Biovac Sets Course To Deliver WHO-Prequalified Pneumonia Vaccine Across Africa In Coming Years

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 the pivotal phase-three randomised, active control trial.

Biological E‘s PCV14 vaccine is already licensed in India and is currently undergoing World Health Organisation (WHO) 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.

Pneumococcal infection, which the vaccine protects against, is a cause of significant disease, being a leading cause of pneumonia, bacterial meningitis, and sepsis. WHO 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. Dr Morena Makhoana, Biovac CEO, states: “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 a 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 E, for a higher valency 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.”

This partnership supports Gavi’s (Gavi, The Vaccine Alliance) vision and strategy for accelerating the expansion of commercially viable vaccine manufacturing in Africa. Thereby ensuring Africa's vaccine self-sufficiency and that the continent is positioned to serve African children with a contemporary, locally manufactured vaccine.

Dr Sania Nishtar, CEO of Gavi, says: "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.”