The Insider April/May 2021

THE

INSIDER INSIDER INSIDE THIS ISSUE: The Anniversary of the 1st Confirmed COVID-19 Case in SA-Page 1 Gauteng Premier David Makhura and Gauteng Health MEC Dr Mokgethi visit Hillbrow Health Precinct - Page 3 Learning from Past Mistakes WHO Chats with Prof Helen Rees -Page 5 Wits RHI’s COVID-19 Initiatives & Projects -Page 7 COREP COVID-19 Household Cluster Investigation -Page 12

Mona Lisa might be shielded by a face mask, but behind it is a smile.

A smile that resembles hope, that one day this virus will be gone and part of history – like the famous smiling portrait in the Louvre museum in Paris.

CONTENTS

The Anniversary of the 1st Confirmed COVID-19 Case in SAPage 1

Gauteng Premier David Makhura and Gauteng Health MEC Dr Mokgethi visit Hillbrow Health Precinct

Page 3

Learning from past mistakes WHO chats with Prof Helen Rees -Page 5

Wits RHI’s COVID-19 Initiatives & Projects -Page 7

Shandukani’s COVID heroes -Page 9

COREP COVID-19 Household Cluster Investigation -Page 10

Editor’s Desk It has been more than a year since the first confirmed case of COVID-19 in South Africa. In one way or another, all of us have been touched by the crisis and people’s willingness to trust scientists and the government has been tested.

This past year has seen numerous vaccines in development worldwide in response to the lingering coronavirus pandemic. With the first phase of COVID-19 jabs being rolled out, South Africa plans to vaccinate two-thirds of the population to achieve herd immunity by the end of 2021.

Bokang Pheto - Editor

Since the start of the pandemic, Wits RHI has been significantly involved in the vaccine studies such as the ChAdOx1 nCOV-19 ZA AstraZeneca trial, the Novavax 2019nCOV-501, and the Johnson and Johnson Ensemble trials.

My PrE Mobile Applica -Page 1

EP e ation 13

Dolutegravir approval announcement IMPAACT P1093 -Page 15

What Are the Side Effects of COVID-19 Vaccines?

-Page 19

What’s happening @ Wits RHI -Page 21

In the first phase of the vaccine rollout, some of our frontline healthcare workers and other staff have received their jabs. The rest of the staff will have a chance to be vaccinated in phase 2 and 3.

In 2021, we are reintroducing our quarterly newsletter, The Insider, which was previously dubbed, WIRED. This is a fresher and more vibrant version of WIRED. The cover of this issue is the famous half-length portrait painting by Italian artist Leonardo da Vincithe Mona Lisa (of cause, wearing a surgical mask and adhering to COVID-19 protocol).

It has been described as “the best known, the most visited, the most written about, the most sung about, the most parodied work of art in the world. Today, the Mona Lisa still influences how art is perceived and created today. Likewise, the COVID-19 phenomena will go down in history as one of the events that shook and shaped the world.

Wits RHI COVID-19 vaccine campaign -Page 23

Vaccine Literacy -Page 25

Stay safe -Page 26

There are already galleries that capture the moments of solidarity, hope, and community building during this pandemic. Not only are we witnessing a profound social and structural change, but how we interpret and write about issues today will affect how future generations will look back on this moment.

Mona Lisa might be shielded by a face mask, but behind it is a smile. A smile that resembles hope, that one day this virus will be gone and part of history – like the famous smiling portrait in the Louvre museum in Paris.

In this issue we feature, The Anniversary of the 1st Confirmed COVID-19 Case in SA (p1),Gauteng Premier and Health MEC visit (p3), Learning from Past Mistakes-WHO Chats with Prof Helen Rees (p5), Wits RHI’s COVID-19 Initiatives and Projects (p7), COREP COVID-19 Household Cluster Investigation (p12) and more.

The

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An

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nniversaryof the

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st Confirmed COVID-19 SA O n 5 March 2020, South Africa recorded its first coronavirus case.

Apart from the constant but often unclear updates from the World Health Organization, very little was known about the virus, whose outbreak was initially detected and mostly concentrated in China.

By the time South Africa’s first case was reported, the virus had spread to other countries, most notably in Europe.

“A 38-year-old male who travelled to Italy with his wife... they were part of a group of 10 people, and they arrived back in South Africa on March 1, 2020.”

This is how health minister Zweli Mkhize announced the first confirmed case of COVID-19 in SA on March 5 last year.

When Prof Salim Abdool Karim received an outbreak alert while hiking in the Drakensberg Mountains during a family vacation, little did he know that weeks later he’d be presenting a strategy to President Cyril Ramaphosa on how to fight the COVID-19 pandemic he had shrugged off.

In an interview with Sowetan ahead of the commemoration of the anniversary of the first case of COVID-19 being detected in SA, Karim said he had mistakenly downplayed the virus.

Limpopo health MEC Phophi Ramathuba says the decision to allow repatriated South Africans from Wuhan, China, to be quarantined at the Protea Ranch Hotel in the province had the potential to end her political career.

The Gauteng government was the first to force people who tested positive for COVID-19 to quarantine in the early stages of the epidemic.

Case in

Ramathuba was reflecting on the anniversary of the first COVID-19 case found in SA and the subsequent arrival of more than 100 South Africans from the coronavirus epicentre at the time in March last year.

Two months after flying an SAA flight on a historic mission to repatriate South Africans from a Chinese city that was the epicentre of COVID-19 last year, Captain Vusi Khumalo spent nine months grounded unable to fly anywhere due to the lockdown imposed by the pandemic.

Khumalo flew his first SAA flight in nine months to Brussels to fetch a batch of 80,000 doses of Johnson & Johnson vaccines for healthcare workers.

Just a month after they were released from a quarantine site in Limpopo, twins Mvuzo and Mvuyisi Nkcosolwana-Vili were stigmatised and threatened at home in Mthatha, Eastern Cape.

The community accused them of bringing the virus home from China where they were medical students.

Today, South Africa has recorded more than 1.5 million COVID-19 cases and over 50,000 deaths, administered nearly 300 000 COVID-19 vaccines, discovered a new more transmissible variant and is only just emerging from a second wave.

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Gauteng Premier David Makhura and Gauteng Health MEC Dr Mokgethi visit Hillbrow Health Precinct

On Tuesday, 20 April 2021, Gauteng Premier David Makhura and Gauteng Health MEC Dr Thembi Mokgethi visited Wits RHI ahead of the vaccine rollout. Prof Helen Rees led the senior delegation to a tour of the Wits RHI offices and projects housed within the Hillbrow Health Precinct (HHP).

The senior officials expressed an interest in the regeneration of the precinct to accommodate the huge urban population in Gauteng. The Premier informed Wits RHI team that government plans to work with University of the Witwatersrand and other partners in reopening the Hillbrow hospital.

The HHP was reconstructed into a world first health precinct addressing reproductive health, primary healthcare, and cutting-edge research around issues of HIV/Aids, poverty, and infectious diseases. The Premier visited Wits RHI to learn more about the research on the effect of the coronavirus.

Premier Makhura has been assessing readiness of the province ahead of the phase two vaccine rollout and wanted to be briefed on the COVID-19 impact on HIV treatment.

The walkabout included a trip to Hugh Solomon Building, Shandukani, Ward 21 CRS, 7 Esselen Street, and 15 Esselen Clinic where various research projects and COVID-19 studies are operating.

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“We need to make sure that scientific evidence drives the response to the coronavirus in the province. We are very interested in what the impact of COVID-19 has been on the section of our population who are HIV positive.” _Gauteng Premier David Makhura.

Prof Rees and other Wits RHI directors gave a brief feedback on the research studies that they are involved in.

“The studies are evolving, and we are still gathering more evidence but at this stage, there isn’t sufficient evidence to say that people living with HIV are at a high risk of severe illness or COVID-19.” _ Dr Gloria Maimela, Director of Health Programmes.

The Premier emphasised using existing infrastructure for the vaccine rollout programme and will be partnering with research and academic institutions, civil society groups and NGOs. Hillbrow has a community health centre run by the provincial government, a clinic run by the city and has research capacity. Makhura stressed that the integration of these health services is crucial.

He praised Wits RHI saying that the institute is an asset to the city and province. He also stated that we need to strengthen the security and improve the health services in the Hillbrow community.

In closing, the Premier informed stakeholders that government will be working closely with Wits RHI as they prepared for phase two of the vaccine rollout.

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Learning from past mistakes WHO chats with

Prof Helen Rees 5

Helen Rees talks to WHO’s Associate News Editor, Gary Humphreys, about lessons learnt in responding to epidemics, the need to maintain focus on polio eradication, and the prospects for building back better.

Helen is Founder and Executive Director of Wits RHI. She is a Personal Professor in the University of Witwatersrand’s Department of Obstetrics and Gynaecology and is the Co-Director of ALIVE (African Leadership in Vaccinology Expertise) which is Wits University’s flagship vaccinology programme. She is an Honorary Professor in the Department of Clinical Research at the London School of Hygiene and Tropical Medicine (LSHTM).

Helen obtained her Medical Degree and Masters in Social and Political Sciences from Murray Edwards College, Cambridge University, where she is now an Honorary Fellow. She is an alumnus of Harvard Business School. Helen has extensive experience in the field of medicines regulation and is the current chair of the South African Health Products Regulatory Authority. She is a member of the Ministerial Advisory Committee on COVID-19 and a member of the Ministerial Advisory Committee on COVID-19 vaccines.

She Chairs the VACC-MAC COVID-19 Variant Technical Working Group. Helen has worked extensively with WHO and other institutions in the African region and is chair of WHO’s African Regional Immunisation Technical Advisory Group on Immunization (RITAG). Helen is widely recognised for her work as a global health practitioner and has been appointed as chair and member of many international scientific committees and Boards.

She has been very involved in national, regional, and global response efforts to COVID-19 including the development of COVID-19 vaccines, their potential rollout and utilization. She is currently the chair of WHO’s International Health Regulation (IHR) Polio Emergency Committee, and a member of the WHO IHR Emergency Committee on COVID-19. She is the Co-Chair of the WHO SAGE Working Group on Ebola Vaccines. Helen is a member of the Global Alliance for Vaccines and Immunization (Gavi) Board and chairs the Gavi Programme and Policy Committee. She is a member of the Coalition for Epidemic Preparedness and Innovation (CEPI) Board and chairs the CEPI Scientific Advisory Committee.

She is a member of the COVAX committee on COVID-19 maternal immunization and a member of the WHO Working Group on COVID-19 vaccines. GAVI, CEPI and WHO are jointly driving the global COVID vaccine effort including the COVAX facility, and Helen is involved with the oversight of the COVAX facility.

Q: You worked as a clinician in a Johannesburg township in the 1980s where you were also an anti-apartheid and women’s health activist. How did you get there from Cambridge University?

A: (laughing) I blame my husband who is from South Africa and left the country because of apartheid. I met him when we were both doing internships in London. After working in Zimbabwe, we returned to South Africa in the 1980s as a mixed-race couple with a one-year-old child and worked as clinicians and anti-apartheid activists in Johannesburg’s townships.

Q: You run the Wits Reproductive Health and HIV Institute, support the national government and WHO, and chair South Africa’s drug regulatory authority. How do you find time to meet all your obligations?

A: I wouldn’t be able to do it without the incredible team that leads Wits RHI and the support of my assistant. But it’s true, I am very busy and with the challenges posed by the pandemic, including the emergence of SARS-CoV-2 variants of concern, never more so.

Q: How has the emergence of the 501Y.V2 variant in South Africa affected the government’s response?

A: Plans to roll out the AstraZeneca vaccine were put on hold in February after data emerged raising concerns about the vaccine’s efficacy against mild to moderate disease caused by the variant. The government is supporting a large 3B clinical trial (a trial used to accumulate additional clinical findings) of the Johnson & Johnson Ad26 vaccine targeting health-care workers. This vaccine will soon be rolled out in groups prioritized within the general population, as will the Pfizer mRNA vaccine.

Q: How important is it going to be for vaccine makers to update COVID-19 vaccines as new variants emerge?

A: Very, particularly as these variants of concern spread. The 501Y.V2 variant – which is the dominant variant in South Africa and in many neighbouring African countries – has now been identified in over 45 countries and new variants are likely to emerge.

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So, we may be moving towards a scenario similar to seasonal influenza in which COVID-19 vaccines will have to be continuously modified to keep up with changing variants.

Q: What are the implications for clinical trial design and regulatory arrangements?

A: Both pre-clinical and clinical research has had to become more nimble. Classical, randomized placebo-controlled studies will be increasingly difficult to undertake, so new robust clinical trial designs will be required.

It’s also vital that safety and efficacy data be generated from post-roll-out studies, and that clinical studies be developed and carried out in low- and middle-income countries. Regulators will also have to continue to be flexible in response to the pandemic, making greater use of regulatory reliance, rather than starting from scratch when they review applications. Going forward, we need to learn the lessons of our recent experiences and rethink our approach to R&D for all vaccines, and for manufacturing and distribution so that we are better prepared when the next major outbreak occurs.

Q: Which lessons do you have in mind?

A: For example, the 2014–2016 Ebola outbreak in West Africa taught us many things. First, the need for speed when outbreaks involving novel pathogens occur.

In the case of the Ebola response, there were significant delays in vaccine trial implementation that were caused by the lack of pre-planning of clinical trial protocols, the lack of rapidly available funding, and the lack of earlier investment in vaccine candidates and vaccine platforms. The establishment of CEPI (Coalition for Epidemic Preparedness Innovations) has been a major step forward, notably in regard to its support for pluripotent vaccine platforms and the development of vaccines for prioritized pathogens.

These were both of vital importance at the beginning of the pandemic, and have made CEPI a leader in COVID-19 vaccine R&D. We should learn from such innovations, and where possible apply new approaches to the development of other vaccines, including for example HIV vaccines where we still have yet to make a breakthrough, despite massive investment.

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Q: Is enough being done to ensure that new vaccine technologies are being shared?

A: I would say not, and without changes to intellectual property protections this is not likely to change. Notwithstanding the obvious sensitivities on this topic, I think there is an argument for the temporary suspension of intellectual property rights during PHEICs (Public Health Emergencies of International Concern). owner. I think efforts should be made to ensure that countries avail themselves of this flexibility, perhaps with a specific link to PHEICs. Q: Do you see any potential for a patent pool for COVID-19 vaccines like the Medicines Patent Pool?

A: The COVID-19 Technology Access Pool created by WHO last year was supported by lowand middle-income countries and a few wealthier ones, but industry did not generally get behind it.

Of course, patents are not the only issue here.

There is also the question of capacity. The pandemic has been a wakeup call with regard to the lack of manufacturing capacity in many regions and efforts should be made to ramp up capacity worldwide. The African Union is prioritizing vaccine manufacturing and regional procurement which are both initiatives that could expand beyond COVID-19 vaccines. In addition, CEPI is investing in new vaccine manufacturing technologies that have the potential for application in low-resource settings.

Q: The focus on COVID-19 has caused other immunization programmes to be neglected.

Which are of most concern to you?

A: There are three issues of great concern.

First is the impact of the pandemic on routine immunization coverage. Limited access to services and fear of COVID transmission in facilities has resulted in falling immunization rates.

WHO and other partners have been working closely with countries to reverse this trend and to ensure readiness for the provision of COVID-19 vaccines. Second, the recurrent outbreaks of Ebola in the DRC (Democratic Republic of the Congo) suggest that Ebola outbreaks are likely to continue for the foreseeable future. So, it is vital that we remain vigilant, making full use of the ring vaccination strategies which have been successful thus far.

Third, as chair of the IHR (International Health Regulations) Emergency Review Committee on polio, I’m very conscious of where we stand with regard to global polio eradication efforts and am concerned about the spread of circulating vaccinederived poliovirus (cVDPV).

Q: Can you explain in simple terms what cVDPV is?

A: Oral polio vaccine (OPV), the most commonly used polio vaccine in low- and middle-income countries, contains a weakened form of the poliovirus, which triggers the desired immune response in the body. The attenuated virus replicates in the intestine for a limited period and can be excreted.

In places where sanitation and access to clean water is lacking, the virus can be transmitted.

Where the local population is under-immunized, excreted virus can circulate and evolve, with potential to change into a form that paralyses.

That is what we are seeing in an increasing number of countries in the African Region and beyond.

Q: The increase of cVDPV has been linked to the decision to remove the type 2 polio component from the trivalent oral vaccine in 2016. Was that decision a mistake?

A: Hindsight is a wonderful thing, but you have to remember that the removal of the type 2 component was associated with significant public health benefits, including a reduction of the risk of cases of cVDPV2, given that until 2015, over 90% of cVDPV cases were due to the type 2 component in OPV. Also, you have to bear in mind that the transmission of wild poliovirus type 2 had been interrupted since 1999.

But the bottom line is that when we dropped the type 2 component we created many susceptible populations at enormous scale. Not only that, but we missed vaccinating certain populations of children altogether. What we are also seeing is the exportation of cVDPV across borders and often in countries with weak health services and surveillance. So the spread of cVDPV is a major concern, made worse during the pandemic because of the suspension of immunization campaigns.

So, I’m hopeful that the nOPV2 will help us maintain momentum towards eradication, as long as the political will is there and support for eradication is sustained.

Q: Are there any other new vaccines that have got your attention?

A: There is research going on regarding a single dose HPV (human papillomavirus) vaccine which if found to be effective would be a wonderful boost for HPV vaccine programmes and would support the ambitious goals set for cervical cancer elimination.

Cancer of the cervix is still a predominant cancer in many low- and middle-income countries, particularly in the African Region where screening is challenging. We are also seeing the emergence of other HPV-related cancers in the northern hemisphere, including oral/pharyngeal cancers for example, so the need for widely available vaccines remains a global priority.

Q: There has been talk of building back better after the epidemic. What would that mean for immunization programmes?

A: Building back better would involve innovation on several fronts, including a renewed commitment to global equity for vaccine access. For COVID-19, vaccine nationalism and the national stockpiling of vaccines makes no epidemiological sense and is morally unacceptable.

Either we are going to keep repeating the mistakes of the past or, as a global community, we are going to tackle some of them. My hope is that the global discussion regarding vaccine hoarding and refusal to export is the beginning of a broader debate about vaccine access and equity.

I am also hopeful that the COVAX facility will drive improved access. With COVAX vaccines now reaching 100 countries, we may be witnessing the beginning of a new global health success story.

On the positive side, we now have the novel oral polio vaccine (nOPV2), which clinical trials have shown provides protection comparable to the type 2 vaccine, while being more genetically stable and less likely to give rise to cVDPV2 in low-immunity settings.

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The Solidarity Trial A global public health emergency trial of different treatments in severely ill COVID-19 patients receiving their hospitals’ standard of care. This study aims to find out whether any of the COVID-19 treatments are effective.

Prof. Helen Rees

Prof. Sínead Delany-Moretlwe

Wits RHI’s COVID-19

Initiatives & Projects Wits RHI’s COVID-19 projects are being spearheaded by our directors who are currently engaged in 15 COVID-19 initiatives and projects.

(Prof. Helen Rees National Co-PI; Dr Thesla Palanee-Phillips: National Coordinator)

CROWN Coronation: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION The main aim of the trial is to see whether Measles, Mumps and Rubella (MMR) vaccine can prevent or reduce the severity of COVID-19 in healthcare workers.

(Prof. Sínead Delany-Moretlwe South African Co-PI, Prof. Helen Rees Global Co-PI)

The South African Ox1Cov-19 Vaccine VIDA-Trial A randomized placebo-controlled study to determine the safety, immunogenicity, and efficacy of a new SARS-CoV-2 vaccine called ChAdOx1 nCoV-19.

(Prof. Lee Fairlie PI)

Prof. Saiqa Mullick

Dr Gloria Maimela

The Pregnancy Surveillance Study The Pregnancy Surveillance Study aims to evaluate the impact of SARS-CoV-2 in pregnancy and household contacts of pregnant women, since there is insufficient research on this population.

(Prof. Lee Fairlie PI)

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Prof. Lee Fairlie

Dr Thesla Palanee-Phillips

UNITY Healthcare Worker Registry The UNITY Healthcare Worker Registry assess the association of potential prophylactic treatments with reduced risk of COVID-19 (or SARSCoV-2 infection) in healthcare workers caring for COVID-19 patients.

(Prof. Sínead Delany-Moretlwe PI)

The EDCTP-COREP COVID-19

Household Cluster Investigation This study aims to determine the epidemiological parameters of COVID-19 through a household transmission study in a rural area of South Africa.

(Dr Gloria Maimela PI)

National testing and contact tracing across our PEPFAR-funded programmes: The Wits RHI PEPFAR COVID-19 Response committee

The committee serves as a nerve centre to coordinate the internal Wits RHI COVID-19 response and to leverage resources and best prac¬tices between the programmes.

This committee response is guided by the Wits RHI Steering committee, PEPFAR and its agencies (USAID, CDC, UNITAID, and ELMA).

(Dr Gloria Maimela PI and Prof. Saiqa Mullick PI)

The National WhatsApp messaging and symptom surveillance pro¬gramme: COVID-19 HealthCheck joint initiative The COVID-19 Digital Risk Assessment and Mapping Tool known as HealthCheck, complements national screening efforts by allowing users to selfreport symptoms and details such as age and location, for early detection, mapping, and linkage of those reporting symptoms to testing services.

(Prof. Saiqa Mullick, Co-PI)

Novovax

The purpose of this study is 2-fold: 1) to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in serologically naïve (to SARS-CoV-2) healthy human immunodeficiency virus (HIV)negative adult subjects (Cohort 1 – HIV-negative) and 2) to evaluate the safety and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in serologically naïve (to SARS-CoV-2) medically stable HIV-positive adult subjects (Cohort 2 – HIV-positive).

(Prof. Lee Fairlie PI)

ENSEMBLE ENSEMBLE’s objective is to demonstrate the efficacy of AD26.COV2.S in the prevention of molecularly confirmed moderate to severe/ critical COVID-19, as compared to Placebo, in SARS-CoV-2 Seronegative adults.

(Prof. Lee Fairlie PI)

COVID vaccine Implementation Science

A COVID-19 vaccine plan led by the Implementation Science team.

(Prof. Saiqa Mullick PI)

HPTN084 CoVPN Preparedness Fund

To provide support to Ward 21 CRS #31966, to strengthen their site capacity to participate in large Phase 111 efficacy trials.

(Prof. Sínead Delany-Moretlwe PI)

COVID-19 Sero Survey

A cross-sectional COVID-19 survey involving questionnaires and sero¬prevalence, with the aim of measuring and understanding COVID-19 perceptions and impacts among residents of Hillbrow.

(Dr Thesla Palanee-Phillips PI, Prof. Matthew Chersich PI)

B-Wise Social Media: Supporting SA youth with HIV edutainment bursts This initiative enables innovative solutions focusing on the HIV preven¬tion among vulnerable groups during the COVID-19 crisis.

(Prof. Saiqa Mullick PI)

The Health Care Worker Health and Wellbeing Study This study focuses on health and mental wellbeing of health workers providing care to patients with COVID-19 in Johannesburg, South Afri¬ca: rapid needs assessment and action research.

(Prof. Lee Fairlie PI)

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Shandukani’s COVID-19

Heroes

Shandukani Research Centre, led by Prof. Lee Fairlie, in March 2020 focussed research work on children, adolescent and maternal populations, HIV and TB treatment and prevention as well as vaccine preventable diseases.

With the first wave of COVID-19 infections and the government-imposed level 5 lockdown, the team quickly shifted gears and added COVID-19 vaccine studies to its’ portfolio. The ChAdOx1 nCOV-19 ZA AstraZeneca trial, initiated screening in June 2020 at 7 Esselen Street SRC @ RES in Hillbrow.

Prof Lee Fairlie

Dr Elizea Horne

The Novavax 2019nCOV-501 and the Johnson and Johnson Ensemble trials followed shortly.

Prof. Lee Fairlie leads the sites AstraZeneca trial with Dr Faeezah Patel and Dr Elizea Horne as support. The South African National Dept of Health procured this vaccine for vaccine rollout after it showed good efficacy worldwide.

The local results released January 2021 drastically changed rollout plans as it showed little efficacy against the 501Y.V2 variant which predominated infections in South Africa’s second COVID-19 wave. International and local results published in peer-reviewed journal include all three leads as authors.

The SAHPRA audited Novavax 2019nCOV-501 trial was also led by Prof. Lee Fairlie with Dr Gabriella Benade as the lead sub-investigator.

Vaccine efficacy has been proven in this trial too and a cross over design portion of the study is due soon.

Dr Gabriella Benade

Faeezah Patel 11

The Johnson and Johnson Ensemble trial, with is single dose vaccine and wider age range was successful worldwide and showed efficacy against the 501Y.V2 variant. Dr Faeezah Patel and Dr Elizea Horne co-lead this trial.

This evolved into the SISONKE vaccine roll-out under the banner of an implementation study across all provinces. Half a million doses are expected to be rolled out by April 2021. Dr Faeezah Patel is the site lead on this history making project.

Shandukani’s women power is leading the sites fight against COVID-19.

COREP COVID-19

Household Cluster Investigation

O

n the 13th March, Wits RHI Health Programmes successfully launched the COREP COVID-19 Household Cluster Investigation in Lejweleputswa District, Free State.

The study is funded through the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Department of Science and Innovation, South Africa.

It forms one component of the COREP project “Determining the epidemiological parameters of COVID-19 through sero-surveillance with Dried Plasma Spots and nested household transmission studies in rural Kenya and South Africa” and is implemented in collaboration with Heidelberg Institute of Global Health (Germany) and Agha Khan University (Kenya) among other partners.

The study in South Africa will enrol approximately 120 household contacts (including children) of primary cases of COVID-19 and follow them for one month. During this time, we will conduct interviews and repeat antibody and PCR testing for SARS-Co-V2.

Through the study we will examine how COVID-19 spreads within households, determine risks for infection and transmission, and how preventive behaviours are implemented, as well as explore how people feel about the COVID-19 vaccine.

The study team is led by Dr. Gloria Maimela, and includes Dr. Catherine Martin, Shobna Sawry, Nkululeko Mngomezula, Modiehi Mopeli and Emly Lekitlane.

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My PrEP Mobile Application We are the generation that will end HIV

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

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Version 1 and 2 of the My PrEP Journey mobile application is available for download on the Google Play store and the App store.

The development of the My PrEP Journey mobile application was carried out in close collaboration with the South African National Department of Health and its partner implementing organizations, Unitaid, She Conquers SA, Wits RHI and the World Health Organization (WHO).

Version 1 of the application was developed to facilitate and support the continued use of Oral PrEP as a method of HIV prevention in Project PrEP’s selected priority districts.

Due to the ongoing COVID-19 outbreak, it was decided that duplicating the existing app for a broader national rollout to PrEP users in South Africa would serve as an excellent source of additional support and linkage to services as well as to support the national roll out of PrEP countrywide, thus contributing positively to the goal of preventing HIV infection, gender-based violence and it empowers young people to access health services especially during the COVID-19 pandemic.

PrEP implementing partners can also fill out a register with patient details and email it to us for system upload and an SMS with a link to download the app will be sent to the PrEP users.

Please email Nakita Sheobalak ( nsheobalak@ wrhi.ac.za ) to request a copy of the register.

The mobile application is multi-pronged- PrEP initiators are encouraged to download the app that will support and reward them on their PrEP journey, encourage continuation, provide PrEP pill taking reminders, build their knowledge in the form of quizzes and be used as a method of data collection allowing for remote monitoring, thus improving health outcomes. The app is user friendly, easily accessible and feasible.

It is only 15MB in size, requiring a minimum of 2 minutes per day of in-app activity and consumes about 10MB of mobile data per month.

PrEP users who have a compatible smart phone and who are interested in installing the app, can do so by searching for the app on the Google Play Store or Apple App Store

There are three main distinctions between the two versions of the app – Version 1 is only for PrEP users who have initiated on PrEP through Project PrEP’s facilities and mobile clinics and are registered by the demand creation team using patient ID’s and are rewarded with mobile data to continue their journey with ease.

Version 2 has increased the number of daily activities on the app with more notifications, quizzes, and social media sharing. Periodic draws will take place, and users who are most active on the app will win a prize.

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Dolutegravir Approval IMPAACT Announcement - P1093

T

he IMPAACT P1093 Team is elated to inform you that on 14 January 2021, ViiV was notified that the European Commission has granted Marketing Authorisation (EMA) approval for the dolutegravir (DTG) 5mg dispersible tablets for paediatric populations living with HIV in Europe.

This decision follows the US Food and Drug Administration approval for this pediatric formulation in June 2020. Use of DTG dispersible tablets was approved for both treatment naïve and experienced populations who are at least four weeks of age and weighing more than 3 kg.

The EMA authorization also includes updated dosing recommendations for dolutegravir film coated tablets (10, 25 and 50 mg) for children weighing 3kg and above and ≥14kg and ≥6years of age, which aligns with weight band dosing recommended by the World Health Organization.

Treatment dosing tables are in accord with those being used in the latest version of IMPAACT P1093.

Dolutegravir pediatric regulatory submissions are now ongoing around the world to ensure that age and developmentally appropriate formulations can become a treatment option for the approximate 1.7 million infected children worldwide.

working together to accelerate the availability of DTG dispersible formulations for use in low income and other countries where access to newer antiretroviral therapies have been limited.

Through this partnership, FDA approval for the first generic formulation of dolutegravir dispersible tablets was granted to Viatris (formerly Mylan Pharmaceuticals) in late 2020. It is anticipated that these activities will continue to evolve and help lead to a future where no child with HIV will be left behind.

The EMA Marketing Authorization is based on data from the ongoing P1093 and ODYSSEY (PENTA20) studies, which are being conducted in collaboration with the international pediatric research networks, IMPAACT and PENTA-ID. The IMPAACT 1093 team would like to thank and commend the IMPAACT Network, ViiV Healthcare and many international clinical sites for their expertise, professionalism and hard work in conducting such a complicated clinical trial leading to regulatory approval for dolutegravir. We especially would like to thank the study participants and families for volunteering for this trial.

Shandukani Research Centre is proud to have been part of this clinical trial.

The Clinton Health Access Initiative (CHAI) and ViiV Healthcare, with funding from Unitaid, are

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COVID-19 One Year On 5 March 2020 First reported case

3 December 2020 COVID-19 second wave announced

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Vaccine Roll Out PHASE 1

Frontline workers (1.2 mil)

PHASE 3

PHASE 2

Targets 22.5 mil members of population over age 18, to vaccinate 67% of the population

Essential workers. 60+ years, people with comobordities 18+ years & people in congregated settings

15 March 2020

National disaster declared

27 March 2020 First COVID-19 death

31 December 2020 Cases: 1.05 Million Recovered: 879K Deaths: 28 469K

Today

Cases: 1.60 Million Recovered: 1.5 Million Deaths: 55 507K

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WHAT ARE THE SIDE EFFECTS OF COVID-19 VACCINES?

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s the coronavirus vaccine rollout continues across the country, health experts say one thing is critical for people to understand before they roll up their sleeves: The vaccines may cause side effects.

Three vaccines – developed by Moderna, PfizerBioNTech and Johnson & Johnson – have been authorized by the U.S. Food and Drug Administration (FDA) to combat the coronavirus.

These are the most commonly reported side effects: • • • • • • • • •

Injection site pain and swelling Fatigue Headache Chills Fever Muscle and joint pain Nausea Delayed swelling, redness or a rash at the injection site Swollen lymph nodes (typically manifests as a lump in your armpit or above your collarbone)

Most of the reactions are temporary and resolve within a few days, according to the U.S. Centers for Disease Control and Prevention (CDC). Since you may feel under the weather, experts recommend not making any big plans for a few days after you get a dose of the vaccine.

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“Where a mistake could be made is in people being surprised or not being prepared for side effects,” says William Moss, M.D., executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health.

CDC data released Feb. 19 indicated that the side effects from the Moderna and Pfizer-BioNTech vaccines were as expected and not serious among the vast majority of the first 22 million people who received them.

The Johnson & Johnson vaccine appears to be somewhat less likely to cause side effects than the other vaccines, Moss said. In its clinical trial data submitted to the FDA, the most common side effects were headache (39 percent), fatigue (38 percent), muscle pain (33 percent), nausea (14 percent) and fever (10 percent).

SIDE EFFECTS ARE A SIGN THE VACCINE IS WORKING Side effects from vaccines are not uncommon. The seasonal flu shot, for example, can cause fever and fatigue, among other reactions. And the vaccine to prevent shingles can induce shivering, muscle pain and an upset stomach.

In some ways, these mild to moderate reactions are “a good thing,” Moss says, because they are “a sign that the immune system is responding to the vaccine.”

The key, experts say, is to weigh the temporary discomfort against the long-term benefits: a potentially high level of protection from a disease that has uprooted everyday life for many of us and has killed more than 2.5 million people globally.

“We are willing to tolerate discomfort in other aspects of our life — many people exercise and have muscle aches afterward, and don’t say, ‘I’m never going to exercise again,’ ” Moss points out. “There are just many aspects of our lives where we need to be willing to make the trade-off of some degree of discomfort for a longer-term gain.”

Source: AARP Article

EXPERTS: Most secondary reactions resolve on thier own in a few days.

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Town Hall with Professor Helen Rees

What’s happening @ Wits RHI

We have concluded the first round of Town Halls with Prof Helen Rees for this quarter. These sessions were successful and insightful!

Thank you for attending and engaging with Prof Rees in these Town Halls. Look out for the next round of Town Halls in the second quarter as Prof Rees continues to meet with various Wits RHI sites across the country.

Zoli Study

On 4 March 2021, Wits RHI hosted its first Vaccine Town Hall with SteerCo This webinar covered everything about vaccines, it’s impact in the workplace and the current vaccine implementation plans in South Africa.

Principal investigator, Prof Sinead DelanyMoretlwe, along with the research division is excited to announce the Wits RHI site activation of the STIZOLI_001 study which aims to assess the efficacy of a potential new antibiotic, Zoliflodacin, to treat uncomplicated gonorrhoea. This phase III trial will take place in the Ward 21/HSB CRS. Wits RHI is one of three South African sites working with sponsors from The Global Antibiotic Research and Development Partnership (GARDP) in launching this phase III trial of Zoliflodacin, in South Africa as well as the United States, the Netherlands and Thailand.

Gonorrhoea is a crucial public health challenge in South Africa with rising concerns around antimicrobial resistance and we look forward to contributing to the science of Gonorrhoea management.

STI/Condom Week 10 - 16 Feb As part of STI/Condom Week (10-16 Feb), Prof Sinead Delany-Moretlwe and Dr Danielle Travill were part of a discussion with the Wits University’s Faculty of Health Sciences about the various Wits RHI initiatives focusing on STIs. Research Centre Research Centre was selected to be a site for the Gilead Phase 3 trial of Lenacapavir, Descovey and Truvada for HIV prevention. This is a large trial that will assess injectable and oral PrEP in young women and the Research Centre team is happy to have been selected for it.

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Wits RHI at HIV4P Wits RHI took part at the HIVR4P Virtual Conference 27 – 28 January and 3 - 4 February 2021.

Our team of experts will share the latest information on the innovative and exciting research that we are busy with.

Upcoming Conferences Upcoming Conferences: 2021 APS Virtual Convention May 26-27, 2021 Join us for a Meeting of the Minds in May 2021! APS will host a virtual conference that convenes psychological scientists from around the world, and features the latest research and luminaries in the field.

Program components from both the APS Annual Convention and the International Convention of Psychological Science (ICPS) will be combined into an interactive online two-day event, plus a Virtual Poster Showcase that will remain available for several months following the live event.

For more information: https://www.psychologicalscience.org/conventions/2021-virtual

Update on the 10th SA AIDS Conference Date In the light of the predicted 3rd COVID-19 wave due in June the SA AIDS Conference Organising Committee has decided that: •The conference will be postponed to 2022 when we hope we will be able to host an in-person conference in Durban; •There will be a two-day virtual mini-conference on 9 and 10 June 2021 themed: HIV and COVID-19 The virtual conference will be held in the evenings from 16:00 – 20:00 over 2 days.

IAS 2021 11th conference on HIV Science This biennial conference presents the critical advances in basic, clinical and operational research that moves science into policy and practice.

Through its open and inclusive programme development, the meeting sets the gold standard of HIV research featuring highly diverse and cutting-edge studies. IAS 2021 participants can expect a full conference experience via an easy-to-use digital platform that connects researchers, health care providers, advocates and policy makers.

Additionally, a “local partner hub” will convene locally based experts in the original host city of Berlin, in accordance with local health advice and regulations.

Registration now open Register for IAS 2021 today and join thousands of HIV professionals at the world’s most influential virtual meeting on HIV research.

Standard registration closes on 31 May 2021.

JOIN the Wits RHI #COVAC Campaign COVID-19 Vaccine Campaign • • • •

Are you a healthcare worker/ profession?

Are you registered on the EVDS system to receive your vaccine?

How were you feeling after taking your jab?

Do you have words of encouragement to those who are hesitant to take the vaccine?

If so, share with us pictures or a video (2 minutes long max) of your remarkable journey and lets raise awareness together! Send these to: rhicomms@wrhi.ac.za Let us stand together and vaccinate!

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WITS RHI

COVID-19 VACCINE CAMPAIGN Sisonke Trial COVAC Ambassadors from Shandukani CRS, Ward 21 CRS & Research Centre

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#VACCINELITERACY 4 facts about vaccines

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#COVID19 #STAYSafe

4 reasons why the COVID-19 vaccine developed so fast

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+27 11 358 5300 www.wrhi.ac.za Hillbrow Health Precinct 22 Esselen Street Hillbrow, 2001 Johannesburg