The Gavi Vaccine Alliance has announced that it will support a WHO-coordinated pilot programme for the malaria vaccine RTS,S/AS01 (RTS,S). In a statement issued today, Gavi noted that its support would be contingent upon co-funding agreements from other sources. WHO welcomes this announcement and encourages commitments from other donor agencies so that the programme can proceed as planned.
“For decades, a malaria vaccine has been one of the holy grails of modern medicine,” said Dr Pedro Alonso, Director of the WHO Global Malaria Programme. “Gavi’s pledge will help us fund the pilot deployment of a first-generation malaria vaccine that has the potential to save tens of thousands of lives in Africa,” he added.
For decades, a malaria vaccine has been one of the holy grails of modern medicine.
- Dr Pedro Alonso, Director of the WHO Global Malaria Programme
The total estimated budget for the vaccine programme is US$ 101 million over 6.5 years. Co-funding from the Bill & Melinda Gates Foundation, and in-kind contributions from WHO, together account for US$ 25 million of the total budget.
The immediate funding gap for the first phase of the programme (2017-2020) is US$ 55 million. Gavi has pledged up to US$ 27.5 million towards this first phase provided the commitment is matched by other funders. A further US$ 21 million will be required for the second phase of the programme, which will run from 2021 to 2022.
“This decision by the Gavi Board truly responds to countries' demands” says Dr Flavia Bustreo, Assistant Director General at WHO and vice-chair of the Gavi board. “We trust that others will be forthcoming so we can take full advantage of this chance to improve malaria control and reduce child mortality in Africa.”
RTS,S confers partial protection against malaria in young children. It is being assessed as a complementary malaria control tool that could potentially be added to – and not replace – the core package of WHO-recommended malaria preventive, diagnostic and treatment measures.
SAGE/ MPAC recommendations
RTS,S is the first malaria vaccine to obtain a positive scientific opinion from the European Medicines Agency (EMA), a stringent medicines regulatory authority. Following the EMA decision in July 2015, 2 independent WHO advisory groups comprised of the world’s foremost experts on vaccines and malaria – the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) – jointly reviewed all available evidence on RTS,S relevant for global policy.
In October 2015, SAGE and MPAC recommended the pilot implementation of the RTS,S vaccine in 3 to 5 settings in sub-Saharan Africa. WHO has adopted these recommendations and is strongly supportive of the need to proceed with the pilots as the next step for the world’s first malaria vaccine.
The pilot programme is designed to assess the feasibility of delivering the required 4 doses of RTS,S; the impact of RTS,S on lives saved; and the safety of the vaccine in the context of routine use. It will assess the extent to which the vaccine’s protective effect demonstrated in children aged 5–17 months old in the Phase 3 trial can be replicated in real-life settings. Details on the Phase 3 trial results can be found in a WHO Q&A.
“RTS,S is not a perfect vaccine. But even a vaccine with partial efficacy, when combined with other tools in the malaria control arsenal, can have great impact,” said Dr Alonso.
Vaccine development
RTS,S was developed through a partnership between GlaxoSmithKline and the PATH Malaria Vaccine Initiative (MVI), with support from the Bill & Melinda Gates Foundation and from a network of African research centres. The clinical testing of RTS,S is at least 5 to 10 years ahead of other candidate malaria vaccines.
More than 20 other malaria candidate vaccines are currently being evaluated in clinical trials or are in advanced preclinical development.