Scientists are hoping that the country’s latest experimental COVID-19 vaccine will protect people from becoming infected with the new coronavirus or developing serious COVID-19 disease. More than 800 volunteers in the United States and Belgium have already received the jab as part of earlier studies that showed it was safe.

 

Now, the vaccine will be part of a much larger study called the ENSEMBLE study in nine countries, including the United States, Argentina and, of course, South Africa. In South Africa, the vaccine trial is being run in partnership by the Desmond Tutu Health Foundation, the South African Medical Research Council and pharmaceutical company Johnson & Johnson.

 

The African Alliance is an NGO working to amplify the social and political incentives for dignified health care for all. The Vaccine Advocacy Resource Group is a global team of vaccine advocates who work for accountable, transparent and community-owned vaccine research.

 

Seyoum: What is the ENSEMBLE trial?

 

Bekker: “There are many vaccine candidates either in preclinical or early clinical later phase studies using various platforms [to deliver] the vaccine, some of which are very new in this era of COVID.

 

“The interesting thing about the Johnson & Johnson vaccine being used in the ENSEMBLE study is that it’s a vector-based platform and will try to prevent both new infections with the novel coronavirus as well as serious COVID-19 disease.

 

“What does a ‘vector-based platform’ mean? It means we use a common virus, called adenovirus 26, which has been proven safe to use in vaccines as a ‘vector’ to deliver a protein into the body. We hope that this protein, called an antigen, will prompt people’s bodies to develop some immunity against the new coronavirus.

 

“Johnson & Johnson have a great deal of experience with adenovirus 26 and have used it when trying to develop vaccines against Zika. And of course, we have used it in HIV vaccine trials, and that’s reassuring because we know there is a certain amount of safety associated with it. There’s also a lot of understanding about how this model of vaccine works and manufacturing capability around it, which helps to get something catapulted forward if it works.

 

“All three COVID-19 vaccine trials in South Africa are using different approaches. What makes the ENSEMBLE study stand out is that it’s a single shot, instead of two injections. Of course, a single injection does make administering the vaccine much easier.”

 

Seyoum: The ENSEMBLE study is also the only COVID-19 vaccine trial that will recruit people most at risk for serious COVID-19 disease. Can you explain a little about how that will work?

 

Bekker: “When it comes to the new coronavirus, the part of the population that is hardest hit and has the most severe disease appears to be our older community members and those who have comorbidities. Hence, any vaccine that’s worth it needs to be safe and effective in those populations.

 

“The way ENSEMBLE is being rolled out in a phased way. Early phases will include volunteers between 18 and 60 years of age just to check that the vaccine is safe and sparks an immune response in that population.

 

“An independent data and safety monitoring board is monitoring safety. If data shows that all is well, then the study will open to volunteers over the age of 60 and to those who have comorbidities.”

 

Seyoum: Recently, the World Economic Forum conducted a survey of 27 countries and found that only 64% of South Africans said they would accept a COVID-19 vaccine when and if it becomes available.

What do you think scientists and civil society can do to increase the confidence in vaccines and to ensure that people trust science despite the speed?

 

Bekker: “I like your tagline, by the way: ‘Trust the science despite the speed.’

 

“It’s a tension, particularly with a pandemic like the one we’re facing: There’s an urgent need to find a way to prevent the new coronavirus. Speed is key because the sooner we can be sure we have a safe working safe vaccine, the sooner we can try and deploy it. So speed is critical, and one doesn’t want to take away from that.

 

“Having said that, this cannot under any circumstance, come at the expense of sound scientific principles of clinical trials.

 

“We can do things in parallel. For instance, we can think about doing manufacturing while still testing a product, but we cannot cut out any of the important steps or phases of clinical trials.

 

We must not allow those minimum standards to slip. And this is where civil society can be our watchdog.

 

“We have seen the power of civil society and advocacy groups to say these minimum standards cannot be transgressed no matter how strong the political pressure. And we can watch each other in that regard.

 

“And where we feel that standards are slipping, we need to be loud and create a great deal of good trouble around that because there is no room for mistakes.

 

“A mistake will cost us an extraordinary amount of goodwill and contribute to this very troubling pushback of vaccine hesitancy and fear.”

 

Seyoum: What commitments, if any, have Johnson & Johnson made to the government of South Africa regarding the availability or the cost of this vaccine for South Africa and Africa as a whole if it’s found to be safe and effective?

 

Bekker: “I’m giving my sort of opinions here, and I’m sure that Johnson & Johnson’s leadership has their own set of responses to this critical question.

 

“There’s no doubt that while we walk the road of the clinical trials, we have to start today working on access and deployment. We have to ask, how do we get those vaccines to the neediest as soon as possible?

 

“We in South Africa have shown that we will be part of looking at the efficacy in our populations and we will know that it’s safe or not in our population. For me, that’s a very important step.

 

“When you’ve contributed to the world’s understanding of a product, there’s a moral right to access that product, and I think that puts us in a strong position to say we as South Africa have contributed.

 

“Vaccine access is absolutely key. It is, if you like, the end chapter in this book that we’re writing at the moment and it cannot be put on hold; it needs to be part of the same story.

 

“Step one is to find out whether a vaccine works.

“Step two is to make sure it gets to the populations that need it as soon as possible.”

 

Seyoum: What are some of HIVs lessons that we have applied to COVID-19?

 

Bekker: “There are some things that we’ve done well and some things that we maybe still need to learn some lessons around.

 

“I would say already we leveraged laboratory [testing] platforms. The vaccine [being used in the ENSEMBLE study] literally has catapulted off HIV vaccine work.

 

“Then there are lessons around how you do the research. We’ve utilised the sites put on the ground over many years to conduct HIV research and of course, there the principles from our HIV work around how you involve the community in research.

 

“It took us some years to learn the importance of community involvement in HIV research, and maybe that’s an aspect we haven’t done as well with during COVID.

 

“I’m disappointed the scientific research community hasn’t applied it as quickly in COVID as I think we should have. However, I think we can still make up some lost ground … in bringing the community on board, for instance, when we think about non-pharmaceutical interventions to prevent COVID-19. How can we engage the community to bring those public health interventions such as social distancing and wearing masks home?”

 

Seyoum: I know from all the work you’ve done on HIV research and TB research over the years that you are well aware of the importance of community engagement in ensuring that not only does research goes well but also produces vaccines or medicines that are accepted by communities. Talk to us a little about how you intend to conduct community engagement in the ENSEMBLE study in South Africa.

 

Bekker: “This is a two-way process. Communities are the ones battling this epidemic, and we as scientists are relying on them in the same way they are relying on us to do good for each other. So it is very much about mutually shared respect and partnership.

 

“And I think it does require all of us to get on board very quickly to say, how do we bring each other up to speed in this regard?

 

“I think HIV clinical trial sites have really led the way in terms of good participatory practice, including the role of community, and community engagement as well as making sure the community is involved from one end of the trial to the other.

 

“Our strategy with ENSEMBLE — and this is the strategy of the international COVID-19 Prevention Trials Network (COVPN) — has been to go into sites that have already been conducting HIV research.

 

“Every single one of those trial sites has tan existing community advisory board (CABs), which is composed of representatives and leaders from communities impacted by trials and work to safeguard their interests. In many cases, the CABs at these sites have been around for years, but they too are having to pivot in the same way that researchers have had to.

 

“CABs are having to ask themselves how they take what they know from HIV, TB and other areas of research and engage around the new coronavirus and COVID-19 prevention trials?

 

“Step one is to go into trial sites that already at least have the foundational good participatory practice mechanisms in place. Step two is a great deal of training that needs to happen in a very short space of time. Then, step three is a lot of honesty and authenticity around what we are learning as we go.

“Frank honesty is the way we’re going to be able to do this in the time, speed and the timeframe that we have while ensuring non-negotiable standards of ethics and excellence that are required to do this right.”

 

Maaza Seyoum is the Partnerships & Communications Lead at the African Alliance and the host of the COVID-19 Conversations Podcast Series.

Follow the African Alliance @Afri_Alliance

Linda-Gail Bekker is the CEO of the Desmond Tutu Health Foundation. Follow her on Twitter @lindagailbekker

1. So far do you have a concrete report from those three organisations on how they would reach out to those needing help? What platforms are there for civil society working in the GBV space to get this status updated continuously? What is the penetration of Personal Protective Equipment (PPE) of the shelter movements? Are we now saying as the result of the support 90% of shelters across this country are covered with Personal Protective Equipment (PPE)?

 

ANS: Okay so, if somebody had told me when we made the announcements that it would take as long as to contract with the entities, I would not have believed them. As you can imagine, because with funds we have public money, we follow stringent governance procedure. We don’t disburse funds until we have the necessary documentation, a Memorandum of Understanding (MOU), project plans and identification. Suppose the shelter movement says that they need PPE. For instance, we need to know, what that PPE is, where they will be sourcing that PPE from, whether they need us to source the PPE or they will source it themselves from their providers. Luckily with the National Shelter Movement, we managed to disburse the funds about two weeks ago. When we disbursed the funds, they found out that at 3 of their shelters, they had cases of COVID which they then had to shut down those shelters and provide sanitation to those affected shelters. So that disbursement has gone out for the National Shelter Movement that is R7.6 million. They satisfied all the government procedures, and issuance has gone out. They are just starting this week with their reporting. We have a reporting agreement with them that they will report to us every two weeks regarding the procurement of the services and PPE they said they need. And to give us visual evidence of those funds’ disbursements. We are expecting the first report to come in this week. In terms of the Thuthuzela Care Centres, we assumed that we would need to get an MOU done with the Department of Health because they based in hospitals. We then found out that they fall under the Department of Justice, under the National Prosecuting Authority (NPA), we then had to go to the NPA. We are still waiting for the last signatory from the NPA on our MOU after which we will then procure the necessary PPE that they need. They have given us the list of PPEs that they need, that will satisfy all, I think it’s 55 of the care centres across the country. Funds will not be dispersed for procuring PPE unless we get all the required signatures. Our donors and stakeholders need us to produce reports; therefore, we will monitor and report every fortnight. With the Gender-Based Violence (GBV) Command Centre that falls under the Department of Social Development as you guys may know, there are three support areas that money will cover. One is the procurement of social work for supervisors; the second is the procurement of laptops and tablets; finally, the third one is furniture for the Command Centre’s extended side.

 

However, getting some of the information, we need to sign agreements from the Department of Social Development (DSD) has been a long process. We finally got the DSD specifications for the laptops and sim cards that they require. We are 99%, we have sent through an MOU, we are waiting for acting Director General (DG) to sign and once that is signed it needs our governing processes. Then disbursement will be done to the different suppliers for the tools required at the GBV Command Centre. The Solidarity Fund follows this approach with all projects from the Humanitarian to Health Response Sectors. There are quite stringent governance process and an implementation process and monitoring and evaluation process. Ultimately, we have to report to donors about what we did with the funds we have (a) committed but (b) dispersed. During commitment announcements and the disbursements of funds, there is quite a lapse in several projects because of admin processes that we need to adhere to. 

 

2. Can the three organisations being funded be stated again? I missed the three names mentioned.

 

ANS: Gender-Based Violence Command Centre falls under the Department of Social Development, The National Shelter Movement and the Thuthuzela Care Centres. 

 

3. Is that correct that you did not issue a public call for proposals, but you contracted Global Health Services? Essentially they did a mapping of what they perceived as the most urgent need across the sector. It was on that basis you approached these three entities.

 

ANS: So they were not contracted to us, they gave of their time, donated their time, the Solidarity Fund doesn’t contract service providers, we don’t pay out unless it’s going to a particular intervention. So they donated their time and did this rapid assessment, and the rapid assessment was in two parts. They did a landscape analysis, but they also talked to several organisations and individuals in the gender-based violence sector. 

 

4. What exactly will the R4.2m allocated to the GBV Command Centre fund?

 

ANS: So it’s going towards the procurement of what they call health care, social work supervisors. It’s going towards the procurement of trade tools for those social worker supervisors, so laptops and tablets that will be used at the Command Centre. It’s going towards sim cards so that there is connectivity enablement for those tools of the trade. And it’s also going towards furniture that would be used at the Command Centre 

 

5. So because those three structures could fall or safely regarded as government entities and not civil society structures. Do you anticipate that with the second round of support a similar model will be followed, or there’ll be an open call, explicitly looking at GBV service provision by civil society that carry the bulk of the country’s response work? 

 

ANS: So the way that we are going about it again is, now that we are at Level 3 of the lockdown and there has been some easing even though we know that hasn’t changed, you know gender-based violence in our country because we know that its endemic right, and the COVID-19 what it has done, exacerbate something horrific. We believe that we need to go back again and engage with stakeholders. Engaging with stakeholders to understand this time around what are the interventions. The first round of intervention was rapid response. We had to do something, and we had to something quickly. In this second round, the interventions that we need to be considering in a particular budget envelope that the Solidarity Fund can catalyse and sustain on an ongoing basis. And what we would like to do, is to invite, I mean, I’m not a gender-based violence activist at all. What I would like to do now; I know about you, and I saw your tweet. I want to extend an invitation to you guys so that you are part of procreating what those interventions could potentially be. But to caution you, there is a limit to the envelope, so the conversations should become robust. Though we can not meet all the needs, we can undoubtedly select interventions that the Solidarity Fund can catalyse and those that have the potential to succeed beyond the Solidarity Fund. In some of the existing solutions and services across the country from the little exposure I had, I have found that there have been great starts to projects and interventions, but maintenance has fallen short. To ensure that if we start something new or catalysing something existing, it can be sustained on an ongoing basis at the same standard and service level as was anticipated. I would love to lean on you Tian and the group of people who are here. I would like to hear your views on where you think the interventions should be, how you feel those interventions should be and without being partisan, to say how this will ultimately benefit the survivor. Then who gets selected to be the implementing partner of whatever intervention that has been chosen. Is this the best implementing partner for that intervention? And that’s the approach that we would like to take for the second round. 

 

6. Is this rapid assessment report publicly available?

 

ANS: Yes, I can email it to you; everything that we receive is sharable. I will share that with you, and it also has the people who were interviewed as part of that rapid assessment and then the process that was followed. And then I would like to, through you Tian I invite you guys to the second round engagements. Some of the delays that we’ve had with disbursement in the first round were to give us a little bit of time to make sure that we are engaging widely and we are co-creating. I think for me the important thing is to co-create, I’m not flustered by criticism, any of that does not unsettle me. As long as we are co-creating and all understand that not everything we want happens. Still, we played a significant role in creating what is decided by the Solidarity Fund in the second round. So if you send this to me, I will answer, I will bucket the question and answer them in the detail as required, it’s open communication. Those who feel strongly and want to be part of it; no-one stops you, and we welcome it because we are volunteers and not experts. So any expert assistance, guidance steering is truly welcome because it makes it so much better and so much more relevant. 

 

7. Where are the 55 care centres in SA?

 

https://www.gov.za/sites/default/files/gcis_speech/THUTHUZELA%20Care%20Centres.pdf

 

8. Is it a correct assessment that the Solidarity Fund (SF) is funding government and not civil society, given who the GBV fund recipients are?

 

ANS: We partner with Government and relevant stakeholders in the business and civil society to be additive to the country’s efforts in responding to the pandemic. These efforts are identified through a process of landscape analysis, stakeholder engagement, the Fund’s mandate of being a rapid-response mechanism with a national reach in response to COVID-19 as well as being intent on assisting the most vulnerable in our communities to the best of the Fund’s resources. The recipients of the Fund’s GBV support are ultimately the survivors of GBV and not the recipient organisations who are merely the providers of these much-needed services.

 

9. She mentioned experts who sit in their Committee of disbursements – can she say who they are?

 ANS: Humanitarian Technical Advisory includes Mark Heywood, Louisa Zondo, Sello Hatang, Nolitha Fakude, the UN and Carley Furness-Symms Further,depending on the area of focus(food relief or GBV), we engage with experts outside the Technical team for guidance and advise.