Latest developments on COVID-19 vaccines, with Ministry; Northern Cape Covid-19 update & vaccine plan
10 February 2021
Chairperson: Dr S Dhlomo (ANC)
Video: Portfolio Committee on Health, 10 February 2021 Part 2 Part 3
Minister Zweli Mkhize on the outcomes of the Coronavirus COVID-19 vaccine efficacy studies
In this virtual meeting, the Northern Cape Provincial Department of Health briefed the Committee on the Covid-19 situation in the province, and outlined its vaccine rollout strategy. It indicated that it had experienced its highest number of positive cases in the second wave, but there had since been a decrease in cases. According to the Department, its R500 million investment in capacitating its health system for Covid-19 had paid dividends, as deaths per 1 000 people infected with the virus were lower than the national death rate.
Members were concerned about how the province could carry out the vaccination rollout considering its unique circumstances, with a large geographical area and a high number of rural areas. The province assured the Committee that it had taken its unique circumstances into consideration. Members asked questions about oxygen supply, the Department’s response to the recent floods in the province, its ambulance services, donations that had been received, its bed capacity and how it was meeting its employee costs.
The Minister of Health briefed the Committee on the latest developments in relation to the AstraZeneca vaccine, following the announcement that it had a lower than expected efficacy rate against the dominant variant in the country, and the subsequent halting of its use which in turn had affected the vaccine rollout programme. The Johnson & Johnson vaccine would be used instead for the initial stage of the programme. Negotiations on the final quantities that would be delivered were still ongoing, but the vaccination programme would begin the following week. He also gave an update on the various other vaccines available, and their status.
Members asked questions about the April expiry date of the AstraZeneca vaccine, and why this had not been established before the order was placed. There was heated debate about the Sinopharm vaccine and the signing of a Non-Disclosure Agreement (NDA) related to it, with Members questioning why information was being withheld from the Committee which was supposed to provide oversight. A Member also wanted to know if a middleman had been involved in the purchase of the AstraZeneca vaccine from the Serum Institute of India.
The Minister assured the Committee that the NDA had been signed in order to get more detailed information, and the Deputy Minister explained how the AstraZeneca vaccine had been ordered before its reduced efficacy against the variant virus became known. In response to a wide range of detailed questions from Members, the Department committed to following up and making the required information available to the Committee.
Chairperson’s opening remarks
The Chairperson welcomed those present. He said that there were requests to meet with the Minister and receive an update on the new developments. He proposed that Members accept the briefing by the Department of Health, but delay it to 11h00 and begin with the Northern Cape presentation. He asked Members to go through the presentation, as it had come in only this morning. He understood the request was late. Since Sunday, he had been asked multiple questions and the matter was one of public interest. He asked to be supported on this change to the agenda.
Ms E Wilson (DA) said in light of what had happened and the recent news that had broken, it was important that the Minister provide an update, as it was a crisis situation. She supported the Chairperson’s proposal.
Ms M Hlengwa (ANC) seconded the proposal
Northern Cape vaccine rollout strategy
Mr Maruping Lekwane, Member of the Executive Council (MEC) for Health, Northern Cape, greeted those present, and introduced members of the delegation.
Dr Dion Theys, Head of Department (HoD), Northern Cape Department of Health (NCDoH) said it was a pleasure to present on the work that had been done since the first wave of the Covid-19 pandemic to the current situation.
The Chairperson requested that the presentation be summarised.
Dr Theys outlined the figures for the Covid-19 infections in the province during the first wave, with the highest peak of cases at 1 644 during the week ending 20 September 2020. For the second wave, there had been a peak of 1 898 in the week ending 17 January 2021. The outlier was the Namakwa district, where there had been a surge. The contributing factors were travelling transmissions, as it was a corridor through the Western Cape and Namibia, and the emerging mining and solar energy industries were located in the area. The Covid-19 statistics per district were outlined.
On how Covid-19 affected citizens in the Northern Cape (NC), he said that the gravity of the situation was tracked according to hospitalisations, intensive care unit(ICU) admissions and the positivity rate. The figures for admissions were given. The number of people admitted due to Covid-19 complications continued to decline week-on-week, for the fourth successive week. Further figures for hospitalisation were outlined in both the private and public sector of the province. The reduced figures for those ventilated in the ICU indicated how the province was prepared for the second wave.
He said that the highest number of deaths since the start of the pandemic were reported in January 2021, at a total of 137. Co-morbidities as contributing factors to Covid-19 related deaths were discussed.
Outlining the figures for Covid-19 related fatalities, Dr Theys indicated that since the emergence of the variant, younger age groups were being affected.
The figures for Covid-19 infected staff were provided, with nurses having the highest number of infection cases, followed by the category of “other,” which included porters and other such workers in hospitals.
The province had invested in health which had returned dividends, as it had 18 deaths per 1 000 people infected with Covid-19, which was lower than the national death rate of 31 deaths per 1 000. As a province, R500 million had been invested in health system capacity. The system had prepared in excess of 3 300 beds, including intensive care and high care capability, with a huge investment in personnel, equipment and vehicles. The Department had appointed more than 424 clinical professionals and had 11 Cuban Medical Brigade staff. It had also invested in additional medical equipment and launched multiple new vehicles which included ambulances, patient transport and bakkies.
Dr Theys said that the Minister would go into more detail on the Covid-19 vaccine.
Regarding access to the vaccine, he said that 67% of its population amounted to just under 900 000 people that would have to be vaccinated. The rollout would be in three phases, with phase one beginning with health care workers (HCWs).
On the procurement of vaccines, he said that the presentation slides’ contents were affected, as a lot had changed since Sunday’s announcement, and he hoped the Minister would discuss the latest developments.
The Chairperson asked what the province’s readiness was for the rollout of vaccinations.
Dr Theys responded that it was ready. Its vaccination stations at 15 hospitals, where vaccines would be delivered, were in order and all staff were prepared. If the announcement had not been made, the programme would have begun that day. In terms of logistics and readiness, it had been ready to hit the ground running when AstraZeneca had landed, but it was ready to roll out for phase one.
The Chairperson asked for more information on the logistical plan, such as vehicles, considering the vast area of the province and other factors such as refrigeration and security. He would allow Dr Theys to respond after Members had asked questions. He asked for a report on those details as well.
The Chairperson asked the MEC to introduce himself, as it was his first time before the Committee.
Mr Lekwane thank the Chairperson for the opportunity, and introduced himself.
Ms A Gela (ANC) asked if the province had received any donations. She said concerns about oxygen demands had been raised by other provinces -- what was its experience in this regard and was there a local supplier in place to address any oxygen challenges that might arise?
She asked what support and motivation was being given to HCWs.
She welcomed the deployment of the Cuban Brigade in the province. She was happy that the Chairperson had highlighted the issue of the vaccine roll out plan.
She asked how the communication strategy reached rural areas, considering the size of the province. Had the Department received additional funds from Treasury to recruit more HCWs? Had additional beds been procured?
Ms Wilson said that the NC was one of the most rural areas, with the population spread out, which created a lot of technicalities. She was concerned as she was aware that there was a limited number of ambulances. She asked what the Department was doing to address this.
Given the vastness and rurality of the province, there were complaints that people could not access health care facilities, considering the current rains. What was being done to provide access for residents to healthcare facilities for reasons other than Covid-19?
Ms H Ismail (DA) asked the MEC to advise where the new ambulances would be placed. There were reports that despite new ambulances being sourced there were still issues, especially considering the rain, to access medical services. How many intern doctors had been placed and where? Had these interns been paid their normal salaries and any overtime hours?
Clinic strikes seemed to be happening often. She asked why this had been happening and what solutions had been reached to address these issues.
There were reports that the Department was in crisis mode as it had run out of funds. What was its current financial state?
The Chairperson had requested more information on vaccinations, but she had noted some questions. How many people had to be vaccinated to ensure herd immunity? How many of the vaccines would go to insured and uninsured residents? How were vaccines to be transported around the province and what vehicles would be used? How many vehicles would be used, and how would this be funded? How much time would there be for distribution, and were storage facilities for vaccines ready? The MEC had said that vaccines would be transported immediately to health care facilities. Were these facilities ready?
What were the infrastructure challenges in the province?
Who would do the public sector vaccinations, and how many staff would be needed for this? How many of the staff would be permanent or contracted for the vaccine rollout programme? What were the associated costs for these employees? Would this come from the Department’s budget, or would it be funded by National Treasury? How would adverse effects to the vaccine be monitored in the province?
Ms N Chirwa (EFF) asked what the impact of the recent torrential rain had been on the province, and how it had been mitigated in preparation for the second wave, as well as for the third wave.
She said that during the National Health Insurance (NHI) public hearing in 2019, it had been raised once too often that Emergency Medical Service (EMS) was a serious issue in the province. How were EMS vehicles distributed across the province?
She asked if the HCWs were employed temporarily or permanently, and requested that the figure of R197 million be broken down. When would temporary workers be made permanent in the province? Was the figure due to a “tenderpreneurship” programme of cleaners and security guards? She requested a detailed breakdown of the HCWs employed to capacitate the province.
On the expected third wave, she asked what the plans and preparations under way were.
What was the latest communication to the province on the vaccination of HCWs, and what was the planned rollout strategy beforehand? How many vaccination sites and vaccinators, storage facilities and transport vehicles did the province have? How many public vaccination sites were there in comparison to private sector sites? What was the latest update from the National Department to the province on vaccination processes, considering the latest developments?
How many Solidarity Fund ventilators had been distributed, and where? How many had been distributed in addition to what the province had procured itself? If all were not distributed, what was the reason for this?
The province had noted that people were hesitant to be vaccinated. What had it done to mainstream vaccine importance on the ground? What would be done to lobby vaccine-hesitant persons? The hesitation was due to a lack of confidence in the province’s Department of Health, and not just a general one. How would this vaccine-hesitation be mitigated?
Mr M Sokatsha (ANC) asked how the province’s rollout plan had been affected by the AstraZeneca announcement.
Regarding oxygen levels, he knew of a couple who had been transported to Bloemfontein due to oxygen shortages in De Aar, and the one partner had passed away on his way to Bloemfontein. What was the availability of oxygen in the province?
What donations had been made by mining companies to help fight Covid-19? How many quarantine sites did the province have?
He asked for more information on the relationship with the private sector for the vaccination rollout plan,
Ms S Gwarube (DA) referred to the vaccine strategy, and said that she agreed with Chairperson that the province had a unique set of challenges, so its detailed logistics and strategy was important.
She asked if the 15 vaccine sites mentioned were only for the first phase, or was the sum total of sites it had. If it was not the sum total, she asked for further clarity, particularly on the strategy. The challenge was unlikely to be the HCWs, as these employees could be reached at facilities, but rather reaching members of communities considering the long distances involved.
What was its strategy for equipping its primary health care (PHC) facilities to ensure that vaccines could be stored? How would it ensure that vaccines would be transported and stored without being affected by various logistical issues? This was important, considering the province’s unique set of circumstances.
How was awareness raised among community members, as its communication strategy had to consider its unique circumstances?
Was the information and communication technology (ICT) infrastructure that was needed for the vaccination roll out programme in place, as there would be central database? How far was implementation of the ICT strategy? How was it on-boarding its PHC facilities, as the issue in the province was not the bigger towns and hospitals, but the PHC facilities in small towns in far-flung areas? She was concerned about this.
Dr S Thembekwayo (EFF) said that during the failed scooter era, a lot of criticism had been leveled at the province. The use of wheelbarrows as emergency transport to reach accessible roads in rural areas had been mentioned. How would the transport it had acquired address this challenge and access difficult areas? How had the issue of wheelbarrow transport of people by their families been addressed?
On the staff infections, she asked what the “other” category was made up of. Similarly, on district statistics, she said the municipality names were given, but “other” was included with a high number. What did this refer to?
There was widely reported corruption in provinces involving personal protective equipment (PPE) procurement, and she asked what measures had been put in place to prevent this.
What was the province’s experience concerning mortuaries? Did the Department have excess deaths, and was this being recorded?
She asked the MEC for a contact to report urgent health issues to, and said it had to be a cellphone number with Whatsapp access.
Mr A Shaik Emam (NFP) said that he would leave to attend a Chief Whips forum after asking his questions, and would perhaps return thereafter. He appreciated the presentation, but had expected it to focus on the vaccine rollout plan.
He asked for an update on the new Kimberley Hospital which had cost R2 billion instead of R219 million, especially considering there were reports that it was only half utilised.
On corruption in the NC, he said that officials had been arrested for R10 million fraud, and there was another allegation of fraud in the Health Department in respect of contracts. He requested an update on this.
What was its funding for the rollout of vaccines, given the high levels for corruption, and what measures were in place to avoid this?
He requested more information on how the vaccines would be effectively rolled out, considering the rural context of the province and timeframes in place for refrigeration of vaccines. Were facilities ready to store vaccines, and who had been contracted as distributors? Did the NC have the necessary trained HCWs on the ground, as the province had a serious problem with funds and a lot of medical officers had been lost during the Covid-19 period? There had been a lot of protests by HCWs and there had been a lot of promises made which it had not fulfilled. Was there an update on this?
Dr K Jacobs (ANC) wanted to speak on costs and legacy projects, the vaccine rollout plan and the training of vaccinators.
He said over R500 million had been spent on the Covid-19 challenge, and money had been spent on beds and other items, which was commendable, but some Members had asked about donations. How better could it have prepared for Covid-19 and its preparation for a resurgence, as well as a possible third wave? Which of the funds spent would be legacy projects? What additional budget had it received from Treasury, and had it received any money from elsewhere? He asked for more information on the training of vaccinators.
On security and tracking of vaccines, he said there had to be awareness about theft and hijacking as a threat in the country when protecting vaccines. He asked for information on the management of this, as well as the use of disposables.
What was its approach on theft and private sales of vaccines? Which ICT platforms would be used for vaccination data to be stored and captured correctly?
Ms M Hlengwa (IFP) said she was disappointed at not having heard about awareness being raised about the vaccine to prepare people to accept vaccination. She asked if the province had prepared for a third wave, if there was currently adequate bed capacity in place, and whether it could meet any additional demands.
How long would the Cuban brigade be stationed in the province, and what were the terms and conditions of their services? Had the existing medical infrastructure been sufficient to meet demands?
Mr P van Staden (FF+) said that there had been a protest at the Dr Harry Surtie Hospital in Upington, as workers had said they were overworked and that there were not enough HCWs. It was reported that there were only 36 HCWs at the hospital. He wanted to know what plans were in place to ensure that provincial hospitals and clinics in the province would have adequate numbers of HCWs to eliminate this challenge so that it did not happen again in future.
He requested a report on the availability of oxygen and bed capacity in the province.
The Chairperson said that Members were requesting additional information on the rollout plan. The Minister would clarify the additional information, but the province had to be ready on the ground.
Mr Theys said that it was Covid-19 ready, and that there had been a misunderstanding over the information sought. To take the Committee into full consideration, he would go through an additional presentation on the vaccine rollout plan.
Mr Lekwane apologised for the presentation having inadequate information on the provincial rollout plan. He said the presentation would go ahead.
Additional information on NCDoH vaccine rollout
Dr Theys outlined the phased approach of the vaccine rollout, and the categories of those who would be vaccinated.
He described the Electronic Vaccine Data System (EVDS) and its objectives, and said it would manage patient information as well as pharmacy registrations for where vaccines would be stored. On the EVDS functionally, he said pre-registration on the system was required in order to receive a vaccination appointment. All the preparations through the country were based on phase one. Phase two and three were work in progress. It only had the preparation for phase one, which was for HCWs, but it was still having discussions with the National Department of Health (NDoH) on phase two to three. He hoped that this information would address the questions raised concerning ICT. Further details on the EVDS were given.
Dr Theys said the Department had received an additional 11 desktops and handheld scanners delivered on Monday, and it was awaiting additional routers and other equipment. In some areas in the province, connectivity was a problem, and it was not blind to the fact that there would be issues.
He gave an example of how the challenge relating to far flung towns would be addressed. He said the Richtersveld would be reached with bakkies, with World Health Organisation (WHO) accredited vaccine cooler boxes, which would go into the communities for phase three. This would happen on a daily basis with the teams it had put together. There were 80 teams consisting of data capturers, nurses and doctors who would carry the vaccines into the far flung areas. The province would make it work for its own conditions.
He gave details of the equipment that it had received or was being procured.
He said that not all HCWs would be vaccinated due to pre-existing conditions or co-morbidities.
On the distribution process, he said there would be 15 sites where stock would be kept. The stock would go straight to hospitals. Initially it had identified the 15 hospitals according to the AstraZeneca 10 000 doses which had been received and distributed. For the private sector, 4 000 doses would have been distributed. The distribution sites were also vaccination sites, and its own nurses would be used to vaccinate the staff on site. All sites had adequate refrigeration for vaccines. The slides contained information of the responsible pharmacists at each hospital to ensure that the cold chains would be maintained.
Regarding time frames, he emphasised that the preparations had been done with AstraZeneca vaccine in mind. The launch would have happened on that day, Wednesday 10 February. He said that vaccine hesitancy would be dealt with during the rollout.
On vaccine dosages, he said the Department was awaiting the new national rollout numbers.
There was director responsible for addressing EVDS registration, and areas where there was a lack of ICT connectivity would be addressed. It had coverage at all the centres for staff to register on EVDS.
The Chairperson said that responses could be given, and additional information on vaccinators had to be provided.
Mr Lekwane asked if a written response could be submitted to address distribution-related matters that required detailed answers. He said 55 bakkies had been bought considering the vast geography of the province, to enhance its work. This was besides EMS vehicles that it had procured. It had also employed clinicians since December to reinforce itself. It was falling short only on its non-clinical staff, such as porters and cleaners. It would have liked to employ more of these workers, but it did not have the required resources. It was engaging with Treasury to address the matter.
On donations, he said R100 million in equipment had been received from different mining houses. The Gift of the Givers had also donated ventilators, and renewable energy companies had given cash. As a province, it had received donations from the private sector to fight the virus.
There was only one company, Afrox, that provided oxygen to all the provinces. The NC was always the last province to experience waves. Afrox had focused on the Western Cape (WC) which had been overwhelmed, and this had affected it, but as soon as the WC was stabilised Namakwa had been sorted out. In the province there were currently no oxygen shortages except for isolated cases, such as the one Mr Sokatsha had mentioned. Namakwa had been visited as it was a potential hotspot and had been given support.
On assistance being provided to HCWs, he said that there were psychosocial programmes, and additional psychologists had been appointed.
The department’s annual budget was around R6 billion, made up of R3.9 billion from the equitable share, and grants which amounted to just more than R2 billion, with a large portion going towards compensation of employees. Therefore, it did not have much available cash in the Department. The budget cuts had affected it severely and adversely. This was why there was picketing in Upington and other areas. The protest in Upington was due to doctor’s contracts not being renewed, but this had been addressed and the doctors had returned. The picketing was not constant, as there were two instances. Medical officers had said they could not continue without reinforcements, but this had been addressed. Its budget had been cut by R262.2 million, which had adversely affected it in the middle of the pandemic, and that was why it was engaging with its Premier and the Treasury.
The province was prepared for a possible third wave. It was a mostly rural province, and ambulances had been distributed to districts the previous year, which had alleviated the pressure. It was awaiting extra ambulances and vehicles for patient transport. The most rural district had been hard hit by the floods. It had been visited the area and a helicopter had been made available, as the floods had damaged the infrastructure. A Red Cross helicopter would be used to transport medication and staff. 13 communities had been affected, and it was mitigating and providing assistance.
In response to Ms Ismail, he said the Department could pay salaries. The only strike had been the national one involving the National Education, Health and Allied Workers’ Union (NEHAWU), and it was negotiating with it. This was a difficult process, as it did not have funds to absorb workers. There was never an instance were salaries could not be paid, and as the former MEC for Finance, he could say this with confidence.
He requested that the Department be allowed to send a detailed report on the breakdown of spending on staff.
The communication strategy for the vaccination rollout was district-based and each district had a programme that it was leading on the ground.
On vaccine hesitation, he said that he could report that there had not been a collective voice from the community to reject a vaccine. It was led by the national Department on the vaccination programme, and it was making people aware that it was the way to go.
He said that the HoD would comment on the beds and quarantine sites. Since the second wave, only 30% of beds had been used and it had not reached any point where it was overwhelmed by the virus. It would protect every life in the province.
The wheelbarrow transporting could not be denied, but the Department was working to address the matter by getting extra ambulances and patient transport. Since extra ambulances had been procured, complaints to the MEC had been reduced.
The direct contact for emergencies was Mr Riaan Strydom, Acting Chief Director: Health Facilities, whose number was 071 201 1497.
He responded to Mr Shaik Emam that the Kimberley Hospital was up and running. It was being utilized, but it was big and would be filled incrementally, as had been determined initially.
The arrested officials would be going to court, as these were crimes involving corruption. The Department had stated that the law had to take its course.
He said that the entire cost of the rollout was R118 million. It did not have the funds, but there was a commitment from the provincial and national treasuries to assist.
The Department had received its first report from the Auditor General (AG) on PPE corruption cases that day, and it was a good one. The issues were the price of surgical gloves and the failure to submit delivery notes, but this had since been done. There was only one corruption case in the province, and the Special Investigating Unit (SIU) and the Hawks had not found anything serious concerning PPE in the province. The generalisation of PPE corruption had to be put into context of who the major beneficiaries in the country were.
The Chairperson asked what total number of workers, including non-medical staff, had to be vaccinated. Would it get 10 000 doses from Johnson & Johnson, and what percentage of workers would be vaccinated in the first phase? He said that Ms Chirwa had been asking about positive motivation, as she did not feel there had been a strong motivation among those who had to be aware of the programme.
He asked for written response from the MEC on his experience concerning the budget, considering he was the former MEC for Finance.
Dr Theys said that the MEC had done a good job in answering almost all of the questions. He emphasised that the Department’s efforts in preparing for the first wave had carried it into the second wave, and there was not much it had to do to prepare for beds and quarantine sites.
It had not used more than 30% of the bed capacity it had built. For quarantine sites, there were 2 737 beds, but there was not much appetite to use quarantine sites. He outlined where the quarantine sites were.
The cost of the rollout was R120 million, but there could not be any further reprioritisation as it had been affected by budget cuts. It was engaging with the NDoH and local treasury to cope with the costs. The big ticket items for expenditure, such as the vaccines and logistics of transport, were covered by the NDoH. Provinces covered the cost of distribution, storage and transport. 80 teams had been created for phase three, and this cost was included. It was still in serious discussions with Treasury due to the effects of the budget cuts.
The Northern Cape had not experienced the challenges with mortuaries that other provinces had.
He said that 245 nurses had been formally trained as vaccinators. It would continue training, as this was inadequate for phases two and three. The training schedules were continuous so that before the community-based rollout, it would have optimum numbers.
The Chairperson thanked presenters, and said if questions had not been answered adequately, then Members had to send them to the Committee secretary.
Mr Sokatsha said that the number of the official had been given, but he did not want there to be a situation where the official did not answer calls. He had experience with officials not answering calls. The Chairperson said the Minister would join the meeting, and the MEC was welcome to remain behind.
The Chairperson welcomed Mr Zweli Mkhize, the Minister of Health.
Minister of Health’s briefing
Mr Mkhize said it was important for him to address the Committee, as it had been raised the previous week that issues went too far before the Committee was briefed. Cabinet had been briefed that day and the day before, as well as the National Coronavirus Command Council (NCCC), as matters had moved quickly. He would make his statement brief, as Members would be aware of what the issues were. He would answer some questions before he had to return to Parliament.
The Department had been dealing with issues of vaccines as the results of research came on screen. In the previous week, it had been brought to its attention that one trial which involved AstraZeneca indicated results that were less than expected. This presentation had been given to the Minister by Prof Shabir Madhi from the University of Witwatersrand, in the company of Professor Andrew Pollard, from the United Kingdom (UK), who was the principal investigator on the AstraZeneca vaccine. In brief, it was indicated that that in others sites, particularly the UK and Brazil, the AstraZeneca had shown high efficiency and protected against mild, moderate and severe diseases. It showed that it acted efficiently against the variants in the UK and Brazil. From this process it had come to SA, and it was discovered that the trial studies indicated that the efficacy was high with the earlier volunteers with the strain, before the variant. However, with the later volunteers it was found that efficacy had decreased. The study had involved around 2 000 people, with HIV-positive people excluded, and in the process it could not be established that the vaccine was not effective in reducing mild and moderate illnesses. Enough information could also not be gathered to determine what it would do in the case of severe illness. This was in contrast to what had happened in the UK and Brazil, and in the process it was established that its efficacy was much lower against the new variant, at 22%. It had been indicated that there was a wide margin on confidence, which meant those figures were possibly even lower.
He had received this presentation, as well as one from Prof Glenda Grey, who had been investigating the Johnson & Johnson study, which indicated a much higher efficacy of 57%. It was confirmed that it was effective in preventing mild, moderate and severe illness, as well as a reduction of hospitalisation and deaths. It had fared well in relation to the variant 501Y.V2, which was dominant in SA. It was clear that when the vaccines were manufactured, it was based on the original structure of the variant. It was also clear that most of the vaccines were showing reduced activity for this variant. There were reductions for some vaccines, while the data for others were still unavailable. Considering this, it was important that scientists had to investigate the matter further. The decision was then taken to delay the usage of AstraZeneca in the country. Scientists had also been asked to do further studies on how to deal with AstraZeneca going forward.
With the expiry date of the AstraZeneca vaccine in April, the original plan would not have been affected, as the vaccines would have been utilised ahead of this date. The scientists would provide guidance on what to do with the vaccines. It would be looking at swapping the vaccine so that it did not become fruitless and wasteful expenditure.
On the other hand, it had been determined that it was important to not delay the vaccine, as it was important for protecting HCWs. It had approached other manufacturers and asked for bridging stock to be made available, to start vaccinations within the determined timelines. The Johnson & Johnson vaccine was preferred because of its results. Johnson & Johnson had then offered to make vaccines available to the country. They would land in the country the following week, and the rollout would begin. The exact date was not determined, but it would be in the following week. In the process, it was currently negotiating to order additional doses above the nine million ordered, and the entire order would be put together in a package and an announcement would be made on the final number of vaccines coming from Johnson & Johnson. This would be finalised in the next two to three days. The doses would include the samples made available from the earlier study, called Ensemble.
The process would start as an implementation study. This meant that at the same time as the vaccinations occurred, the Medical Research Council (MRC) would observe the trends regarding the efficacy of the Johnson & Johnson vaccine, because it was interested in what of kind break-through infection would occur after use. It was a precaution, but important to protect HCWs going forward.
Another study would be done as well. It had negotiated with Pfizer to have delivery dates moved closer. All of this meant that the vaccination programme would continue. These companies had applied for registration for the new doses, and there would be a new schedule on delivery after this.
Johnson & Johnson was doing some work in SA through Aspen, and furnishing the Aspen factory. The work was going on well, and most of the supplies coming to SA -- and probably the rest of the continent -- would come from Aspen.
There was continuous interaction involving other vaccines.
Possible joint research work on Sputnik V was being discussed.
On Sinopharm, there had been offers from China of some doses. There was a non-disclosure agreement (NDA) with China, and its application had been put to the South African Health Products Regulatory Authority (SAHPRA) for registration.
This meant that the Department would continue engaging with manufacturers, and the vaccination programme would begin the following week. When the details of schedules and the number of doses being delivered from which supplier were clear, they would be announced. At the moment, the NDoH, vaccination sites and MRC were combining to start the programme. The storage issue had also been dealt with, considering the cold chain. It could ensure that there was adequate infrastructure. In addition, Pfizer would be supplying in batches, and it was not likely that many vaccines would have to be stored. Batches would be received at regular intervals. Considering this, storage would be well maintained.
Dr Mkhize said that the Department had been in touch with the WHO on the issue. The WHO’s view was that AstraZeneca was still a good vaccine that should be used everywhere, as it offered protection. It was awaiting guidance from it. The Covax facility had said that an impression that AstraZeneca was condemned must not be created, when the issue was that more research was required. The NDoH accepted this approach.
He said that there was additional information and slides, but he wanted to know that questions could be answered. He requested questions for his attention to be raised first so that he could provide answers and leave the Department to continue thereafter.
The Chairperson said he had forwarded the statement made by the Minister in the webinar to Members.
Dr Jacobs thanked the Minister for attending and providing clarity. He was pleased that vaccines had been secured from Johnson & Johnson, and wanted to know when they would be rolled out. Regarding the Sputnik V and Sinopharm vaccinations, he hoped more information on the progress on the offer from China would be given. All the costs for the rollout of the programme had to be considered. He asked how far the preparation of the rollout plan was, and when vaccination would begin.
Ms Wilson asked when the Minister had received the information from Prof Madhi, and why this issue had not been raised on Friday during his meeting with Committee. If he had been aware of the matter before, why were Members not taken into his confidence?
An SA-based company had made an application to the Serum Institute of India (SII) for doses of vaccines in October the previous year, and would have been funded this order, but it had been advised that government would be the sole purchaser. There could have been a delivery earlier -- this company had been trying to get hold of the Department but could not, and this was very concerning. This was the struggle, with only the government doing the purchasing. Could the Minister advise if the country would continue with AstraZeneca, but start with the Johnson & Johnson? How much of Johnson & Johnson’s vaccine would be coming in, and when would it land? How many people would be saved?
Mr Van Staden said the government had discussions earlier on in the previous year to get the AstraZeneca vaccine, and considering the variant had been identified in December, could the necessary tests not have been conducted before the procurement of Astrazeneca and huge expenditure made? Could the situation have been prevented?
Would the Johnson & Johnson vaccine be effective on the variant, considering its 57% efficacy rate? Would this be enough? How far was it with the procurement process for it, and had the necessary tests been conducted on it as well?
What had the results of the other vaccines on the variant been? Would the AstraZeneca vaccine be returned to its supplier, and would there be a refund? Would the remaining 500 00 doses ordered be cancelled? In the light of the recent developments with vaccines, would the government roll out the programme again to highlight the importance of health protocols? It appeared that the vaccine would not be rolled out in time. What was the new timeline for the roll out, and how would each province be affected?
Dr Thembekwayo said the clinical trials on AstraZeneca had been done before its arrival, yet the President and the Minister had continued with the procurement and made sure the same vaccine arrived in SA. She asked how much had been paid, and who the middlemen were. A third wave was anticipated. What were the contingency plans for this, considering the distribution of vaccines and if the efficacy results yielded were the same as those of AstraZeneca?
On accountability, she asked why enough resources had not been provided for local vaccine trials specifically for preventative measures.
Ms Ismail asked if SAHPRA had approved the Pfizer and Johnson & Johnson vaccines. How much data was available to indicate that the Sputnik V vaccine was effective against the local variant? How many doses of the Johnson & Johnson vaccine would be administered to HCWs? When ordering the vaccine, had government not realised that the expiry date had to be discussed? Would each province start vaccinations at the same time?
Ms Hlengwa asked what the status of SAHPRA’s approval on the Johnson & Johnson vaccine was, and when the public would be informed about this vaccine. How many doses would be received? What was the study on the efficacy of using vaccines in combination indicating? Would there be bigger studies on the efficacy against the SA variant?
The Chairperson said that if a question had already been asked by another Member, Members should not repeat it.
Mr Sokatsha said he was pleased by the Minister’s briefing, which indicated that there had been engagement to avoid a wastage of the AstraZeneca vaccine. The Minister had to keep up the good work.
Ms Chirwa asked on exactly which dates the SA government had procured vaccines from the manufacturers. According to the Department, the decision to opt for AstraZeneca had been taken because it was immediately available. What specific date was this? She would elaborate why she had asked this later on, if given a chance.
She understood that the Johnson & Johnson study did not have placebo details in the trial, as per Prof Karim’s presentation. What had been the reason for this, and the effect of this on efficacy? Why was this information not requested by the Department?
Why was information about Sinopharm not included in numerous presentations in detail like the manufacturers from other countries? What was the offer by Sinopharm, and why was this information not made public? What did Pfizer and Sinopharm’s neutralisation against the dominant variant mean?
An impression had been shared with government that only the AstraZeneca vaccine had efficacy against the dominant variety in SA, but this was not the case according to the BioRxiv site where Prof Karim had got his information. Why were details and information about the efficacy of Sinopharm -- two vaccines from China to be precise -- against the variant first found in SA not shared with the public during the NDoH presentation on 4 February?
She asked the Department to comment on vaccines and re-infections, and how this had guided the Department on procurement. What was the reporting process for procuring vaccines? What were the prices for Pfizer, AstraZeneca and Moderna? Why did government not opt to procure Sinopharm, noting that the storage requirements for it were the same as for AstraZeneca? According to the previous presentation, the general efficacy of this vaccine was higher than the AZ vaccine, and the manufacturer had also reached out to government. She asked for the details of what was happening with this manufacturer.
She raised a general inquiry and interest in Sinopharm and the relationship of the state in not procuring the vaccine, noting that it was not mRNA-based. She had raised this because the research on it had been taken away and details were available only here and there. The prices of the vaccines were not available.
The Chairperson said she was referring to the placebo, and said the prices of the vaccines had been made available.
Ms Chirwa said she was asking because Sinopharm was not included in numerous presentations. The Minister had to clarify.
Mr Shaik Emam said he understood that the Indian government had nothing to do with the AstraZeneca vaccine, and there had been a middle man. Who was this middle man, and how much had been paid? He asked for clarity on the use of two vaccines on a particular person, and how this would affect studies on side effects.
Regarding the expiry date of the vaccines, he said it was strange that eight days later it had been determined that the vaccines would expire. What was the manufacturing date of the vaccine, and what was its lifespan? When exactly in April would it expire? Was the government aware of this beforehand, and how did anticipate dealing with this challenge? How had it agreed to procure the vaccine when there was a risk of it not being distributed timeously?
Would the 500 000 doses that had already been ordered be cancelled and paid for? What was the total cost implication of this?
He was concerned whether SAHPRA was an effective body, because with the AstraZeneca trials there was no evidence it would have worked. He had noted that whenever the NDoH needed authorisation without local trials or evidence, it had given authorisation for the drug. What was SAPHRA’s role in this situation, as it had authorised and approved the vaccine?
He asked if the vaccines would arrive for the third wave, and what the possibility of a new variant was that the vaccines might not be effective against.
A local distributor had said it had Sputnik V available. Could the Department comment on this?
He said that if Johnson & Johnson was able to provided vaccines at such short notice, why had it not been considered prior to AstraZeneca, considering its greater efficacy?
Ms Gela asked if the results of the Johnson & Johnson trial showed it was safe, of good quality and effective against the variant? When would the final rollout plan be provided?
Ms Gwarube said that she had followed the Minister’s briefing this morning. How many Johnson & Johnson vaccines were expected, and what was the timeline? She wanted to know the timelines going forward. What did this mean for the 40 million vaccination target, and would this be adjusted?
She asked for further clarification on the expiry date of the vaccine and how it had arisen, as well as the SII’s position on it. Where were the other vaccines with their SAHPRA applications?
The Chairperson said that someone from an institution had said that it appeared as if the Department was shunning Sinopharm, and other vaccines like the Cuban vaccine. He had a different view, but it appeared that it was leaning towards a group of countries, and not others.
He said that officials could continue answering questions after the Minister had completed his response.
The Minister said that it would be disingenuous to say some countries would be preferred. The choice of vaccines was led by scientific evidence, and he had indicated before what considerations were taken into account when choosing vaccines.
It was untrue that vaccines from other countries, such as Sinopharm, were being shunned, and those who raised this claim had to ask for details on the status of matters. There had been a presentation to the Committee on Sinopharm, and requested to be allowed to get the details from those presentations in order to answer questions that required a detailed response.
A letter had been sent to request a collaboration on the Cuban vaccine a few weeks back. The Department did not have much information about the vaccine, and got most of its information from published research that was available to all countries. The conversation would continue at that level.
Regarding Sinopharm, there had been a meeting with the new Chinese ambassador and it had been agreed that they would work together. The discussion had been picked up again, and they had offered to make available about two million doses of the vaccine. In the process, the team had been told to continue discussions. The first issue discussed thereafter was the pricing of the vaccines, and there were some outstanding results about Sinopharm. From this process, some countries had sent reports. The team was dealing with them, and since then an NDA had been signed which allowed the Department to get more detailed information from China about the vaccine, so it would continue to process it. The structure of the vaccine that it used was one that the team thought was a lot stronger, in the sense that it was using the whole virus. This was not an alive virus, but the structure of the body was to allow the development of antibodies and stimulate other forms of immunity for purposes of rebuilding the immune response. There was an NDA, with submissions to SAHPRA, and the process was ongoing.
On Sputnik V, there had been a meeting with the ambassador, and thereafter several interactions with the Gamaleya Research Institute and some partners. At the time, the information it required was not clear, but a few days ago research on it had been published in the Lancet, which indicated it was a significant advancement. There were technical issues that the team had raised on the vaccines which had to be discussed. Work was being done, and a few days ago a letter had been received from one of their partners in the country who had asked to collaborate on the research.
These were the details of what had transpired concerning the various vaccines. He thought that anyone who said that the Department was shunning any option was making a political point which was not based on reality, as it was untrue.
Ms Chirwa raised a point of order. She said the Minister could not say it was political when information was being requested. He kept repeating that an NDA had been signed, and he could not share information. Information was being requested which was not political, but if no information was received it meant the Minister was making it political. This sentiment was provocative, and the Minister had to be accountable to the Committee. This was not the first time that the issue of efficacy had been brought up, as it had already been raised the previous week, and proper answers had not been received.
With regard to the NDA, it was unconstitutional for the Minister to not share the information he had. He was bound by the Constitution to share information, if asked. He could not say it was political -- information requested had to be shared.
The Chairperson spoke in the vernacular.
The Minister said the issue was whether there had been shunning, and he was saying “no” -- as a political statement, it was untrue. This was the point he was making. He would provide details of certain issues which could be provided, and these would be made available.
The dates of procurement would be made available, as he did not have them on hand. The information on Sinopharm in relation to efficacy issues and trials would be made available, but these could also not be answered off-hand. It was untrue that details on Sinopharm had not been provided, but more would be provided.
He said he had no knowledge of the Johnson & Johnson trial not including placebos. He suggested that the investigators who did the report be called to present the details to the Committee. The details were available, but he did not have them with him at the moment.
It was not true that only AstraZeneca had research work done. There had been almost 200 vaccine candidates, and 11 or so were taken forward. If there was such an impression, he was unaware where it came from.
Information on the Pfizer and Moderna prices could be made available. At the moment, the Pfizer price was US$10 and the Moderna price US$42 per vaccine. This was all subject to negotiation.
Ms Chirwa said she felt that Parliament’s legal advisory service had to be called, as she was uncomfortable with the NDA being cited, and called for a break until then. The state was supposed to share information it had with the public, according to the Constitution. The Minister could not continue to talk about NDAs. She asked for a legal opinion to be provided.
She clarified that on efficacy, she was not asking generally but asking in relation to the SA variant, as there was an impression that only AstraZeneca had conducted research to this effect, while BioRxiv had said there was other research. Sinopharm had used research on efficacy in relation to the SA variant. She requested that there be a break and a legal opinion provided.
The Chairperson said that her point was taken and it would happen, but the meeting would continue.
The Minister said that the NDA was an explanation of how far it had gone with Sinopharm, and it was to state that there was progress on the matter. An NDA was signed to get more information. The other information would be made available, as it was technical, but the Department would require time to collate the information. Once completed, the documents could be made available.
On the efficacy of different vaccines and the nature of trials, he suggested that scientists be called to present to the Committee on this. He reiterated that the NDA had been mentioned to indicate where the progress was, but if there was an issue about the NDA, that was a separate matter. He had provided the prices of the vaccines and indicated the progress with Sinopharm. The Department did not jump to take decisions on issues -- there was analysis.
On the comments that it was not an mRNA vaccine, but a kind of attenuated virus, he said that it was basic science. The question really was that when the Department presented, it did not present on the mRNA technology or adenovirus vaccines -- decisions were based on the available information. There had been a bit of a misunderstanding.
On the halting of the AstraZeneca vaccine rollout being welcomed, he said that it was not a simple decision. The issue was that the Department would not condemn it because the studies done in SA would assist with it with the additional information on the environment. However, it had been determined that the use of it had to be delayed.
A number of questions had been asked on the nature of the research that had to be done on AstraZeneca, but it had not reached that stage yet. It meant that the team of experts would provide a proposal on how to deal with AstraZeneca. It needed some time for this.
An offer of two million doses from China had been made, and there were negotiations. The work was ongoing. More information would be provided. Transparency meant that once matters had been completed, the public was entitled to the information, but before matters were concluded, the Department was not able to do so. Once concluded, it would take accountability for the agreements it would have been signed. There was no saying that these agreements could not come to Parliament. There was no concrete document to bring, as negotiating was ongoing, but it would be brought once it was completed.
He hoped the team could make the information on the total cost of vaccinations available. Various factors had been included in the cost, but he did not have the figures on hand.
The initial vaccination rollout plan had been disturbed, as it was based on AstraZeneca, where there would have been a million doses to start off. Therefore, there would be a delay in the process, but it would start next week. The nature of the process was that it would start with fewer doses than before, which would affect the plan, but it would be readjusted and this would be shared.
He was not aware of the company that wanted to procure doses, as raised by Ms Wilson, and the information had to be provided. Companies that were not manufacturers, but agents and middlemen, had been coming to the Department. The matter would be looked into. The Department’s impression was that Johnson & Johnson had not produced that many vaccines at that time, but it would look into the matter.
At that this time, nobody had been denied and if a company wanted to go they were not stopped, but manufacturers preferred to deal with governments. When it was said that the national vaccination programme was led by government, it had discussed the situation with the private sector to combine efforts. Nevertheless, if other companies wanted to make vaccines available outside the government, it might not have much to say about it. The way things stood at the moment, the government had found lots of support from the private sector to distribute from authentic sources of the vaccines where it had concluded price negotiations.
Confirmation from Johnson & Johnson on how many vaccines would be received would take another a day or two, but they would land some time the following week. It would receive bridging stock, which was an advantage, as the order was supposed to be coming much later. It had also asked Johnson & Johnson to consider sending everything that was available, because the stock that was manufactured for research purposes remained available and was just as effective and had already been analysed. The details on the vaccine delivery schedule would be shared once made available, but it had asked for the provision to be expedited by Johnson & Johnson.
Ms Chirwa raised a point of order. She said that the Committee would find itself on the wrong side of history if it rubber stamped matters. The Minister had said the government was at advanced stages with Sinopharm, but could not say what these stages were. What were the advanced stages? He did not answer questions by Mr Shaik Emam on efficacy related to variants last week as well.
Dr Jacobs said matters could not continue in this fashion.
Ms Chirwa responded that this was why she had requested a break for legal intervention. The Minister could not be allowed to repeat the same sentiment three meetings in a row. He had said that information could not be shared due to NDAs, but had mentioned advanced stages of the agreement with Sinopharm.
Dr Jacobs asked the Chairperson to intervene.
Ms Chirwa continued. When had the vaccines been procured? The Minister had been unable to provide dates. It was not the truth that the variant situation had arisen after the vaccines were procured. The issue of the variant had come out on 18 December.
The Chairperson asked for Ms Chirwa to be removed from the platform, and asked the Minister to continue.
The Minister continued that in response to the question raised by Mr Van Staden, the main variant that was available and circulating throughout the world had been used to develop the vaccines, and trials were then started. In the course of starting those trials, it was later discovered that there was a variant and a mutation. This was not predicted, and it arose in the process. When the trials were done, the investigators had to manufacture for the new variant. When the variant was announced in SA, the government had then asked its scientists to start relating it to the manufacturers and ask them to test the effectiveness of the vaccines against the variant. At this time, it was able to share the variant material with the manufacturers to test it if it could be neutralised The results that had come through had varied. Most of the manufacturers had indicated the extent to which their vaccines had responded to the variant. With Johnson & Johnson, for the 501Y.V2 variant, it had an efficacy of 57%, and for prevention the figure was much higher. When this was happening, there were promising write-ups about most of vaccines. It had then procured AstraZeneca, understanding that some results were outstanding, but in terms of what had happened throughout the world it was clear that there were promising results. It was disappointing when it found out that AstraZeneca was unable to show effectiveness against the dominant variant in SA.
There had been a discussion with Prof Madhi much earlier -- before the results were due to be released -- but it could not release results that had not been released by the scientists themselves first and published formally. This was what had transpired with Prof Madhi. The issue could be dealt with only when Prof Madhi had made the information public.
On possible issues with Johnson & Johnson, he said that the report had been given and the results were promising, and the Department did not expect the same challenges it had with AstraZeneca.
The SII had already been contacted on the 500 000 doses that had already been ordered, and discussions were ongoing with Covax as well, as the vaccine had not been delivered yet and he hoped that it could be swapped for a different vaccine.
He was still awaiting details related to the Johnson & Johnson doses and dates of delivery. Once available, it would be shared.
The clinical trials had been in progress when the order was placed, but the main issue around the order was that the results had been quite promising, and if what happened in SA had not occurred, the world would not be talking about AstraZeneca not being used. There had been a briefing from the principal investigating scientist who had provided the results to the rest of the world.
He said middle men were not dealt with in order to get the AstraZeneca vaccine -- it was procured from SII as it had a license. Middle men provided proposals, then verification was first sought from manufacturers before considering proposals. The process had not reached a stage where there was finalisation through middle men.
On the anticipated third wave, he said that the second had wave had come and it came due to the conditions in the country, and while there was an issue of poor social distancing, and a lack of use of masks and various prevention methods, there would be a risk of a third wave. The Department would continue to preach the ways to ensure prevention, and hoped that people would adhere to preventative protocols so that it delayed the next wave.
More details on AstraZeneca efficacy could be sent to the Committee.
The rollout plan would be changing and once all the details on vaccines were available, it would be presented.
Investing in local research would continue, as well as investing in the local manufacture of both vaccines. The case of Aspen had been a step in the right direction.
Regarding the state of approval of the various vaccines, he said that the Johnson & Johnson doses linked to the trial were already approved by SAHPRA, and there was a certificate of analysis. Applications went to SAHPRA, who would confirm the analysis of the particular vaccines which had already been done. New manufacturers had to go through the necessary processes that had been followed for AstraZeneca. Sinopharm, Pfizer, Johnson & Johnson and others had made submissions, and it was waiting for SAHPRA to finalise them.
The scientists had to present on the Sputnik V vaccine and the variant.
On the emergency use of vaccines, he said there were different ways of applying for vaccine authorization, such as emergency licensing, which covered the research that had to be done.
The information on the Johnson & Johnson doses would be made available.
Dr Mkhize said the use of combination vaccines was a new discussion, and was still at the conversation level.
The impression given by scientists on the studies needed for AstraZeneca was that there was a need for be a couple of hundreds of thousands of people to participate, and they would wait until there was something concrete to report about it.
He said that the SII had sold the vaccines to the country, and it had negotiated with it directly. AstraZeneca had been engaged as a company who had made it clear that the jurisdiction for selling to SA was with the SII. There was no middleman, and the negotiated dosage procurement rate was US$5.25, but the officials could confirm this. For Europe, the price was lower as there had been early investment in research and development, and therefore it had been given a lower price. SA had been unable to do this at that time, as it had fewer resources available to invest without proof.
The Indian government was a seller of the vaccine, but the SII had a relationship with it. The SII was paid – it was not a donation -- but SA’s relationship with India remained strong.
The issues on the expiry date would be addressed by Dr Anban Pillay, Deputy Director General: Health Regulation and Compliance, NDoH.
The third wave was one of the challenges that the Department had considered, and it would do as much as possible to reduce the risk of infection for the people. It had to be upfront that some information that had been requested was not ready, but when it was it would be provided. The Department would try its best to make information available but it was a challenge to give information that was not ready.
The Johnson & Johnson results had indicated good quality while used in earlier trials in South Africa, and it was expected that the quality would remain the same.
The total number of vaccines that would be administered would be finalised only when information from the manufacturers was received. Delivery schedules would be finalised after all terms and conditions were finalised.
Regarding the view that the AstraZeneca situation was disappointing, he said that no one had made a mistake. It had been scientific research.
There were a number of applications for SAHPRA vaccine authorisation. For AstraZeneca, the emergency authorisation had been granted, and this was a legal document. It was not as if it was dangerous or unsafe, but the SA conditions were different. He had not heard that Moderna had submitted, but had been told that the process was under way with Sputnik V and Sinopharm. He suggested that SAHPRA present on the status of these applications.
The Minister concluded that some questions had required detailed information, and this would be made available.
Department of Health’s response
Dr Pillay said he would provide a background on the issue of the AstraZeneca expiry date. The SII had been producing vaccines in the initial period, and all the vaccines that it had produced were to ensure that the rollout in India would be smooth, with adequate doses. When the Department was in negotiations with it, the SII had been clear that it had committed most of its doses to the Indian government, and it would be difficult for it to release doses from that allocation. The Department had been able to persuade it on the basis of requiring it for the HCWs, which made it more responsive. Therefore, doses had been released.
At the time that the shipment left India, the Department had not been aware of the expiry date. When it had landed, it was discovered through inspection that the expiry date was in April. The April expiry date was not really a problem, because if the initial timeline for vaccinations was adhered, to the doses would have been used by that time.
As for an extension of the expiry date, he explained that when a manufacturer produced the first batch, its expiry date was very short thereafter, as it was unknown how long the product would last. The product was thereafter put on stability studies to determine how long the product would last. It took samples from those batches, which got tested, and then it was able to extend the expiration date from there. The Department had requested that this data on expiry be shared and if that information was made available, then SAHPRA would consider if the expiry could be extended. This was a regulatory matter and not in the NDoH’s jurisdiction, as it was a SAHPRA regulatory process.
The Chairperson asked if this was all that would be said.
Dr Pillay said that the questions had been addressed.
Ms Gwarube asked if she could ask Dr Pillay a question.
Ms Chirwa asked to follow up, but was told she was not allowed on the platform by the Chairperson. She said she had to be treated as an equal.
The Chairperson asked that she be removed from the platform.
Ms Chirwa continued that she had to be allowed to be on the platform as a Member. The Department had to provide dates, and it could not mislead the nation by saying it had procured the vaccines before the news of the variant had emerged. She asked for accountability, as news of the variant came out on 18 December. She was asking for accountability, and said the Minister could not be given immunity.
Ms Gela raised a point of order, and said Ms Chirwa was out of order.
The Chairperson asked who in the IT department was responsible for allowing Ms Chirwa to enter the meeting, as he had made a ruling that she was not allowed in the meeting. He wanted to know which member of the IT staff had allowed Ms Chirwa back in the meeting and would take it to the House Chair, as he had made a ruling. He requested that the Committee secretary to follow up.
Mr Van Staden said that he would not be asking follow up questions, as he wanted clarity from the Minister himself.
Ms Gwarube asked why the issue around the vaccines’ shelf life had not been discussed beforehand in negotiations. Why had the issue not been addressed early on in discussions? It appeared that due diligence was not done.
Mr Jacobs said that there a seemed to be a misunderstanding of the Committee and what its role was. It did have an oversight role, but the question was whether it had oversight over ongoing work, documents that were not completed yet, and processes where the Department had ongoing negotiations. It was a dangerous situation if the Committee thought that it had to be working as part of the Department. Its role was to have oversight over work that had been completed, as it could not be involved in its choices and have oversight at the same time. It was a very complex technical state of affairs, and trained expert opinions had to be respected. He urged that the Committee have its role explained, especially in this regard, and not have the Minister challenged in the manner he had been that day.
Dr Thembekwayo said that considering that Dr Pillay was the longest serving member in the NDoH, it was frustrating to hear from him that the expiry date had not been questioned, which was quite unacceptable. She did not accept the explanation about this. She said that people like him had to step aside and let fresh minds come in. As for Dr Jacobs’ statement, there was a time for commenting on in-house matters. and this was not the time. as relevant issues had to be addressed.
Mr Shaik Emam said that there had to be engagement with the House, as the entire process of questions and responses were ineffective. Dr Pillay had admitted that the Department had not considered the issue of expiry dates before the goods left India. The NDoH had failed the country, as it had not considered this matter. He did not believe it had picked this issue up only when the stock arrived. It indicated that there were shortcomings, and work had to be done.
The Committee had to have its own meeting on how it conducted oversight. Oversight included ongoing work, as the Department had to be assisted in identifying weakness to close gaps. The Minister had been alone when recording the questions, and this had affected his responses, which was the problem.
There was more to the matter of the expiry date, and the Ms Chirwa had been correct that the variants had appeared the previous year and the vaccines had been ordered in January. If mistakes were made, these had to be corrected.
Deputy Minister’s response
Dr Joe Phaahla, Deputy Minister, Department of Health, said Mr Shaik Emam was incorrect in saying that the variant had been there previously for some time. The Department had received a report from the scientists at the KwaZulu-Natal Research Innovation and Sequencing Platform (KRISP) institute at the University of KwaZulu-Natal in late in December, after Christmas. According to the report, it had discovered the variant through its genomic studies, and had updated the Department then. This information was then also shared with the UK, which then discovered a variant as well. In the meantime, the mutations had been monitored, but it was said that mutations were not of a significant nature until the time that the particular variant was identified. By the time that this happened, manufacturers had already been doing research work and trials. The human trials had been running before the variant was identified, so even the trials that Prof Madhi was supervising on AstraZeneca had been on course already. The trials were conducted and then there was an analysis, and due to this the report was given only the previous week on what had been discovered. Members had to get the facts correct on the sequence of events for these aspects. This was an unprecedented situation, and therefore there were a lot of studies that still had to be done.
On the expiry issue, it had to be noted that these were new products and the shelf lives were still being determined. If the efficacy of AstraZeneca had not become an issue, then the expiry date in April would not have been a “train smash” because the vaccines would have been utilised by then. The vaccine was not expiring immediately -- there was still two and a half months before then -- and a lot could be done in this time. He pleaded that Members be cautious when dealing with new matters that no one had dealt with before.
The Chairperson said he had written to the House Chair to schedule an in-house meeting for the Committee. The Committee had to engage with the Auditor General (AG) on the expiry date matter, as it did not want there to be fruitless expenditure. However, the Department had said it had plans to mitigate this loss.
The Chairperson said a date for a meeting with Chair of Chair was unlikely that week, but he would wait for a date.
Mr Shaik Emam said that in response to the Deputy Minister stating that he had been incorrect, two weeks before 31 December the second variant had been reported in SA. The fact was that there had been knowledge of the variant since around 18/19 December, and procurement processes began just after the first week of January. This was the truth, and he felt that a workshop on the matter would be helpful.
The Chairperson said that the Department had to provide the dates for the timeline on the variant.
Dr Pillay said that the Department would review its records and provide the exact dates.
He said that the date of the discovery of the variant did not mean that the variant was resistant to the vaccine on that date. There were a few thousand variants across the world that the vaccine was effective against, therefore having a variant in the country did not mean that it was resistant to the vaccine. It had to be understood that the two were separate matters, and the vaccine was still effective in the UK and Brazil. The dates would be provided, but the date that the variant was identified and when it was found to be resistant differed.
Mr Shaik Emam said that the response was not good enough, and there had to be further engagement.
The Chairperson said that the discovery of a variant had to be subjected to scientific processes and did not necessary mean the stopping of orders.
Mr Shaik Emam said that it had already had a 22% efficacy rate.
Dr Phaahla said that Mr Shaik Emam was incorrect, and that the 22% had arisen from the study of the previous last week.
Dr Thembekwayo asked that the Chairperson rule on what was happening.
The Chairperson said that as the Deputy Minister was present he could still respond.
Dr Phaala said Dr Pillay was correct -- the 22% referred to was in relation to the results of the trial by Prof Madhi that had been made available last Monday.
The Chairperson requested a presentation that indicated a narrative of the events.
The meeting was adjourned.
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- Media Statement: Committee on Health Hears from Minister Mkhize about Suspension of Distribution of Astrazeneca Vaccine
- DoH Northern Cape: COVID-19 Epidemiology & Vaccines
- NDoH: Vaccines Progress
Dhlomo, Dr SM
Chirwa, Ms NN
Gela, Ms A
Gwarube, Ms S
Hlengwa, Ms MD
Ismail, Ms H
Jacobs, Dr KL
Mkhize, Dr Z
Phaahla, Dr JM
Shaik Emam, Mr AM
Sokatsha, Mr MS
Thembekwayo, Dr S
Tseke, Ms GK
Van Staden, Mr PA
Wilson, Ms ER
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