Statement from the Department of Health – Status of Vaccine Rollout in South Africa

In a media statement made by Dr. Zwelini Mkhize- Minister of Health on the 26th of April 2021.

Today we are pleased to announce that, following SAHPRA’s recommendation on 17
April 2021 and Cabinet’s concurrence on 21 April 2021, the vaccine rollout will resume
through the Sisonke Programme on Wednesday, 28 April 2021. The programme
has, on hand, all the doses it needs to complete vaccinating 500 000 health
care workers through the early access protocol and the the teams have been eagerly
standing by, looking forward to making up for lost time by completing this programme
in the shortest possible time.

As such, I am happy to say that when Sisonke resumes, vaccination sites will be expanded
to 95 sites across the country and these sites will continue to vaccinate
health care workers during phase one beyond the Sisonke Protocol. Phase one is
due to end on 16 May 2021 and we remain committed to vaccinating as many of the
1,2 million health care workers targeted as possible, despite the unforeseen interruption
to our programme. The 95 sites will be published in the next issue of I Choose
Vaccination Bulletin and on the Health and SA Coronavirus website. We call on all
health care workers, including traditional healers, who have not registered for vaccination
to do so by going onto the website – vaccine.enroll.health.gov.za. When you
are on the first page click on “YES” where it asks “are you a health care worker”
and register for vaccination.

As you are all aware, we had to pause the rollout of Johnson and Johnson across
the world when 6 (now 8) patients developed a rare clot, called a VITT (which stands
for Vaccine Induced Thrombotic Thrombocytopenia), after being vaccinated in the
United States of America. The pause was to allow scientists to guide health authorities
on the potential relationship between the Johnson and Johnson vaccines and
these clots so that a determination could be made if it is still safe to continue using
Johnson and Johnson as a vaccine. It has since been established there is a one in a
million chance of getting the clot after the vaccine and that it appears that women
between the ages of 18 and 48 years old are particularly at risk. With such a low
probability of developing a clot, all the regulators across the world have recommended
the continued use of Johnson and Johnson.

Here at home, during the hiatus, the South African Medical Research Council and
the Department of Health worked very closely with SAHPRA and various ethics
committees to ensure that there is intensified pre-vaccination assessment and post
vaccination monitoring when the rollout is resumed. SAHPRA has also added a requirement
that all Sisonke participants need to be informed of this potential risk and
therefore consent to participating in the trial with this knowledge.

As such, we need to inform Health Care Workers participating in the Sisonke Protocol
that, upon registration, they will receive a welcome SMS which will direct them to
give consent to participate in the programme. Health Care Workers that have previously
consented before the pause but have not yet been vaccinated, will receive an
SMS requesting them to consent again to the new version of the consent form,
which is dated 24rd April 2021. This new consent form will be accompanied by a “Patient
Information Leaflet” which will contain all the information a participant needs on
the safety and efficacy of the Johnson and Johnson vaccine. It is important that you
consent again if you are registered but have not received your vaccine because the
the EVDS system will generate a new vaccine voucher for Health Care Workers who
will be vaccinated from now to the end of the Sisonke Protocol.

The Health Care Workers that have already been vaccinated will receive an SMS
directing them to a “Dear Participant Letter.” This letter will explain the updated safety
information of the Johnson and Johnson Vaccine. The EVDS system is being updated
to accommodate these changes- health care workers participating in the
Sisonke Protocol only need to follow the instructions when the system sends them
an SMS.

I also need to inform the nation that SAHPRA has recommended that pregnant and
lactating women be excluded from the Sisonke Protocol at this stage. The Medical
Research Council, along with other academic and scientific bodies, will engage
SAHPRA on this recommendation and we hope that, whilst SAHPRA may have
elected to err on the side of caution, the scientists will be able to make the case for
pregnant and lactating women to receive the vaccine.

Having said all this, I wish to reassure you all, fellow South Africans, that it is much
better to have the vaccine than to avoid taking it for fear of getting a blood clot. In
fact, there are many times more cases of blood clots related to the Coronavirus itself
than the one in a million chance of getting a blood clot from the Johnson and Johnson
vaccine. In America about 7 million people have now received the Johnson and
Johnson vaccine and are protected from COVID-19. Let us remember that Johnson
and Johnson is currently the best vaccine against the 501Y.V2 variant, which is dominant
in this country. The Johnson and Johnson vaccine is effective, easy to use and
it is still considered safer to get vaccinated with it than not to.

As we move forward with the rollout, if anyone develops headaches or abdominal
pain, vomiting, blurry vision or other neurological or abdominal symptoms after being
vaccinated, one should seek medical attention immediately as these could be signs
of a VITT. There are also several ways of reporting any vaccine related side effectsyou
may call the COVID-19 hotline on 0800 029 999, use the newly launched SAHPRA
Med Safety App or, if you are a Sisonke participant, you can call the Sisonke
Safety Desk on 0800 014 956.

I am very pleased that the Minister of COGTA, Hon. Dr. Nkosazana- Dlamini Zuma,
has gazetted the regulations for the COVID-19 Vaccine Injury No Fault Compensation
Scheme. This is a rubber-stamp of government’s commitment to protecting all
our citizens by ensuring there is adequate recourse for anyone who may suffer from
a severe or serious adverse event following vaccination. We will soon publish the directions
and forms along with a step by step guideline. You will not need a lawyer to
be able to engage the No Fault Compensation Scheme- if you experience a severe
or serious adverse event from a COVID-19 vaccine, all you will need to do is get the
form from your nearest health facility or from the Department of Health website, fill it
in and send it to the address (either email or physical) that will be clearly indicated on
the form. The relevant independent committees- which will comprise scientists, clinicians,
legal and other experts- will then evaluate your claim and, should they determine
that indeed you have suffered a severe or serious adverse event from a registered
COVID-19 vaccine, will recommend the appropriate recourse and compensation.
We believe that the government and claimants should be able to interact directly
without third party assistance to make it easier for anyone to claim and to ensure
that the compensation is awarded in an efficient manner.

As I have announced, we have secured enough doses to vaccinate at least 45 million
people residing in South Africa- and we are still seeking to secure more vaccines.
I am therefore thrilled that the first 1,1 million doses of market Johnson and
Johnson COVID-19 vaccines are ready for dispatch from the Gqebherha plant- we
have engaged Johnson and Johnson who have indicated that, with the No Fault
Compensation Scheme now in place they are finalising the last administrative obligations
with international health authorities and we should expect the doses to be dispatched
in the coming days. These vaccines will be flown from the plant in Gqebherha
where the final steps of manufacturing, that is fill- and- finish, were completed.
They will land in Johannesburg OR Tambo International Airport on the same day and
will be transported to the central storage warehouse. Once quality assurance processes
are completed with the South African National Control Laboratory, then the
vaccines will be dispatched to the various provinces where they will be stored at over
900 distribution sites across the country. Some of these sites may already be vaccination
centres but some are storage hubs from where vaccines will be distributed to
vaccination facilities. Media coverage arrangements for the departure of the vaccines
from PE and the arrival of the vaccines at OR Tambo international airport will
be relayed by government communicators.

In addition, we will have received over 650 000 doses of Pfizer before 17 May, with a
further 325 560 arriving in the week of 17 May. We are therefore more than ready to
begin phase two on time.

I wish to congratulate the service providers that have been appointed to execute the
transporting, warehousing and distribution services for COVID-19 vaccines for the
period of 1 April 2021 to 31 December 2022- these companies are DSV Healthcare,
Imperial Logistics and BIOVAC. We entrust, arguably, our most valuable assets to
these companies and we wish them well as they embark on this auspicious national
duty.

On the 21st of April, Cabinet had announced that more than 3 338 vaccination sites
had been identified by provinces and we are very glad that, of these, 2 369 sites are
now registered on the Masters Facility List and are undergoing various stages of approval.
The provinces will continue to identify more sites- as and when sites are activated,
we will publish them onto the Department of Health and SA Coronavirus websites.
Sites will be activated and deactivated according to the need at any particular
time.

The government has secured all the vaccines we need and I continue to visit provinces
to ensure that they are ready to rollout the vaccines within the timeframes we
had committed to. To date I have visited Gauteng, Eastern Cape and Western Cape
and I will next be visiting the North West Province. So far, both during the site visits
and in my engagements with the MEC’s through formal and informal arrangements, I
am satisfied that the provinces fully appreciate the mammoth task ahead of us and
are preparing accordingly. I also commend the collaboration between the public and
private sectors as well as business, which has grown deep roots and anchored a
comprehensive vaccination campaign driven by an all of society approach. It is for
this reason that Cabinet has expressed its confidence in the vaccination plans we
presented and I must convey my sincere gratitude to the Director General and Department
of Health Officials, representatives at NEDLAC, leaders of various sectors
from business and civil society to traditional leadership and community leadership,
for the wonderful collaborative spirit that has seen our mass vaccination aspirations
take shape.

It has been a difficult start for our country with the vaccination rollout, however despite
all the challenges we have faced, we still have a positive outlook both for the
recovery of public health and the economy at large.

It would be remiss of me not to draw attention to the upsurge of infections in the
Northern Cape, the Free State and the North West Provinces. We must continue to
urge fellow citizens in all the provinces to adhere to basic health protocols- in particular
we must remind South Africans that the wearing of masks in public places is still
compulsory under the Disaster Management Act. We know that social distancing and
avoiding crowded situations like parties, funerals and other gatherings is very difficult
but we must continue to do our best to avoid a third wave and harsher restrictions.
We seriously condemn some posts we have seen on social media depicting large
parties and where youngsters make a mockery of super-spreader events, even
boasting to host some of their own. We must remind our youth that, while they may
escape relatively unharmed by COVID-19, they could pass the virus to their parents,
teachers, grandparents or peers with co-morbidities, causing them to become seriously
ill or die. Nobody wants to be responsible for that and so we must all continue
to be considerate of one another and remain disciplined during this very difficult time.
I would finally like to conclude by saying that we all have a role to play in the overall
recovery of our country- by getting vaccinated. We already have nearly half a million
citizens 60 years and above who have registered on the EVDS- we continue to call
on senior citizens to register on the EVDS and implore everyone to help a senior citizen
to register on the EVDS portal at vaccine.enroll.health.gov.za.

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