A 'home-grown' Covid-19 vaccine deal is near, says Biovac CEO

In a move that could dramatically alter SA's access to more Covid-19 vaccine, Cape Town-based biopharmaceutical company Biovac is negotiating with international pharmaceutical companies to produce their vaccines locally.

Biovac CEO Dr Morena Makhoana said on Friday that talks were under way with a number of vaccine manufacturers in the hope of a deal for the Cape Town firm formulating Covid-19 vaccines here.

"We are talking to a few parties but we have not signed any deals yet," said Makhoana, adding that the emergence of the new variant of Covid-19 meant it was vital not to rush the process.

"Unfortunately this variant is causing a little bit of havoc in dealing with manufacturers because the question is, what do we bet on?" he said.

"What if the vaccine we are currently negotiating [to buy] may not be the flavour of the month in two years' time?"

How quickly Biovac would be able to supply extra vaccines to SA would depend on the complexity of the technology.

"If it's complex, we can complete a technology transfer in a year," said Makhoana. "If it's straightforward, it could be six to nine months."

Regulatory approvals could add another three months.

SA was likely to have a mix of imported and locally manufactured products.

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"The main challenge is that if in time some vaccines have better efficacy than others, government may be forced to purchase more of that vaccine that is suitable for SA."

If an agreement is reached with any manufacturer, Biovac's role will be either formulating the vaccine or doing what is known as "fill-finish", which involves filling vials from a bulk supply of material and packaging them.

The vaccine itself would determine whether Biovac did formulation of fill-and-finish work.

"It's simple to assume that fill-finish would be quicker. But all vaccines are different. Some need to be formulated within days after manufacture."

Biovac had excess capacity of between 20-million and 30-million doses.

Vaccine capacity was not straightforward, however.

"Our filling line can produce 18,000 vials an hour but for some vaccines you may need to reduce the speed of the line, especially for sensitive vaccines. If we have to stretch all parameters and use multi-dose vials we can do a maximum of 60-million doses a year."

Biovac hoped to have an answer "within the next few months", he said.

Meanwhile, with SA's first health-care workers due to get the jab next week, the company was forging ahead with plans to ensure smooth distribution.

Makhoana admitted to feeling anxious about the rollout.

"I have mixed emotions," he said. "We need to execute. So on the one hand there's anxiety. On another, I'm relieved that the public is getting to know vaccines in general and the manufacturing issues that come with them."

While discussions on vaccine distribution had been going on for some time, news that Biovac would handle distribution of the first 1.5-million doses of the AstraZeneca vaccine was kept under wraps.

"We work with government on a daily basis," said Makhoana. "They made some inquiry about availability in around Christmas when I think they were close to finalising which vaccine they would get initially."

The South African Health Products Regulatory Authority approved the vaccine under emergency use authorisation, said Makhoana, which removed the requirement for a tender process.

"They need to work quickly [and] obviously didn't have time to go out on tender."

The 1.5-million doses are contained in 150,000 vials of 10 doses each.

While vaccine samples were being tested in a Bloemfontein laboratory pending final approval for distribution, Biovac was working with the health department and the government security cluster to ensure a safe and speedy rollout.

Using Biovac to distribute the vaccine was a logical step. The company already has a deal to formulate Prevnar 13, a childhood vaccine made by Pfizer, on behalf of the US pharma giant.

Under the terms of the deal, Pfizer supplies Biovac with raw material that it then formulates in its Cape Town facility.

The company was awaiting final approval from the regulatory authority following an inspection in November, after which production would begin.

Biovac had spent years working on the tech transfer with Pfizer on the Prevnar 13 vaccine, said Makhoana.

"It's a no 1 product globally," he said. "The work is critical - a very delicate process."

In November, Biovac had also started producing a six-in-one hexavalent paediatric vaccine on behalf of global pharmaceutical company Sanofi Pasteur, which aims to prevent diphtheria, tetanus, pertussis, hepatitis B, haemophilus influenza B and poliomyelitis.

Biovac was formed as a public-private partnership in 2003 to boost SA's vaccine manufacturing capability.

It started by doing packaging and labelling until it was able to raise Industrial Development Corporation funding to build facilities capable of doing fill-finish work.

"We established two facilities, one that would be doing it in bulk, and one that would be doing pre-fill syringes," said Makhoana, who became CEO in 2010.