Aspen and a subsidiary of global brand Johnson & Johnson, Janssen Pharmaceuticals, have signed a provisional agreement that will see Aspen Pharmacare manufacturing J&J’s Covid-19 vaccine candidate at its plant in Port Elizabeth.

The vaccine candidate, Ad26.COV2-S, is currently in stage 3 of clinical trials and is one of the leading trials underway at present, with 60,000 adults in eight countries including South Africa and the US.

Other big trials underway include AstraZeneca/Oxford Covid-19 vaccine trial, which is being conducted in the United Kingdom, the United States, Brazil and South Africa.

In addition, Pfizer and its partner BioNTech are well advanced in their vaccine trials and hope to know whether the vaccine works by the end of November. 

In the case of J&J and AstraZeneca, indications of vaccine efficacy are expected in the first quarter of 2021. 

Whether or not the trial is a success, the agreement with Aspen is still subject to the successful completion of the relevant technology transfer activities and finalisation of certain commercial manufacturing terms. 

“We live in a world of unknowns,” says Aspen deputy CEO Gus Attridge. 

“We have to see whether this vaccine succeeds and whether it can get traction in global delivery. What is important for us, is that we have been recognised as a company that can operate in this space. 

“Facilities with this kind of contained, sterile vial filling, that are certified by European and US agencies, are not easy to come by.” 

Over the last decade or more, Aspen has invested over R3.5-billion in its sterile manufacturing production capacity.

Initially, this was for the manufacture of oral solid dose, liquids and semi-solids, which kickstarted its international capacity and allowed the company to support ARV initiatives across Africa.

More recently, however, the company has pivoted from the dog-eat-dog world of generic pharmaceuticals production towards the manufacture of high-end and niche pharmaceuticals. 

It has invested in a high containment facility in Port Elizabeth which allows it to produce state-of-the-art sterile drugs and vaccines, packaged into vials, ampoules and pre-filled syringes.

While the facility will be fully operational by 2023, it already has the capacity to produce more than 300 million doses of the Covid-19 vaccine candidate a year. 

“When we began the implementation of our plans to establish a complex manufacturing facility, we didn’t expect a Covid-19 crisis,” says Attridge. 

“That said, we will have a reasonable amount of capacity available once the capex is concluded… and we hope we can continue to attract the likes of J&J. It’s great to have a foot in the door.”   

The investment in this facility was one of the first flagship investments announced at the President Ramaphosa’s inaugural South African investment conference. DM/BM