SA and US firm in talks to produce 'game changing' vaccine locally

SA could have its own vaccine manufacturing capability in as little as three years if a deal between local pharmaceutical firm Biovac and a US vaccine developer comes to fruition.

Cape Town-based Biovac announced on Thursday it had formed a partnership with ImmunityBio to manufacture the US firm's candidate Covid-19 vaccine.

In a move that will dramatically alter vaccine distribution, it is also being tested in the form of a tablet. "That will be a game-changer," said Biovac CEO Morena Makhoana.

The currently approved Covid-19 vaccines all need to be stored at temperatures ranging from about -6°C to -70°C in the case of the Pfizer vaccine.

"There's a billion people who won't get vaccinated if we rely on the cold chain," SA-born ImmunityBio MD Patrick Soon-Shiong told the Sunday Times this week.

"If those billion people don't get vaccinated and they get infected - especially in places where there's HIV and immune suppression - you will have continuous mutations because the viral evolution will cause this virus to find a way."

ImmunityBio's candidate vaccine can be taken orally by swallowing a capsule or placing it under the tongue, or administered by injection.

"There isn't anybody else in the world that's taken one vaccine and given three routes of administration," Soon-Shiong said.

Makhoana said the two companies had been in talks since July last year as they thrashed out the details for the partnership, over which Soon-Shiong had had high-level discussions with SA's health ministry.

"We had to ensure it was not just a bilateral agreement but also that government was on board," Makhoana said.

Soon-Shiong confirmed he had been in talks with Biovac for about six months about expanding SA's vaccine manufacturing capability.

"One of the problems with this vaccine nationalism is that South Africa has to be completely self-sufficient in manufacturing, all the way from manufacturing the raw material," he said.

"We need scale. Biovac is fantastic medium-scale - about 30-million vials [a year]. We need a billion vials."

The partnership is a shot in the arm for Biovac, a state-backed company established in 2003 to revive local human vaccine production in Southern Africa. Africa does not have any vaccine-manufacturing capability.

The new vaccine is designed to work in two ways, firstly by triggering an immune response and also killing the virus.

The hAd5 T-cell SARS-CoV-2 vaccine is undergoing parallel first-phase clinical trials in the US as well as at the Wellcome Centre for Infectious Diseases Research in Africa in Khayelitsha, Cape Town.

The vaccine will need to undergo phase two and three trials before it is approved. It will also have to be tested against other vaccines as well as the usual placebo.

The rigorous process means the ImmunityBio vaccine is unlikely to be available any time soon. "All going well, it should be ready by early 2022," said Makhoana.

The first batch of ImmunityBio's vaccine will have to be imported as Biovac will first have to build a new facility to manufacture it in SA, which could take at least two years.

Part of the lag is because firms are often reluctant to part with their intellectual property. Setting up vaccine plants to manufacture the active pharmaceutical ingredients is also expensive.

Makhoana said he hoped the partnership would help push SA into the spotlight as a vaccine manufacturer.

In November, Biovac was cleared to begin formulating Prevnar 13, a childhood anti-pneumonia vaccine, on behalf of US-based pharma giant Pfizer. It also produces a paediatric vaccine on behalf of global pharma company Sanofi Pasteur that aims to prevent diphtheria, tetanus, pertussis, hepatitis B, haemophilus influenzae B and poliomyelitis.

ImmunityBio makes late-clinical-stage immunotherapy drugs and vaccines for combating cancers and infectious diseases.