In a virtual meeting, the Western Cape Department of Health gave the Committee an update on progress, as at 31 March 2021. The South African Health Products Regulatory Authority (SAHPRA) also briefed the Committee.
The Western Cape Department of Health said new COVID cases showed a slight increase of five percent, but for the most part reached a plateau. Admissions and deaths continued to decrease, with a 22 percent and 62 percent decrease respectively, in this last week, compared to the week before. The proportion of positive cases was still stable and low at five point one percent on 26 March 2021.
The Department saw a similar number of cases, admissions, and deaths, as in October 2020, which was the lowest period between the first and second waves.
The Department would have to significantly scale up the implementation of vaccines over the coming months as the key driving factor to try and combat COVID-19.
With the UK variant being found in South Africa, a Member asked if the variant was more deadly than the others; and asked for the expected time of arrival of the third wave. George Hospital was one of the sites which catered to both public and private healthcare professionals who were to receive vaccinations - Members asked if the facility was functional and if so, how many vaccinations were completed thus far. Members also asked about the advantages of J and J’s one-shot vaccine, when compared to alternatives.
Members asked if the appointments made were in regard to temporary or permanent employment; what the Department’s stance on Ivermectin was; and if any research had been done on its effectiveness in dealing with COVID-19.
Members asked if limited approval of the Pfizer and J and J vaccines would have an impact on South Africa’s ability to move into Phase Two; asked about SAHPRA’s position regarding Ivermectin; asked if a timeframe could be provided regarding when the Committee could receive feedback on the process outcomes of the Sputnik, Sinovac, and Sinopharm applications; if the current staff complement of the organisation was adequate enough to deal with the tasks it was confronting; under which circumstances provinces could procure vaccines; and what processes had to be followed to procure vaccines.
SAHPRA provided the Committee with an update on COVID19 vaccines. Members asked about the status of the various vaccines in the approval stage to be rolled out to the general population, which were not part of the trials, if limited approval of the Pfizer and J and J vaccines would have an impact on South Africa’s ability to move into phase two and SAHPRA’s position regarding Ivermectin. Members also wanted to know if there was a timeframe regarding when the Committee could receive feedback on the process outcomes of the Sputnik, Sinovac, and Sinopharm applications, if the COVID-19 processes impacted on the other aspects of the Department’s work and if the current staff complement was adequate to deal with the tasks the Department was confronting. Further questions probed under which circumstances provinces could procure vaccines, and what processes needed to be followed to procure vaccines and if government would wait until the vaccine had been approved by SAHPRA before procuring it.
The Committee resolved that:
- feedback be given on the ban on liquor, and if it served its purpose in reducing the amount of casualties and strain on hospitals during the Easter Weekend, compared to previous years.
- information include the previous years Christmas and Easter period. The previous Easter saw the country in lockdown level five, and the current year saw the country at lockdown level one.
- asking for the data for the past three years, to make a real comparison between the festive periods.
Western Cape Government: Health Update as at 31 March 2021
Dr Keith Cloete, Head of the Western Cape Department of Health, said new cases showed a slight increase of five percent, but for the most part, it reached a plateau. Admissions and deaths continued to decrease, with a 22 percent and 62 percent decrease respectively in the past week, compared to the week before. The proportion of positive cases was still stable and low at five point one percent on 26 March 2021.The Department was seeing a similar number of cases, admissions, and deaths to what it saw in October 2020, which was the lowest period between the first and second waves.
Variant emerged in South Africa (SA)
- First detected in SA
- October 2020
- Increased transmissibility
- Reported in 75 countries (11 new countries in the last week)
Variant emerged in United Kingdom (UK)
- First detected in UK
- September 2020
- Increased transmissibility
- Reported in 125 countries (seven new countries in the last week)
Summary of implications for the third wave preparedness
- Plan for additional mitigation in rural districts, especially West Coast and Overberg, and with the private sector in general.
- Access to beds with oxygen supply, and specifically access to high-flow nasal oxygen, will be a key focus for the Third wave.
Acute service platform – general comments
- Currently 794 COVID patients in acute hospitals (471 in public hospitals and 323 in private hospitals.)
- COVID hospitalisations have continued to decline; there has however been an increase in trauma cases
- The metro hospitals have an average occupancy rate of 86 percent; George drainage area hospitals at 64 percent; Paarl drainage area hospitals at 71 percent, and Worcester drainage area hospitals at 76 percent.
- Occupancies in COVID beds show metro hospitals at 11 percent; George drainage area hospitals at 16 percent; Paarl drainage area hospitals at 21 percent; Worcester drainage area hospitals at 21 percent.
Oxygen utilisation – general comments
- The public sector total bulk oxygen consumption has reduced to 15.45 tons/day, or 21.44 percent of the Afrox Western Cape plant for the seven day period ending 19th March. This is compared to 51 tons/day in the first week of January.
- The Western Cape still has four bulk oxygen tankers allocated for the daily delivery of oxygen supplies during the week.
Vaccine Roll-out Update
Health Care Workers:
- Public and Private Health Sectors
- Care Workers
- Health Science students
- Traditional Healer
- Estimated target: 132 000
- Essential Workers
- Clients in congregate settings
- Older than 60 years
- Older than 18 years with co-morbidities
- Estimated target: two million
- Older than 18 years
- Estimated target: 2.9 million
Vaccine Update: J and J Sisonke Programme
- Since the launch of the J and J Sisonke Programme took place on 17 February 2021, the province is currently implementing its fourth tranche of the initial 300 000 vaccines.
- Additional tranches are expected after 10th April from the additional 200 000 doses, projecting 30 000 doses.
- The total number of doses received thus far is 54 068.
- As of 30 March 2021, a total of 45 960 health care workers have been vaccinated in the province, public and private sectors.
Vaccine Update: Implementation
- Initial operational challenges with regards to the Electronic Vaccine Data System (EVDS) have largely been resolved.
- There is greater awareness and understanding amongst healthcare workers of the process to follow to access the vaccines.
- The province now has more provincial level control permissions on EVDS, which helps for a smoother facilitation of processes at the local level.
- Prioritisation and sequencing of most-at-risk healthcare workers continues to ensure equitable access to the vaccine programme for those healthcare workers at greatest need.
Vaccines options in SA – South African Health Products Regulatory Authority (SAHPRA) approvals
- Pfizer and J and J - approvals granted by SAHPRA.
- Covishield - approval granted, but roll-out put on hold.
- Moderna – no submission made to SAHPRA yet, and is not imminent before 3rd quarter.
- Sputnik, Sinovac, and Sinopharm – submitted applications to SAHPRA, approvals not imminent.
- Novavax & Bharat Biotech – no applications submitted to SAHPRA yet.
Ms W Philander (DA) wanted to know if the Department was assured of receiving the vaccines in time to complete phase one by the anticipated date of completion. With the UK variant being found in South Africa, she wanted confirmation regarding if the variant was more deadly than the others. She asked when the Department expected the third wave to take place.
Mr C Dugmore (ANC) said the George Hospital was one of the sites which catered to both public and private healthcare professionals to receive vaccinations. He asked if the facility was up and running; and how many vaccinations were already given at the George Hospital. Regarding the process of vaccine procurement, he asked how many unsolicited bids the Western Cape received. He also asked for a list of the companies who submitted the unsolicited bids. The President’s announcement gave the impression there was progress with the J and J vaccine, and there were advantages of a one-shot vaccine. He asked the Department of Health’s position regarding the issue of a one-shot vaccine, as opposed to a two-shot vaccine, and possible alternatives.
Ms R Windvogel (ANC) wanted to know how the rollout of the vaccines would work in the rural areas. Workers from Swellendam would have to go to Caledon to be vaccinated. This seemed a problem. She asked if the Department would be decentralising the vaccines, as was done with the testing program. Regarding the 1 132 new appointments, she asked if the jobs were temporary or permanent.
Mr F Christians (ACDP) said for the holiday period, people would be travelling for religious reasons and for family gatherings. Regarding religious institutions, he wanted to know if data showed if there was super spreading at these institutions. He wanted to know if it was possible for private hospitals to independently source vaccines. He also asked if there would be collaboration between private and public hospitals to ensure people were vaccinated.
Dr Nomafrench Mbombo, the Western Cape Provincial Minister of Health, said nobody knew when the third wave would take place. However, data showed, while some countries experienced a long second wave, others like South Africa saw a period of differentiation where gaps took place between the waves. The numbers decreased, only to eventually dramatically increase again.
A huge indicator of a third wave was the 501Y.V2 variant, which was highly transmissible. It could be transmitted immediately from one place to another. This meant a large amount of people could be infected at the same time. The ever-evolving nature of the viruses meant it kept changing, and as such, it transmissibility kept changing.
Regarding places of worship such as churches and mosques, it has been found most people adhered to COVID-19 protocols, kept masks on, and social distanced. It was generally not found to be places of super spreading. Events such as funerals became a source of infection, likely due to people wishing to comfort each other. People in restaurants were also found to be a source of high level spreading, as people tended to speak and not wear masks while interacting with other people.
The 501Y.V2 variant was the one found in South Africa. It was currently located in more than a hundred other countries, similar to the variant found in the United Kingdom, Brazil, and New York. International travel and hosting people from other countries meant the variants depended on the level of vaccination from those countries. In South Africa, only 50 percent of health care workers had been vaccinated.
Dr Cloete said the Department was confident it would receive the allocated doses to allow it to complete phase one during the course of April. The Department was confident it would get the allocated doses to allow it to commence to phase two as well. It was included in the consultations regarding the allocation amounts.
Regarding the third wave projections, nobody knew exactly when it would occur. The infectious disease specialist was part of the Ministerial Advisory Committee, and was working with the National Modelling Consortium who had done the previous projections. It was currently considering the various factors, and would be developing its first set of modelling scenarios over the coming weeks.
The UK strand of the virus had been detected in South Africa. This occurred approximately three weeks prior to the current date. It had not been discovered amongst other samples. It was unlikely the UK variant would spread rapidly in the Western Cape. The George Hospital had completed 3 618 vaccinations, and was due to complete another 9 760.
It had 28 unsolicited bids. Those were the ones which had a clear supply-chain process. The J and J vaccine would be its first prize, as a single dose was cheaper and logistically easier to administer. The Pfizer vaccines were to be used to supplement the shortfall in J and J vaccines. The 1 132 employees have been employed on contract.
Both the private and public sectors hospitals opted to receive vaccines from the national programme. By the August/September period, it could potentially start procuring vaccines directly from suppliers to supplement the national programme. Private entities could potentially do the same. However, it committed itself to working within the government programme.
Vaccinations are meant to be equitably available for everyone who needs it, despite socio-economic circumstances. As such, nobody would get charged at the point of vaccination. In the event the person had medical aid, the medical aid would be charged for it. If a person did not have any medical aid, the vaccine would be free of charge. The public and private sector were jointly working together to make sure everyone had access to the vaccines.
Ms Philander said the sooner the vaccines were received, the sooner the Department could conclude Phase One. She wanted to know why so little vaccines were received, and why it arrived in batches. The President previously said government was still finalising the agreement for another 20 million vaccines from J and J, to supplement the 20 million Pfizer vaccines, which would ultimately vaccinate the 41 million South African citizens. She asked the Department’s opinion on Ivermectin and its efficacy.
Ms Windvogel wanted to know why there were no posts mentioned for EMS personnel, despite the challenges. Referring to Slide 33, she asked for a breakdown of vaccination by Health Department facilities. She asked why private and public workers were vaccinated at different sites in the metro, while the rural area saw a combination of private and public health workers at vaccination sites.
Mr Dugmore wanted to know if the funding given to the Western Cape by the national government related specifically to the vaccine itself. If so, he wanted to know how all the other expenses were dealt with. He asked for a breakdown of what the funding policy received from national government covered.
Mr Christians wanted to know what the Department’s stance on Ivermectin was. Many institutions and universities were doing research on its curing properties, and he wanted an update regarding any breakthroughs with the research done. Secondly, he wanted to know which strategy would be implemented to vaccinate homeless people.
Dr Cloete said Sisonke was a research project. The Department has not used any procured vaccines in South Africa yet. People tended to get confused in thinking the mass-rollout program began. Due to the absence of research, the Department had not started this yet. The Department and government did not pay for the J and J vaccines. The vaccines were leftover stock from the research vaccines gathered from across the world. It arrived in batches of 80 000, with another 200 000 on the way, again in batches. Once the additional 200 000 had arrived and been allocated, the Sisonke program would be done. This was expected to be completed by the middle of April.
In rural areas, there was not sufficient capacity to distinguish between private and public institutions. This was the main reason for the joint venture in the rural areas. Once, the Pfizer vaccine arrived, additional sites would be allocated to deal with the vaccine rollout programme. The red dot transport system was a possible solution to help get people to vaccination sites. Whatever the impediment, the Department was working to guarantee equal access for those who needed vaccines.
There has been evidence the UK variant is not only more transmissible, but also causes more severe diseases. There is no evidence the 501Y.V2 variant, which originated in South Africa, causes more severe illnesses. Once the Pfizer vaccines are received and delivered to the province, a distribution system has been set up. This would be the first time the Western Cape would be conducting mass vaccinations. Regarding the 1 132 job appointments, a breakdown of those numbers into categories could be provided to the Committee. The jobs have been given on a contract basis for the year. A look at the budget for year two would decide on the appointments going forward. Critical posts across all categories were mostly looked at when making the appointments.
The budget itself was already under pressure, the pandemic has only added to the pressure. There was no surplus of budget. Not only was the whole healthcare system in the country suffering from a shortage of budget, but the whole of government’s resources faced a shortage at every sector in the country.
A National Advisory Committee was busy looking at all the evidence and data regarding Ivermectin. There was not sufficient evidence to suggest it was effective in managing COVID-19 within South Africa.
The steering committee would be looking at each geographical area to decide how to deal with the vulnerable groups. Registered refugees would also be assisted. One of the requirements was individuals needed to be registered and have a South African identity number (ID). A challenge would be getting homeless and street people without an ID onto the system. However, it was something the Department was trying to deal with.
Consideration and adoption of the Draft Minutes dated 4 March 2021
The minutes were adopted.
South African Health Products Regulatory Authority
Dr Boitumelo Semete-Makokotela, CEO: SAHPRA, said several pre-submission meetings were held with prospective applicants to advise on the following:
- Application requirements.
- Establishing the available information, the applicant has to support the application.
- Types of reviews and documentation required for each route.
- Possibility of reliance, where evaluation reports from other National Regulatory Authority’s (NRA’s) which SAHPRA aligns with, are available
Expedited review approaches for Covid-19 vaccines
- Rolling reviews of submissions - reviewing available data and accepting ongoing data in batches for review.
- Reliance - an act whereby the NRA in one jurisdiction may take into account and give significant weight to assessments performed by another NRA or trusted institution, or to any other authoritative information in reaching its own decision.
- Includes reliance on National Control Laboratories.
- The relying authority remains independent, responsible, and accountable regarding the decisions taken, even when it relies on the decisions and information of others.
- Joint reviews with World Health Organisation (WHO) - a collaborative review approach with WHO Prequalification (PQ) programme, SAHPRA’s external and internal evaluators are part of this collaborative review.
Section 21 of the Medicines Act
- Equivalent to Emergency Use Authorisation in other jurisdictions.
- Section 21 - authority may authorise sale of unregistered medicines, medical devices, or in vitro diagnostic product (IVDs) for certain purposes:
- (1) The Authority may in writing authorise any person to sell during a specified period to any specified person or institution a specified quantity of any medicine, medical device, or IVD which is not registered.
- (2) Any medicine, medical device, or IVD sold in pursuance of any authority granted under subsection (1) may be used for such purposes and in such manner and during such period as the Authority may in writing determine.
- (3) The Authority may at any time by notice in writing withdraw any authority granted in accordance with subsection (1) if effect is not given to any determination made in terms of subsection (2).
- Supported by Regulation 29 and the guideline.
SAHPRA Covid-19 Vaccine studies in process
- Four COVID-19 vaccine clinical trials which were submitted recently are under review. Two of these are in pregnant women and one in children.
The Chairperson asked about the status of the various vaccines in the approval stage to be rolled out to the general population, which were not part of the trials. The President announced the previous night, phase two of the rollout which would be amongst the general population above the age of 60, was scheduled to begin around the middle of May. She asked if limited approval of the Pfizer and J and J vaccines would have an impact on South Africa’s ability to move into phase two. She asked about SAHPRA’s position regarding Ivermectin.
Dr Semete said the Pfizer vaccine had the Section 21 authorisation. The other one, the J and J vaccine, was at an advanced stage of review. Any other vaccine which was not under a clinical study would then be available for the government to access. Despite Section 21 being for emergency use, it meant government could procure it to be able to implement it into the different phases if the quantities authorised were insufficient. The applicant could go back and ask for the quantities to be increased. Any new product developed still had to undergo clinical trials to generate sufficient data to make sure it met the correct endpoints. Regarding Ivermectin, the Department had insufficient data to say Ivermectin was effective for the management of COVID-19. The studies were ongoing, but currently, the data was insufficient to comment on its efficacy.
Mr Dugmore wanted to know if there was a timeframe regarding when the Committee could receive feedback on the process outcomes of the Sputnik, Sinovac, and Sinopharm applications. He wanted to know if the COVID-19 processes impacted on the other aspects of the Department’s work. He asked if additional staff and personnel were requested to help with what was obviously a particularly busy process. Lastly, he asked if the current staff complement was adequate to deal with the tasks the Department was confronting.
Ms Windvogel asked under which circumstances provinces could procure vaccines, and what processes needed to be followed to procure vaccines. She asked if government would wait until the vaccine had been approved by SAHPRA before procuring it; and asked for an update on the reviews currently underway, as of end March.
Dr Semete said SAHPRA did not get involved in the procurement process. The question was best posed to the Department of Health. SAHPRA’s goal was to ensure products were registered and monitored once available. While J and J submitted reviews the previous year, vaccines such as Sinovac were only received late February of the current year. Unfortunately, it would take approximately two months to get Sinovac registered. It largely depended on the quality of the data. The review already started and there would be engagement with role players, however, no specific time frame could be given. A big challenge faced during the COVID-19 period was other areas of work could not be neglected, and as such the Department was stretched. The entire team was working non-stop since the start of the pandemic. The total staff complement was approximately 450. However, currently the Department is running with a staff complement of about 280. While the Department was understaffed, it was not only putting mechanisms in place to recruit employees, but was also working on raising funds from National Treasury to be able to fully capacitate the organisation.
Ms Philander asked for an overview of the efficacy of the current vaccines submissions.
Dr Semete said she could not give away too much information, as officials were bound by confidentiality when it came to applicants. Regarding the efficacies surrounding the variant which was dominant in South Arica, the data indicated the following: J and J had an efficacy of approximately 59 percent; the WHO was approximately 50 percent; AstraZeneca was reduced to approximately 20 percent, which led to not proceeding with it; and Novavax had an efficacy above 50 percent. However, Novavax had not submitted an application as yet.
Regarding the Pfizer vaccine which the Department authorised, it would submit a protocol on how it would monitor its performance, and its efficacy. When the Department looked at its lab-based data, it was still quite confident to proceed with its authorisation.
The Chairperson said the COVID-19 variant which was first discovered in the United Kingdom had now appeared in South Africa. The different vaccines showed different efficacies against the different types of variants. The Chairperson asked for an explanation regarding the process of approval, and asked how it would work if the UK variant became the dominant variant in South Africa.
Dr Semete said, as regulators, the Department authorised the vaccines. However, it became more complicated when a new variant emerged. The Department held a meeting with the various regulators on Monday of the current week, to align those protocols. Very soon it would publish guidelines on what it would do. The complexity of the process was noted, elaborating on the need to be flexible for the guidelines to be updated as required, while building mechanisms to say how to collect more data. In all those instances, the Department needed the data to be available to enable it to make the required decisions.
Mr A Van der Westhuizen (DA) recommended feedback be given on the ban on liquor, and if it served its purpose in reducing the amount of casualties and strain on hospitals during the Easter Weekend, compared to previous years.
Mr Dugmore recommended the information include the previous years Christmas and Easter period. The previous Easter saw the country in lockdown level five, and the current year saw the country at lockdown level one. It would be interesting to compare the data.
The Chairperson agreed. The Chairperson recommended asking for the data for the past three years, to make a real comparison between the festive periods. The requests would then be included in the Chairperson’s next letter to the Department of Health, to be in included in its next briefing to the Committee.
The meeting was adjourned.
Download as PDF
You can download this page as a PDF using your browser's print functionality. Click on the "Print" button below and select the "PDF" option under destinations/printers.
See detailed instructions for your browser here.