Gavi has joined forces with GlaxoSmithKline (GSK) and MedAccess to create this innovative financing structure.
The Reed Smith team advising on the project was led by finance partner Andrzej Janiszewski and corporate partner Sakil Suleman, supported by lead associate Kelly Knight. The team drafted and negotiated the transaction documents between Gavi and GSK and negotiated the agreement between Gavi and Medaccess.
The RTS,S/AS01e vaccine – the first malaria vaccine to be proven safe and effective in phase three clinical trials – is currently being piloted in routine immunisation programmes in Ghana, Kenya and Malawi, through the Malaria Vaccine Implementation Programme (MVIP). The World Health Organization (WHO) is expected to decide later this year whether to recommend the vaccine for broader use based on data emerging from the MVIP. GSK has donated 10 million doses for the pilot programme.
Following the completion of the manufacturing of the donated doses, and in advance of the key decisions from WHO and Gavi and to address the associated uncertainty around future production, Gavi, GSK and MedAccess have developed an innovative financing solution to ensure continued manufacturing of the vaccine antigen.
Gavi will fund GSK’s continued manufacturing of the RTS,S antigen for a period of up to three years with a replacement of a proportion of such costs if the vaccine is not ultimately recommended for use by the WHO and Gavi.
This arrangement will ensure that vaccine doses made from the production of Gavi-funded bulk antigen can be supplied rapidly after a potential WHO vaccine recommendation and Gavi financing decisions. This will help accelerate vaccine access, if a programme is approved, by avoiding the long production ramp-up phase that would occur if GSK had to restart the dedicated antigen production facility.
A MedAccess analysis estimates that this continuous manufacture agreement could catalyse the vaccine reaching up to 7.5 million more children than would otherwise have been possible if there was a production delay.
“Malaria kills over a quarter of a million children every year; this vaccine has the potential to have a real impact on this toll,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “That’s why it is vital that we keep production lines running while waiting for important decisions around its global availability. This is innovative financing at its best: tackling risk and uncertainty to ensure access to what could be an important additional tool in the battle against malaria.”
Andrzej Janiszewski said: “We are delighted to have supported Gavi on this crucially important financing arrangement that could help save the lives of millions of children.”
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