Biovac in partnership with Sanofi – a French based multinational company – has commenced the local manufacture of Hexaxim, punted as the world’s first fully liquid hexavalent (6-in-1) vaccine.
Biovac was founded in 17 years ago to revive and restore South Africa’s vaccine manufacturing capabilities. Sanofi has been operating in South Africa for 46 years and one of its divisions, Sanofi Pasteur, is dedicated to vaccines and is also a leading provider of vaccines globally.
The vaccine protects against six childhood diseases, which include among others, diphtheria, tetanus, whooping cough, hepatitis B, Haemophilus influenza Type B and poliomyelitis.
Speaking during a virtual ceremony to celebrate the achievement, the minister of Higher Education, Science and Innovation, Dr Blade Nzimande described the development a “critical milestone”. Said Dr. Nzimande: “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.”
He 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. For two decades South Africa experienced a decline in the production of vaccine and it expected that the manufacture of Hexaxim will have many positive spin-offs for the country.
According to the minister, in 2003 when Biovac was formed the estimated annual cost of vaccine used to be in the region of R188 million and since then this has escalated to more than a billion a year. More than 3 million doses of Hexaxim are purchased annually and this accounts for more than 37% of this annual expenditure. Until now, the vaccines have been imported by Biovac for distribution under the EPI.
One of the direct benefits of the development is that the local manufacture will also contribute to a reduction in the costs for Hexaxim compared to international procurement. It is estimated that about R350 million per annum will be retained in the country.
Currently, 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.
Dr. Nzimande said that the development also creates an opportunity for scale-up and possibly supply to other countries in the Southern African Development Community (SADC) and sub-Saharan Africa. Furthermore, the minister said, with the backward integration process and the technology transfer from Sanofi, significant skills transfer has become part of the process of establishing local formulation and filling capacity.
He said the skills transfer will continue to enable the establishment of local technical skills and allow South Africa to become an expert in the GMP production process on the African continent, said the minister. This could allow future skills and training opportunities to the rest of the African continent.
“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.
Through the partnership Sanofi has trained Biovac personnel at its plants in production, quality control, engineering and procurement, and the exchange of processes and documentation to enable Biovac to manufacture the product locally.
In 2018 the South African Health Products Regulatory Authority granted Biovac a licence to manufacture Hexaxim, therefore 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.
Nzimande said a combination vaccine like Hexaxim is therefore of great value. It 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, he added.
Nzimande said that building local vaccine manufacturing capacity comes at the time when countries are grappling with the devastating health, social and economic impact of the coronavirus pandemic.
He said globally governments and pharmaceutical companies are making deals to accelerate 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. Nzimande said it is vital that South Africa and the rest of Africa establish local capacity to respond to future pandemics saying South Africa and the rest of the African continent will be last in the queue to receive vaccine.
Nzimande pledged his ministry’s and DSI’s continued support to Biovac to strengthen its vaccine production and its manufacturing capacity to deal with future pandemics.