Pfizer, Sanofi, to Boost South African Biovac's Vaccine Output

By Wendell Roelf

July 05, 2019

CAPE TOWN (Reuters) - South Africa's Biovac Institute will start local production of Sanofi's hexavalent Hexaxim vaccine next year and Pfizer's anti-pneumonia Prevnar 13 vaccine in 2021, boosting supply of life-saving drugs in its main market, its CEO said.

Local output of the two human vaccines is a step change for Biovac, a public-private partnership 47.5%-owned by the South African government with long-term ambitions of expanding sales into the continent.

The new production lines follow years of technology transfers and skills upgrades with partners Sanofi and Pfizer in Africa's largest pharmaceutical market. The companies were tight-lipped about commercial details of the partnership.

"We start production of (the) hexavalent in Q3 2020," Morena Makhoana, Biovac's chief executive said at its state-of-the art facility in Cape Town, referring to the Sanofi vaccine.

The plant, modernized at a cost of around 1 billion rand ($70 million), will produce four million doses of Hexaxim vaccine a year and has capacity to ramp up significantly as it explores new markets in neighboring Namibia, Mozambique and Angola, he said.

South Africa's government buys about 95% of the total 25 million doses of vaccine supplied annually by Biovac, covering diseases such as tuberculosis, cervical cancer and influenza.

Biovac's dose of Hexaxim, a six-in-one vaccine for several diseases including diphtheria, tetanus and polio, is the only one in the world that is fully liquid and unlike other versions on the market, Makhoana said, does not have to be mixed before injecting. This makes it easier to administer in remote and resource-poor clinics across Africa, he added.

"On this particular six-in-one vaccine we are the only tech transfer partner with Sanofi in the world, so we are very proud," Makhoana told Reuters.

Sanofi said it will continue to invest in South Africa's vaccine program as it looks to bolster its position.

"South Africa, and Africa for that matter, is an emerging market and showing strong growth year-on-year and hence will remain a priority for Sanofi," Merilynn Matthew, who heads Sanofi's South African vaccines unit, said.

Around one-in-five African children do not get immunized, with measles alone accounting for 61,000 preventable deaths a year on the continent, according to the World Health Organisation.

SECURITY OF SUPPLY

Biovac, the rest of which is owned by a consortium led by local investment holding firm Immunotek, has also made progress preparing Pfizer's pneumonia vaccine for infants, Prevnar 13, Makhoana said. It expects full output of 3 million doses to start in the first half of 2021.

Under a five-year agreement signed with Pfizer in 2015, Biovac only packaged labeled syringes but it is now acquiring the formulation and filling processes ahead of the new product line launch.

"Security of supply is one big issue and the second is the economic benefits local production brings, while making sure that prices are equally benchmarked and South Africa pays a fair price in line with other middle income countries such as Brazil or Turkey," Makhoana said.

At the partnership launch four years ago, a cabinet minister said the pneumonia vaccine alone used up 40% of South Africa’s total budget for vaccines, with the government then paying around 185 rand ($13.11) per single dose of imported Prevenar 13. Each infant will eventually need three doses. Pfizer did not provide the current cost of the vaccine.

"The technology transfer process has enabled significant knowledge transfer, job creation and direct investment," said Rhulani Nhlaniki, Pfizer's country manager.

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