The world’s first malaria vaccine will be rolled out in pilot projects in sub-Saharan Africa, WHO confirmed today. Funding is now secured for the initial phase of the programme and vaccinations are due to begin in 2018.
The vaccine, known as RTS,S, acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa. Advanced clinical trials have shown RTS,S to provide partial protection against malaria in young children.
“The pilot deployment of this first-generation vaccine marks a milestone in the fight against malaria,” said Dr Pedro Alonso, Director of the WHO Global Malaria Programme. “These pilot projects will provide the evidence we need from real-life settings to make informed decisions on whether to deploy the vaccine on a wide scale.”
Vaccine financing and development
The Global Fund to Fight AIDS, Tuberculosis and Malaria today approved US$ 15 million for the malaria vaccine pilots, assuring full funding for the first phase of the programme. Earlier this year, Gavi, the Vaccine Alliance and UNITAID announced commitments of up to US$ 27.5 million and US$ 9.6 million, respectively, for the first 4 years of the vaccine programme.
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.
“WHO recognizes and commends the leadership and support of all funding agencies and partners who have made this achievement possible,” said Dr Jean-Marie Okwo-Bele, Director of the WHO Department of Immunization, Vaccines and Biologicals.
Vaccine programme recommended by two WHO advisory bodies
In October 2015, two 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) – recommended pilot implementation of the RTS,S vaccine in 3 to 5 settings in sub-Saharan Africa. These recommendations followed a July 2015 announcement that the European Medicines Agency (EMA) had issued a positive scientific opinion of the RTS,S vaccine.
WHO officially adopted the SAGE-MPAC recommendations in January 2016 and has since worked to mobilize financial support for the pilots and to finalize the programme design. The pilot programme will evaluate 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 also 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.