🔒 How far are we from a trustworthy Covid-19 vaccine in SA?

As of mid-August about 570,00 cases of Covid-19 have been identified in South Africa. More than 11,000 individuals have succumbed to the virus. However, there is some positive news. Just over 432,000 people have recovered in South Africa. Recently, Russia announced that it has released the world’s first Covid-19 vaccine. Across the world, analysts and medical experts are questioning how the Russians managed to bring the vaccine to fruition so quickly. In this interview, BizNews founder Alec Hogg chats to Dr Noluthando Nematswerani, head of the Clinical Policy Unit at Discovery Health, who gives her thoughts on the Russian vaccine, and discusses which Covid-19 vaccine trials are in the pipeline locally. – Jarryd Neves

Dr Noluthando Nematswerani

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Welcome back to Dr Noluthando Nematswerani from Discovery. There are a couple of things that have hit the news that we need some unpacking on. First of all, the Russian vaccine. Now, we’ve just played a clip a little earlier from our colleagues at the Wall Street Journal, who are a little sceptical that the Russians were able to put this vaccine together so quickly. How are you reading it? 

The time it takes for a vaccine to be developed is usually years. In this situation of a pandemic, it’s fast tracked and we were expecting a commercially available product in 12 to 18 months. The reason why it takes long is because there are various phases of testing the vaccine.

If you think about the process, it starts in the pre-clinical stages where it’s still in the lab, where you then make sure that the vaccine is ready to be used in humans.

Pre-clinical? We usually use animal studies to almost prove that the vaccine actually does what we intend for it to do. Once we have tested it in that environment, it moves into clinical trials. The human trials have got various phases.

There’s phase one trials, it’s usually small numbers of people where you are still testing the dose to see if it will be the right amount that people can take without getting adverse effects. After that, you move to phase two trials. These are usually several hundreds of cases that you test your vaccine in and you are actually testing mainly the safety and efficacy of the vaccine.

Read also: US sceptical about Covid-19 vaccine gamble by SA’s Russian friend – Wall Street Journal

I think most of the trials that we’ve heard about were reporting on some of the early data around the response of the immune system to the vaccine. The most important trial data – that is critical before licencing takes place – is the phase three trials. Phase three trials enrol thousands of patients.

Here you actually want to test just beyond basic safety and efficacy to say, “Does it actually work, does it work in a broader group of patients and is it really safe?” I think the scepticism and the concern that has been raised around the Russian vaccine, is that it does not seem to have the phase three trials.

I think they’ve not been able to deny that fact. So the registration of the vaccine is based on phase two trials. It was very interesting to read that they actually amended their regulations around April to almost allow for registration and licencing of Covid-19 related products with phase two trial data.

I think that’s the concern, because as much as there is a rush from everyone to actually get a vaccine that is going to be effective in managing and curbing the spread of Covid-19, we actually want to make sure that we do have a safe vaccine. That’s where the concern is right now, that there is this rush to register, provide licencing and approval for this from the Russian government without the necessary steps having been adhered to according to global standards.

The President, Putin, has been saying that even his own daughter has already had the vaccine. So there might just be a tad of politics involved here?

Yes, I think there is a bit of that. It’s also just politics and the rush to say we are the first to have registered this particular product, which the world is waiting for. I don’t know if people are aware that the only two therapeutic agents that have been approved for Covid-19 are also from Russia.

There is not much known about those two as well, in terms of clinical data.

Interestingly enough, this product was also in the news about a week ago where the president of Russia was indicating that South Africa will be recipients of this product and that it has already received approval.

But locally, evaluation clinically, has not really shown a great support for that molecule as well. So there seems to be a trend towards any approval of some of these Covid-19 related therapeutics without following the normal standards and trial phases that are ordinarily followed by other countries.

This is fascinating, because it’s a whole new world for most of us to observe. One of the trials that has got the approval – it seems – of everybody in the community is the one with Oxford University, which is also happening here in South Africa. Which includes Professor Glenda Gray, the head of the Medical Research Council, who went in to get vaccinated herself. That must tell you that there’s perhaps some confidence? 

Definitely. South Africa is going to be involved in two trials. A third vaccine trial is going to be announced. The first one is the Wits vaccine, collaborating with Oxford – I think the principal investigator is Professor Shabir Madhi. Professor Glenda Gray is partnering with Johnson and Johnson. They are testing a different Covid-19 vaccine. She is – I think – the principal investigator in that particular trial.

There’s a third one that South Africa is going to be involved in. It’s important when we see scientists on the other side becoming the recipients of the trial vaccine, showing confidence and wanting to participate – not only as a scientist, but also as a patient.

It’s gathering data for future use in terms of the trial data that will come up once we have completed the studies done locally. I think it’s important for South Africa to participate in these trials because we must be part of a data generation. We must contribute when these Covid-19 vaccines are licenced in future.

We must have been part of that generation of knowledge and information. It’s important because it also brings diversity into the patient population and patient pool that the vaccines are tested in terms of the participants that the vaccine is tested on. So we really are very happy that Professor Gray has led the way and shown that she is confident about what the vaccine can do and is willing to be a participant, rather than just an observer and scientist who is sitting on the sidelines.

How are you reading the whole vaccine story at the moment? There is, for instance, with Russia, there’s room for hope. Maybe they’ve got it right, although they haven’t got the processes here in South Africa. We’re intimately involved, as you said, with some very promising vaccine trials, and there’s many elsewhere in the world also being tested.

Looking at the data that says more than 200 vaccines are currently being trialed, 25 of them are almost getting into trial phases. Then there’s about five studies in terms of human trials. There’s lots of activity and we are getting some early results around the vaccine’s showing some positive immune response from the participants that have participated in these trials. I think for now, if you are a commission and scientist and immunologist, you want to be cautiously optimistic.

Read also: AstraZeneca promises people before profits as it rolls out Covid-19 vaccine

We don’t want to be optimistic without understanding that there are various steps that still need to take place before we can get to a level that says now we’re confident there is a product that can be commercially available. It’s going to take a few more months.

We do need that rigour for public trust, because if the public feels like we’re taking shortcuts and cutting corners – specifically thinking about the anti-vaxxers – if anything goes wrong, it will actually set back the whole vaccine trial story.

We don’t want that. We want to make sure that all the necessary steps are taken, so that we can have an effective vaccine that does what it is intended to do.

As far as South Africa’s experience is concerned, we are bucking the world trend on mortality percentages. It does look like we’ve peaked as well here in this country. There is room for optimism, surely, on that front?

Definitely, but I have to emphasise this, because we’ve seen – I mean, if I think about the story of the U.S – where they started seeing a decrease in the number of cases and they became complacent. Suddenly they saw a second peak. This is not even unique to Covid-19. We know of previous pandemics where the first wave was not as bad as the second wave.

It is up to us to make sure that we don’t experience that terrible second wave. There’s no room for complacency. We need to continue with our non-pharmacological interventions, making sure that we adhere to social distancing and wearing of masks. We have to make sure that we get rid of Covid-19. We cannot afford a second wave. 

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