how an early stage industry can be developed

The issue of vaccine production has become a hot topic of debate following the approval of treatments for COVID-19. In South Africa, angry exchanges have been boosted by the country’s delay in access to COVID-19 vaccines.

In general, vaccines are produced by private companies who sell the vaccine under contract. In some cases, producers will make arrangements to access particular markets. This is sometimes a condition for receiving early development funding or for allowing certain parts of production to occur in a particular country. Some middle-income countries, especially India, Argentina and Mexico, have sufficient production capacity to be partly essential. These countries have strategic leverage to obtain vaccines because of their own vaccine manufacturing capacity.

India is a good illustration of this. The Serum Institute of India, a private pharmaceutical company, manufactures large quantities of COVID-19 vaccines from the University of Oxford / AstraZeneca and Novavax. The company is expected to reach 100 million doses produced per month by March 2021. In return, India will keep some of the vaccines it makes – 100 million doses at first.

What about South Africa’s own capacity to produce vaccines? What can the country do?

South Africa does not have a large-scale vaccine manufacturing capacity. The Biovac Institute – a public-private partnership between the South African government and a consortium of South African healthcare companies – begins to embark on vaccine manufacturing to provide safer and more accessible childhood vaccines for southern Africa. But this capability is still in its infancy. It’s small compared to the COVID-19 vaccine market.

In addition, Aspen Pharmaceuticals, a listed global pharmaceutical company owned by South Africa, operates four pharmaceutical manufacturing and packaging plants in the country. The company is also entering the vaccine packaging market.

We see a clear gap between what would be needed to make the Biovac Institute a strategic vaccine asset in the future and what is planned for Biovac.

If South Africa is serious about providing pandemic vaccines in the future, it needs to rethink the scale of financial, technical and strategic investments in vaccine production. This investment must be made not only in the private sector, but also, critically, in publicly accountable institutions such as the Biovac Institute. Only if investments are increased, sustained and backed by political commitment, will the country have sufficient vaccine production capacity to use as leverage to gain national and regional access to future pandemic vaccines.

Vaccine production capacity

The main mission of the Biovac Institute is to make childhood vaccines available for the South African market, mainly for the public sector.

For its part, Aspen’s current pharmaceutical manufacturing capacity is approximately 10 billion tablets per year. It produces generic drugs (including pain relievers, a proton pump inhibitor and sleeping pills), nutritional supplements (including iron supplements) and hormones for local African and other middle-income markets, like Turkey.

Aspen is expected to start producing the Johnson & Johnson COVID-19 vaccine in March or April 2021 at these facilities. He will fill and package vials with vaccine products produced in bulk outside of South Africa.

Most vials will be returned to Johnson & Johnson for international distribution. A recent announcement says 9 million doses will remain in South Africa for local use. The original packaging deal between Aspen and Johnson & Johnson was announced more than two months earlier. There had been no mention of a purchase agreement for South Africa until pressure began to mount recently on all parties.

Unlike Aspen, Biovac’s mission is to provide vaccines in the public interest. Part of its mission is

provide long-term capacity for the development and introduction of new vaccines, focusing on the development of vaccines tailored to the specific needs of South Africa and Africa.

The main activity of Biovac is to import, label and distribute vaccines in the South African market. For example, it supplied six vaccines made by international vaccine manufacturers for South Africa’s childhood immunization program. It also supplies other countries in the region.

The crowning achievement of Biovac was the local production (filling and packaging) of Hexaxim, a combination of six vaccines for children from Sanofi, the French multinational pharmaceutical company. Production started very recently, in November 2020.

Biovac is the first external company with which Sanofi has partnered to fill and package Hexaxim.

Biovac also plans to manufacture Prevnar-13, a vaccine manufactured by Pfizer, the American multinational pharmaceutical company. The vaccine prevents pneumococcal disease and death. Biovac will formulate the product using components supplied by Pfizer prior to filling and packaging the vaccine in bulk. Production is expected to start within the next six months.

The development of local capacity to formulate a complex vaccine marks another important step towards establishing a vaccine manufacturing capacity in South Africa.

How to be better prepared next time

To be in a better position to procure pandemic vaccines, South Africa will need to have greater vaccine manufacturing capacity. And the country should be more willing to use this capacity as leverage.

Scale is a key consideration. Biovac plans to fill 4 million doses of hexaxime in 2021. This is minimal compared to the enormous capacity of the Serum Institute of India and Aspen’s reported capacity of 300 million doses of vaccine per year.

Beyond the scale, two other conditions must be met.

The first is simply more experience. The transfer of technology for each vaccine produced by Biovac would give the company the experience and technical ability to retool for the formulation, filling and testing of each particular vaccine. The second is that a smarter entrepreneurial risk-taking environment must be developed. This needs to be backed up by political commitment within government.

The Aspen example shows that developing local manufacturing capacity is possible if enough capital is available and the right strategic partnerships are established. Private facilities like Aspen can clearly become a lever for local access; but, that does not seem well assured.

If Biovac’s current trajectory is maintained and sustained, it should be able to deliver other vaccines (mainly childhood vaccines) in the future. The strategic value of this assured supply should not be underestimated.

In addition, Biovac could be one of the answers to this problem because it is a publicly responsible institution and because it can point to its mission of making vaccines accessible locally during any production transaction. But in its current incarnation and scale, Biovac will not be able to deliver pandemic vaccines for southern Africa. Neither can it act as a strategic asset like the Serum Institute of India has been for India. South Africa has about one-twentieth of India’s population. This means that it will need its public vaccine production capacity to grow to a smaller size to become a strategic asset.

Jeffrey Dorfman received personal honoraria for vaccine information lectures from Sanofi Vaccines South Africa.

Frank Kirstein worked for the Biovac Institute from July 2017 to November 2020.

By Jeffrey Dorfman, Associate Professor of Medical Virology, University of Stellenbosch and

Frank Kirstein, Honorary Research Associate / Lecturer; Division of Immunology, Faculty of Health Sciences, University of Cape Town