ASPEN PHARMACARE: Vaccine Manufacture is a Monumental Moment for Africa

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A 160-year heritage as a global specialty and branded multinational pharmaceutical company, Aspen Pharmacare is one of South Africa’s largest and most important enterprises. Now it is making its expertise across multiple product types count more than ever before, as delivery of its first Johnson & Johnson doses sees an African-manufactured Covid-19 vaccine finally delivered to South Africa, already rolling into arms throughout the continent.

Vaccines have long been hailed as a crucial, if not the fundamental, aspect of stopping the spread of Covid-19 in South Africa. They offer vital protection at both an individual and also a population level, reducing the risk of infection or the severity of symptoms.  

“Vaccination is a safe and effective way to prevent disease and save lives,” the South African government states plainly. “When we get vaccinated, we do not just protect ourselves, but also those around us.” 

A priority in the fightback against the spread of Covid-19, a vaccination programme is nonetheless an incredibly logistically complex procedure to execute, particularly at the speed required of the endless waves of the pandemic. South Africa’s has been hampered by almost every factor imaginable, including delays in the global race for procurement, uncertainty around efficacy and access challenges. 

A LANDMARK COUP 

News in December that Aspen was to join the vaccine rollout as a contract manufacturer for Johnson & Johnson (J&J) was greeted with jubilation across the nation, and its involvement has been integral in helping the nationwide process to gather pace. “We’ve worked very closely with J&J to complete a tech transfer in record time, which is kudos to us both,” begins Aspen’s Group Operating Officer Lorraine Hill. 

“J&J freely gave resources, knowledge and time to ensure that we could adequately transfer the vaccine. Once the widely publicised setbacks regarding the Emergent issues had been overcome, we have been able to commence manufacture and it is beginning to pay off and give J&J more stock to distribute. 

“We receive the drug substance form J&J, and then do the full formulation, fill and finish in Gqeberha, before packing and freezing it prior to collection by J&J from the factory.” 

These first J&J doses of the Covid-19 vaccines packaged at its Gqeberha plant were released by Aspen at the end of July. “This represents a significant landmark for South Africa and the African continent,” commented Stephen Saad, Aspen Group Chief Executive, “as these are the first Covid-19 vaccines to be produced on the African continent by an African producer for South African and African patients.”  

The release of the doses is a huge boost to the local vaccination drive and marks a huge step forward in ensuring that Africa can address its healthcare priorities, with these the first set of jabs manufactured locally from active pharmaceutical ingredients (API) imported from Europe. “It has start rolling into people’s arms now,” Hill proudly states. 

South Africa has placed an initial order for 30 million doses, which earlier this year President Cyril Ramaphosa said will increase to 400 million. No plant in South Africa has produced a vaccine itself in 25 years, and demand for the vaccine could never have been met in the time it would take to build such capacity. Instead, J&J is producing the vaccine at three existing plants and shipping it to just six centres across the world, one of which is Aspen’s Gqeberha factory. 

“This is a real watershed moment,” Hill confirms. “There simply hasn’t been the capacity and capability in Africa before now, and for us to be able to use some of the investments that we have put in place and work with J&J to maximise that capacity so quickly is a really massive achievement on both sides. 

“Our line capacity is 300 million doses, which is on track and running well. It was a mammoth effort from all the teams involved to ensure that there was an African response to the pandemic.” 

WORLD-CLASS FACILITY 

The massive investment plunged into Aspen’s manufacturing facility has been an ongoing process, initiated back in 2019 at the time of its purchase of GSK and AstraZeneca’s anaesthetics portfolios. “The shortage of sterile capacity then started to become evident,” Hill delineates. “Not a lot of sites globally have the completely modernised capacity, like ours, with the latest isolator technology. 

“It was fortuitous for us that we had already started the build of this fully certified sterile injectables facility at our existing site, from which our teams have tirelessly worked to optimise production of J&J’s Covid-19 vaccine for Africa.” 

Stephen Saad added: “We are actively seeking opportunities to further extend and capacitate Covid-19 vaccine manufacturing at this world class production facility. Aspen is seeking to play a meaningful role in contributing to the objective of delivering the majority of Africa’s needs from production sites located in Africa.”  

Aspen has invested over R3 billion in the Eastern Cape-based facility to date, the single largest investment in the pharmaceutical industry in South Africa. It was subject to the highest praise in the run-up to the historic vaccine delivery, as President Ramaphosa relayed the findings of his personal visit.  

“This is a world-class vaccination manufacturing facility which ranks among the best on the planet,” he effused. “It is a great achievement for South Africa and demonstrates our capabilities in advanced manufacturing. I wish to commend Aspen for having had the foresight to invest in this facility and for the speed with which they have readied themselves for production.”  

The facility will have no shortage of demand any time soon, Hill predicts. “The issue will not be available capacity, but we will face decisions on when and where to increase it. The vaccine may require boosters, or indeed a different vaccine entirely could be needed. 

“The supply chain could go in any direction and we will work closely with J&J to align with their forecasts. Looking at Germany and Hungary, who have just rolled out boosters, it is clear that in the short to medium term there will still be a lot of demand for vaccines. 

“We are working on a number of initiatives that will either fill the gap left by the vaccine or that will drive extra capacity when required.” 

POSITIVE INTERIM IMPACT  

Aspen has succeeded in maintaining uninterrupted operations throughout these most extraordinary of times, including at its 15 manufacturing sites, as robust business continuity plans and the customary resilience and commitment of its nearly 10,000 employees have come to the fore.  

“This has enabled us to continue to supply our medicines to patients in need across the world,” the company notes, “and to make an important contribution in assisting to combat the effects of the virus.” It has had another equally positive impact, with the group reporting revenue growth in its interim results at the close of 2020 of 17% to R18.6 billion, following 12% and 36% increases by Commercial Pharmaceuticals and Manufacturing respectively. 

“The business has proven to be in robust shape over the past six months,” Saad summarised. “We persevered with the build project to increase our sterile capabilities and capacity, we began the transfer of our Anaesthetics products to Aspen sites and remained steadfast in our commitment to patients and customers.” 

Hill is equally confident. “We have a number of initiatives aside from our valuable vaccine work underway, and the December results show that the underlying strategy and the delivery are in great shape,” she states. “People recognise that we are here for South Africa, and we can transfer what we are achieving here to many other countries. 

“We always rise to the challenges as they crop up in South Africa and find real solutions to enhance the people and the continent. The world has learnt to cope with Covid now; countries are not completely shutting down and it is longer paralysing. It will certainly not stop us continuing to deliver.” 

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