South Africa aims to become the first African country to manufacture a cholera vaccine with the launch this week of a clinical trial of an oral vaccine developed by local company Biovac.

The vaccine candidate was developed thanks to a technology transfer partnership between Biovac and the International Vaccine Institute in South Korea in 2022.

At present, the only manufacturer of a cholera vaccine is EuBiologics in South Korea, which makes a vaccine marketed as Euvichol-Plus.

This has severely constrained the global supply of cholera vaccines, leading to rationing and global shortages as cholera outbreaks have surged worldwide, spurred by waves of climate-related weather crises and conflict, particularly in Africa.

This week, Biovac announced the launch a Phase 1 safety trial of the vaccine at the University of the Witwatersrand in Johannesburg.

If the vaccine is deemed safe, in the larger Phase 3 study, the Biovac Oral Cholera Vaccine will be compared to Euvichol-Plus, EuBiologics vaccine.

“Biovac is proud to be manufacturing this vaccine entirely in South Africa, the first time in over fifty years that such a milestone has been achieved,” said company CEO Dr Morena Makhoana.

Biovac has evolved from a vaccine distributor to a” full-scale manufacturing hub”, the company noted in a statement.

“Vaccines manufactured in South Africa usually receive the active pharmaceutical ingredient from abroad, with the final vaccine being completed in South Africa (often referred to as ‘fill and finish’), but in this case, the vaccine candidate is being manufactured from start to end by Biovac,” the company added.

“If the trials are successful, South Africa will become the first country on the continent to produce a cholera vaccine,” Makhoana said. “This development addresses a critical, life-saving need, given the ongoing global shortages of the vaccine amid recurring cholera outbreaks.”

Depending on the trial outcomes, the vaccine could be approved and ready for use in Africa in 2028.

Enhanced health security

South African Minister of Health, Dr Aaron Motsoaledi, described the trial as “a historic milestone, not only for Biovac and our nation, but for the entire continent”. 

“Building local vaccine manufacturing capability is not a luxury; it is a national necessity. It strengthens our sovereignty, enhances our health security, and ensures that our people are not left behind when the next global health crisis strikes,” said Motsoaledi. 

“When we can research, develop, and manufacture vaccines locally, we reduce our vulnerability to supply chain disruptions, geopolitical pressures, international market competition and vaccine hoarding or vaccine nationalism, which was apparent during the height of COVID-19 pandemic.”

The African Union has set a target for 60% of all routine vaccines used in Africa to be manufactured on the continent by 2030, a major advancement from today’s level of less than 1%.

Gavi, the Vaccine Alliance, has put incentives in place for African-made vaccines, putting Biovac in a strong position to secure market share and making it a frontrunner in the bid to sell the vaccine to African countries and those who need it.

Gavi’s African Vaccine Manufacturing Accelerator (AVMA) will make up to $1 billion available over the next 10 years to support the growth of Africa’s medicines and vaccines manufacturing base.

The Biovac vaccine development project is supported by the Gates Foundation, Open Philanthropy, Wellcome, and the ELMA Vaccines & Immunization Foundation, among others.

Florian von Groote, Wellcome’s head of clinical research (infectious disease), said that the trial “could be a major step in strengthening the African vaccine manufacturing landscape, showing that local manufacturers can make vaccines that meet the needs of communities on the continent.

“Through long-term support and investment, local manufacturing can deliver accessible and affordable vaccines made by Africa, for Africa.” 

Image Credits: WHO.