Biovac now manufacturing six-in-one paediatric vaccine locally

The Minister of Higher Education, Science and Innovation, Dr Blade Nzimande, spoke at a virtual ceremony on 19 November 2020 to celebrate the fact that Biovac has commenced the local manufacture of Hexaxim in partnership with Sanofi. This is the world's first fully liquid hexavalent (6-in-1) vaccine, which protects against six childhood diseases, namely, diphtheria, tetanus, whooping cough, hepatitis B, Haemophilus influenza Type B and poliomyelitis.

"This is a significant milestone for Biovac and South Africa's ability to build manufacturing capabilities for vaccines, and follows years of technology transfer from Sanofi to Biovac," said Minister Nzimande.

Minister Nzimande said that Hexaxim is the first Expanded Programme on Immunisation (EPI) vaccine to be manufactured in South Africa and is a strong indication of the technical abilities of South African scientists.

Following almost two decades during which South Africa's vaccine production declined, this development will have many positive spin-offs for the country.

When Biovac was created, the annual cost of vaccines was estimated to be in the region of R188 million. This has subsequently escalated to more than a billion rand a year. More than 3 million doses of Hexaxim are purchased annually, accounting for more than 37% of this annual expenditure. Until now, the vaccines have been imported by Biovac for distribution under the EPI.

Local manufacture will also contribute to a reduction in South Africa's technology balance of payments, with an estimated R350 million per annum retained in the country. Hexaxim provides for a large portion of the sales by Biovac and is one of the vaccines essential for ensuring the sustainability of Biovac. The Department of Science and Innovation and its entity the Technology Innovation Agency own a 47,5% stake in Biovac.

Minister Nzimande said that Biovac had followed a backward integration strategy, which involved moving from a distribution model to becoming a fully integrated vaccine manufacturer.

"In order to fast-track the process of backward integration, Biovac has entered into a number of technology transfer agreements with a number of international partners for the formulation, filing and labelling of some of the current vaccines used by the Department of Health. These technology transfer partnerships are aimed at enabling Biovac to formulate vaccines and to fill either vials or pre-filled syringes," said Minister Nzimande.

Sanofi is a French-based multinational that has been operating in South Africa for 46 years. One of its divisions, Sanofi Pasteur, is dedicated to vaccines and is a leading provider of vaccines globally.

Sanofi is the only company to have developed a stable fully liquid six-in-one vaccine. The clinical trials were conducted in South Africa and the vaccine was licensed in South Africa in 2014.

The partnership with Sanofi saw the training of Biovac personnel at Sanofi plants in production, quality control, engineering and procurement, and the exchange of processes and documentation to enable Biovac to manufacture the product locally.

The South African Health Products Regulatory Authority granted Biovac a licence to manufacture Hexaxim in 2018, thus paving the way for Biovac to commence production locally.

The Department of Health's EPI sees more than three million children vaccinated against 11 preventable diseases every year. If each of them were to be administered individually, infants would experience unnecessary discomfort, and multiple visits to the clinic would be needed. The more clinic visits required, the higher the risk of default, as each visit entails costs and time. This could lead to delayed or missed vaccines, increasing the likelihood of a child contracting a preventable disease and possibly passing it on to other vulnerable groups.

A combination vaccine like Hexaxim is therefore of great value. Hexaxim is the only 6-in-1 vaccine that has World Health Organisation prequalification status, and the only one available in both pre-filled syringes and single-dose vials. As the vaccine is fully liquid and ready to use, it does not need reconstitution before administration and is therefore more convenient for healthcare professionals to use. It also decreases containment sizes, cold chain handling and administration costs.

The local manufacture of Hexaxim could create opportunities for scale-up and supply to other countries in the Southern African Development Community and sub-Saharan Africa. Ongoing technology transfer will enable local technical skills to become established, and allow South Africa to become an expert in good manufacturing practice. This might open up opportunities for the rest of the African continent.

Minister Nzimande said that this significant step in building local vaccine manufacturing capacity comes at a critical time, as the global community continues to grapple with the devastating health, social and economic impact of the coronavirus pandemic. Governments and pharmaceutical companies are making deals aimed at accelerating the development and production of select SARS-CoV-2 vaccine candidates in exchange for hundreds of millions of doses, and South Africa may have to wait its turn. It is therefore vital that South Africa and the rest of Africa establish local capacity to respond to future pandemics.


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