South Africa's Biovac, India's Biological E ink vaccine tech transfer deal to boost Africa supply

Biovac, a biopharmaceutical company in South Africa, and Biological E, a Supplier of vaccines globally from India, have signed a groundbreaking technology transfer agreement to manufacture and distribute a vaccine against pneumonia across Africa. 

Pneumococcal infection, which the vaccine protects against, is a cause of significant disease, being a leading cause of pneumonia, bacterial meningitis, and sepsis. The World Health Organisation estimated that in 2005, pneumococcal infections were responsible for the death of 1.6 million children worldwide and while this has reduced significantly over time, newer and better vaccines are still needed. 

The agreement aligns with the African Union Commission and Africa CDC’s 2022 commitment to ensure that 60% of vaccines used in Africa are manufactured on the continent by 2040. Currently, Africa produces only about 1% of its vaccines, a gap this initiative will help to close.

Biovac said in a statement on Thursday this partnership between Biovac and Biological E represents a step in addressing the continent’s high disease burden with locally driven solutions.  

Biological E’s PCV14, a 14 valent pneumococcal conjugate vaccine, having broad serotype coverage was found to be non-inferior to Prevenar 13, for all shared serotypes in pivotal phase-III randomised, active control trial.  

Biological E‘s PCV14 vaccine is already licensed in India and currently undergoing World Health Organisation prequalification with the aim being to make the vaccine available to Unicef and Gavi markets soon thereafter. In parallel, a technology transfer is being initiated with Biovac that is anticipated to take three years including regulatory approval.

"This collaboration is thus a significant development for Biovac, as it enables the company to expand access to this vaccine that has been prioritised by Gavi, an alliance that makes available millions of doses of vaccines for children in developing nations.  Gavi has recognised this vaccine as important for global health and as having strategic importance to address disease burden on the African continent," Biovac said.

Dr Morena Makhoana, Biovac CEO, said, “Biovac is on a steady journey of ensuring that it expands its footprint beyond South Africa. We do so by carefully selecting our partners and the type of products that meet our customers’ needs. Biovac and Biological E have long standing relationship for Tetanus Toxide, Tetanus Diphtheria and Measles Rubella vaccines for South Africa and now Biovac is happy to further strengthen its partnership with Biological for a higher valency (wider coverage) pneumococcal vaccine, which has been identified as a need on the African continent. This technology transfer also contributes to Africa CDC’s call for 60% of vaccines to be manufactured on the continent by 2040, ensuring sustainable vaccine manufacturing capability, vaccine self-sufficiency and pandemic readiness.  We look forward to a long and lasting relationship with Biological E.” 

Mahima Datla, the managing director Biological E, said, “We are pleased to have signed an agreement for this technology transfer and supply of PCV14, in partnership with Biovac. The collaboration between our two companies, will contribute significantly to the improvement in global public health, capacity building of an African manufacturer, and most importantly impact children’s lives against pneumococcal diseases in Africa.”

Dr Sania Nishtar, the CEO of Gavi, the Vaccine Alliance, said, "Gavi’s AVMA mechanism is designed specifically to incentivise investment in vaccines that meet critical needs. We thus welcome this technology transfer agreement, both as a means of boosting further supply of PCV vaccines and as a solid step forward towards sustainable vaccine manufacturing on the continent of Africa.”

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