Biovac awarded manufacturing licence

The Department of Science and Technology has welcomed the awarding of manufacturing licence to the Biovac Institute.

Biovac Institute, a South African company that has vaccine development capabilities, has been awarded a manufacturing licence, which paves the way for the company to fill and package a ready to use Sanofi Pasteur hexavalent vaccine.

Biovac entered into a partnership with Sanofi Pasteur (one of the largest companies in the world devoted entirely to vaccine development) in 2012 and have since been working to ensure a successful hexavalent technology transfer.

Hexavalent vaccine protects against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenza type b, in one injection - as well as filling other small parenteral volume products.

Biovac CEO, Dr Morena Makhoana, said the Hexavalent vaccine technology transfer was the first of its kind for Biovac with a global vaccine company. Vaccines and biological technology transfer are more complex than standard pharmaceutical products.

“Therefore, we are pleased that we have been able to develop and demonstrate how South Africa is growing this type of capability in this industry,” said Dr Makhoana, adding that this will enable effective control of the supply chain and further strengthen security of supply.

Biovac was established in 2003 as a public-private partnership with the aim of restructuring state vaccine assets to ensure domestic capacity in vaccine production, as well as a local skills base.

The Department of Science and Technology and its entity, the Technology Innovation Agency (TIA) hold a 47.5 percent stake in Biovac, which currently supplies millions of doses of vaccines a year to fight a range of diseases, including measles, tuberculosis and polio.

Over the recent years, Biovac has entered into partnerships with global pharmaceutical companies such as Pfizer and Path to manufacture vaccines for children’s and mothers’ protection.

The DST Deputy Director-General for Technology Innovation, Mmboneni Muofhe, said South Africa was committed to establishing essential infrastructure to assist in the development of the pharmaceutical value chain. This includes medicinal chemistry, high-throughput screening, preclinical testing facilities and the manufacturing of active pharmaceutical ingredients (APIs).

“Building on existing networks and creating new synergies, we also look to extend our collaborations in this regard with partners in both developed and developing countries, including research institutions, governments, pharmaceutical and biotech companies and international organisations,” said Mr Muofhe.

Mr Muofhe said public-private partnerships  were critical in that they enabled South Africa  to build the much needed local vaccine manufacturing capability, facilitating technology transfer and providing training and exposure which is resulting in facilities here becoming GMP approved.

“The economic and social impact of this strategy is huge as this can shield us from price fluctuations, contribute to local employment creation, ensuring security of supply of critical vaccines while at the same time also enabling us to respond to emergency outbreaks.  Most importantly, manufacturing vaccines locally will reduce our very high health-related technology balance of payment due to imports,” he said.

Sanofi Pasteur’s Head of SVP Vaccines International Commercial Operations, Fabrice Baschiera, said to fulfil their public health mission and ensure access to the company’s vaccines for those who need them, Sanofi Pasteur supported Biovac and the South African authorities in this technology transfer.

“Biovac’s technology transfers of hexavalent stands out as one of the best-executed technology transfer in our history. Sanofi is pleased to have empowered Biovac and we believe this is an important milestone for South Africa and the African continent should be proud of,” said Fabrice Baschiera.

For enquiries contact Veronica Mohapeloa @ 083 400 5750 or This email address is being protected from spambots. You need JavaScript enabled to view it. 
Nonhlanhla Kumalo at This email address is being protected from spambots. You need JavaScript enabled to view it.  or 060 498 7509


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