summary

The Portfolio Committee on Health convened an online video conference to be briefed by the Minister and Department of Health about the COVID-19 vaccine rollout strategy as well as other healthcare issues related to the pandemic.

The Minister of Health announced that South Africa would receive 1 million vaccine doses from the Serum Institute of India in January 2021 and a further 500 000 doses in February 2021.

The Minister took the Committee through considerations around the vaccine rollout. The plan is for 40 million people to be vaccinated over 12 months – 6 300 full-time vaccinators, injecting up to 50 people per day. The Minister said the only measure of protection [against Covid-19] is going to come from the vaccination programme, with a minimum of 67% of the South African population needing to receive a Covid-19 vaccine in order for the cycle of transmission to be broken. It was highlighted that government would be sole procurer of the vaccine. SA is expected to receive its Covax allocation of vaccines in April but there are also discussions with vaccine manufacturers. Although Treasury is going to carry the “major burden” of procuring the vaccine, two other financing measures will be investigated: asking private medical schemes to cross-subsidise the vaccines and asking donors and business to make contributions.

The presentation outlined issues related to the epidemiology and surveillance of candidate vaccines; trends in new cases, hospitalisations and deaths; the framework for the vaccine implementation; key principles of the rollout; the identification and prioritisation of certain target populations; the phased approach for vaccine introduction; regulatory matters; vaccine distribution and security issues; resource requirements; safety, effectiveness, uptake, and the second dose; public communication, stakeholder guidance and training; the respective roles and responsibilities for the National Department of Health and for the provinces; and finally the indicative budget for the rollout strategy.

With regard to the second surge of Covid-19 in South Africa, the Minister reported that there is a huge demand for hospital beds and oxygen, necessitating the “reactivation” of beds that had previously been decommissioned.

In provinces such as the Eastern Cape and the Western Cape, infection numbers have now exceeded what they were at the peak of the first wave in 2020, while in KwaZulu-Natal almost twice the number of patients are being admitted to hospital as in 2020

Members of the Committee posed sharp questions about, among other things, discrepancies in, and in perceived inaccuracy of, official statistics especially between the provinces.

Members voiced extreme concern regarding whether the necessary treatment is being provided to all patients in order to increase the survival rate. There was also concern about the high death rate of patients not infected with COVID19 – it was said “there are people dying that should not be dying”. Members said that they were “desperately disturbed” by the situation which was at crisis level. Members asked about the availability of beds and oxygen. The Minister was asked to explain why South Africa’s hospitals were still not prepared despite it being day 287 of lockdown and why the field hospitals were decommissioned given the anticipation of further waves. It was said that while the SA government was wasting its time with the regulations under level five, other countries were getting their health sectors ready and were acquiring vaccines. Members objected to government emphasising the role of citizens taking preventive measures (wearing masks, sanitising, and the like) when the emphasis should be on acquiring vaccines. Thus while citizens where holding their end of the bargain, the state has not secured the vaccine and the National Department of Health was “regressing”.

Members expressed in unison their concern about misinformation and the lack of information provided to the public. The Department was urged to reconsider its communication strategies regarding not only the vaccine but to ensure people make their way to hospitals on time and have the information on how to take care of themselves after being discharged. There was also concern that some Members found it difficult to get hold of the Minister, Deputy Minister and salient entities of the Department which were accountable to the Committee. Members expressed concern around the opportunity for corruption around the procurement and rollout of the vaccine.

Members appealed for clarity on how the situation on the ground would be addressed, and how optimal treatment will be provided in the coming weeks

Concern was also expressed that it seemed some vaccines were simply unaffordable for SA yet government prioritised the bailing out of SA Airways. Further worries were aired whether the central procurement of the vaccines would result in a “sluggish” process especially has government does not have this experience and the centrality prevents other actors from participating in the rollout. It was stressed there must be a codified and comprehensive plan for the vaccine which can be made public.

Members questioned what was happening t the border posts, whether vaccines were compulsory, how the vaccines fared in light of the new strain of the virus identified, the role of private medical aids, detail around when the bilateral engagements with vaccine manufacturers occurred, the placement of interns and retired physicians to assist with staff shortages, the role of provinces in the rollout of the vaccine, palliative care and collaboration with universities.

There were questions around the use of ivermectin and its efficacy in reducing morality and whether the SA Health Products Regulatory Authority had done enough research on this.

Some Members called for a meeting with the Minister of Finance to explain certain financial particulars relating to the rollout plan, without whose input the details remained murky.

The Committee and the Minister agreed on the need to regulrise meetings between the parties in order to ensure Members were regularly updated to ensure everyone was on the same page especially as the Committee was a partner in the process.

Summary provided by Parliamentary Monitoring Group

The Portfolio Committee on Health met on a virtual platform for a briefing by the Health MECs and Heads of Departments of Health in the Eastern Cape and the Western Cape on the progress that the provinces were making in coping with the Covid-19 pandemic and in preparing for the roll-out of the Covid-19 vaccine.

The Eastern Cape Department of Health briefed the Committee on the Covid-19 cases in the province, bed availability, Covid-19 admissions, oxygen supply, Covid-19 testing, circumcision schools, testing of mortal remains, availability of medicine and personal protection equipment as well as the plan for the vaccination roll-out in the Eastern Cape. The resurgence in infections in the province had peaked in the middle of December 2020, but the rise in infections had happened in different districts at different times and so the second wave was lasting longer than the first wave. The pandemic had seriously impacted health workers in the province with 9249 testing positive and 161 dying of the virus. 3.7 million people in the Eastern Cape were to be vaccinated against Covid-19, starting with 200 000 healthcare and related workers.

Committee Members asked what could be done from a national perspective to help the Department and to improve the quality of life in the Eastern Cape. What were the root causes of the challenges and what could national  government do to assist? What was the normal number of deaths in the Eastern Cape compared to the number during the pandemic? A Member asked if research had been done on Ivermectin, currently classified as a veterinary medicine, given to Eastern Cape patients who contracted Covid-19. Another asked what the province had done to hold accountable those who had given Ivermectin to humans without the approval of the South African Health Products Regulatory Authority (SAPHRA).

Members were concerned about the number of vacant posts in the Eastern Cape, even the Department of Health had an Acting Head of Department. As the province did not yet have a plan for the vaccine roll-out, when could the Committee receive a comprehensive plan? Had the planned bulk installation of oxygen started on 11 January 2021? Was there a need for new field hospitals in the three districts which had reached maximum bed capacity or could wards be changed into Covid-19 wards? Would the Rapid Antigen Test, recommended by the World Health Organisation to identify cases in high infection rate areas, be used for diagnostic purposes and what were the benefits of that?

Members noted that communities did not know what to do when people were ill with Covid. What plans did the Eastern Cape have in place to address that? When would the community health care workers be given permanent contracts so that they could assist in the response to the pandemic? Why was Joe Gqabi district experiencing an increase in new cases when the peak had passed? Why had Covid-19 patients been mixed with TB patients in the Empilweni TB Hospital? How were mortuaries in the Eastern Cape being helped to deal with the backlog? Were legal processes being followed before the exhumation of bodies to test them for Covid-19?

The Western Cape Health MEC declared that the Western Cape was ahead of the pack in managing the pandemic. The province’s technology system was well-developed to facilitate data collection and reporting of intelligence on a daily basis. Even deaths outside of the health system could be examined because the system checked against the data of Home Affairs. The province was working with organised labour on a planning level and municipal mayors were required to report on Covid-19 data and interventions in their municipalities. A critical lesson was that one could not strengthen the system without addressing the need for healthcare workers and they had been made a priority in the province. The Western Cape had urged the President to ban alcohol for two weeks during the festive season to create a breather from the usual high number of alcohol-related trauma cases at that time.

The Head of Department spoke on the Western Cape’s 5-point COVID Resurgence Strategy which was aimed at changing community behaviour, surveillance and response, scaling up health services capacity, maintaining comprehensive services and protecting healthcare workers. He said how the province would scale up the health platform, manage fatalities and he described the province’s vaccine strategy. All Western Cape districts were hotspots at the time, but the Garden Route had clearly passed the peak of the second wave and was on a downward trajectory. The West Coast showed an increase in cases, which was indicative of the area being at an earlier stage of the second wave than the other districts. The province had a large number of diabetic patients who were at a high risk of succumbing to the pandemic, but strategies had been learnt about how to manage diabetics during the first wave. Home delivery of medicines was taking place so that patients did not go to hospitals to collect their medication. The province was particularly concerned about the trauma experienced by health care workers that would require long-term healing.

Members asked what measures the Western Cape put in place to deal with problems associated with diabetes and alcohol; had the Health Department spoken to the Provincial Command Council about the low the level of compliance in the province for wearing masks and social distancing; and what was the province’s view on the country having paid R283 million for a vaccine which SAHPRA had not yet approved. A Member noted that some workers reported that they were being forced to go to work even if they were sick as long as they had no symptoms. How true was that? Who was filling the 1029 vacant positions of health workers who were ill? How did the province intend to close the gap in the oxygen ratio used in the public versus the private sector? Did patients disadvantaged by poverty who relied on public healthcare have a lower probability of access to oxygen? Was Afrox the only supplier of oxygen at the levels required? What would happen if Afrox could not supply sufficient oxygen as oxygen was a critical intervention?

Members asked if the Western Cape knew why districts that had been badly hit in the first wave were not suffering as badly in the second wave. Were there plans for allocation, transportation and storage of the vaccine, not just in the metro, but also in the districts? What was the plan to address the full ICU wards as the province did not want temporary structures? What were the critical areas that contributed to the high fatality rate in the province? What interventions would be introduced to reverse that trend? How was it communicating with communities about how to deal with Covid-19 at home and when to seek medical attention? Was the vaccine voluntary or mandatory and would that be clearly communicated to those who would be receiving the vaccine?

Summary provided by Parliamentary Monitoring Group

India has approved two (2) made in India vaccines – Oxford-AstraZeneca’s ‘Covishield’ and Bharat Biotech’s ‘Covaxin’ for emergency use authorization. Here’s what we know about the efficiency of these vaccines so far:

• Covishield

This vaccine has been developed by the University of Oxford and British-Swedish pharmaceutical company AstraZeneca. Adar Poonawalla, Chief Executive Officer, Serum Institute of India (SII) — which is British-Swedish pharma giant AstraZeneca’s manufacturing partner – said that the vaccine would be 90 to 95 per cent effective if the two shots are parted by around 2-3 months. “You’ll be hearing some good news from the UK very soon… It would be a 90-95% effective vaccine if you just keep a two-to-three months’ gap between dose 1 and dose 2. They will make that public with documentation.”  Covishield, Poonawalla added, is a highly effective vaccine against novel coronavirus. The vaccine is being touted as one of the most promising vaccines for India where cost and logistics play a big role. Apparently, unlike the Pfizer and Moderna vaccines, which use a newer approach called mRNA, making them more complex, fragile and thus require ultracold temperatures, Covishield is a vector vaccine which are slower but cheaper and importantly, can be kept stable for six months at standard refrigerator temperatures.

• Covaxin

Covaxin has been developed by Indian biotechnology company Bharat Biotech and clinical research body Indian Council of Medical Research (ICMR). The NDTV report calls Covaxin an inactivated vaccine — one of the oldest methods for vaccinating people – which means that whole, inactivated viruses are injected in the body to trigger an immune response. These whole batches of coronavirus must be grown, “killed” using a chemical or heat and then made into a vaccine, making it a longer process, the report says.  Covaxin consent forms state that the beneficiaries will be provided care in government-designated and authorized hospitals in case of any serious side effects due to the vaccine, a Times of India report said. Beneficiaries who receive Covaxin will be paid compensation if they suffer adverse events due to the vaccine. The compensation was among the points highlighted on top of the consent form shared with the vaccination centre on Friday. According to reports, “the clinical efficacy of Covaxin is yet to be established and it is being studied in phase 3 clinical trials”.

SAHPRA’S GUIDANCE ON THE USE OF IVERMECTIN IN THE PROPHYLAXIS OR TREATMENT OF COVID-19

What is ivermectin?

Ivermectin is a widely used drug for the treatment and control of parasites in animals and is used to treat several tropical diseases in humans not commonly seen in South Africa, as well as scabies and head lice. Ivermectin is a synthetic derivative of the antiparasitic class of compounds known as avermectins.

In South Africa ivermectin is registered for use under Act 36 of 1947 (Department of Agriculture) for use in animals. This means that veterinarians and other trained personnel are allowed to prescribe it as an antiparasitic agent for a variety of animals. The drug is not currently registered for human use, but SAHPRA occasionally grants Section 21 permits for the use of topical ivermectin as an unregistered product for the treatment of individual patients with conditions such as scabies or head lice.

Several investigators have reported that when tested in the laboratory, ivermectin inhibits replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Given the current coronavirus disease-19 (COVID-19) pandemic, this has understandably received a lot of media attention.  Thus, several clinical studies have been undertaken to evaluate ivermectin’s efficacy in treating the COVID-19 infection.

In some countries where ivermectin is registered for human use, the human use formulation is being used off-label in the management of Covid-19 infections where the clinical responsibility for monitoring of safety and efficacy lies solely with the prescriber.  Furthermore, there are widespread reports of use of ivermectin for prophylaxis or treatment of COVID-19 in South Africa using the veterinary product.

SAHPRA’s view on the use of ivermectin communicated in December 2020

On the 22 December 2020, SAHPRA indicated that in relation to ivermectin use for COVID-19, that “Ivermectin is not indicated nor approved by SAHPRA for use in humans. There is no confirmatory data on ivermectin available as yet for its use in the management of COVID-19 infections. In terms of safety and efficacy there is no evidence to support the use of ivermectin and we do not have any clinical trial evidence to justify its use.

The Essential Medicines List (EML) COVID-19 Sub-committee Rapid Review on ivermectin (21 December 2020)

SAHPRA also notes that the EML COVID-19 Sub-committee published a Rapid Review on ivermectin (21 December2020) in which they similarly conclude that:

• The overall quality of the randomized trials involving ivermectin in COVID‐19 patients is extremely low.
• From the available randomized control trial evidence, ivermectin is not superior to placebo in terms of viral load reduction or clinical progression. There is no evidence from randomized control trials for any reduction in mortality.

Eligible patients with COVID‐19 in South Africa should be considered for enrolment in relevant therapeutic trials.

SAHPRA’s review of the current data on the use of ivermectin for the treatment or prophylaxis of COVID-19 infections

In response to this growing interest in ivermectin and the growing amount of data on its use in COVID-19 treatment and prevention, SAHPRA has now reviewed again, the available data from clinical studies.

A recent meta-analysis, i.e. systematic review, of the clinical trial data for the treatment of COVID-19 has been conducted by Dr Andrew Hill of the University of Liverpool, sponsored by Unitaid which is a global health initiative that works with partners to bring about innovations to prevent, diagnose and treat major diseases in low- and middle-income countries). Although this report is widely available publicly, it has not yet been published in a peer-reviewed scientific journal.

The meta-analysis concluded that the use of ivermectin in the management of COVID-19 infections is associated with faster time to viral clearance, shorter duration of hospitalisation and higher rates of clinical recovery and some improvement in survival rates.

However, the meta-analysis also concluded that additional randomized clinical trial data were needed to confirm clinical benefit in COVID-19 infections as well as define an optimized dosing regimen. Furthermore, Dr Hill identified a number of limitations with the data from these clinical trials, including that:

• Current results are based on limited randomised trials
• There is potential for publication bias
• The individual trials reviewed had limited statistical power
• Several trials were open-label presenting a potential for investigator bias
• Range of doses and durations were not standardised
• Endpoints differed between trials

In his conclusion, Dr Hill indicated that well designed clinical trials are required to provide sufficient scientific data for the use of ivermectin for the treatment of COVID-19.

Based on the Hill meta-analysis and the Front Line COVID-19 Critical Care Alliance (FLCCC), SAHPRA notes the following:

• The overall quality of the randomized clinical trials involving ivermectin in COVID‐19 patients is poor and underpowered. From the available randomized control trial evidence, ivermectin appears not to be superior to placebo in terms of viral load reduction or clinical progression. There is no evidence from randomized controlled trials for any reduction in mortality.
• The studies vary with respect to the population groups included in the studies i.e. out-patients, early hospitalizations, patients with longer duration hospitalizations, patients in ICU etc.
• The dosages in the various studies are not uniform. As a result, dose-finding cannot be established for the safe and effective management of COVID-19 infections (whether it is for treatment or prophylaxis).
• Ivermectin has been trialed with several other concomitant medicines (proven and unproven, either alone or in combination with other medicines) and this limits the conclusions that can be made about ivermectin’s safety and efficacy.
• These studies have further limitations that have been identified by the reviewers themselves as indicated above, the most notable being that not enough trial data is currently available. But it is noted that there will be further clinical data available by mid-to-end January 2021. SAHPRA eagerly awaits this information in order to review its stance on the use of ivermectin in the management of Covid-19 infections.

SAHPRA notes that to date, there have been no positive recommendations for the use of ivermectin in the management of Covid-19 infections by any regulatory authority with which SAHPRA has reliance agreements, e.g. USFDA, EMA, MHRA, etc., and that the WHO does not currently recommend the use of ivermectin for the treatment or prophylaxis of COVID-19 infections.

Furthermore, a report on the pharmacokinetics of ivermectin concluded that ‘Preliminary findings suggest that standard doses of ivermectin would not result in efficacious concentrations, and that extraordinary doses to achieve efficacious concentrations may result in unacceptable toxicity in COVID-19 patients.’ (Ref: Pharmacometrics Africa and CERTARA).

It is also important to note that while ivermectin is considered generally safe, side-effects include skin rash, nausea, vomiting, diarrhoea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, and confusion), sudden drop in blood pressure, severe skin rash potentially requiring hospitalization and liver injury (hepatitis). Laboratory test abnormalities include decrease in white cell count and elevated liver tests.

Current status of applications to SAHPRA for clinical trial approval or for registration

At present, no ivermectin clinical trial applications have been submitted to SAHPRA for review. SAHPRA encourages the submission of clinical trial applications designed to establish the safety and efficacy of ivermectin in the management of Covid-19 infections for both treatment and prophylaxis and commits to expediting their review. This approach has previously been applied to clinical trial applications for other investigational medicines that were being evaluated for COVID-19 management.

In addition, SAHPRA has received no applications to register ivermectin for either prophylaxis or treatment of COVID-19 but commits to fast track the review of any such application should this be submitted.

Conclusion

There are currently no applications either for clinical trials or for the registration of ivermectin for the treatment or as prophylaxis for COVID-19. However, SAHPRA encourages and supports all well- designed, ethically approved, scientific studies designed to identify new or existing medicines that are used for the treatment or prophylaxis of COVID-19. SAHPRA reiterates its commitment to expedite the review of such studies. Furthermore, as the South African regulatory authority, SAHPRA will continue to evaluate any emerging peer reviewed publications or data on the use of ivermectin for the treatment of COVID-19, and notes that according to the global clinical trials register, additional data should become available in the course of the next few months. SAHPRA will also consider enabling access to approved formulations of ivermectin intended for human use, including through Section 21 authorisation, provided such a request is supported by evidence for the indication requested and is justified based on a risk benefit assessment that includes safety and clinical efficacy data.