Regulatory Focus™ > News Articles > Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed

Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed

Posted 23 June 2016 | By Zachary Brennan 

Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed

The public-private vaccine alliance known as Gavi on Thursday pledged $27.5 million to a pilot project that the World Health Organization is running to introduce a malaria vaccine candidate into sub-Saharan Africa.

As part of the project, WHO, GlaxoSmithKline, the developer of the vaccine, and the nonprofit PATH will collaborate to donate doses of the vaccine candidate, known as RTS,S, for use in the WHO pilots.

In addition to the Gavi funds, WHO will provide about $17 million in contributions and PATH, a grantee of the Bill & Melinda Gates Foundation, will receive a grant of approximately $8 million for the project.

The funds committed by Gavi, which itself is funded by various countries’ governments, are for the first phase of the pilot program and contingent upon WHO securing funding from other sources to fill the remaining gap, and which will be complementary to the follow-up Phase IV clinical studies. GSK says it has invested more than $200 million in those studies and other remaining development costs.

Carla Botting, managing director of the RTS,S Malaria Vaccine Project at PATH, told Focus: “The funding gap for the first phase of the pilot implementation programme is estimated to be similar to what Gavi has committed—i.e., $27.5 million, although the precise budget will only be known when the design of the pilot implementation programme is fully finalized.”

She also explained that the pilot’s implementation, under the leadership of the World Health Organization, is “quite different from either a clinical trial (such as the Phase 3 efficacy and safety trial) or the Phase 4 studies that are part of the Risk Management Plan agreed upon between GSK and the European Medicines Agency… As a not-for-profit vaccine, for which there is little or no return in investment, we think that it is appropriate for certain costs to be shared. To date, GSK has invested more than $350 million in the development of RTS,S, while PATH’s Malaria Vaccine Initiative has received more than $200 million in grants from the Bill & Melinda Gates Foundation to advance the clinical development of RTS,S.”

David Kaslow, MD, head of PATH’s Center for Vaccine Innovation and Access also said that the results of Phase 3 studies demonstrated the potential public health impact of RTS,S, when used alongside bed nets and other malaria control interventions, in the setting of clinical trials.

Global health efforts have led to a 60% reduction in malaria deaths between 2000 and 2015, though approximately 438,000 people died of the disease in 2015, the vast majority of them young children in Africa.

RTS,S is the first malaria vaccine candidate to receive a positive scientific opinion from the EMA.

Gavi


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe