South Africa's Biovac to make, distribute pneumonia vaccine across Africa
Cape Town-based biopharmaceutical company Biovac has signed a transfer agreement with Biological E in India to manufacture and distribute a pneumonia vaccine across Africa.
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.
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Cape Town-based biopharmaceutical company Biovac has signed a transfer agreement with Biological E in India to manufacture and distribute a pneumonia vaccine across Africa. 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.
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