BIOVAC: Healthy New Industry Growing From Cape Town 

In 2003, when the South African government partnered with the private sector to establish Biovac, the ambition was clear: build a domestic vaccine manufacturing capability that could serve national and regional health needs. More than two decades later, that ambition is crystallising into something tangible. From its base in Cape Town, Biovac has steadily positioned itself at the forefront of African vaccine production, determined to address one of the continent’s most persistent structural weaknesses – an overwhelming reliance on imported vaccines.

For years, Africa has consumed vaccines produced elsewhere, at cost. While countries across Europe, North America and Asia developed deep, vertically integrated life sciences industries, most African nations remained dependent on global supply chains. The Covid-19 pandemic brutally exposed the risks of that imbalance. When demand surged and export controls tightened, the continent found itself at the back of the queue. The lesson was stark: health security and industrial capability are inseparable.

Biovac was created to close that gap. Structured as a public-private partnership, it has combined state backing with commercial discipline, building capabilities in vaccine formulation, filling, packaging, cold chain management, and distribution. Its mandate has been to ensure sustainable local supply of essential vaccines, while progressively deepening technological know-how. Over time, the company has become an anchor institution in South Africa’s healthcare manufacturing ecosystem, working alongside research bodies, regulators, and global pharmaceutical partners.

Today, the company stands at a pivotal moment. The opening of a new state-of-the-art vaccine manufacturing facility in Cape Town and regulatory approval to begin clinical trials of a locally developed oral cholera vaccine represent significant milestones – not only for Biovac, but for African healthcare manufacturing more broadly.

HISTORIC MOMENT

For CEO Dr Morena Makhoana, the significance is not lost. “It is a historic moment, not only for our company but for the country. Vaccine development is difficult, expensive, and tough. A lot of the vaccines we use a daily basis, whether for children or for flu or whatever it might be, were all developed overseas, large in Europe and the USA. They have big, thriving industries that manufacture many vaccines from scratch. Hence, they were able to respond to the pandemic when the likes of South Africa was not able to respond fully.

“With us developing this cholera vaccine from scratch ticks a number of boxes, firstly cholera in terms of the disease, but more broadly it enables the capability that the country has so long been lacking, having end-to-end vaccine manufacturing.”

That phrase – end-to-end – is critical. Historically, much of Africa’s limited vaccine activity has focused on fill-and-finish operations, where bulk product manufactured elsewhere is bottled and packaged locally. While valuable, that does not confer full technological sovereignty. End-to-end capability, by contrast, includes research and development, process design, bulk antigen production, formulation, quality control, and regulatory compliance. It is complex, capital-intensive work, requiring skilled scientists, engineers, and stringent oversight.

The newly opened Cape Town facility substantially strengthens Biovac’s infrastructure. Equipped with advanced laboratories and manufacturing suites designed to international good manufacturing practice standards, it enhances capacity for both development and production. In a continent where vaccine manufacturing accounts for less than 1% of global output, such investments are transformative.

“Pre-Covid-19, less than 1% was manufactured on the continent. In 2025, that statistic hasn’t changed. However, there has been a lot of work behind the scenes to change that in the future,” Makhoana noted for SABC.

The cholera vaccine is the first major test of this expanded capability. Cholera remains a persistent threat in many parts of Africa, with outbreaks driven by inadequate sanitation, climate-related flooding, and fragile health systems. Global shortages of oral cholera vaccines in recent years have underscored the urgency of diversified production. By advancing a locally developed candidate into clinical trials, Biovac is seeking to create a sustainable regional solution.

CLINICAL PATHWAY

Progressing from laboratory concept to clinical trials is neither quick nor straightforward. It requires not only scientific rigour but regulatory confidence. “To go to clinical trials, we had to get the blessing and approval of the regulatory authority, the South African Health Product Regulatory Authority (SAHPRA). The regulator has come to our site, inspected our facility, and ensure we manufactured under good manufacturing practice. We also had to compile a detailed dossier on how we are going to go about things. That was approved in September which allows us to start trials now. It will happen across five sites around the country. Firstly, we will conduct a safety study where we take volunteers to make sure there are no adverse events that we do not expect. The second phase, which will take most of 2026, is where we take the vaccine through different age groups, particularly younger groups, eventually into the paediatric population, and we look at safety and ensuring the vaccine actually works. We will constantly be taking blood to see if the level of antibodies expected are received. The trial will last for the next 18 months,” Makhoana explains.

The structured, phased approach reflects global best practice. Initial safety assessments are followed by broader immunogenicity and efficacy studies, with careful monitoring at every stage. For South Africa’s regulator, the process reinforces credibility; for Biovac, it validates the depth of its manufacturing and quality systems.

Importantly, the cholera programme is about more than a single disease. It is about platform capability. Once validated, the same infrastructure, skills, and regulatory frameworks can be applied to other high-burden illnesses. “There are promising signs that, in the next five years, there will be new TB vaccines. But those will be developed overseas. What we are doing with cholera allows for when other high-burden diseases and their vaccines come through, the country has the capability to manufacture them locally from scratch. There are many discussions happening around that. With malaria, we know there is a high-burden across the continent. We are opening capability so that going forward we can deal with day-to-day diseases and gain pandemic readiness,” says Makhoana.

This is where healthcare strategy crosses with industrial policy. Vaccine production is not simply a public health intervention; it is an advanced manufacturing discipline. It requires bioprocess engineering, cleanroom design, supply chain coordination, data management, and highly specialised quality assurance. Each of these components contributes to a broader innovation economy. For decision-makers in government and industry alike, Biovac’s progress demonstrates how targeted investment can yield both social and economic dividends.

The company’s model also highlights the power of partnership. From inception, Biovac has worked closely with the South African Medical Research Council, universities, global pharmaceutical firms, and international health organisations. Such collaboration mitigates risk, accelerates knowledge transfer, and ensures alignment with global standards. In an industry where scale and trust are paramount, these networks are indispensable.

At the same time, there are no illusions about the scale of the challenge. Moving from less than 1% of global production to even 10% will demand sustained capital, policy coherence, and market shaping. Procurement strategies, advance purchase commitments, and regional coordination will all play a role in ensuring that locally manufactured vaccines have predictable demand.

LONG HORIZON

Makhoana is candid about the long road ahead. “We need to ensure preparedness is not a fashionable topic in 2025 or 2026 only. It must be topical and centre in 2036 and 2046, and beyond that. In that way, we will gain the full capacity that we need, not only for South Africa, but for the region. It will bring benefits in terms of skills as our children, our future pharmacists and engineers, will not have to go overseas to find a home in the biotech sector. For health security, we need our own. We are a long way from that right now, but I am encouraged by the start that is being made. For us to go from 1% of global production to even 10% is going to take a long time and a lot of effort, and the start is always difficult.”

That emphasis on skills is particularly important. Biovac’s expansion is already contributing to the development of a local talent pipeline, from laboratory scientists to process engineers and regulatory specialists. Over time, this human capital base can seed further biotech ventures, strengthening the broader ecosystem. In a country grappling with youth unemployment and brain drain, high-value scientific careers offer both opportunity and retention.

Biovac’s story is instructive. It illustrates how strategic clarity, public-private collaboration, and sustained investment can translate ambition into capability. It also underscores that resilience cannot be improvised in a crisis; it must be built patiently, over years.

The opening of the Cape Town facility and the launch of the cholera vaccine trials do not mark the end of a journey. Rather, they signal that a foundation is firmly in place. In a continent where infectious disease burdens remain high and global supply chains remain volatile, that foundation is urgently needed.

Biovac is emerging not only as a healthcare company, but as an industrial leader. Its progress shows what is possible when vision aligns with execution. Through partnership and persistence, it is helping to redefine Africa’s role in the global vaccine landscape – from passive recipient to active producer. The task is immense and the road long, but the direction is clear. For a region seeking both health security and industrial depth, the example being set in Cape Town could prove transformative.