# summary

- Link: https://dearsouthafrica.co.za/c19vaccine/summary/
- Published: 2021-01-14T15:11:23+02:00
- Author: dearSA

[ View the Vaccine Rollout campaign](https://dearsouthafrica.co.za/c19vaccine/)

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### Portfolio Committee on Health’s Zoom Meeting, 7 January 2021

Briefing by the Minister of Health on the status of health care services in provinces
as they relate to Coviid-19 and the latest developments including the roll-out strategy
of the Covid-19 Vaccine.

### Portfolio Committee on Health. 13 January 2021

Briefing by the Eastern Cape & Western Cape Provincial Departments of Health on 
health care services in relation to Covid-19 and on challenges faced by these provinces.

### Portfolio Committee on Health. 14 January 2021

Briefing by KwaZulu-Natal and Limpopo Provincial Departments of Health on health
care services in relation to Covid-19 and on challenges faced by these provinces.

### DOCUMENTS

 * [Parliament presentation on Covid – 7 Jan 2021](https://cdn.dearsouthafrica.co.za/wp-content/uploads/2021/01/20190756/210107COVID_Presentation_07_January_2020s.pdf)
 * [Western Cape Department of Health Presentation – 13 Jan 2021](https://pmg.org.za/files/WCDOH.pptx)
 * [Eastern Cape Department of Health Presentation – 13 Jan 2021](https://pmg.org.za/files/EC_Updated_Presentation_-_13_January_2021.pptx)
 * [KZN DoH Presentation](https://pmg.org.za/files/KZN_Presentation_-_14_January_2021.pptx)–
   14 Jan 2021
 * [Limpopo DoH Presentation](https://pmg.org.za/files/Limpopo_Presentation_-_14_January_2021.pptx)–
   14 Jan 2021

#### 󠀁[Written summary of 7 Jan video](https://dearsouthafrica.co.za/c19vaccine/summary/#1610889442111-1526df40-963f)󠁿

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](https://pmg.org.za/)_

#### 󠀁[Written summary of 13 Jan video](https://dearsouthafrica.co.za/c19vaccine/summary/#1611058172405-14d63614-cc04)󠁿

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](https://pmg.org.za/)_

#### 󠀁[Two types of Vaccine available from India:](https://dearsouthafrica.co.za/c19vaccine/summary/#1610889442133-4e45c49d-b9df)󠁿

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 information on Ivermectin](https://dearsouthafrica.co.za/c19vaccine/summary/#1610890214498-c7fb5c70-9654)󠁿

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

[Download as PDF ](https://www.sahpra.org.za/wp-content/uploads/2021/01/Statement-from-SAHPRA-on-Ivermectin-use-for-treatment-of-COVID-19_06.01.2020_v2.pdf)

**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.

### IN THE MEDIA

    - [listen] ChaiFM – [New Blue Review with Benji Shulman (Rob Hutchinson as guest)](https://www.chaifm.com/wp-content/uploads/2021/01/2021.01.18-Rob-Hutchinson-from-Dear-South-Africa-Paliarmentary-Matters-1-1.mp3)
    - BusinessTech – [South Africa is getting a Covid-19 vaccine ‘ID system’ – how it will work](https://businesstech.co.za/news/technology/461960/south-africa-is-getting-a-covid-19-vaccine-id-system-how-it-will-work/)
    - The Citizen – [Eastern Cape to vaccinate 3.7 million people within the next 9 months](https://citizen.co.za/news/covid-19/treatment-news/2419586/eastern-cape-to-vaccinate-3-7-million-people-within-the-next-9-months/)
    - IOL – [Calls grow louder for Ivermectin to be endorsed for Covid-19](https://www.iol.co.za/sunday-tribune/news/calls-grow-louder-for-ivermectin-to-be-endorsed-for-covid-19-34a72eb1-179a-40c4-8f13-84ad22b2c8e7)
    - IOL – [Mr President, people are dying’: Doctors plead with Ramaphosa to review Ivermectin](https://www.iol.co.za/news/politics/mr-president-people-are-dying-doctors-plead-with-ramaphosa-to-review-ivermectin-e42c3548-5a10-405d-86d7-f60c80f630d9)