Is South African president Ramaphosa correct about country’s ability to make vaccines?

Before 2001, South Africa produced a number of its own human vaccines, including vaccines for polio and smallpox. This was done through its State Vaccine Institute, the South African Institute of Medical Research and National Institute of Virology. However, production at these facilities was terminated between 1995 and 2001. This was in part because of the high cost required to bring the vaccines in line with global best practice.

South Africa’s Biovac Institute, formed in 2003, is a public-private entity responsible for the government’s human vaccine procurement. It sources and provides vaccines as part of the government’s expanded programme on immunisation. It currently supplies 25-million doses of vaccines annually.

But the institute does not manufacture human vaccines from start to finish. “Biovac is here for human vaccine manufacture … but right now, we are not manufacturing human vaccines,” the institute's CEO, Dr Morena Makhoana, told Africa Check.

Making vaccines from scratch work in progress

In a joint emailed statement, Makhoana, Medical Research Council president Glenda Gray, and Glaudina Loots from the national department of science and innovation confirmed to Africa Check that South Africa has the capability to manufacture human vaccines. 

“This is critical for our country to expand its vaccine capability,” they said.

“People have different definitions of ‘manufacture’,” Makhoana told Africa Check.

The steps to manufacturing a vaccine range from growing and isolating the antigen which causes an immune response, to filling the vaccine into sterile containers and ensuring quality control.

In the next two months, Biovac will begin producing Sanofi’s six-in-one Hexaxim vaccine, which protects against diseases such as diphtheria, tetanus, pertussis, hepatitis B and polio. It expects to produce Pfizer’s Prevnar 13, a pneumonia vaccine, next year. But the company will import the blended or formulated material and fill it locally under sterile conditions, Makhoana said.

“We’re yet to establish capability of raw material manufacture for the active pharmaceutical ingredient [which] is sometimes called the ‘drug substance’,” he said. “We can develop vaccines, but we have yet to establish the raw material manufacture. We’re working on it, but it’s still a few years [away].”

Could country manufacture Covid-19 vaccine?

There are many different ways to make a vaccine. An RNA vaccine uses the genetic fingerprints of the antigen, a DNA vaccine contains the DNA sequence which will ignite an immune response, an inactivated vaccine employs a dead virus or bacterium and a subunit vaccine uses a specific piece of the germ (such as a protein or its casing) to elicit an immune response. A live vaccine contains a weakened living pathogen.

Each of these vaccines requires specific technology to manufacture. “There are some vaccines we can’t manufacture,” said Makhoana, “because technologically they can’t fit with what we have. But some are, and we’re exploring those capabilities.”

He said Biovac could manufacture mRNA, DNA, protein-subunit and inactivated vaccines. It would, however, need to import the raw material to do so. It does not have the capability to manufacture a live vaccine. 

Makhoana said they were closely monitoring the development of Covid-19 vaccine candidates. “We’re betting on most horses, rather than one or two.

South Africa has ability to develop some vaccines

Ramaphosa claimed that South Africa “has an established vaccine manufacturing capability”. The Biovac Institute, a public-private entity, procures and supplies vaccines for the government.

However, the institute is not currently manufacturing any vaccines. It does have the capability to manufacture some types of vaccines using imported raw materials. We rate the claim “mostly correct”. 

South Africa has a great deal of expertise in the development of vaccines, particularly in veterinary science. 

But there is only one locally developed human vaccine that has made it to the human-trial stage in the country, said Prof Ed Rybicki. He is a vaccine biotechnologist and director of the Biopharming Research Unit at the University of Cape Town (UCT).

The vaccine, developed by a team mostly from UCT, aimed to protect people against a strain of HIV. Makhoana, Gray and Loots confirmed this. 

Biovac, on the other hand, has developed technology to create bacterial vaccines. 

“We have developed a technology package for the manufacture of Haemophilus influenzae type b (Hib) conjugate vaccine,” it says on its website. This bacterium is responsible for severe pneumonia and meningitis in children under five. “To date, this has been transferred to two international vaccine manufacturers.” 

Biovac does not manufacture these vaccines locally, but had the expertise to develop them.

Biovac’s Makhoana said the institute is currently developing a vaccine against group b strep, or GBS. This bacterium is usually found in the gut, and can cause pneumonia and meningitis in newborns.

Country has vaccine development, trial expertise

The country also has an extensive capability to trial vaccines and pharmaceuticals. There are currently more than a thousand clinical trials underway in South Africa, according to the South African National Clinical Trial Register.

A human clinical trial is a study that tests a new drug or treatment on people to determine its safety and efficacy. There are a number of stages involved in a trial. These are the exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, manufacturing, and quality control, according to the US Centers for Disease Control and Prevention.

“SA has excellent infrastructure for doing vaccine safety and efficacy trials, and has participated in a number of especially TB and HIV vaccine trials, but also a number of others on a regular basis,” said Rybicki.

“Most definitely we are able to trial a range of vaccines,” Makhoana, Gray and Loots said. “South Africa has the infrastructure to do this, and is unparalleled in Africa and most other [low- and middle-income country] settings.”

The country, through Wits University, is participating in the clinical trial for a Covid-19 vaccine candidate developed by the Jenner Institute at the University of Oxford in the UK.

Experts confirmed that the country has expertise in the development and trial of a number of vaccines for viruses and bacteria. It is currently participating in a clinical trial for a Covid-19 vaccine. We rate this claim “correct”.