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Pfizer partners with Cape Town’s Biovac in vaccine manufacturing deal

Biovac CEO Dr Morena Makhoana explains the arrangement and the fill-and-finish process involved.

FIFI PETERS: We’ve had some developments on getting more Covid-19 vaccines into Africa. South Africa’s Biovac has struck a deal with Pfizer and BioNTech to process and distribute over 100 million doses of Covid-19 vaccines a year for the African Union, beginning in 2022.

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Here to explain the dynamics of the deal is Dr Morena Makhoana, the CEO of Biovac. Dr Morena, thanks so much for your time, sir. Exactly what does this deal mean?

Dr MORENA MAKHOANA: Good evening Fifi, and good evening to your listeners. This is a historic deal for not only ourselves as Biovac but for the continent in that this is the first mRNA technology transfer that will be occurring on the continent – in actual fact the first in southern Africa. I think, as most of your listeners would know, mRNA is the latest technology that only in December of 2020 was proven in clinical trials. Seven months post that validation that it actually works, we’re very proud that, as an African and a South African company, we’re able to announce today that we’ve struck this partnership with Pfizer and BioNTech.

Each technology is different in its makeup and each vaccine is different. So once we get to learn a lot more about the technology from Pfizer and we’ve looked at our facility, what is required is that we do slight modifications to our facility – and that will commence as soon as possible. Those modifications should be completed by the end of the year, which would allow for the actual tech transfer, which essentially means that Pfizer will be sending us the raw material for us to show that it can actually work in our facility.

Assuming everything goes well, we then go to the regulator, to report we have modified our facility, we have absorbed the technology, and here are the results – can we go ahead and manufacture for the market? We are hoping that that process will be completed by the end of quarter two 2022 for us to be able to start to manufacture for the market from quarter three 2022. As per our announcement it’s not only going to be for South Africa but it’s going to be for the African continent as well.

FIFI PETERS: So we’re talking about manufacturing taking place next year. We have a very big problem with Covid-19 now, so what happens in the interim?

Dr MORENA MAKHOANA: Absolutely. We can look at our case and we can look at the continent because those dynamics have similarities, but they actually have differences. So in South Africa, the current government committed to buy Pfizer vaccines and J&J, and in fact Biovac is also involved in the distribution of those two vaccines.

Pertaining to Pfizer in particular, they have committed about 30 million doses of the Pfizer vaccine. This was prior to Biovac entering into this arrangement. So what government needs to get for mainly this year is signed and sealed and all we’re waiting for is the vaccines to be rolling – and we are receiving vaccines on a weekly basis. As soon as it comes we then roll it out. Part of that has enabled the government to open up to the over-35s, which is the current status of the vaccine programme. So that is happening.

Now, on the continent we know that the situation is even more dire because a lot of the supplies were reliant on the likes of Covax, and Covax had committed mainly Indian manufacturers – and now there’s an export ban. So the situation is even worse, which means that the continent will take longer to reach even 50% of the population. While the tech transfer that we have that’s going to extend over 12 months before we start producing for the market, there’ll still be a very great need for this vaccine on the continent.

I think even in South Africa we don’t know whether we’ll still need boosters, we don’t know whether we’ll have more variants. The only constant that I think everybody knows is that the virus will be with us. We just don’t know how severe it will be. So there will be a need for the product that Biovac will be manufacturing, even from next year onward.

FIFI PETERS: Exactly. That brings me to my next question. From my understanding – and please correct me here if I’m wrong – this deal entails most of the manufacturing or the footwork being done in Europe, and those doses being exported here to South Africa, with Biovac doing the final touches, the fill-and-finish, I believe it’s called, in that process. Is that the case and, if that is the case, then is this deal a really positive development, given that we are not yet manufacturing vaccines here in South Africa or here on the continent from start to finish?

Dr MORENA MAKHOANA: Fifi, at a high level you’re correct, but I wouldn’t want to say that most of the work is being done in Europe. You have to segment it into two. What is called ‘drug substance’, or API [active pharmaceutical ingredient] manufacturing, depending on the technology, can do about 50% of the work. The 50% is on the downstream side, which essentially means that a big chunk of the value chain lies in the downstream side, which is the fill-finish.

In many companies you find that the upstream side is not the bottleneck, but the downstream side is the bottleneck. So it is a significant part of the manufacturing. Without that you won’t have a vaccine – having raw materials just sitting is of no use to anybody. It has to be processed, and so even the bottleneck is a part of the process – that is a very important part of the value chain. So I don’t think we need to minimise it. As I say, if it takes about 12 months for us, you can imagine the intricacies that are involved.

Now Biovac, in terms of going to your question about the upstream side, which is the drug process side, we still have a vision to get there. In our discussions with Pfizer we wanted to also start doing the whole value chain. Once we unpacked and we saw how long it would take for all of that to happen, we said, okay, let’s just start with the downstream side, because the equipment is there with slight modifications that we need to do – let’s get that going. Hopefully at a later period we can open up the discussions about the upstream manufacturing.

FIFI PETERS: Just a quick one – the 100 million doses a year that will be processed and distributed, how is that going to be shared across the continent? Who gets what, and who gets how much?

Dr MORENA MAKHOANA: Oh, yes. I think that is a discussion that is yet to be had with in particular the African Union. And we also need to see, at the time, which vaccine and which country needs more of what. I’ll make an example. Obviously the continent will get multiple vaccines. There will be some countries that will prefer an mRNA vaccine and there will be countries that will prefer a J&J or an AstraZenica vaccine. It all depends on, firstly, their preference. The second thing that it would depend on is whether there’s a need for a booster. There are indications that it may not be a bad idea to mix, to start with an mRNA and finish off with another vaccine, or start with another vaccine and finish off with an mRNA. If all of those things will be at play, that will tell us how much we supply to the eastern part of the continent versus the west, versus this country versus Ireland.

FIFI PETERS: Okay. I certainly hope we don’t end up with a situation like we’re seeing in the developed world, where they’re being accused of vaccine-hoarding and an uneven distribution of the doses here on the continent.

Dr Morena, we’ll leave it there for now, sir. Thanks so much for giving us your time. Dr Morena Makhoana is the CEO of Biovac.

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