somewhat. But it had not gone away. Every time there was a new variant one needed to assess how effective the vaccines were in South Africa and in development against the variant. Vaccines might have been very effective right at the beginning but that could have dropped. The minimum bar that SAHPRA had set for South Africa, which was an international bar, was 50 percent effectiveness. The vaccines were good at preventing severe illness but not necessarily good at preventing asymptomatic infection and mild to moderate disease and that was one of the problems. That was why even if one had the vaccine, one could still get infected, the use of the vaccine was to stop the severity thereof. That was why it was advised that people continued to wear masks. If one was infected, one could infect others. There were many vulnerable groups, be it age or people with co-morbidities that could inadvertently be infected.
SAHPRA was monitoring how the vaccines were working worldwide. It was one of the most important questions. In South Africa, led by the National Institute for Communicable Diseases (NICD), the MRC and academics, were looking all the time at the effectiveness of vaccines once they were rolled out. This was considered in different ways, how the vaccines were responding to new variants and breakthrough infections (and the severity thereof i.e. hospital admittance). Breakthrough infections were monitored in relation to the variant, the severity of the infection and when the vaccine was admitted.
There were a number of ‘big world-wide messages’ that had been observed. In the United States there was the largest number of COVID-19 cases and deaths currently in the world from COVID-19. The US was calling it a ‘pandemic of the unvaccinated’. The people that were being admitted to hospitals for COVID-19 related illness were predominantly people who had not received the vaccination. Similarly, in the United Kingdom, because their vaccination roll-out started early, they had managed to vaccinate a very high percentage of the population including high coverage of the most vulnerable. The UK was vaccinating very aggressively and testing aggressively–the UK was still seeing cases of COVID-19 but they were not seeing the number of deaths that were seen before the vaccination numbers went up. One of the ways that effectiveness would be evaluated would be to look at what was happening in other countries and understand the effectiveness of vaccines; some of these were vaccines that South Africa was using. South Africa would be looking and working with other countries to see what the effectiveness was of various vaccines. WHO had committees that were looking at that on a daily basis and were giving global guidance.
She noted the very practical questions asked by Members, which made her realise that SAHPRA needed to do a better job of communication. If one had a COVID-19 infection, according to the current guidance from the Department of Health, one’s own immune system was kicking in and trying to fight back. If one gave that person a vaccine on top of that it would stimulate the immune system ‘from two sides’. That could cause side effects and ‘over-stimulate’ one’s immune system. This ‘would not kill one’ but it might give one a huge immune response. There had ‘not been cases of deaths in that instance anywhere in the world’, and she served on the WHO committees. The Department of Health was recommending that people wait 30 days after COVID-19 symptoms had stopped to get vaccinated. If one had been infected with COVID-19 and got natural immunity, it was good to get a vaccine because that would really stimulate the immune system effectively and it was quite safe to do it. SAHPRA was strongly recommending that.
South Africa was fortunate to have a very active group of academics around the country who were monitoring the variants. The academics were picking up the emergence of new variants. The C.1.2 variant was the latest variant that had been detected. It was detected in May 2021, and represented about two percent of the current testing – but had been detected in eight of the nine provinces. It had also been detected in eight countries around the world from Europe, Asia and other African countries. It was widely detected, but it had not done what the Delta variant had done which was ‘takeoff’.The changes in this variant had been seen in earlier variants. The concern was that some of the changes and mutations suggested that the variant could be more transmissible or could be better at evading ones immune system and resisting the immune response. It was being monitored very closely. For each variant that was seen in the country, the vaccines that the Country had would be tested against variants to ensure that the vaccines that were being rolled out remained effective.
She thanked the Chairperson for his comment. She realised that people were frustrated and angry, but they were all in this together. SAHPRA was there to work with the Members, the Department of Health and communities. SAHPRA wanted to save lives and were totally committed to doing that and committed to ongoing dialogue.
Dr Semete-Makokotlela appreciated the questions asked as it highlighted the questions that were being asked by people on the ground. Many of the questions had been received by SAHPRA on other occasions. The pandemic had highlighted the need for SAHPRA as a regulator to continuously communicate, specifically what it was that SAHPRA did, how they did it and engage with the public on that. As a regulator, the safety of the public was paramount, wherein they were made aware of any safety concerns, SAHPRA acted on those. She stated that the questions that could not be responded to during the meeting would be responded to in writing.
The matter of the variants had largely been addressed. SAHPRA continuously monitored this. There was also the International Coalition of Medicines Regulatory Authorities (ICMRA) that SAHPRA was part of – thus SAHPRA was part of the global discussions around the variants and the safety of the vaccines. SAHPRA was keeping abreast of the developments. There were quite a number of questions about the safety of the vaccines. This was indeed under SAHPRA’s mandate, but they did not work alone in this. NISEC was a vital component that SAHPRA worked with. Within SAHPRA, there was the Pharmacovigilance Committee that contained a number of experts. SAHPRA put together the group of experts that looked at every single case.
For SAHPRA to come to a conclusion to state that it was ‘incidental’ - SAHPRA had gone through a lot of information. She suggested that the next engagement with the Committee could be around how SAHPRA did the safety assessment. In the webinar that SAHPRA held, they went into great detail. SAHPRA had shared with the public the type of forms that needed to be completed and the type of information that SAHPRA required. This would also be seen on their microsite where SAHPRA indicated that they needed details about what other medications individuals were on, age and other ailments they may have. It was a very detailed exercise that SAHPRA went through. The ‘incidental’ cases effectively meant that the deaths were not related to people having been vaccinated. 98 percent of the 30 cases were the elderly (over 60 years) that received their vaccines quite early on in the roll-out. Age, co-morbidities, and other medications that they were on, were taken into consideration. She was happy to bring NISEC as well as the Pharmacovigilance Committee to present to the Committee. She suggested that it may take a separate session to take the Committee through the detailed exercise that SAHPRA went through.
SAHPRA could not engage enough with the public around safety. SAHPRA was cognisant of the need to constantly engage with the public. SAHPRA had reached out to some NGOs. SAHPRA had indicated that it wanted to share the information in indigenous languages. She was of the view that was where there was a gap. SAHPRA had engaged with the public on various local radio stations but were not doing it enough. This would be something that SAHPRA would focus on as they partnered with other organisations to disseminate the message across the Country. There was a lot more that SAHPRA could and would be doing around communication.
From a safety perspective, no age specific adverse effects had been noted with the vaccines. More data would be gained from the 18 to 34 year old age group and this was something that would be continuously monitored. The slides that were shared with the Committee were really a ‘drop in the ocean’ of the amount of data that SAHPRA considered from an age perspective. Nothing alarming had been noted nor anything that was cause for concern at this point.
She responded to the questions about AstraZeneca. SAHPRA received the application sometime in late December 2020. She did not have the exact date but was happy to supply this in a written format. The authorisation was in late January 2021. SAHPRA would consider all the elements of the eight processes that were indicated. SAHPRA looked at the manufacturing site; it was a Good Manufacturing Practice (GMP) compliant site. There were no queries. This helped fast-track the approval. At the time, the bulk of the data that SAHPRA had was around the original strain. The AstraZeneca vaccine was one of the vaccines where clinical trials were conducted in the country – that data was readily available. To demonstrate SAHPRA’s commitment to public safety, the minute SAHPRA knew that there was reduced efficacy of the vaccine (as shared by the applicant and principal investigator of the study), the Country made a decision to not roll it out. Likewise, when the J&J batches were not compliant with manufacturing practices it was agreed that those batches should not be released to the public. SAHPRA aligned itself with the Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA). As a regulator, they were of the view that they were able to make decisions in the interests of the safety of the public of South Africa.
The application process was quite a rigorous one. There were other countries in that would fully rely on a decision that was made by another authority or WHO. In the case of South Africa, because of the nuances that were seen locally in the epidemic and variants of concern, SAHPRA would conduct an evaluation of every single dossier. This took place regardless of being authorised by WHO. SAHPRA would consider other regulators reports and rely on aspects of the reports, but SAHPRA did its own assessment. There were evaluators that would look at the quality, and evaluators that would look at the safety, as well as the clinical efficacy of every vaccine. One of SAHPRA’s minimum requirements was that the vaccines must have a minimum threshold of 50 percent efficacy. SAHPRA had also stated what the minimum phase three data required was. Until SAHPRA got the full phase three data, those vaccines would be under emergency use listing. Those were some of the mechanisms that SAHPRA had put in place. She could say with confidence that SAHPRA had done a stringent review of these.
She responded to the questions about aspects that some applicants had provided that those in review had not. She could not discuss every application in detail as SAHPRA was bound by confidentiality, but she could speak in general terms. The two aspects that were causing delays pertained to the GMP compliance of the respective sites. If there were queries that were outstanding, SAHPRA would not be able to address that. In the case of the Russian Sputnik vaccine and the Sinopharm vaccine, these were not manufactured in the country, so the applicants had to engage with their principals to ensure that they were able to get the required information. In some instances, the reports needed to be translated because South Africa had been very clear that SAHPRA operated in the English language medium. There were some delays due to this.
The other important area where SAHPRA found there were delays was usually around the clinical data for the variants of concern. One of the other requirements was lab-based data. There were instances where applicants did not have that information ready, so they submitted and indicated that they would do a rolling review submission, where the submission would be done over a number of stages, called ‘sequences.’ A lot of this depended on how ready the applicant was with the information that was required by the Authority. SAHPRA would then review that and provide feedback. That was typically the process SHAPRA would follow in evaluating.
She noted that there was a point made that SAHPRA ‘had not engaged with Sputnik.’ She stated that there were two applicants for Sputnik, she could say with confidence that SAHPRA had engaged with the applicants and provided feedback to both of them. She had been copied in on the email communications between them and her team. There had been discussions and engagements with them.
In an assessment of a vaccine, SAHPRA would always consider the benefit versus risk. It had been accepted globally that the benefits of being vaccinated far outweighed the risk. While there was some risk, SAHPRA was monitoring that risk through the mechanisms that SAHPRA had put in place from a safety perspective.
She responded to the issue of the surgical mesh. She proposed that she come back to the Committee on this issue and would be happy to provide a report to Members on surgical mesh. Her team was considering that particular matter. She had not come prepared to engage on that. SAHPRA had been communicating with the manufacturers of the products. She knew her team was working on it. She was happy to, in the coming days, share an update or report on that.
Ms Gela stated that her question had not been answered. She had asked if SAHPRA had received any application from Cuba for vaccine registration.
Mr Munyai appreciated the responses that were provided by SAHPRA and the agreement to engage in debate with the scientists – that would be ‘very exciting’. As Members of Parliament, they had a moral obligation, or national duty, to mobilise and organise people for vaccinations. There needed to be a strengthened campaign against fake news which was not based on science. To some degree they needed to ensure that there was a mass media campaign by the Ministry of Health down to the people – and ‘take the vaccine to the people’, as was done in KZN.
Ms Chirwa stated that in the interests of preserving cordial engagement, SAHPRA must at least acknowledge the issue of surgical mesh. She had previously raised the issue with SAHPRA, the CEO had responded to state that ‘SAHPRA had never received any grievances about surgical mesh’. She had raised the issue with the Department of Health on two occasions. The suggestion that SAHPRA would respond at a later time did not suffice, especially because the CEO of SAHPRA was unable to make a recollection of historical engagements on this issue. It was an important issue because the CEO had ‘misled’ the Portfolio Committee. This was ‘not a lie’; it was in the minutes. It had been years since SAHPRA had engaged on the issue of surgical mesh. There had been other health regulatory authorities in the world that had dealt with the issue of surgical mesh. SAHPRA was ‘beating around the bush’ on the issue. She asked to understand what had initiated the processes SAHPRA was now undertaking on the issue. She reiterated that the CEO had ‘lied’ about not receiving a complaint about surgical mesh.
The Chairperson interrupted Ms Chirwa.
Ms Chirwa stated that SAHPRA could not be allowed to bully the Committee.
The Chairperson again attempted to interrupt Ms Chirwa.
Ms Chirwa repeated that the CEO ‘had lied;. She stated that the CEO must ‘take stock’ of the fact that she ‘lied’. Then update the Committee about the investigations that SAHPRA was conducting. It was a simple thing.
Again, the Chairperson interrupted Ms Chirwa.
Ms Chirwa stated that she was not done, she asked that she be given a chance. Prof Helen Rees came to the Committee and told the Committee that the ‘work of SAHPRA was so important because people could use medicines, and stuff like that, without having an anxiety’. That was ‘not the reality’ for all the cases of litigation against the National Department of Health. The majority were about the kinds of medicines that were used on their bodies. There was activism in the country on the issue of surgical mesh and SAHPRA had never addressed it. After raising it consistently, SAHPRA had suggested that it would give ‘her a report privately outside’. It could not work like that, ‘first apologise that you lied’! The CEO ‘lied to the Portfolio Committee of Parliament’.
The Chairperson asked Ms Chirwa to choose her words properly.
Ms Chirwa stated ‘what does one call it when someone does not tell the truth’?
The Chairperson stated that he would rule on the matter.
Ms Chirwa stated that she ‘already knew his ruling’.
Ms Chirwa repeated multiple times that the ‘Chairperson could not even protect his own Portfolio Committee Members. First day at work, second day at work and you cannot protect us!’ ‘We cannot raise our ideas, we cannot raise our grievances’. The Chairperson ‘wants to silence us’! She asked the Chairperson ‘if he was proud of himself as a Chairperson for silencing the Portfolio Committee’.
The Chairperson stated that he was not silencing Ms Chirwa, he was asking to be given a moment to speak. He stated that she did not need to speak a thousand words on one topic. He stated that she did not need to repeat the same point repeatedly. The Committee did understand the point being made.
Ms Chirwa stated that it was in the interest of the health of the people, ‘people were dying because of surgical mesh!’
The Chairperson stated that he was trying to help Ms Chirwa by making a proposal on the issue she had raised. He asked that the written reply from the CEO of SAHPRA be sent to both Ms Chirwa and the Portfolio Committee. That would allow Ms Chirwa to raise the point again.
Ms Sukers stated that she would clarify the question she had asked previously, as it might not have been clear. Most people, especially in rural areas, would not be reading the issues that were raised or the answer that was given by Prof Rees. What people did listen to were the experiences of the people that lived next door to them, the people within their communities – that was what informed their decisions. Her question was, should people get tested for COVID-19 before being vaccinated? The reason being, that there were many cases where people ‘took the vaccine and then died’ within a week or two or became ‘severely ill and were hospitalised’. She noted what Prof Rees had said about their being adverse effects that people would suffer, if one had been infected by COVID-19 when getting the vaccine. She was not talking of cases where people knew that they were infected with COVID-19. She was asking if people should, as a precaution, test themselves before they went for a vaccination.
It needed to be recognised that most people were not interested in the mandates of SAHPRA – they did not even read newspaper articles or research. There had not been a good job in empowering people to make decisions on their own health – that was across the Board, in government and other institutions.
What was not clear was how the CEO had again emphasised the ‘stringent requirements’ that were applied before the approval was given – it did not answer the question about the AstraZeneca vaccine. She asked for further clarity about the approval and withdrawal of the AstraZeneca vaccine.
Dr Semete-Makokotlela responded to the question about whether vaccines had been authorised for the under-18 year olds. At this point there were no vaccines that had been authorised for that age group. SAHPRA had received data from one of the applicants for persons between 12 and 18 years and that data was currently under evaluation. Currently all the vaccines were only for those over the age of 18 years.
She responded to the question about deliberating with other experts, SAHPRA was happy to do so. SAHPRA had not received an application from Cuba. As a regulatory authority, they could not go out and solicit applications. SAHPRA only reviewed what had been submitted to them.
She responded to the questions about AstraZeneca. She was unsure if the Member was referring to the trial that indicated a reduced efficacy against the Beta variant. What happened was that information about the variant was released about two weeks after SAHPRA had authorised the AstraZeneca vaccine. It spoke to the nature of the pandemic, in that there was constantly emerging data. Based on the emerging data, all the applicants then needed to update SAHPRA about the vaccine efficacy for each of their vaccines on the variant of concern. When the data was provided, that was when the efficacy was indicated of 20 percent, which was below the minimum threshold of 50 percent. That was why it could not be made available.
She stated that the surgical mesh report would be shared with the Committee. This was not an item indicated on the agenda and she had not come prepared to speak on the matter.
Prof Rees agreed that the public was not in the least bit interested in the mandate of SAHPRA. In normal times a drug regulatory authority should be doing their job behind the scenes. It was a critical pillar of the health sector, but should not necessarily be in-front, except when it came to communicating with the public about the safety and effectiveness of medicines. It was something that SAHPRA was working on, so that when SAHPRA saw that something was unsafe on the shelf and it was withdrawn people could be informed of that.
She did not think SAHPRA was doing a good job at communicating on vaccine safety, on vaccine questions nor on the need to get vaccinated. As some Members had said, the dialogue in chats and the anecdotes that people were hearing were frightening people. SAHPRA would work hand-in-hand with Parliament. She would also put this back to Parliament to suggest that the Members work with their constituencies to communicate with people on the ground. In her day job she was an academic. The night before, she was in dialogue with media experts discussing how to communicate better.
She responded to the question about whether there was a need to test for COVID-19 before getting vaccinated. If one had symptoms of COVID-19, irrespective of the vaccine, one should get tested. It was good to know if one had a COVID-19 infection as it could influence one’s management thereof, especially for the people around one (i.e. If one was in contact with the elderly or vulnerable people). If one had been in very close contact with somebody who tested positive, she suggested one got tested. If one had symptoms, it was suggested that one did not get immunised at that time. There were no cases of associated death because one got immunised at the same time as having a COVID-19 infection; she had not seen reported cases of that. SAHPRA was saying that if one stimulated the immune system from two ends, one might get worse side effects, such as muscle aches and fatigue. SAHPRA was not suggesting that everyone needed to get tested. If one was feeling well and had not been in contact with anyone with COVID-19, one could get a vaccine very safely.
The Chairperson stated that a date would be set when SAHPRA could return to the Committee to answer some of the questions. There would also be a response to Ms Chirwa in writing from the CEO that would be forwarded to the Portfolio Committee. There would be a joint meeting with the Security Cluster Committee. There would be discussion with a panel of scientists and SAHPRA and another discussion with SAHPRA to better understand how the assessments and applications were made and how authorisation was given. That would assist the Committee, so as not to have the same discussion so many times. The questions about forced sterilisations and the proposal made by Ms Chirwa would be taken forward by the Committee.
Consideration and Adoption of Oversight Visit Reports
Gauteng Oversight Report
The Committee went on an oversight visit to the Gauteng province on Monday 23 August 2021. The Committee visited the following sites in the Ekurhuleni District, Tembisa Provincial Tertiary Hospital, Houghton ‘Drive-thru’ Vaccination Sites and the Alexandra Community Health Centre. The Committee held a meeting with the MEC for Health in Gauteng and Departmental officials.
The Chairperson took the Committee briefly through the report highlighting certain areas for confirmation.
Challenges at Tembisa Provincial Tertiary Hospital
Human Resource challenges:
● Shortage of staff for both clinical and non-clinical services.
● 1 500 New posts were required for the Hospital to function optimally.
● The current doctor to patient ratio was 1:100.
● The hospital was upgraded from a regional to a tertiary hospital in 2012 without the necessary budget to match the status.
● The Hospital was underfunded and under-budgeted.
● The Hospital was expected to have tertiary outputs, however as a level 3 facility it saw 60 percent of level 1 patients.
● The Hospital is built on dolomitic ground.
● The Hospital was small and old.
● Long-term plans include the relocation of tertiary services.
● The hospital does not have the support of a district or regional health facility that would feed into it as a tertiary hospital. Therefore, it functions as a level 1, 2 and 3 health facility
● Infrastructure sees a demand that outstrips supply.
● Lack of funding to maintain and service current infrastructure
● The emergency unit and maternity ward were overcrowded as a result of the lack of adequate infrastructure.
● Budget contraints
● The ‘rand and resources were stretched to the limit’
● The Tembisa Provincial Tertiary Hospital opened a vaccination site to vaccinate its staff during the Sisonke programme.
● The facility has continued to vaccinate the general community.
Challenges with vaccination drive
● Staff shortages – request submitted to Ekurhuleni District for HR support.
● Increase in demand for vaccination in the catchment area – informed to cap bookings at 160 and allow space for walk-ins.
● Competing priorities with COVID-19 and other departments
● Infrastructure challenges.
COVID 19 Update from MEC
The Committee received a breakdown of the COVID-19 statistics at the time of the visit in the province.
Discussion and Adoption of Report
Mr Munyai raised an issue about the healthcare infrastructure. He asked if all the issues were covered. He stated that the cleanliness needed to be improved at the Tembisa Provincial Tertiary Hospital. The Committee recommended the reopening of the Kempton Park Hospital to ease pressure on the Tembisa Provincial Tertiary Hospital. The Committee recommended that there should be an additional regional hospital as the Committee noticed that Tembisa Provincial Tertiary Hospital serviced the three metros, being Johannesburg, the City of Tshwane and Ekurhuleni. He stated that all the concerns of the Committee were raised with the MEC in Gauteng. Practical and urgent interventions were required.
Mr Van Staden stated that the MEC was asked for a full report on the Tembisa Provincial Tertiary Hospital. A report was also requested on the Kempton Park Hospital and the reasons for the closure thereof, what equipment was still in the Hospital and so on. He asked that this be added to the conclusion of the Oversight Report.
He stated that he had brought the issue up in the meeting on the 23 August 2021, about the Committee’s engagement with the MEC on the 11 June 2021 about the Charlotte Maxeke Hospital and another hospital: that report had not been received. The MEC said that she had sent it. Mr Van Staden had still not received anything. It did not need to be put in the conclusion.
Mr Van Staden moved to adopt the Report with the amendments.
Mr Munyai concurred with Mr Van Staden’s request for the inclusion of the request for the Report in the meeting to be included in the conclusion.
Ms Gela stated that the Report was a true reflection of the oversight visit. She seconded the adoption of the Report. She asked if any report was received from the MEC since the visit. She asked that the Report be forwarded to Members.
The Gauteng Oversight Report was adopted.
KwaZulu-Natal Oversight Report
The Portfolio Committee went on an oversight visit to uMgungundlovu District and eThekwini Municipality in KZN from 20 to 21 August 2021. The Committee visited Imbalenhle Community Health Centre, Grey’s Hospital, Northdale Hospital, Ekuhlengeni Psychiatric Hospital, Mahatma Gandhi Memorial Hospital.
Challenges at Imbalenhle Community Health Centre
● Shortage of storage areas
● Shortage of parking spaces
● Currently using a borrowed HST bus and gazebos as flu clinics.
● Lack of waiting areas which results in patients waiting outside the gate in unpleasant weather.
● Shortage of staff members
● Some staff in isolation due to COVID-19.
● A lot of vaccine hesitancy in the community due to fake news, word of mouth and social media.
Damage caused by unrest
● The functionality of the facilities was compromised and the vaccination numbers dropped. A catch-up plan has been implemented and involves working on weekends.
● Employees were threatened.
● The Centre’s vehicle was sent for repairs.
● Vehicles on site were destroyed and burnt.
Challenges at Grey’s Hospital
● Pfizer vaccine manufacturing faults: some vial providing less or more dosages than the required amount (i.e. some vials would provide 5 or 7 doses/particles instead of 6.
● Reaching target of 800 vaccines administered per day.
● Staff shortages
● Lack of equipment
● Lack of adequate staff
● Vaccine shortages (as a result of unrest) and uncertainty/delays with transport etc
Challenges at Northdale Hospital
● Non-filing of non-exempted posts
● High staff turnover
● No retention strategies
● No career pathing.
● No rural and danger allowance.
● Inadequate budget for infrastructure and maintenance needs.
● Equipment budget exhausted due to carry over from previous financial year.
Maintenance and infrastructure:
● Old buildings – these require major continuous maintenance.
● Delay in finalising the renovations for the psychiatric ward.
● Spacing norms for COVID-19 wards not met.
● Promises of developing and building new wards has since not been fulfilled.
● No referral policy and guidelines on referral of COVID-19 positive patients
KZN Provincial health challenges
● Understaffing: due to cost-cutting measures.
● Lack of funding
● Lack of adequate infrastructure
● The spread of fake news and anti-vaccine messages on social media.
● Vandalised and damaged infrastructure
● Stolen and damaged equipment
● Loss of important files and information
● Limited staff reported to work across the provinces.
● Hospitals and community centres experienced high volumes of trauma patients as a result of gunshot wounds, burns and motor vehicle accidents.
● Threats to healthcare facilities.
● Lack of public transport
● Delays with inter-facility transfer.
● Lack of food in healthcare facilities
● Mortuary services affected.
● Supply of linen affected.
● Ambulances and other state vehicles burnt.
Challenges at the Ekuhlengeni Psychiatric Hospital
● The average length of stay remains high because of the lack of places to discharge mental health care users.
● High risk of hospital acquired infections e.g. COVID-19 due to patient numbers and space constraints.
Related to unrest:
● Facility suffered quite a lot – a mob of people forcefully entered through the main gate of the Hospital.
● Various buildings were broken into, Human Resource Department, Finance Department, Administration Building, Section 1 and 5, Registry, Physio and Occupational Therapy.
● Staff could not access premises due to road blockage.
● Clinical care affected and some staff members had to stay at the facility for continuity of care.
● Nineteen computers, a router and server were looted which affected the HR and finance department.
● Fridges, printers, CCTV monitors and more property was looted.
● Shortage of food.
● Staff and mental health care users were traumatised by the incident.
● Property was damaged. Doors were broken down.
Mahatma Gandhi Memorial Hospital
● Shortage of staff during unrest
● Shortage of linen
● Shortage of food at hospital
● Security (not full complement)
● Waste management delays.
● HR and Finance department had no staff during the unrest.
● Pharmacy also did not function during the unrest.
● The hospital received a number of unrest related trauma cases ie. Gunshot wounds, assault, trauma and burns
● Incorrect data on register – number of ‘missing patients in casualty and mortuary.’
● Discharged patients were unable to go home.
● Transfer of patients to other facilities grossly delayed.
● No records of where each transfer was sent.
● No registration of patients at admitting departments and wards
● Vaccination site was closed.
● Patient care grossly compromised.
Mr Munyai moved to adopt the Oversight Report.
Ms Gela seconded the adoption of the Report.
The KZN Oversight Report was adopted.
Ms Gela requested that the Committee needed to do oversight visits in other provinces to assess the vaccination roll-out. Previously, the former Chairperson had suggested that the Committee go to North West province, Limpopo and other parts of the Country. She asked that the Chairperson consider this.
The Chairperson noted the suggestion. He noted the other proposal to meet with the Minister and the National Department of Health. The Committee had a meeting setup for every two weeks with them but he would follow-up on that and come back to the Committee.
The previous minutes would be adopted at another time, as the Committee Secretary was not present. There was a tentative programme setup. That programme was already full; the Committee needed to be mindful that it was still busy with the oral representations on the National Health Insurance (NHI) Bill.
Mr Van Staden stated that there was an outstanding matter that was discussed on the 4 August 2021, and the minutes thereof were approved on the 18 August 2021. In the meeting on 4 August 2021 with the Special Investigating Unit Report on the Digital Vibes matter, there were three resolutions taken by the Committee. He wanted to remind the Committee of the last resolution. The former Chairperson was going to write a letter to the Speaker asking her to request the President to send the Report to Parliament so that it could be shared with the Committee. The response from the Speaker needed to be shared with the Committee. The response would then guide the Committee about when to schedule a meeting with the SIU. He noted that since his request the Cabinet had reshuffled and the former Chairperson was appointed as Deputy Minister; this was why he wanted to remind the Chairperson that the matter still needed attention.
The Chairperson stated that he would do so. He noted that he needed to apply his mind to the tentative programme which was already full. There would be the quarterly reports of the Department of Health which would be brought to the Committee soon, tentatively on the 8 September 2021. A briefing would take place from the Department on those reports on 15 September 2021. There was a request from Dr James of the WHO, to have a briefing with the Committee – he did not know what the briefing would be about. He asked the Committee to consider having the NHI public hearings for a few hours on Tuesdays and Fridays going forward. He asked for the Committee’s support for that.
Mr Van Staden asked how many entities needed to still come before the Committee. He presumed it was still a lot.
The Chairperson stated that the Committee was starting with the Auditor-General, then the Financial and Fiscal Commission, the Medical Research Council, the Office of Health Standards Compliance, the Compensation Commission, SAHPRA, the National Health Laboratory Service, Council for Medical Schemes etc. The consideration and adoption of the Committee’s Budgetary Review and Recommendations Report was very important as the Committee should not be late on this again. There was still quite a lot of work ahead.
Mr Van Staden agreed. He supported Ms Gela’s suggestion of oversight visits to other provinces. That would also need to be worked into the programme. He supported the Chairperson’s proposal of NHI hearings taking place on Tuesdays and Fridays.
Ms Gela also supported the proposal of the NHI hearings on Tuesdays and Fridays.
Mr Van Staden requested that a draft programme be presented to the Members at the following meeting.
The Chairperson stated that this would be done. He wanted some time to review it before it was presented to the Committee.
The meeting was adjourned.