Leading Covid-19 vaccine candidate to be manufactured in SA

• Aspen SA has entered into an agreement with J&J to manufacture one of its Covid-19 vaccine candidates in Port Elizabeth
• The vaccine is still undergoing clinical trials, and should it be successful, manufacturing can begin as early as March 2021
• Aspen's Group Chief Executive, Stephen Saad, spoke to Health24 about the agreement

South African pharmaceutical company Aspen has announced that one of its subsidiaries, which trades as Aspen Pharmacare, has entered into a preliminary agreement with Janssen Pharmaceuticals, Inc, and Janssen Pharmaceutica NV – two of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the "technical transfer and proposed commercial manufacture of their Covid-19 vaccine candidate, Ad26.COV2-S".

The vaccine candidate is currently undergoing Phase 3 clinical trials and is included in the World Health Organization’s (WHO) list of the 26 most viable candidate vaccines to go into human clinical trials.

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According to the statement, published on Monday, “Aspen Pharmacare will perform formulation, filling and secondary packaging of the vaccine for supply to Johnson & Johnson.

The manufacturing is planned to take place at its existing sterile facility in Port Elizabeth, South Africa.

Aspen's Group Chief Executive, Stephen Saad, told Health24 that should the vaccine prove efficacious, manufacturing should begin in March or April 2021.

"There are quite a lot of factors to consider here, but it's mostly about making sure that we have our technology transfers spot on. And that we get production done as soon as possible," Saad said.

Commitments to developing countries

The group also revealed that it has invested in excess of R3 billion in the facility containing the high technology equipment and systems that will be used to manufacture state-of-the-art sterile drugs and vaccines, packaged into vials, ampoules and pre-filled syringes.

The PE production area has capacity to produce more than 300 million doses per annum, Saad said.

"J&J has made a couple of big commitments – one to provide universal access (through the Bill & Melinda Gates Foundation), and the second commitment is to make up to 500 million doses available to lower income countries at a cost price.

"So they’ve made some really big commitments to the developing world. And so for us [Aspen] to give these really big capacities of hundreds of millions of doses, and knowing that in doing that, a percentage is going into developing countries is really a positive," Saad said.

How big will the first batch be?

Responding to how many vaccine doses would likely become available with the first batch of production, Saad explained that this information is unknown at this stage.

"I would assume production would ramp up quickly, and we’re really putting in a lot of effort into dedicating focus into the production line of this vaccine.

"But right now, the focus is on getting the technology transfers right. It’s a big project. Think about making 300-odd million doses. There’s a tremendous amount of logistics around it."

Will SA be at an advantage to receiving the vaccine?

"Effectively, J&J is intellectual property, and we are part of the manufacturing footprint," said Saad.

"But they have made those global commitments. I don’t know the allocations down to country level, but J&J have been pretty clear on universal access and they’ve gone out and said at least 500 million will be made available to developing countries.

"And really, we’re hoping to make it a reality for them for putting out capacity," he said.

Correction, November 2, 2020: An earlier version of this article incorrectly referred to J&J's plans to allocate up to 500 billion vaccine doses to lower income countries. The correct number is 500 million.

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