Picture: REUTERS
Picture: REUTERS

The department of science and innovation says the state-backed vaccine developer Biovac has met its expectations, despite the fact that it has yet to manufacture any of its own shots more than 15 years after its inception.

Biovac is a public-private partnership that was established in 2003 to revive SA’s human vaccine manufacturing capacity. Earlier this week, it emerged that the health department is running a new tender that threatens Biovac’s income, raising questions about how the government sees the future of this venture.

The government holds 47.5 % of the equity in Biovac, of which 35% is held by the department of science and innovation (previously the department of science and technology), and 12.5% is held by the Technology Innovation Agency (TIA). The remainder is held by a private consortium led by Immunotek.

When asked whether the government had got value for money for its investment in Biovac, department of science and innovation spokesperson Ishmael Mnisi said: “Biovac is successfully providing labelling and packaging facilities and has almost completed the fill and finishing component of vaccine manufacturing, thereby fulfilling the requirement to establish local manufacturing as per the original strategic equity partner undertakings.”

Biovac has until now enjoyed an exclusive supply agreement with the health department to source and distribute vaccines made by international pharmaceutical companies for the government’s childhood immunisation programme, which sees it paid a premium to help develop its manufacturing capacity.

However, that is set to change in 2020, with a new tender run by the health department that Biovac says has been structured in a way that could leave it out in the cold. The development threatens Biovac’s viability and puts jobs on the line, its CEO, Morena Makhoana, said earlier this week. 

When asked whether the government would step in to assist Biovac should it fail to secure any of the supply contracts set out in the new tender, Mnisi did not answer directly, saying only that the department of science and innovation was “in discussions with relevant sister departments to look at home-grown manufacturing capability of products to serve the SA and continental market”.

He said Biovac had initially begun developing a pentavalent vaccine, but had been forced to change tack when the health department decided to stop using this product in the childhood immunisation programme. The pentavalent shot combined vaccines against diptheria, tetanus, pertussis, hepatitis B and haemophilus influenzae B.

Biovac had successfully developed the technology to make the five-in-one vaccine, which it then out-licensed to two other vaccine manufacturers — Indonesia’s Biofarma and Japan’s Kaketsuken, said Mnisi.

Biovac then pursued a strategy of backward integration for the products the health department had decided to introduce, which included securing technology transfer deals for Sanofi’s six-in-one shot Hexaxim, and Pfizer’s pneumonia vaccine Prevnar-13, he said.

“The vial fill and finishing line for Hexaxim is completed. Biovac is in the process of doing the final stability testing in order to be able to commercially produce Hexaxim in 2020,” said Mnisi.

The facility for formulation, filling and finishing Prevnar-13 had been completed, and Biovac expected to have the site approved by the SA Health Products Regulatory Authority (Sahpra) in early 2020, which would enable commercial production to begin in 2021, he said.