Update by Acting Minister on vaccine roll-out programme & variants; SAHPRA on Covid-19 vaccines pipeline, use of Ivermectin & application process for vaccine manufacturers


21 July 2021


Meeting Summary

Video: Portfolio Committee on Health, 21 July 2021

In a virtual meeting, the Committee received a briefing from the South African Health Products Regulatory Authority (SAHPRA) on the COVID-19 vaccine pipeline and Ivermectin, as well as its regular fortnightly update from the Department of Health on the COVID-19 vaccination roll-out.

SAHPRA reported in detail on the process it followed in evaluating vaccines for authorisation, which usually took around 90 days. Thus far, it had authorised the use of the AstraZeneca, Pfizer, Johnson & Johnson, and Sinovac vaccines; the Sputnik and Sinopharm vaccines were under review, with two separate applications apiece. Causality studies were ongoing to investigate the 3 730 adverse events and 28 fatalities that had been reported by recipients of the Pfizer and Johnson & Johnson vaccines.

SAHPRA’s position on Ivermectin had not changed. It maintained that there was insufficient evidence to recommend the use of Ivermectin against COVID-19, and that Ivermectin should not routinely be used to manage COVID-19 at any stage. An exception was the compassionate use programme, which was intended to stem the illicit and unsafe use of Ivermectin products and which had authorised 632 applicants to prescribe Ivermectin at their discretion. To date, SAHPRA had not received an application for the registration of Ivermectin as a COVID-19 treatment, but it continued to monitor clinical trials and developments abroad. It would not change its position without scientific evidence from a large, well-designed clinical study.

The Committee asked for further details about the status of the Sputnik vaccine application. It encouraged public disclosure of information about adverse events and breakthrough infections following vaccination, which would help mitigate against vaccine hesitancy. Members also questioned SAHPRA’s stance on Ivermectin and asked about early treatment regimens and vaccine procurement.

The Department reported that it had administered 5.57 million vaccines to date. It was currently administering close to 250 000 vaccines daily, and aimed to ramp up to 333 333 vaccinations daily in the following week, in order to reach 35 million people by Christmas. Thus far, the programme had more effectively reached the insured population, with 17.8% of the insured population and 6.1% of the uninsured population vaccinated. The rate of coverage was lowest in Mpumalanga (5%), the North West (5.8%), and the Northern Cape (6.8%); it was highest in the Western Cape (10.4%), the Eastern Cape (9.7%), and Limpopo (8.9%). Vaccination of the security cluster was ongoing, but the Department was reconsidering its sectoral approach, intending instead to focus on rolling out to successive age groups of the general population. This would reduce the administrative burden and remove the practical and ethical difficulties of deciding which groups should be prioritised.

The Committee sought clarity about which groups the Department planned to target in the various phases of the vaccination roll-out. Moreover, Members were concerned that only 68.6% of public healthcare workers had been fully vaccinated to date, and that the vaccination programme was not reaching uninsured people. Also of interest were plans to procure the Sinovac vaccine, breakthrough infections among vaccinated people, and the effects of the KwaZulu-Natal unrest on health services and COVID-19 transmission.

Meeting report

The Chairperson welcomed attendees to what was, for the Committee, a continuation of its morning meeting. He asked the Committee secretariat whether it was necessary to record Members’ attendance again.

The Committee secretary replied that Ms S Gwarube (DA) and Ms N Chirwa (EFF) had not been present in the morning session but were present now.

The Chairperson said that Ms Gwarube and Ms Chirwa had joined the morning meeting, though they had not officially been recognised as present.

The Chairperson reminded attendees that all parliamentary Committee meetings were open to the public, but that only Members and the invited delegations would interact on the virtual platform. The meeting constituted a meeting of the National Assembly (NA) for official purposes. Thus NA rules, including the rules of debate, and as well as the rules for virtual sittings, applied. Members enjoyed the same powers and privileges as in a sitting of the NA. Anything said during the meeting was considered to have been said before the NA and could be ruled upon accordingly. All Members should mute their microphones unless recognised by the Chairperson, and should refrain from making unnecessary points of order or interjections.

The Chairperson welcomed the South African Health Products Regulatory Authority (SAHPRA), which would brief the Committee on its processing of COVID-19 vaccines and on Ivermectin. He asked Members to read a message he had sent to the Committee’s group chat about the Committee’s plans for next week.

SAHPRA briefing: COVID-19 vaccine pipeline and Ivermectin

Prof Helen Rees, Board Chairperson, SAHPRA, thanked the Committee for the opportunity. Although SAHPRA would present on certain items as requested, delegates were very willing to answer any other questions that Members might have.

Dr Boitumelo Semete-Makokotlela, Chief Executive Officer, SAHPRA, introduced the SAHPRA delegation and presented on behalf of SAHPRA. She began by outlining the 21 COVID-19 vaccines reviewed or under review by the World Health Organisation (WHO) for emergency use authorisation (see slides). Globally, there were about 200 COVID-19 vaccines at different stages of development, with many still in the clinical trial stage.

Dr Semete-Makokotlela reported on the 17 pre-submission meetings that SAHPRA had held with potential vaccine applicants from November 2020 to date (see slides). Pre-submission meetings were held with applicants before they submitted their applications, allowing SAHPRA to appraise them of its regulatory requirements. With this mechanism, SAHPRA could fast-track applications while maintaining the quality of companies’ submissions.

The status of the various applications for section 21 approval was as follows:
- AstraZeneca: authorised on 22 January;
- Pfizer/Biontech: authorised on 10 March;
- Johnson & Johnson (J&J): conditionally authorised on 30 March;
- Sinovac: authorised on 2 July;
- Sputnik V: two applications, submitted 23 February and 30 April, under review; and
- Sinopharm: two applications, submitted 22 June and 8 July, under review.

Dr Semete-Makokotlela detailed the steps SAHPRA took in evaluating a vaccine (see slides). It usually took about 90 days for SAHPRA to finalise the approval of a vaccine, depending on the quality of the applicant’s submission and the availability of information. SAHPRA had expedited its processes for all COVID-19-related products, but the process still required some “back-and-forth” between SAHPRA and the applicants. SAHPRA only made a final decision once it was completely satisfied.

Dr Semete-Makokotlela reported on the adverse events that individuals had reported following vaccination against COVID-19. 564 recipients of the Pfizer vaccine had made reports regarding a total of 24 fatalities and 1 243 adverse events, most commonly dyspnoea and syncope. 930 recipients of the J&J vaccine had made reports regarding a total of 4 fatalities and 2 487 adverse effects, most commonly syncope, dyspnoea, and chest pain. The number of fatalities did not currently exceed the number expected in the general population, but causality studies – which aimed to investigate a causal link between an event and the vaccine – were ongoing.

As SAHPRA had reported in a prior meeting, Ivermectin was not registered for human use in South Africa, and therefore could not be used off-label. Globally, there were more than 80 ongoing Ivermectin trials, which SAHPRA continued to monitor. However, the current evidence was limited to small studies with various design strengths and weaknesses, and meta-analyses faced design difficulties. Many of the randomised control trials were of low methodological quality, and there was no convincing evidence of clinical or virological benefits from the use of Ivermectin. Therefore, currently, there was insufficient evidence to recommend the use of Ivermectin against COVID-19, and Ivermectin should not routinely be used to manage COVID-19 at any stage, except in a controlled context.

SAHPRA had allowed a controlled compassionate use programme for Ivermectin under section 21, which had approved 632 applications to date. The programme had been set up to ensure that Ivermectin was supplied legitimately and used in a safe setting. Prior to the programme, the product had often been used illicitly and imported illegally. However, the reporting under the compassionate use programme was very poor. SAHPRA urged the authorised entities and individuals to report back to SAHPRA, so that it could collect as much data as possible.

Currently, there was no application to SAHPRA for the registration of Ivermectin as a COVID-19 treatment. SAHPRA had registered an Ivermectin cream formulation, and was reviewing an application for an Ivermectin tablet, but in neither case was the product indicated for COVID-19.


Ms Chirwa asked SAHPRA to explain in detail what data was outstanding in the Sputnik application. What data had SAHPRA received from Sputnik about the vaccine’s efficacy, and what data was outstanding from Sputnik that had been provided for the other, authorised vaccines?

Ms Chirwa said that she had raised with the Minister of Health the case of a patient who had suffered a complication arising from the use of surgical mesh. The American Food and Drug Association (FDA) had flagged surgical mesh, and Australia was offering free removals and corrective surgeries to people who had had surgical mesh inserted, she thought especially during hernia surgeries. She knew of two people who were having complications relating to surgical mesh, and her research had shown that this was a global phenomenon. Yet surgical mesh was still in use in South Africa. What was SAHPRA’s position on the use of surgical mesh? Moreover, SAHPRA had created the perception that the FDA and other regulators had influence over its decisions – yet in this case it seemed to have diverged from other regulators.

Ms Chirwa noted that SAHPRA monitored the adverse effects suffered by recipients of all vaccines currently in use in the country. What, in detail, were those adverse effects; how severe were they; and how predominant were they? What investigations were underway or had been concluded? It was important to avoid fuelling the vaccine hesitancy that the national Department of Health (NDOH) claimed to observe – although her experience contradicted those claims, because in fact “there are no vaccines” in the country for people to be hesitant of.

Ms E Wilson (DA) said that the briefing had covered many of her current concerns about the vaccines. She had consistently asked for numerical detail about the prevalence of adverse effects, and she was glad that detail had been provided. Members of Parliament (MPs) were obviously inundated with calls and messages from anti-vax people, who often used information that they had found online and that did not come from South African authorities. It was a difficult issue to deal with, so it was helpful to be able to respond using SAHPRA’s information.

Ms Wilson was slightly concerned about the adverse effects of special interest, especially those related to the Pfizer vaccine. Severe breathing difficulties were a prevalent adverse effect (see slide 17-18). She knew that SAHPRA was still investigating, but could it provide any further information? What was causing it? She knew people who had been vaccinated and then had ended up hospitalised with COVID-19 several days later. She tended to think that that was a coincidence, and did not believe that the vaccine had caused them to contract COVID-19 – but perhaps SAHPRA could clarify that for her. Moreover, she was slightly concerned that the Pfizer vaccine was linked to more adverse effects than the J&J vaccine – what could explain that? The 4.2% fatality rate among Pfizer reaction reports also struck her as a bit high (see slide 16). Was SAHPRA able to compare that rate with the fatality rate in other countries? She knew that the vaccination roll-out was in an early stage, but she would appreciate further information, because it helped Members to respond to the anti-vax complaints that were common on social media. Such complaints had to be “put to bed.”

Ms H Ismail (DA) asked why adverse effects following immunisation were more prevalent among females.

Ms Ismail also had several questions about Ivermectin. She had been approached by many doctors and other interested parties, who had asked her to raise these issues with SAHPRA so that their voices could be heard and so that South Africans could make informed decisions. Why did NDOH follow the recommendations of a rapid review of current science by the National Emergency Medicine List Committee (NEMLC), which had not been peer-reviewed? That review was permitted to constrain the use of Ivermectin by the doctors and patients who wanted to use it – yet there was international peer-reviewed data that showed contradictory findings. Moreover, was SAHPRA aware of the problems with the Columbian study that it cited?

Ms Ismail noted that SAHPRA claimed to consult with other regulatory bodies when it made decisions. Had SAHPRA consulted with international bodies which had successfully introduced early treatment for COVID-19, including using Ivermectin? Some had done so as recently as late April, and their results had shown the efficacy of Ivermectin in reducing infection rates and mortality rates. For example, had SAHPRA studied the successful early treatment programmes in Venezuela, Slovakia, and India, and contacted the regulators in those countries, to see how they achieved great success using Ivermectin? Why did South Africa not have a formal guideline for the treatment and management of COVID-19, using cheap and safe therapeutics that were easily accessible to all patients, including to public patients? Why had NDOH and SAHPRA not engaged urgently with the many South African doctors who had were successfully treating outpatients and saving lives every day? That would allow NDOH and SAHPRA to learn for the country’s benefit, especially considering that the country did not have the capacity to handle high hospital intakes. There were shortages in beds and oxygen, for example.

Ms Ismail said that NEMLC’s mandate was to propose therapeutics for various diseases. During the pandemic, the NEMLC had failed the public by focusing only on late-stage and ICU treatment for COVID-19. What recommendations had NEMLC come up with for out-patient treatment? Early treatment was clearly key to fighting the COVID-19 virus, which roughly doubled every nine hours. Many doctors, both in South Africa and in countries like Venezuela, Slovakia, and India, offered early treatment with great success. They had dramatically reduced COVID-19 infections by introducing Ivermectin for early treatment. In many patients, COVID-19 was treatable. In terms of section 7 of the high court order, both treatment and prevention options were allowed. Why was the public not at least informed of this provision and “given hope,” so that they could make informed decisions?

Dr S Thembekwayo (EFF) noted that SAHPRA said that, in the first phase of clinical trials, effective evaluation required an adequate number of vaccine recipients and monitoring over a sufficiently long period. In this context, what exactly qualified as a sufficiently long period? This was especially important given the dire need for vaccines in South Africa. Moreover, why was it difficult for SAHPRA to give South Africans the vaccines of their choice?

Dr Thembekwayo said that an article about Ivermectin, with positive findings, had been retracted. She thought that it had been retracted because the authors or publishers had received threats. It was unfortunate that SAHPRA also “fell for” this and celebrated the article’s wrongful retraction.

Dr K Jacobs (ANC) said that he thought the biggest challenge currently was certainty around reporting, both in post-market surveillance and about adverse events. For any drug or vaccine to be authorised, there had to be continuous monitoring of that drug’s safety. How did SAHPRA monitor post-market surveillance and adverse events? Who made the reports – was it self-reporting, or did the vaccine companies provide reports? Were the reports made electronically? How regularly were reports made and monitored? How did SAHPRA ensure that monitoring was done? How certain was SAHPRA that the information received through the reporting system was reliable?

Dr Jacobs said that the Committee often discussed various vaccine manufacturers, and there was a continuous challenge or even “battle” among certain Members, who sought to “exert pressure” on SAHPRA to allow the use of certain vaccines. He thought that Members had to clearly understand the importance of the safety measures that were in place, including post-market surveillance and the reporting of adverse events. Members had to understand the importance of the safety of all the country’s people. Members should take this opportunity to “read up” and learn. He had raised this before. Members of the Committee should not use their public platform to raise issues about which they were misinformed or uninformed.

Mr M Sokatsha (ANC) said that Dr Jacobs had touched on a point that he had wanted to raise. He thanked SAHPRA for covering his concerns – most importantly, around the steps that are taken to authorise drugs and vaccines. SAHPRA had also covered misunderstandings and misinformation about the authorisation of certain foreign vaccines, and it had covered Ivermectin and its use in South Africa, which was one of his biggest concerns.

Mr T Munyai (ANC) said that SAHPRA always attended the Committee when invited. The briefing had been very comprehensive and had addressed the issues that the Committee had asked to have addressed. He had just been reading an article in the Guardian, the English newspaper, from 15 July. The article discussed a huge Ivermectin study which had been withdrawn over ethical concerns. He had shared the article with the Committee for other Members to read. It was important that decisions were made only when there was sufficient data – if decisions were made without scientific evidence, they could send the country into “disarray.” Parliament should protect SAHPRA’s independence.

Mr Munyai suggested that the Committee should hold a separate meeting focused on the issue of the vaccines’ adverse effects. He was satisfied that the other issues had been dealt with.

Ms M Hlengwa (IFP) conveyed condolences to the ANC for the death of MP, Ms Joyce Maluleke and her husband. God had given and taken.

Ms Hlengwa said that SAHPRA’s report had been comprehensive and very informative. Recently, there had been spikes in COVID-19 infections in countries, such as the United Kingdom and the United States, where many people were vaccinated and whose vaccination programmes were considered successful. The governments of those countries had publicly expressed concern about the high infection rate among vaccinated people. Should this worry the Committee? Did it cast doubt on the efficacy of vaccines? Was there something that these countries had missed that South Africa should take note of?

The Chairperson noted that two different applicants had made applications to SAHPRA for the Sputnik vaccine. What did SAHPRA do in such a situation?

The Chairperson agreed with Ms Chirwa that he would like to hear more than that a vaccine like Sputnik was “under review.” To avoid SAHPRA having to come back to the Committee, it would be helpful for the presentation to specify what exactly was outstanding in the review process – for example, it could specify that all documentation had been submitted but that the vaccine’s safety was in doubt and was under investigation, or whatever the true situation might be. Simply “under review” was very general.

The Chairperson asked whether SAHPRA had received an application for the Cuban vaccine.

The Chairperson said that he belonged to a chat group with members of the South African Medical Association, in which there was much debate about Ivermectin. Some said to use it, and others said to be cautious. He would like to ask Ms Ismail’s question in a different way: were there any doctors in the country who had begun prescribing Ivermectin to their patients and who were submitting information to SAHPRA? That was the right way around – SAHPRA would not go countrywide, asking for information about Ivermectin. Instead, the onus was on those who saw value in Ivermectin to make a collective submission of data verifying their claims. He saw SAHPRA as an airline company that was grounding one of its flights because of concerns about safety and efficacy. If the airline said that the flight would be grounded until it was satisfied of certain things, then you could not challenge its decision, no matter how much you wanted to. There were certain protocols that had to be followed. He appreciated that SAHPRA had prioritised COVID-19-related health products, but the onus was on others to meet SAHPRA’s requirements. South Africa could not allow something simply because of a recommendation made by another country’s authorities. South Africa’s own regulatory body had to be satisfied that each product had met the requirements for safety, efficacy, and quality. His understanding was that if SAHPRA had not received enough information about a given product, its stance on that product would not change. The onus was on others to make submissions and satisfy SAHPRA that the product met the requirements.

Prof Rees began responding to the questions, but the Chairperson noted that Mr A Shaik Emam (NFP) had joined the meeting. He said that Mr Shaik Emam appeared to have questions and had presumably read SAHPRA’s presentation in writing, though he had missed the beginning of the meeting.

Mr Shaik Emam apologised for arriving late – he had been in a media briefing. He had just learnt that SAHPRA and NDOH had responded to his letter, though he would need time to study the response. He said that vaccines had to be approved by SAHPRA before the government procured them. Yet was he correct to say that certain vaccines had been procured in South Africa before a section 21 application had been lodged and before they had received SAHPRA approval?

Mr Shaik Emam said that SAHPRA evaluated the success of vaccines with a very long-term perspective. Vaccine trials also usually included animals. Yet was it correct that, with the COVID-19 vaccines, there had been no animal trials, nor any long-term trials? He did not want to be misunderstood – personally, he had gotten vaccinated. But, in his understanding, even as vaccines were now being rolled out nationally, the trial period should properly continue until about 2023. This meant that effectively the trial was still ongoing. Only in 2023 would SAHPRA have comprehensive reports about the efficacy and safety of vaccines, including about any side effects and fatality risks.

Mr Shaik Emam said that SAHPRA said that it would allow doctors to prescribe Ivermectin if they wanted to, but that those doctors had to take full responsibility. Yet, with the vaccines, SAHPRA was asking the recipients of the vaccine to take full responsibility. SAHPRA had given indemnity to the vaccine manufacturers, and was happy to put patients “in the firing line” when it suited SAHPRA. If something went wrong, recipients of the vaccine had no claim against the manufacturers – there was a no-fault claim.

Mr Shaik Emam acknowledged that SAHPRA monitored reports and trials at different institutions worldwide. Yet there were many reports showing that Ivermectin was efficacious. He knew that SAHPRA would respond that it had not seen such reports, but that was inconsistent with the claim that they monitored external publications. SAHPRA was not going to change his mind, and he was not going to change SAHPRA’s mind.

Mr Shaik Emam said that he was not sure whether SAHPRA had presented an update on the status of Ivermectin. If not, he was sure it was covered in the written response to his letter.

Mr Shaik Emam said that in his understanding, the Pfizer vaccine had a higher efficacy rate than the J&J vaccine. He had heard that the Pfizer vaccine was about 97% efficacious, while the J&J vaccine was only about 63% efficacious. In that case, why had South Africa procured so many J&J vaccines?

Mr Shaik Emam said that he thought the government was procuring the Chinese vaccine, Sinovac. He was concerned, because he had heard that Sinovac had been used in Indonesia and other countries where the fatality rate and rate of serious side effects had been “enormous.” Had SAHPRA done its homework, or had it approved Sinovac due to undue external pressure?


SAHPRA processes

Prof Rees said that she thought many of the attendees belonged to Whatsapp chats in which participants raised the same issues that Members were raising now. It was difficult, and it was difficult to explain to the lay public what a regulator did. During the pandemic, regulatory processes had gotten more attention than ever before – she suspected that many people had not previously known that there was such a thing as a drug regulator. Many of the issues Members raised were difficult precisely because there were strongly held views on all sides. But the point of a regulatory authority was for it to remain as neutral as possible. Related to Mr Shaik Emam’s comment about undue pressure, it was “incredibly important” for the regulator to be independent and not to be pressurised. As South Africans with parents, children, relatives, and friends, people wanted to know that they could trust the process that led to a product being approved by the regulatory authority. That was why SAHPRA was happy to repeatedly explain its processes, just as Dr Semete-Makokotlela had in the briefing. It was crucial that everybody could trust that the drugs they took, and the drugs they gave to their children, were efficacious, safe, and of good quality. If people could not trust the regulatory process, it could not trust any medicines. The process had to be independent, influenced by nothing but science and the public health interest.

Prof Rees said that Dr Semete-Makokotlela could answer Ms Chirwa’s specific question about surgical mesh, but Ms Chirwa’s question also alluded to the influence of external agencies on SAHPRA’s decision-making. These days, most regulatory authorities participated in what was called regulatory reliance. Increasingly, regulators tried to share information with each other. That started very locally. SAHPRA belonged to sub-regional groups with authorities in neighbouring countries, which reviewed dossiers together. In Africa, there was the African Vaccine Regulatory Forum (AVAREF), whose development had accelerated after the Ebola outbreak in West Africa. At AVAREF, regulators and ethicists from many African countries conducted collective reviews of clinical trial applications and vaccine registration applications, and then shared their conclusions with regulatory authorities. On a broader scale, SAHPRA shared information with bodies like the European Medicines Agency and, as Ms Chirwa had said, the American FDA.

Currently, and importantly for both vaccines and Ivermectin, SAHPRA was in close contact with the WHO. Because the COVID-19 pandemic was a global public health emergency under the International Health Regulations (IHR), the WHO could implement emergency use licensure. The WHO was studying each of the vaccines. SAHPRA had given itself two criteria or benchmarks in evaluating vaccines. First, it only considered vaccines that had had 50% effectiveness in early clinical trials. Second, it only considered vaccines which were also subject to the WHO approval process. SAHPRA also worked closely with the WHO during the WHO’s own approval process, so there was a sort of “synergy.” Dr Semete-Makokotlela could provide details about the Sputnik vaccine, but Sputnik had not yet received emergency use licensure from the WHO. Data was still being submitted about Sputnik, and a WHO announcement was not expected until later in the third quarter.

COVID-19 vaccine authorisation

Prof Rees said that in the current context, one of the obvious public health factors that influenced SAHPRA’s decisions was the fact that the country was amid a pandemic. In such a context, it could not be “business as usual” for anyone, especially not for the regulatory authority. That was why all COVID-19-related processes were being fast-tracked. Yet that did not mean that corners were being cut. Mr Shaik Emam had asked about the safety of the vaccines, given that the approval periods had been condensed. This tied into pharmacovigilance – monitoring for the vaccines’ safety. Certainly, most common vaccines were not developed in less than six or seven years. Some were very difficult and took decades. For example, HIV and tuberculosis vaccines were proving very difficult to develop. But, because of the pandemic, the process had been condensed and consolidated. The various stages – animal studies, pre-clinical studies, and the various clinical phases – overlapped, instead of proceeding sequentially. Animal data would continue to be generated, but it would overlap with the lab data, which would overlap with the first phase clinical data, and so on. Even once the vaccines had been introduced, SAHPRA worked on effectiveness studies, investigating breakthrough infections to establish how safe and effective the vaccines were once introduced into the wider community. The process could not stop at the clinical trials. In sum, the COVID-19-related approval processes were not business as usual, but they remained science-driven.

Dr Semete-Makokotlela said that the COVID-19 vaccines had been developed and authorised more quickly than usual. The context was a global public health emergency. A lot of the assessments had therefore been conducted in parallel. Around the world, regulators had diverged from the regular sequential process, whereby an applicant waited for a pre-clinical study, then applied for a first-phase study, then reviewed the data and moved onto the second phase, and so on. At the same time, the global community of regulators maintained certain standardised minimum requirements that all vaccines had to meet. One minimum requirement was a 50% efficacy rate. SAHPRA was also evaluating the efficacy of vaccines against variants of concerns, considering both lab data and clinical trials, since COVID-19, as everybody knew, was an evolving virus. SAHPRA was complying with international guidelines.

Dr Semete-Makokotlela added that none of the vaccines had received full market authorisation. It was therefore understood that the vaccines were effectively still under assessment – though they had been given emergency authorisation since it was a public health emergency and they had met the minimum requirements. Globally, no vaccine had full market authorisation. There were parallel review processes. SAHPRA participated in collaborative processes through the WHO, which leveraged skill sets from across the world and data generated across the world. Alongside the emergency use authorisation status, and with the understanding that the virus continued to evolve, SAHPRA had also placed conditions on all authorisations. As the vaccines were analysed through post-market surveillance, if any vaccine failed to meet a requirement, the authorisation could be suspended or even retracted. SAHPRA met with the applicants regularly. Some of the conditions spoke to the requirement of continuous reporting to SAHPRA about safety and efficacy against variants of concern. Prof Rees had already mentioned the national protocols around studying breakthrough infections – SAHPRA was obviously part of such discussions. It was important to understand the breakthrough infections as they appeared in relation to various vaccines, in various countries, and so on. For example, Mr Shaik Emam had mentioned that Sinovac had been used in some countries where there had been a high number of breakthrough infections, such as in Chile. SAHPRA was monitoring such situations. Not just Sinovac but all vaccine manufacturers had to report to SAHPRA as the vaccines were rolled out to the public.

Dr Semete-Makokotlela said that it would be helpful to clarify SAHPRA’s role as regulator, in light of certain questions from Members. For example, Dr Thembekwayo had asked why SAHPRA did not allow the public to choose which vaccine they received. SAHPRA was not involved in the procurement or roll-out of vaccines – that was done in partnership between the public and private sector, under the leadership of NDOH. SAHPRA could not determine which vaccines members of the public had access to. However, SAHPRA ensured that it reviewed every application it received, which gave the country options on a broader level in procuring vaccines. As the virus evolved, the government needed to be able to explore different types of vaccines. For example, now that the delta variant was predominant, the government needed to be able to compare the efficacy of various vaccines against that variant.

COVID-19 vaccine adverse events

Ms Portia Nkambule, Chief Regulatory Officer, SAHPRA, said that as Dr Semete-Makokotlela had said, when vaccines were approved, SAHPRA included certain conditions for the applicant, known as pharmacovigilance commitments. The applicant had to report any serious adverse events within 24 hours. Every fortnight, it had to submit a summary of adverse events following immunisation. Every month, it had to submit a simplified periodic safety update report, which included worldwide data and various specific details, including an analysis of breakthrough infections. The applicant also had to submit an annual review of drug safety information to identify any potential risks that had not previously been captured. Recipients of the vaccine usually reported adverse effects to healthcare professionals, who reported in turn to SAHPRA. Individuals could also report directly to SAHPRA using the Med Safety app, which SAHPRA had launched in April; the e-reporting portal on SAHPRA’s website; or the paper forms provided at healthcare facilities. The database of adverse events was accessible to NDOH as well as to SAHPRA. As mentioned in the briefing, SAHPRA had thus far received a total of 1 494 reports of adverse events related to the COVID-19 vaccines, though some of those reports referred to more than one adverse event. Once the data was collected, a causal assessment was conducted by the National Immunisation Safety Expert Committee.

Prof Rees said that she was sure that Dr Semete-Makokotlela’s team would discuss pharmacovigilance in further detail. However, Members should remember that vaccines had initially been rolled out to people over the age of 60. People in that age group were more likely to experience conditions like deep vein thrombosis, stroke, heart problems, and respiratory problems – simply because of their age and because they tended to have many more comorbidities. So, for example, when respiratory difficulties were observed as an adverse event, one had to ask whether they were caused by the vaccine. Alternatively, would the adverse event have happened to the individual in the normal course of events, even without the vaccine, because of other risk factors? When this data was collected, there was a very specific process for investigating whether there was a causal link between the vaccine and the adverse effect that had been observed. If SAHPRA concluded that there was a causal link, it then asked how common that link was. Was it serious enough that SAHPRA should exclude people with certain risk factors from accessing the vaccine? Importantly, SAHPRA did not embark on this process alone. It shared its safety information through the WHO, which had a global advisory committee on vaccine safety to look at such data from around the world. With a much bigger dataset, the WHO committee could investigate the causal associations and their prevalence, and decide whether the benefit of the vaccine outweighed any particular side effects. This was an incredibly important global process in which SAHPRA participated.

Mr Tohlang Sehlolo, Senior Manager: Clinical Evaluation Management, SAHPRA, said that the apparent disparity in adverse effects between Pfizer and J&J could be explained in similar terms. Pfizer appeared to have worse safety outcomes because it had initially been administered to older persons with more comorbidities. Of course, a causality assessment was underway to establish conclusively whether the vaccine itself was responsible for the adverse events, and the assessment would include post-mortems and other investigations.

Mr Sehlolo said that SAHPRA had taken on the project of communicating with the public about adverse events, including their prevalence and provincial distribution. There was a steering committee, which was responsible for communications about vaccine safety issues and which involved NDOH, SAHPRA, and the Government Communication and Information System (GCIS). The steering committee was quite advanced in formulating its communications strategy and messaging, which would help to tackle vaccine hesitancy, public perceptions of adverse events reports, and other issues. The crux of the strategy was to give “the real story,” as openly as possible, and to ensure that the public was informed about adverse effects. It would provide details about prevalence, provincial distribution, and any other indicators it thought were helpful in conveying its message. The strategy was in place and was progressing daily. The first publication would be a Q&A, hopefully published by Friday [23 July], which would allay common concerns and answer common questions. The first dashboard, which was at an advanced stage and should be ready by the end of July, would stratify the adverse events in terms of numbers of cases, provincial distribution, and other indicators.

Mr Sehlolo said that the fatality rate had been compared with that in other countries. Based on the available data, there were no discrepancies in fatality outcomes in South Africa compared with those in the rest of the world – it looked comparable. Of course, SAHPRA was monitoring the data very closely to ensure that that remained the case.

Status of Sputnik vaccine

Dr Semete-Makokotlela said that SAHPRA had had several engagements with the applicants for the Sputnik vaccine, through a rolling review under section 21. The applicants had provided the safety and efficacy data that SAHPRA had requested, and SAHPRA was busy evaluating that data. SAHPRA was also busy evaluating the quality aspects, which involved an assessment of the manufacturing sites. So the requested data had been submitted, and SAHPRA was evaluating it. The next step depended on the quality of the submission – SAHPRA might be satisfied, or it might have to continue engaging with the applicants until it was satisfied.

To the Chairperson’s question about how SAHPRA handled multiple applications for the same vaccine, Dr Semete-Makokotlela replied that SAHPRA had to consider how similar the respective dossiers were. Were the vaccines manufactured at the same site, and was the data the same? If not, then SAHPRA evaluated the applications separately. SAHPRA also required that applicants had to provide confirmation of their agreement with the manufacturer, whether that was Sinopharm, the Gamaleya Research Institute, or so on. It was important that the applicant had the capacity to monitor the vaccine once it entered the country. That way, there was a company that could deal with and be held accountable for any quality defects or other issues that arose. Mechanisms had been put in place to ensure that that requirement was met.

Status of Cuban vaccine

Dr Semete-Makokotlela said that SAHPRA had not yet received an application from the manufacturers of the Cuban vaccine.

Efficacy of Sinovac vaccine

Dr Semete-Makokotlela said that in evaluating vaccines like Sinovac, SAHPRA looked at the reviews of the strategic advisory committees, as well as the WHO review. While the vaccines did not prevent infection, SAHPRA was satisfied that all authorised vaccines reduced the severity of illness and the likelihood of hospitalisation and death. Those were the parameters that it had looked at, and it would not have authorised a given vaccine unless it was satisfied that it met those requirements. SAHPRA was not saying that there would not be breakthrough infections with an authorised vaccine, however. Breakthrough infections were being seen with the Pfizer and J&J vaccines, for example. The extent of breakthrough infections would have to be investigated.


Prof Rees said that the Ivermectin issue was difficult. Everybody absolutely understood the desperation – especially among primary care doctors – to have medications that worked and that could be prescribed to ambulant patients to prevent COVID-19-related illness from progressing. Unfortunately, this was one area in which it was extremely difficult to do the requisite research. There was much less data on early treatment interventions than there was on advanced treatment interventions for hospitalised patients, and there was even less data on preventative medications other than vaccines. A regulator could only work with the available data. To date, despite the many applicants for vaccine approval, nobody had made an application for the use of Ivermectin products in treating COVID-19, even for emergency use. Most recently, as Dr Semete-Makokotlela had reported, SAHPRA had received an application for the recognised indication of Ivermectin – that is, for the use of Ivermectin in treating parasitic diseases, rather than COVID-19. SAHPRA could not approve anything until somebody applied for the product with the requisite data.

Prof Rees said that SAHPRA had always encouraged the submission of Ivermectin clinical trials. The data that was needed to evaluate Ivermectin could be provided by a well-designed, well-conducted clinical trial. Regulators around the world were appealing for such trials. There was an application in the United Kingdom for such a trial – a large clinical trial using Ivermectin for the treatment of COVID-19. This was a positive development, because trials of that kind would dissolve the current problems, whereby people had really strongly held views and interpreted the available data differently.

To Ms Ismail’s remarks about the NEMLC, Dr Semete-Makokotlela said that the NEMLC was a credible review committee which considered all available information. The NEMLC recommendations were based on an extensive review of published data, and they reviewed new data continuously to provide regular updates. Similarly, SAHPRA did internal reviews of emerging data, which it used to decide whether it should change its position on products like Ivermectin.

Dr Semete-Makokotlela said that SAHPRA had consulted with medical practitioners and other regulators about Ivermectin. It had indicated that it was willing to engage with such parties and it continued to do so. It had held an open webinar and received information from other regulatory authorities, and it continued to monitor relevant publications and the positions of other regulators. She thought that SAHPRA had taken sufficient steps to ensure that it kept abreast of developments. Prof Rees had already discussed the pressure that medical practitioners were under during the COVID-19 pandemic. Yet for SAHPRA as regulator, what was important was ensuring public safety, and it did this by making decisions based on scientific information. SAHPRA was also helping to ensure that helpful data on Ivermectin was generated by allowing the controlled access programme.

Dr Semete-Makokotlela said that SAHPRA did not inform treatment protocols for various therapeutic indications. Its role was focused on the health products themselves. However, she was sure that NDOH could speak to Ms Ismail’s concern about early treatment recommendations.

Dr Semete-Makokotlela said that her presentation had listed the publications which SAHPRA had considered in evaluating Ivermectin, and SAHPRA continued to monitor all peer-reviewed papers as they were published.

Surgical mesh complications

Mr Deon Poovan, Senior Manager: Inspectorate and Regulatory Compliance, SAHPRA, said that SAHPRA had not received reports of any adverse events related to the use of surgical mesh. It would continue to monitor the situation from a post-market surveillance perspective.

Dr Semete-Makokotlela confirmed that the issue had been raised with SAHPRA and was being monitored.

Follow-up discussion

The Chairperson said that he thought the Committee had received everything it had wanted to receive from SAHPRA. It had received an update on the vaccines and had heard that there was no application for the Cuban vaccine and that the Sputnik vaccine was still being considered. The Committee would like to be appraised by SAHPRA on any new developments, so it would expect to hear about SAHPRA’s progress when new findings were made. He invited Members to ask follow-up questions.

Ms Ismail noted that SAHPRA, as regulator, wanted to remain neutral. In that case, why did it not emulate the American National Institutes of Health (NIH), and say that, given insufficient evidence, it recommended neither for nor against the use of Ivermectin for COVID-19? She was asking because she had been made aware that doctors at certain hospitals had been prohibited from prescribing Ivermectin, even for emergency usage. She was “sceptical” about this. SAHPRA had allowed for the discretionary prescription of Ivermectin by doctors who were willing to take responsibility – yet, in practice, this option was not open to some doctors, who obviously had to follow instructions from the hospital executive. Those doctors’ hands were tied. Where did one go from there? How was this being addressed?

Dr Semete-Makokotlela replied that the NIH was not a regulator. In fact, the FDA was SAHPRA’s regulatory counterpart in America. The NIH had communicated its position about Ivermectin, but, likewise, in South Africa, many bodies had communicated their positions, including the ministerial advisory committee (MAC) and the NEMLC. SAHPRA had communicated its own position as regulator.

Prof Rees said that the regulatory mandate of SAHPRA was closely prescribed by the law. SAHPRA could not deviate from assessing the parameters of safety, quality, and efficacy, within the public interest. For example, it could not consider the price or popularity of health products. That SAHPRA was independent and science-driven did not mean that the ultimate outcome was neutral. SAHPRA’s role was to decide about the authorisation – or sometimes the de-authorisation – of products, based on the available data about safety, quality, and efficacy. It did not decide whether doctors prescribed or did not prescribe products like Ivermectin. It reviewed products which had been submitted for authorisation for a specific indication. Moreover, it could only review what had been submitted to it. In this case, nothing had been submitted, so there was nothing for SAHPRA to approve.

Prof Rees said that SAHPRA had given section 21 authorisation for the importation of the human Ivermectin product in a situation which had clearly been “out of control.” Prior to the authorisation, Ivermectin was being imported illegally, with some of the product contaminated and therefore unsafe. There was also widespread use of the veterinary product, which was intended for very large animals and which people struggled to dose correctly. Section 21 authorisation allowed doctors to prescribe the human product, taking responsibility for doing so, if they believed it might be beneficial for prevention or treatment. By allowing this, SAHPRA intended to create a safer environment for the use of Ivermectin, where doctors could decide for themselves whether they thought there was sufficient data to support its use. However, currently, there was a consensus among SAHPRA, the MAC, the NEMLC, and even the WHO – that there was insufficient data to support the use of Ivermectin for COVID-19, and that better clinical trials were needed. SAHPRA still promised to fast-track any applications for Ivermectin studies or emergency licensure – as it had all COVID-19-related applications – but such applications had not been forthcoming thus far.

Ms Chirwa noted that according to Dr Semete-Makokotlela, the outstanding data on the Sputnik vaccine had been submitted. This had not been made clear to the public. SAHPRA had consistently said that there was data outstanding on the Sputnik application – and indeed, previously, that there had been data outstanding on the Sinopharm application, which Ms Chirwa had been interested in before shifting her focus to the Sputnik process. There was a perception created that the EFF was putting pressure on SAHPRA, but wanting to know about SAHPRA’s process did not qualify as undue pressure. On what dates had the Sputnik data been outstanding, and on what dates had it been submitted to SAHPRA? When had SAHPRA begun to evaluate the data? What data had been outstanding?

Dr Semete-Makokotlela said that there were two applicants for the Sputnik vaccine. The first application had been received in February and the second in April. As she had said, the issue was not just the submission of the data but the quality of the data. SAHPRA issued queries which the applicant had to respond to. Thereafter, SAHPRA analysed the response, and went back with further queries if the response was inadequate. There were numerous rounds of queries with each applicant. The central point was how satisfied SAHPRA was with the data provided by the applicant.

Ms Chirwa interrupted with a point of order. She had asked a very specific and clear question. SAHPRA had said consistently that there had been outstanding data on the Sputnik vaccine. What was that data? When had it been submitted? When had SAHPRA begun evaluating it?

Dr Semete-Makokotlela said that the briefing had described in detail the type of data that SAHPRA requested.

The Chairperson told Ms Chirwa that SAHPRA received data in each of the six steps of evaluation (see slide 10).

Ms Chirwa said that she was asking in relation to Sputnik specifically. She had listened to the briefing and Dr Semete-Makokotlela need not refer back to it. What, specifically, had been outstanding in the Sputnik application?

Dr Semete-Makokotlela said that she would describe the process again, because SAHPRA aimed to educate the public about the detailed investigations it undertook as regulator. SAHPRA looked at safety, efficacy, and quality. At any point, it could issue queries around any of those three elements. Applicants in the sector understood how SAHPRA worked. An applicant would receive a list of queries from SAHPRA – perhaps 10 to 20 queries on each element. As shown in the briefing (see slide 10), SAHPRA evaluated and issued queries about production, including about compliance with good manufacturing practice; later in the process, it evaluated and issued queries about safety, efficacy, and quality. That SAHPRA had received a response to its queries did not mean that SAHPRA would be satisfied.

Dr Semete-Makokotlela said that in the Sputnik applications there had been data outstanding on all three elements – safety, efficacy, and quality. There were two applicants for the Sputnik vaccine, being dealt with separately, and their applications were at different stages. She did not have the relevant dates on hand, although she would be happy to provide them in writing. However, there were some matters that SAHPRA could not disclose, because some parts of every application were confidential. Only the applicants themselves could disclose that confidential information.

Ms Chirwa said that she was very concerned about SAHPRA’s position on surgical mesh. Numerous countries had banned the mesh, including New Zealand and Scotland, and authorities in the United Kingdom had warned against the mesh, especially transvaginal mesh. Countries like Scotland and Australia were doing free corrective surgery in cases where hernia and transvaginal mesh had been used. The problems with the mesh were known globally, and there had been many studies and publications. SAHPRA was a regulatory body, and Prof Rees claimed that it had strong relationships with foreign regulators – but foreign regulators had banned or flagged the mesh, while it remained in mainstream use in South Africa. NDOH was even involved in litigation with South African citizens who had suffered related surgical complications. SAHPRA should know more about this than any Members. She was aware of it because she had been alerted to the case of a person who was being refused corrective surgery. It “raised eyebrows” that SAHPRA said they were not aware of any adverse effects. SAHPRA should have gone out and found the information and publications. How was it possible that SAHPRA did not know about it? What should be the next step, and how could the Committee take the matter further? She was unhappy with SAHPRA saying that they were not aware of adverse effects – how could the public trust SAHPRA to monitor other health products?

The Chairperson suggested that the Committee should give SAHPRA “the benefit of the doubt.” There had been no complaints to SAHPRA from the users of the surgical mesh. Instead, the Committee could meet with a surgical society, and speak to the surgeons themselves.

Ms Chirwa said that that could be an alternative route. However, she was asking her question of SAHPRA, who should not be able to say that they did not know about the adverse effects of the product.

The Chairperson suggested that later in the meeting, Ms Chirwa could also raise her concern with the Minister of Health and see how the surgeons viewed the matter.

Dr Semete-Makokotlela said that Ms Chirwa was correct that there had been developments around surgical mesh in other countries. But it was important for SAHPRA to work within its jurisdiction, and it had not received any specific safety reports. In the meantime, it could assess what was happening elsewhere, and it was doing so. For example, it was looking at the foreign surgical mesh products and their manufacturers – were they exactly the same products that SAHPRA had authorised for use in South Africa? There were multiple surgical mesh products, and SAHPRA dealt with them through multiple applicants. It was crucial to get the details in such matters, which was why Mr Poovan had emphasised the importance of waiting to receive a specific complaint. Once it received specific complaints, SAHPRA would know which applicant it needed to deal with, and it would certainly act. So it was not the case that SAHPRA was not aware of the matter – it had the information to which Ms Chirwa referred. However, it had not received any specific reports of any adverse effects from users in South Africa.

The Chairperson said that Members should write to SAHPRA if they felt their questions had not received adequate responses.

Mr Shaik Emam said that he had a follow-up question.

The Chairperson said that Mr Shaik Emam had arrived late to the meeting and had been given the opportunity to ask questions anyway. Now he was asking to disrupt the meeting again, though he had not responded when the Chairperson had asked which Members wanted to ask follow-up questions.  

Mr Shaik Emam said that he would not ask his follow-up question. There was never “justice” in the health portfolio, so he would not waste his time and energy.

The Chairperson said that he would not prevent Mr Shaik Emam from asking his question. He was merely pointing out that Mr Shaik Emam had been offered the opportunity earlier alongside other Members.

Mr Shaik Emam said that he thought he had raised his hand on the virtual platform. He would rephrase his earlier question, which SAHPRA had not answered. SAHPRA claimed to be independent, yet it had allowed vaccines to be procured in South Africa without any section 21 application and without SAHPRA authorisation. SAHPRA was not being consistent and it was not telling the truth. Why had it initially allowed vaccines to be brought into the country without evaluating, registering, and approving those vaccines? He was concerned about SAHPRA’s independence.

Dr Semete-Makokotlela replied that she would need Mr Shaik Emam to provide details. SAHPRA certainly had not operated in that way. All the vaccines that had been procured had been approved by SAHPRA. As reflected in her briefing, the first authorisation had been made under section 21 for AstraZeneca, for which NDOH had applied. Subsequently, SAHPRA had approved Pfizer, J&J, and now Sinovac. SAHPRA had been very consistent and clear in its role as regulator – it assessed health products without bias. It did not concern itself with the procurement of vaccines. It considered every application it received, and did not decide which vaccines were ultimately procured. However, NDOH had not procured any vaccine that did not have SAHPRA authorisation.

The Chairperson said that Mr Shaik Emam needed to separate authorisation and registration, for which SAHPRA was responsible, from procurement, for which it was not responsible.

Mr Shaik Emam said that SAHPRA was misleading the Committee again. He was talking about the AstraZeneca vaccine. As all Members knew, Minister Zweli Mkhize had admitted that NDOH had procured the AstraZeneca vaccine before it had been registered and authorised, and even before any section 21 application had been made. Minister Mkhize had told the Committee that he planned to apply to SAHPRA, and he had done so only while AstraZeneca was arriving in the country. This issue had been brought up 20 or 30 times, and SAHPRA knew what he was talking about. He would rephrase his question: would SAHPRA “resign” if he proved that SAHPRA had attempted to mislead the Committee?

Dr Semete-Makokotlela replied that Mr Shaik Emam’s question seemed to concern procurement. As the Chairperson had said, SAHPRA was not involved in procurement – SAHPRA authorised vaccines. She thought her earlier response still stood.

Prof Rees agreed that Mr Shaik Emam seemed to be raising a procurement issue. However, no vaccines could be rolled out unless they had SAHPRA approval. That was “an absolute given.”

Prof Rees said that SAHPRA understood that people had a variety of views, to which it had to listen and respond. However, statutory bodies were key to any democracy. Their integrity, reliability, and public image were “absolutely essential.” As she had said earlier, the public was probably starting to understand SAHPRA’s work and its importance more than ever before. It was crucial that the public had faith in the regulatory body. So it was important that SAHPRA answered Members’ questions with complete honesty, recognising shortcomings where appropriate and following up in writing if necessary. She encouraged Members to submit written questions, such as Ms Chirwa’s question about the surgical mesh.

At the same time, however, the work and the independence of statutory bodies were very important, especially in the context of a pandemic. It was important for Parliament to feel confident that SAHPRA was serving its purpose. She therefore wanted to ask Members to be very careful in how they expressed themselves – for example, in claiming that SAHPRA was not telling the truth. Such modes of expression might be politically valuable to MPs, but it was difficult for a regulatory body to respond to such accusations. SAHPRA was certainly telling the truth to the Committee and to the public. It would always come forward and own up to any mistakes or omissions. She chaired the SAHPRA board. The executive, staff, and expert advisors did the technical work, but the board had ultimate oversight, and the board was responsible for ensuring that the executive was delivering. The board recognised that the staff, expert advisors, and Dr Semete-Makokotlela had been working “incredibly hard,” despite all the pressure on SAHPRA. It was quite possible that SAHPRA did not get everything completely right, and it had to keep evaluating its work and trying to improve. But it was trying to honour its mandate, with a lot of hard work and integrity. It was important that SAHPRA did its work, that the board oversaw its work, and that Parliament and the Committee were convinced that it had indeed been “outstanding” over the course of the pandemic.

The Chairperson encouraged Members to write to SAHPRA if they had any remaining questions and concerns. However, Members should give SAHPRA its due, and should not suggest that SAHPRA lacked integrity. They should express their concerns to SAHPRA in writing. He was glad that Mr Shaik Emam had received a letter from SAHPRA and NDOH, which he had said he would look at and which hopefully addressed some of his concerns. The Committee would continue to engage with SAHPRA. The Committee and SAHPRA needed each other, and they had to find a way to work together “cordially.”

The Chairperson said that the bottom line was that there was science and there were emotions. Members were concerned that certain products could save lives – but that was why doctors had been allowed to prescribe at their discretion, provided they were prepared to take responsibility. SAHPRA was saying that it could not yet make a conclusion about Ivermectin’s safety, efficacy, and quality, and that it was still trying to get the requisite data. Why should Members ask SAHPRA to compromise on its requirements? He had heard that there was now a debate about the relative merits of Ivermectin and vaccines. In handling such issues, Members had to understand that though they might not like what SAHPRA had to say about Ivermectin, SAHPRA was only saying what the science guided it to say. The Committee would have SAHPRA return to provide an update on the vaccine pipeline – especially on the applications still under review. The country needed access to as many vaccines as possible, so that it could reach herd immunity quickly.

Dr Semete-Makokotlela said that SAHPRA appreciated the Committee’s invitation and the opportunity to engage in “robust discussion.” Parliament and the Committee had to hold SAHPRA accountable. If any questions had not been adequately answered, Members should write to SAHPRA.

Dr Semete-Makokotlela added that SAHPRA had laid a complaint with Parliament. She requested a response to that complaint.

Prof Rees agreed that there had rightly been “robust debate.” In a pandemic, many things were happening very fast. SAHPRA had to keep up with those developments while also taking into account what the public health interest was in the current context. She urged Members to raise any questions and concerns in writing, and SAHPRA would happily respond. Finally, she expressed SAHPRA’s support for NDOH’s efforts in the vaccination roll-out. SAHPRA understood that it was crucial to make COVID-19 vaccines available and to roll them out as quickly as possible, to as many people as possible.

The Committee adjourned for a break.

Opening remarks by the acting Minister

The Chairperson welcomed the Ministry and the NDOH delegation. Their fortnightly briefings provided the Committee with updates on the COVID-19 vaccination roll-out and other relevant issues, such as the delta variant.

Ms Mmamoloko Kubayi, acting Minister of Health, said that she had understood that the current briefing would cover the vaccination roll-out, not the pandemic more generally – she hoped her understanding was correct. Members would be aware that NDOH had made progress in the vaccination roll-out since its last meeting with the Committee. The roll-out was “ramping up,” and it had passed the milestone of vaccinating 5 million people. As others had correctly pointed out, this was still not sufficient – it represented only a small proportion of the population. However, NDOH thought that it was improving very well. With registration opened to the general population over the age of 35, there had been over 1 million registrations within 24 hours. This age group was not waiting, but was immediately presenting itself for vaccination. Their enthusiastic response had added a “positive spin” to the roll-out, and was helping to remedy vaccine hesitancy issues. Evidently, this age group was willing to take the vaccination programme “to another level.”

Minister Kubayi said that since its last meeting with the Committee, NDOH had launched the roll-out of vaccines to the security cluster – the military, the police, correctional services, and so on. Department of Social Development (DSD personnel were also being included in the roll-out. Occupational health services programmes had also commenced. However, NDOH was seeing that targeted vaccine programmes – sectoral programmes – required a lot of administrative work. It was demanding to prepare the programmes and verify the data to ensure its reliability. NDOH was now thinking about changing its approach. Instead of proceeding on a sectoral basis, it would ensure security of vaccine supply so that it could quickly open the roll-out to the next age cohort. NDOH had learnt from the sectoral programmes it had organised so far, and its experiences had prompted it to consider the best way forward. On the following day, it would present some recommendations to the inter-ministerial committee (IMC) – though it could not reveal those recommendations publicly until they were approved by cabinet.

NDOH was beginning to monitor the performance of districts and provinces. Engagements with premiers and Members of the Executive Council (MECs) for local government and health, organised through the Presidential Coordinating Council, were very helpful. Following an engagement last week, NDOH was seeing that provinces were beginning to focus more rigorously on their vaccination programmes.

However, as she had said, there was still a lot to be done in rolling out vaccines. NDOH would continue to brief the Committee with updates, accounting for the progress it made and explaining any changes to its strategy. Dr Nicholas Crisp, Deputy Director-General: National Health Insurance, NDOH, would be leading that day’s presentation. The Director-General was also present – he had not been planning to join, but his meeting with the provincial teams had finished early.

Minister Kubayi added that the recent unrest had affected the vaccination roll-out in KwaZulu-Natal. NDOH had had to halt vaccinations in some places. That decision had been necessary – NDOH needed time to understand the situation and its impact, and to ensure the security of the vaccines. It had wanted to avoid vaccines ending up in the wrong hands, and also to avoid losing stock of vaccines when people could not travel to the vaccination sites. Vaccinations had since resumed in KwaZulu-Natal and also in Gauteng, where vaccinations had halted for only one day. The unrest had had other effects on health services. It had affected facilities which supplied or distributed medicines, and it had affected people’s access to hospitals, where they received medicines or treatments like dialysis. NDOH had been able to forestall oxygen shortages by using police escorts to secure the distribution of oxygen to hospitals. It had engaged the security cluster on various matters where intervention or support was needed, and it continued to do so. NDOH continued to work on quantifying the effects and losses of the unrest, especially in KwaZulu-Natal. It had a general sense, but the specifics were not yet finalised, because the situation was still being assessed at some sites.

Minister Kubayi appealed to the public to be careful with any black-market medicines – those medicines might be contaminated and therefore dangerous. The public also had to be careful in interacting with people who had been involved in looting, some of whom would be infected with COVID-19. If people had symptoms, they should present themselves for testing, so that the delta variant could be contained in KwaZulu-Natal. NDOH worried about the likely effects of the gatherings. Increased case numbers would probably be seen within the next two weeks, given the virus’s incubation period.

NDOH briefing: COVID-19 vaccination roll-out

Dr Crisp made the presentation on behalf of NDOH. He said that as of that morning, 5 572 352 vaccines had been administered – 1 027 697 J&J vaccines and 4 544 655 Pfizer vaccines, including 873 533 second-dose Pfizer vaccines. He discussed in detail the vaccination trends across provinces and districts (see slides). The unrest in KwaZulu-Natal had had visible effects, slowing the vaccination rate in the province. All provinces were doing what they could to support KwaZulu-Natal in recouping the “lost opportunities.” Nationally, more sites were beginning to operate, and some with the requisite capacity were beginning to administer vaccines on weekends.

Dr Crisp said that 7.85% of the population had received a vaccine, meaning that the proportion had doubled over the last three weeks. He discussed vaccine coverage in each province (see slides). NDOH monitored these figures in order to intervene with assistance if a given province or district lagged behind. Currently, coverage was lowest in Mpumalanga (5.03%), the North West (5.84%), and the Northern Cape (6.83%); it was highest in the Western Cape (10.45%), the Eastern Cape (9.75%), and Limpopo (8.9%).

17.8% of the insured population and 6.09% of the uninsured population had been vaccinated. This disparity was concerning on equity grounds. However, it was at least partially explained by the high concentration of private sector sites in urban areas, where insured people tended to reside, and by the fact that the programme had thus far targeted many public sector employees, who were mostly insured.

Dr Crisp also reported on the sectoral vaccination programmes. 244 996 public healthcare workers (68.61%) were fully vaccinated, as well as 439 632 education workers (53.2%), 5 093 South African Defence Force (SANDF) personnel (7.08%), and 24 692 South African Police Service (SAPS) workers (13.19%).

Currently, NDOH was vaccinating close to a million people every four days. By the end of next week, it aimed to vaccinate close to a million people every three days. At that rate, 35 million people would receive at least one dose of the vaccine by Christmas.


Ms Gwarube said that she knew that there was reluctance to quantify the damage done by the unrest over the last week. However, it would be helpful for the Committee to have some sense, especially since communications were generally centralised through the Presidency. The South African Pharmacy Council said that at least 131 pharmacies had been destroyed, 80% of them in KwaZulu-Natal. Obviously, this would lead to a situation in which hundreds of thousands of people were unable to access their medications. What was NDOH’s initial understanding of the damage? More importantly, what were the concrete plans for getting those facilities operating again, especially for people with chronic illnesses who needed to access their medications?

Dr Crisp replied that NDOH estimated that over the past week or 10 days, about 250 000 vaccinations had been lost. That estimate was based on the number of people that the provinces had been vaccinating daily before the disruptions. As Minister Kubayihad said, NDOH was still receiving reports about the effects on the vaccine supply. It looked as though about 25 000 doses of the vaccine had been lost to theft or destruction. In terms of infrastructure and delivery, Ms Gwarube was right that many private pharmacies had been damaged. Not all of them were vaccination sites, but patients obviously used them to access other medications, so it was still concerning to NDOH. One bulk store, containing some of the 25 000 lost vaccine doses, had been completely gutted and emptied. Those were the medicines that NDOH was concerned might enter an illicit market. There had been substantial losses in medicines other than vaccines – the private sector might have lost as much as a third of the medicines stored in the province. It would take time to recover those losses. The vaccine losses were not huge, but every lost vaccine was obviously a lost opportunity to vaccinate somebody.

Ms Gwarube asked about NDOH’s projections for COVID-19 cases. There had been large gatherings, during the unrest and also in earlier weeks, in KwaZulu-Natal and Tshwane, and large movements of people not only within provinces but also across provincial lines. Did NDOH project an increase in infections? How did it plan to deal with any such increase? Was there a targeted approach to try and accelerate the vaccination programme, especially in the affected provinces of KwaZulu-Natal and Gauteng?

Dr Crisp replied that the impact was “anybody’s guess.” The modellers had looked at it. NDOH did expect to see a spike in infections for the reasons that Ms Gwarube mentioned, but it did not know how big the spike would be or when exactly it would arrive. It would likely arrive seven to ten days after the gatherings.

Ms Gwarube noted that “just over 60%” of public healthcare workers had been fully inoculated against COVID-19. Of course, NDOH had said months ago that it wanted to inoculate all 1.2 million people in the healthcare sector before moving on to other population groups – so that 60% figure was quite low. Why was this? Was the problem about vaccine hesitancy, or about access? What was NDOH’s plan to deal with it? She would have assumed that at least 80% of healthcare workers would be vaccinated by now, making allowance for those who chose not to receive the vaccine.

Following from Ms Gwarube’s question, Mr Sokatsha asked whether there were still outstanding healthcare workers or frontline workers who had not come forward to be vaccinated. If there were, what was NDOH’s plan to ensure that such workers were covered?

The Chairperson said that he had wanted to ask the same question. However, he corrected Ms Gwarube: 76% of public healthcare workers had been vaccinated, and 68.61% – not 60% but closer to 70% – had been fully vaccinated. That figure was quite high, but naturally it would be desirable to vaccinate all healthcare workers, given their high exposure to the public. In what timeline did NDOH expect to vaccinate the balance of the healthcare workers? NDOH likely did not expect to ever reach the 100% mark – as Ms Gwarube had said, some people would probably be reluctant to receive the vaccine.

Dr Crisp replied that many healthcare workers did not register for vaccination as healthcare workers – they just got vaccinated as part of the general population. NDOH could only confidently measure the vaccination of public healthcare workers, because for that segment it could cross-check a worker’s ID number and PERSAL number to ascertain his vaccination status. NDOH would obviously continue to target the 24% of public healthcare workers who had not presented themselves for vaccination. Private healthcare workers could access a portal for registration. NDOH had had to close the original portal, because thousands of people were registering and NDOH had been unable to confirm which were genuinely healthcare workers. Some months ago, an expanded definition of healthcare workers had been published, and people fitting into that definition made up the balance of the 1.2 million. On its system, NDOH had recorded that it had vaccinated just over 900 000 people who declared themselves to be either public or private healthcare workers. So it still had some way to go to reach the remainder of the sector – there were maybe around 300 000 outstanding healthcare workers – and it encouraged such people to come forward and get vaccinated.

However, Dr Crisp said that NDOH understood that vaccine hesitancy was an issue even among healthcare workers. It would take hard work to reach those recalcitrant workers. NDOH did not know why they had not come forward, but it had no reason to suspect that their reasons were any different from those of the general population – religious reasons, for example, and fears about the vaccine. Studies had recently been published from outside the healthcare system, including the quarterly reports from the Human Sciences Research Council and various universities. There would always be some portion of the population who just did not want to be vaccinated.

Ms Gwarube said that the population categories used by the NDOH had changed. Initially, there had been a focus on people with comorbidities, incarcerated people, and so on. Now teachers and SAPS personnel, as well as people over the age of 35, were being targeted. Where did NDOH stand on targeting people with comorbidities, in line with the science and the risk factors? It seemed as though the initial strategy had been “tossed away,” and that the current strategy was to “move down a list” according to age without any clear plan for high-risk groups like incarcerated people.

Ms Chirwa said that there were also reports that journalists had been cleared for vaccination. Her concern, which she thought had been raised previously, was about people with comorbidities. NDOH seemed to be digressing further and further from the WHO’s guidelines for prioritising certain groups in the roll-out. Why would NDOH prioritise “a desktop writer” over someone with cerebral palsy, for example? Or over cashiers and petrol attendants, who should also be prioritised as frontline workers? She was not saying that journalists, or any other groups, were unimportant. But the conversation about priorities was only necessary because the country was “scrambling” for vaccines – a situation for which NDOH, as part of the current administration, was directly responsible.

Dr Crisp replied that there was now a lot of evidence – which Dr Anban Pillay had presented to the Committee in the past – that age was, by far, the single most important factor in predicting severe infection and hospitalisation, even more important than any comorbidity. Both domestic and international evidence, including evidence from the National Health Laboratory Service (NHLS) and National Institute for Communicable Diseases (NICD), showed that people over the age of 50 were more vulnerable than younger people with comorbidities. Even many people over the age of 40 were more vulnerable than younger people with comorbidities. As NDOH had learned from the experience of other countries, the central challenge was to go as fast as possible, and not to burden the roll-out with a lot of administratively difficult sectoral programmes. The key was to roll out as fast as possible and get to a stage where a million vaccines were being administered every three days, so that everybody could be reached. Moreover, it impinged on people’s privacy to ask them to prove publicly that they had comorbidities. It was also very easy to forge the relevant paperwork. Such an approach resulted in an “administrative nightmare,” with people “pointing fingers” at one another. For that reason, the roll-out was now based on age, targeting older people first. The programme was being opened to people over the age of 35, and he was sure that there would be a subsequent announcement about how NDOH was going to deal with the last age cohort.

Minister Kubayi said that at the beginning of the vaccination programme, NDOH had had certain plans. But when it had begun implementing and delivering on those plans, it had become very clear that certain aspects would be “practically impossible” to implement. That was what had necessitated NDOH going back to the drawing board to review the plan. NDOH had wanted the vaccination roll-out to prioritise citizens of all ages who had comorbidities. But when it had begun rolling out, and in engagements with practitioners on the ground, it had become clear that it would be difficult to define and identify persons with comorbidities. Similarly, NDOH had planned sectoral programmes. But when the first sectoral programmes began, and NDOH evaluated them, it realised that sectoral programmes required a huge amount of administration – almost four weeks worth of work, depending on whether the sector had reliable data for its personnel. It needed data to identify and verify individuals in the sector, and then to allocate them to nearby vaccination sites. NDOH had realised that it was not in its interests to roll out this way – it was not efficient or effective. In fact, it was time-consuming, and it hindered a mass roll-out of the kind that would ensure the numbers that NDOH wanted.

So NDOH planned to meet with the IMC on the following day, and to appeal to and persuade the IMC to collapse the current approach, based on sectors and other categories, in favour of rolling out to age-based population cohorts. NDOH believed that was the most efficient way of rolling out, and preparing for it required less administration. Such an approach also removed the burden of deciding who to prioritise and why. Ms Chirwa said that there was a call for media personnel to be vaccinated, and others sought to prioritise the religious sector, the retail sector, petrol attendants, municipal workers, or other groups. There were many competing demands. For one example, retail workers were frontline, because they interacted with customers every day. But where would NDOH get the requisite data from – how would it capture and verify it? How would it ensure that workers in the informal retail sector were not left out?

Minister Kubayi concluded that these were lessons that NDOH was learning as it rolled out the programme. NDOH was trying to find inclusive mechanisms that would ensure the equitable spread of the vaccine, giving each South African an equal opportunity to get vaccinated. The Committee would forgive NDOH if it had to change plans that it had reported on earlier. As she had said in a previous meeting, NDOH would endeavour to explain and justify any changes to the Committee. NDOH appreciated receiving feedback from practitioners on the ground, who told it what would or would not work, and from members of the public, who told it what they had or had not found easy at the vaccination sites.

Ms Hlengwa conveyed her condolences to Minister Kubayiand the ANC for the death of Ms Maluleke and her husband.

Ms Hlengwa asked whether NDOH knew of any fully vaccinated people who had been hospitalised with COVID-19. If so, how many, and in what age group? Was SA at risk of experiencing a spike in infections among vaccinated people, as was being seen in the United States and United Kingdom? If so, had any steps been taken to minimise infections among vaccinated people? How was NDOH minimising doubts about the vaccine and encouraging people to get vaccinated?

Dr Crisp replied that NDOH did not have an accurate figure for the number of hospitalisations among fully vaccinated people, but it had received anecdotal reports. An NICD team was investigating the reports, cross-checking the ID numbers of hospital patients with their status on the electronic vaccination data system (EVDS). Once that information had been verified and analysed, NDOH would be able to supply the information, including with a breakdown by age group.

Dr Crisp said that vaccinated people could be infected with and spread the virus, though fortunately they were likely to contract only mild infections. This meant that, to protect everybody from COVID-19, non-pharmaceutical interventions were still needed. In line with the global norm, NDOH advised people to continue to follow protocols around masking, social distancing, and hand-washing. NDOH also had a joint programme with GCIS to provide information to the public, including through a myth-busting website. It just needed to publish the details more prominently so that everybody knew where to find the information.

Minister Kubayi said that anti-vax movements had been getting a lot of attention, though she was not sure why. One had to continuously emphasise that it was a democratic right for South Africans to decide whether to get vaccinated. NDOH had decided that it would not force people to get vaccinated. At the same time, NDOH appealed to the public that if they decided not to get vaccinated, they should nonetheless respect the decision and democratic right of others to get vaccinated. She was seeing quite a lot of stories about people who had experienced side-effects, or had even been hospitalised, after receiving the vaccine. People were sharing stories on both sides. One had to continuously emphasise that a vaccinated person might still contract COVID-19 – but that the vaccine reduced the likelihood of getting severely ill or dying. The government had to be very clear in its messaging. Non-pharmaceutical interventions remained important precisely because the vaccine did not prevent all infections. NDOH also appealed to the public to report to the authorities if they experienced side-effects, especially severe side-effects, after receiving the vaccine, or if they knew someone who had died after doing so. That way, a proper investigation and analysis could be conducted, and the additional data would assist scientists to reach proper conclusions.

Minister Kubayi said that NDOH continued to provide information to the public. Members would recall that at a past media briefing NDOH had had Prof Glenda Gray present the findings of an investigation. NDOH observed, and wanted to caution against, a rise in “fake news”. She appealed to South Africans to be cautious, because some anti-vax people created fake posts to discourage others from receiving the vaccine. She urged people to verify the information they saw and to reach out, even if that meant taking a walk to the nearest health facility to get properly informed. NDOH’s website hosted a list of frequently asked questions with answers, which was being continuously updated and which the public could consult. NDOH would continue to do its best to use media briefings and so on to inform the public of any dangers or of any precautions they should take. For example, one question which NDOH frequently answered was about when somebody should get vaccinated if he has tested positive for COVID-19. NDOH was trying to ensure that people were properly informed to make the right decisions. It also encouraged people to disclose their medical information to the health practitioners at vaccination sites, so that they could receive proper advice.

Mr Sokatsha asked about NDOH’s vaccination targets. Was NDOH meeting its targets? If not, was there any plan to ensure that it did so?

Dr Crisp replied that NDOH was definitely meeting its current targets. Last week it had aimed to reach 200 000 vaccinations daily, and had reached 191 000. Its current target was to reach 250 000 vaccinations daily by the end of the week, and it had already exceeded that target. So NDOH was confident that the programme was scaling up as anticipated. It had also been comparing its programme with the programmes of other countries, and its scale-up was very competitive. The current scale-up was ranked somewhere around 52nd out of 255 countries. NDOH was very happy with that and it was inspired by its achievements to move even faster.

Mr Sokatsha asked if NDOH had any expired vaccines. If so, what was it doing with those doses?

Dr Crisp replied that there had only been one incident, arising from an error some weeks ago. A small batch had been provided to a private hospital for vaccinating a mining community, and some of those doses had expired. However, expiry dates were known to NDOH and reflected on the stock visibility system. Normally, when pharmacists saw that doses were approaching their expiry date, those doses were moved to a high-volume area so that they could be used timeously.

Mr Sokatsha said that he was very happy to hear that NDOH was intervening in provinces whose vaccination programmes were not doing well. He guessed that most of the uninsured population lived in rural and distant areas of the country. What was NDOH doing to reach out to people in rural areas? He was impressed by the approach in Limpopo, where officials went out to reach people in the villages.

Dr Crisp replied that interestingly, NDOH found it most difficult to reach uninsured people in urban areas, particularly in urban townships and informal settlements. As reflected in his briefing, Limpopo and the Eastern Cape were doing “incredibly well,” including in vaccinating uninsured people, and uninsured people in rural areas. It seemed that it was more difficult to mobilise people in urban areas. NDOH believed that the younger population would be more likely to engage with the roll-out, and time would tell whether that was correct. NDOH also appealed to younger people to motivate their elder relatives and bring them along to be vaccinated.

Ms Chirwa said that a Sinovac representative had appeared on Power FM last week – she thought on 16 July. The representative had said that NDOH had not honoured its commitment with Sinovac regarding the delivery of vaccines – an initial 2.5 million vaccines, and then a subsequent 7.5 million. What was the commitment or agreement between NDOH and Sinovac? Given the country’s “dire, desperate need” for vaccines, why had NDOH and the Ministry not honoured that commitment? She also asked for an update on the Sinopharm vaccine. SAHPRA had reported that the Sinovac and Sinopharm vaccines had both been approved. In February, there had been high-level engagements between Sinopharm and NDOH. What was the situation now? Had NDOH decided to eschew the Sinopharm vaccine in favour of the Pfizer and J&J vaccines? This was important, given that both Sinopharm and Sinovac had been approved, and given that NDOH had failed to honour its commitment to Sinovac.

Dr Crisp replied that Sinovac had conditional registration with SAHPRA. Now, the Sinovac vaccine had to go through the internal process that was followed for all medicines and vaccines. A committee within NDOH looked at all essential medicines and made a recommendation, which was parlayed into the procurement process. The company had been in touch with NDOH in the previous week, and hopefully that would expedite the process.

Dr Sandile Buthelezi, Director-General, NDOH, added that NDOH had never had any commitment to Sinovac. If there had been any such agreement, it would have been signed by his office, since he was the authorised signatory of NDOH. There was no agreement. NDOH’s internal committee was processing the matter, and NDOH would take the next step once it had received that committee’s recommendations.

Dr Joe Phaahla, Deputy Minister of Health, added that, as far as NDOH knew, Sinopharm had not met SAHPRA’s requirements. Ms Chirwa was therefore incorrect in saying that Sinopharm been approved by SAHPRA.

Ms Chirwa said that there were reports that the delivery of J&J vaccines had been delayed. What were the reasons for this, and what interventions were being made? How had the delays affected the roll-out to rural areas and to other areas in which NDOH had prioritised J&J over other vaccines?

Dr Crisp replied that the J&J supply had been restored. He thought everybody was aware of what had happened with the foreign stock contaminated abroad. But NDOH believed that it was now on top of the situation, and J&J had begun to provide NDOH with delivery schedules.

Following up, Ms Chirwa said that she did not feel her questions had been answered. She had wanted to know why NDOH and the MAC on vaccines (VMAC) had not taken up Sinovac’s offer to provide vaccines to South Africa. Sinovac had offered 10 million vaccines, with 2.5 million delivered immediately upon procurement. Sinovac had prioritised South Africa because of China’s good relationship with South Africa through BRICS. Why had Sinovac’s offer not been taken up? It was not sufficient for NDOH to explain what was going to happen – she wanted to hear why there had been delays up to now. Was the delay because the MAC had not met, or because NDOH had focused on procuring J&J vaccines? Why was NDOH waiting on J&J, whose deliveries had been delayed, while Sinovac was offering 2.5 million doses immediately? NDOH could not even provide the anticipated J&J delivery dates to the Committee and to the public. This was a blatant example of the government’s bias in favour of J&J, which the EFF had raised many times. NDOH had been “crying” over obstacles to African vaccine procurement created by Western countries – but instead of taking up Sinovac’s offer, it was waiting for J&J.

The Chairperson cautioned Ms Chirwa that her remarks were becoming repetitive.

Ms Chirwa said that she also wanted an update on Sinopharm, because the Sinopharm process had been at an advanced stage in February. NDOH delegates should answer her questions as she had asked them and ask her to clarify her questions if necessary.

Minister Kubayi replied that if Sinovac had offered a donation, she would have received that offer, as acting Minister of Health. She had had bilateral meetings with the Chinese ambassador, and could confirm that there had been no such offer. She could explain the process that was followed.

Ms Chirwa interrupted, saying that she had not mentioned a donation. She had said that Sinovac had 2.5 million doses available for South Africa.

The Chairperson admonished Ms Chirwa not to interject while Minister Kubayiwas speaking.

Ms Chirwa said that she was just clarifying her question, because she did not want to be misunderstood.

Minister Kubayi asked Ms Chirwa to wait until she had finished speaking, so that Ms Chirwa could understand her answer.

The Chairperson told Ms Chirwa not to speak until she had heard the full response to her question.

Minister Kubayi said that Sinovac had not made any offer. She was beginning by clarifying that there had been no donation offered, because Ms Chirwa was not the first person to allege publicly that there had been some offer from Sinovac. There was quite a lot of “misinformation,” and the narrative tended to switch between an offer for donation and an offer for sale, so she would clarify in both regards. Parliamentary committee meetings were not just for MPs, and NDOH had to clarify broader issues too.

Minister Kubayi said that once a vaccine had been conditionally approved by SAHPRA, it went to the VMAC, who provided advice to NDOH. On Sinovac, NDOH had not received a final recommendation from the VMAC. She had urged the VMAC to understand the urgency of the matter. NDOH had been in contact with the VMAC, asking for updates as soon as possible, and the VMAC had provided assurance that the work was being done. Once the VMAC had made its recommendation based on the available data, NDOH passed the recommendation onto the National Coronavirus Command Council (NCCC). After that, the internal NDOH processes, led by Dr Buthelezi, kicked in. So Ms Chirwa could not rightly say that NDOH was sitting with information about Sinovac – whether relating to an offer or to a donation – that it was not processing. Sinovac had to be processed in line with the proper procurement and contracting process.

Minister Kubayi thought that there was misinformation spreading which implied that NDOH was deliberately “stalling” or not procuring certain vaccines. She wanted to clear that up now. NDOH was “desperate” for vaccines, and wanted to vaccinate everybody in the country. It had surpassed 250 000 vaccinations daily, and – in driving towards 300 000 vaccinations daily – it wanted to ensure the security of its vaccine supply. But it could not surpass the proper processes. If NDOH was seen to give preferential treatment to a company that was aligned to South Africa ideologically, or that was a “friend” to South Africa, it would be accused of putting South Africans’ lives at risk and of privileging its friendships above its people’s lives. It was crucial for the government to be consistent and to follow the proper process. SAHPRA had briefed the Committee on its processes and NDOH was now updating the Committee on the current situation. She assured the Committee that NDOH was not dedicated to procuring one or two particular vaccines – it needed any vaccine that would save South Africans’ lives. The minute the VMAC process was finalised, NDOH would start working on the Sinovac procurement.

Minister Kubayi confirmed that, to her knowledge, SAHPRA had not approved the Sinopharm vaccine.

Minister Kubayi said that there had been a delay in receiving a delivery schedule from J&J. However, the schedule had now been received and NDOH was expecting a delivery by the following week. When she took up the health portfolio, she had written to J&J and Pfizer to obtain their commitment to a delivery schedule. Initially, the companies had been committed to providing a certain number of doses each quarter. Now, however, NDOH needed to know the exact dates of delivery, in order to plan properly and to confirm that it could roll out vaccines at a given pace. NDOH also wanted the vaccines to be front-loaded, to prevent any delay or disruption to the roll-out. She could confirm that NDOH had received delivery schedules from both J&J and Pfizer.

Ms Chirwa said that earlier in the meeting, SAHPRA had said that it had not received any complaints about complications arising from the use of surgical mesh. In fact, it transpired that SAHPRA had thereby “misled” the Committee. She was in contact with a Ministry official, who said that she had been in constant communication with SAHPRA, raising the issue of surgical mesh complications with it. So SAHPRA had “effectively lied” in saying that it had not received any communications about such complications. Other countries – such as New Zealand, Australia, and Scotland – were offering free surgical removals. Yet in South Africa, the mesh, especially transvaginal surgical mesh and hernia surgical mesh, was still being used in mainstream procedures. Why had NDOH not informed SAHPRA about this very important global phenomenon? There was related litigation against NDOH, yet it had not even informed the regulatory body. If SAHPRA had indeed been informed, that was a different conversation, and she would deal separately with the issue of SAHPRA lying to the Committee.

Dr Buthelezi replied that it would be very difficult to comment, since NDOH had not been party to the meeting with SAHPRA. It would have to follow up on the matter.

Ms Chirwa asked for an update on Ketlaphela. Biovac would reportedly be producing the Pfizer vaccine. Why could the state-owned pharmaceutical company not do so? Moreover, what was Ketlaphela’s status more generally?

Dr Crisp replied that a pharmaceutical company was not the same as a vaccine manufacturer – working with biologicals was quite a different process. Both Ketlaphela and Biovac were important to the sustainability of South Africa’s pharmaceutical supplies. South Africa needed both – it was not an “either-or” situation. Biovac was in fact also partly state-owned, and NDOH was very happy that Biovac had “passed the test,” with the WHO and partner companies satisfied that it had the domestic capacity to manufacture vaccines for the continent.

Dr Buthelezi confirmed that the state owned 47% of Biovac. It was possible that by the end of the year, the state could become, through the Department of Science and Innovation (DSI), a majority stakeholder in Biovac.

Deputy Minister Phaahla added that the Ketlaphela project was still ongoing under DSI. It had the support of NDOH and the whole of government, but it was a complex matter, managed within DSI. Government could not go into manufacturing medicines alone. So, as far as NDOH knew, DSI continued to talk to various manufacturers to look for possible partnerships, and to work with National Treasury and the Department of Trade, Industry and Competition (DTIC) to plan how the project should be managed once potential partners were found.

Ms Chirwa followed up, feeling that her question had not been answered. She had asked for a “diagnosis” of the current status of Ketlaphela. Was it operating, and how? Had it stopped operating, and when?

Minister Kubayi replied that as Deputy Minister Phaahla had said, Ketlaphela did not operate under NDOH. It was not courteous for one ministry to take responsibility for the work of other departments. NDOH, as part of the government, could provide a general response, but Ms Chirwa’s question would be best answered by the Minister of Higher Education, Science, and Technology. It was unfair for Ms Chirwa to expect NDOH to provide details about the status of Ketlaphela, a project that was not NDOH’s responsibility or within NDOH’s ambit.

Ms Chirwa said that it was predictable that the privatisation of the vaccination programme would “compromise” the poor and people living in townships and rural areas. Those people did not have access to the private facilities. The issue had been raised with the NDOH a long time ago, both in the Committee and in an EFF statement. To address the risk, she had called for the capacitating of state-owned facilities – and that had not happened. Instead, NDOH had “outsourced” vaccination services to private companies, who had predictably done what private companies did: prioritising their clientele over the rest of the public. It was “disingenuous” for NDOH to raise the private-public divide as though it was a new issue, when it fact it had been flagged to NDOH long ago – even before the tender with private pharmacies like Clicks and Dischem. NDOH had been warned and had not acted upon the Committee’s foresight.

Dr Crisp replied that there had been no tender for private facilities to deliver vaccines. Moreover, NDOH wanted every health professional who was allowed to administer vaccines to be available to vaccinate everybody. Thus NDOH had agreed with private providers that all vaccination sites, whether public or private, had to be available to both the insured and the uninsured. Insured people had gotten a “head start” in vaccinations because of the location of the private facilities. There were many private facilities located in communities where insured people lived. That was due to their front shops and other products that private pharmacies sold to make their businesses viable. Throughout the health system, the public sector had to concentrate on the population who did not have access to private services. Again, it was not an “either-or” situation – NDOH wanted every single vaccination capability to add to the government’s capacity, so that the programme could reach people more quickly.

Deputy Minister Phaahla confirmed that NDOH was definitely not privatising any services. It had a joint working relationship with several private providers, who had done quite a good job in contributing additional capacity to the roll-out. The private providers had initially focused on vaccinating insured people. This was because the private providers paid for the vaccines it received, and they were reimbursed by insurers when it vaccinated insured people. Since then, however, an agreement with NDOH had been finalised, under which private providers were also reimbursed when they vaccinated uninsured people. With that finalised, uninsured people were also receiving services from private providers. It was important for such arrangements to continue, which meant that service delivery was affected when private pharmacies were destroyed.

Ms A Gela (ANC) said that she did not have a question, but she welcomed the update from NDOH and the Ministry. The Committee understood the effects of last week’s unrest, but she lived in Gauteng and could see that the province’s vaccination programme was continuing. She urged NDOH to keep up the good work.

Ms Gwarube asked about the country’s current supply of vaccines, which would guide NDOH’s ability to deliver on its programme in the coming weeks. While all these vaccinations were happening, what supply was left “in the kitty”? What consignments were pending?

Dr Crisp replied that NDOH had administered many vaccines over the course of the previous day, but at the start of the morning there had been 2.68 million doses of the vaccine – both J&J and Pfizer – in the country. At the current rate, that was about 15 days of stock. NDOH expected to receive another 900 000 doses over the weekend [of 24-25 July], and it had a pipeline planned from early August involving over 5.6 million doses of Pfizer. The first delivery from J&J should arrive in that same week in August, but NDOH would not “hold [its] breath” until it actually saw those doses arrive. For the first time, NDOH had in its sight a large stock vaccines, from now until the end of October. It was confident that it could scale up the vaccination programme without running out of doses.

Ms Ismail said that she was curious about the phases of the NDOH’s vaccination roll-out. She knew that the roll-out had reached the over-35 age group. Yet there were also people with “special needs,” including older teenagers – people with disabilities, for example, who needed caregivers and had comorbidities. Those people were high-risk and needed to be prioritised for vaccination. The pace of vaccination was steadily increasing, but when were such people going to be reached?

Dr Crisp replied that none of the country’s vaccines were registered for use in people under the age of 18. The vaccines were on an emergency release condition, like that applied by the WHO in other countries, and were not currently licensed for use by children – though that would not necessarily always be case.

Ms Ismail said that some healthcare workers had difficulty registering on the system. She had escalated quite a few such complaints to NDOH, and the individuals had been assisted on a case-by-case basis. But how was NDOH going to address the general problem? This might be one reason why there were some healthcare workers who wanted to be vaccinated but had not yet been vaccinated.

Dr Crisp replied that people should not be experiencing any problems in accessing the portal or registering. Those cases should be brought to the attention of NDOH, which dealt with all such issues immediately. NDOH had received anecdotal reports that many healthcare workers of the appropriate age had gone to be vaccinated as members of the general public, without registering as healthcare workers on the portal. In such cases, NDOH could not count them as healthcare workers in the system.

Ms Ismail asked when caregivers of children with special needs would be vaccinated. Such caregivers were not strictly educators, but they were being “left behind.”

Dr Crisp replied that such caregivers, and all special care environments, were covered under the congregate settings programmes. If any people in those groups had not been vaccinated, NDOH needed to know so that it could bring them to the attention of the provincial health departments, which were running the congregate settings programmes. NDOH was under the impression that congregate settings had been dealt with, but it would happily vaccinate anybody who had been left out.

Minister Kubayi said that caregivers fell under the early childhood development (ECD) category. The vaccination programme had that week been opened for the registration and vaccination of ECD workers, both public and private, under the Department of Social Development (DSD). Such people needed to register, and they could reach out to DSD for details.

Ms Ismail asked when pregnant women under the age of 35 would be vaccinated. She thought that such women were also at risk.

Dr Crisp replied that a circular had been published with recommendations specifying when it was safe or unsafe to get vaccinated while pregnant. Some pregnant women were being vaccinated as part of the over-35 age cohort. That was why it was important to move as quickly as possible in vaccinating that cohort, so that the roll-out could be extended to the 18-34 age group and cover more people, pregnant women among them.

The Chairperson noted Minister Kubayi-Ngubane’s appeal for the public to exercise caution if they encountered black-market medicines, which might be contaminated. He would like the Committee to assist in amplifying the Ministry’s message. What was the Ministry’s advice for members of the public who came across black-market medicines that had probably been stolen during the looting?

The Chairperson raised an issue that might be at the back of attendee’s minds. As the vaccination programme advanced, was NDOH still dedicating attention to its other programmes? NDOH had a wide range of programmes outside of infectious diseases. Before the COVID-19 pandemic, the country had already been dealing with a “quadruple burden of disease” – there was also HIV, tuberculosis, maternal deaths, non-communicable diseases, and violence and trauma. Did NDOH still find time to maintain and advance those programmes, or were some programmes being left behind? Would NDOH face challenges when it went back to pick up those programmes again?

Dr Crisp replied that other services were certainly being provided. Chronic medicines and other programmes continued across the provinces. However, NDOH could not deny that they had been affected by the fact that many personnel were working on the vaccination programme.

Deputy Minister Phaahla said that NDOH was trying “by all means” to ensure that no services got left behind. However, the COVID-19 pandemic created exceptional pressures. Healthcare professionals were needed for screening, isolation and quarantine, treating COVID-19 patients, and now also vaccination. The health services were also occasionally overwhelmed during surges of infections. NDOH hoped that as it pushed the vaccination roll-out to reach 70% coverage – hopefully by December or January at the latest – it would reap the benefits of fewer infections and less severe illness. Then many healthcare workers could be released to continue providing comprehensive healthcare. Currently, NDOH was trying to ensure that it did not lose too much ground around non-communicable diseases and other chronic illnesses like HIV/Aids, tuberculosis, and malaria.

Closing remarks by the Chairperson

The Chairperson suggested that Members should not rely solely on its fortnightly meetings with NDOH and the Ministry. Members were also able to send questions in writing and to receive comprehensive written responses. He had just been thinking that he had forgotten to ask a certain question about the mining community, so he would be writing to NDOH to ask for an explanation. He invited other Members to continuously engage with NDOH in the same way. It would assist the Committee’s oversight efforts to engage outside of these meetings.

The Chairperson thanked Minister Kubayi and her team for the update. The President had asked NDOH to reach 300 000 vaccinations daily, and NDOH was getting close. The Committee encouraged it to keep working. When NDOH returned for its next meeting with the Committee, it would probably be able to report that it had exceeded that target.

Minister Kubayi said that she appreciated Members’ support for the vaccination roll-out and for NDOH’s broader fight against COVID-19.

The Chairperson thanked the Members. The Committee had been sitting since the morning, for over ten hours, and he was encouraged by Members’ enthusiasm in continuing to engage with the delegations.

The meeting was adjourned.