The world’s first malaria vaccine will be rolled out in sub-Saharan Africa in 2018, the World Health Organisation (WHO) has confirmed.
It says funding is now secured for the initial phase of the programme and vaccinations.
The vaccine, known as RTS,S, acts against P. falciparum, the most deadly malaria parasite globally and the most prevalent in Africa.
A statement by WHO said advanced clinical trials had 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.
“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,” the Director of the WHO Global Malaria Programme, Dr Pedro Alonso, said.
The Global Fund to Fight AIDS, Tuberculosis and Malaria on Thursday approved $15 million for the malaria vaccine pilots, giving assurance of full funding for the first phase of the programme.
Earlier this year, Gavi, the Vaccine Alliance and UNITAID announced commitments of up to US$ 27.5 million and $9.6 million, respectively, for the first four 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 recognises and commends the leadership and support of all funding agencies and partners who have made this achievement possible,” Director of the WHO Department of Immunization, Vaccines and Biologicals, Dr Jean-Marie Okwo-Bele, said.
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 three to five settings in sub-Saharan Africa.
Required Four Doses
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 mobilise financial support for the pilots and to finalise the programme design.
The pilot programme will evaluate the feasibility of delivering the required four 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 Three trial can be replicated in real-life settings.
RTS,S is the first malaria vaccine to successfully complete pivotal Phase Three testing.
The Phase Three trial enrolled more than 15,000 infants and young children in seven countries in sub-Saharan Africa. Countries that participated in the Phase three clinical trials will be prioritised for inclusion in the WHO pilot programme, who said.
Consultations are ongoing and the names of the three selected countries will be announced in the coming weeks.
Who explained that there were two target age groups in the Phase Three RTS,S trials – infants who received the malaria vaccine together with other routine childhood vaccines at six, 10 and 14 weeks of age and older children who received their first dose of the malaria vaccine between five and 17 months of age.
The RTS,S vaccine is proposed as a tool to complement the existing package of WHO-recommended malaria preventive, diagnostic and treatment measures and will be used in combination with the current interventions. Other tools include: long-lasting insecticidal bed-nets, spraying inside walls of dwellings with insecticides, preventive treatment for infants and during pregnancy, prompt diagnostic testing, and treatment of confirmed cases with effective anti-malarial medicines.
Deployment of these tools has already dramatically lowered malaria disease burden in many African settings. Between 2,000 and 2015, the rate of new malaria cases in sub-Saharan Africa fell by 42% and malaria mortality rates fell by 66%.
However, this region continues to account for approximately 90% of global malaria cases and deaths.
As RTS,S is only partially effective, it will be essential that any vaccinated patients with a fever be tested for malaria, and that all those with a confirmed malaria diagnosis are treated with high quality, effective anti-malarial medicines.