The mRNA Vaccine Technology Transfer Hub in South Africa will start animal studies on its first COVID-19 vaccine candidate in October, a senior World Health Organization official said Wednesday.

If all goes according to plan, human clinical trials will begin towards the end of 2023. 

“We did start this (mRNA vaccine hub) with a longer term view, beyond COVID-19. The idea was not to come up, necessarily, with a vaccine for COVID-19 though that would be a proof of principle. But it is going to take time,” World Health Organization (WH)O Chief Scientist Dr Soumya Swamination said at the global health body’s weekly media briefing. 

The WHO’s ambitious project is hosted by the South African company Afrigen Biologics, and aims to equip low and middle income countries (LMICs) with the skills to manufacture mRNA vaccines.  

Over 15 other global sites have been chosen to manufacture mRNA vaccines to  address the massive vaccine inequity between the wealthy and the LMICs exposed by the COVID-19 pandemic.  

While over 60% of the world population have been fully vaccinated against SARS-CoV-2, only around 24% of the population in low income countries have received their first dose of the vaccine. 

African countries currently import over 90% of their vaccines, lacking the capacity to develop and manufacture vaccines locally. Local manufacture of vaccines will enable the easy distribution to nearby countries, which will also address the accessibility and coverage gap. 

Scientists from across the world have also been receiving bio-manufacturing training in South Korea, supported by WHO. This training will equip them with the technical know-how to manufacture advanced vaccines in their own countries.  

“The idea is to build this network, capacity, put the technology in the hands of scientists in these companies, who will then make products that are needed for their own populations,” Swaminathan added. 

South African regulatory body ranked ‘stable and well-functioning’ 

The WHO also announced that it has ranked South Africa’s vaccine regulatory system at the ML-3 level in its global classification system for medical products regulatory authorities. This is the second highest level in this system, and means that the country has “a stable, well-functioning and integrated regulatory system” that ensures the quality, safety and efficacy of vaccines produced, imported or distributed in the country. 

“This is an important new step, not only for South Africa, but for the region towards self-sufficiency in vaccines and medicines,” WHO Regional Director for Africa Dr Matshidiso Moeti said in a press release. 

Indian company under WHO radar

Meanwhile, an Indian pharmaceutical company, Maiden Pharmaceuticals Limited, is under investigation for allegedly manufacturing contaminated cold and cough syrups, according to the WHO.

The medicines have been linked to acute kidney injuries and 66 deaths among children in The Gambia. 

“Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” according to WHO’s medical product alert issued on Wednesday. 

“While the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries. WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients,” WHO Chief Dr Tedros Adhanom Ghebreyesus said.  

Image Credits: Rodger Bosch for MPP/WHO.