Regulator gives Biovac green light to manufacture vaccines

The Biovac Institute (Biovac) has been awarded a manufacturing licence by a South African regulator, taking it one step closer to realising the government’s ambition of producing its own vaccines.

Biovac is a public-private partnership that was formed in 2003 to try and revitalise the state’s human vaccine manufacturing capacity, after the demise of the state vaccine institute.

Part of the rationale for local vaccine manufacture is to try and improve security of supply for SA and the region, as there are no significant vaccine manufacturers on the continent.

SA has confronted numerous vaccine shortages recently, including the BCG inoculation, which is used to protect babies against tuberculosis.

Biovac currently sources and distributes vaccines, and its biggest customer is the state, which runs a national programme for immunising infants and children. It also provides vaccines to the private sector.

Biovac was notified by the Medicines Control Council in January that its Pinelands, Cape Town facility had been approved for the manufacturing of vaccines and other small-volume parenterals, said CEO Morena Makhoana. Small-volume parenterals are liquid medications and are usually less than 100ml.

Biovac has dossiers approved for Sanofi Pasteur’s six-in-one childhood vaccine Hexaxim and Pfizer’s pneumonia vaccine Prevnar-13, and expects to begin commercial production of Hexaxim in the fourth quarter of 2018, said Makhoana. Sanofi will provide the various active pharmaceutical ingredients (APIs) used in Hexaxim, which will be combined and packaged in Biovac’s Pinelands facility, he said.

“We are not seeking a premium [from the government] for our product, but we are hoping local manufacturing becomes a favoured way of doing business,” he said.

Makhoana said Biovac was pursuing a strategy of backward integration and was steadily building the capacity to do increasingly technical work. Its aim is to span the entire value chain, from research and clinical trials to manufacturing and marketing. “We have been doing packaging and distribution for ages, and are now getting into sterile manufacturing. The next step will be formulation and then API manufacturing.”

API manufacturing is the goal of a partnership between Biovac, global health organisation PATH and the Bill and Melinda Gates Foundation that aims to manufacture a novel vaccine against group B streptococcus.

There are no licensed vaccines that offer protection against the potentially deadly bacteria, which can be passed from mothers to their infants during childbirth.

While paediatric vaccines remained the focus of Biovac’s work, it was also pursuing partnerships to build the capacity to manufacture flu vaccines, said Makhoana.

“We are hoping to strike a deal this year or next to manufacture seasonal flu vaccine so we could deal with a pandemic. We need to get an assurance [from] whoever we partner with that they would support us in the event of a pandemic.”