Gavi, the Vaccine Alliance, global health agency Unitaid and the Global Fund to Fight AIDS, Tuberculosis and Malaria welcome the WHO recommendation for wider routine use of the RTS,S malaria vaccine.
The recommendation is based on data gathered through the Malaria Vaccine Implementation Programme (MVIP) which took place in Kenya, Ghana and Malawi over a two-year period and a clinical trial around the seasonal delivery of the vaccine in Mali and Burkina Faso, countries that experience high seasonal variation in malaria transmission.
The RTS,S pilots achieved and maintained good coverage levels, despite the COVID-19 pandemic. As of September 2021, over two years after the start of vaccinations, more than 2.3 million RTS,S doses have been administered across the three countries and more than 800,000 children have been reached with at least one dose of the vaccine.
The pilots provided an opportunity to evaluate the feasibility of delivering four doses of RTS,S in real-life settings, where the vaccine was successfully rolled into existing immunisation programmes, widely accepted by both caregivers and healthcare workers, and reduced hospitalisations from severe malaria by 30%.
A further clinical trial led by the London School of Hygiene & Tropical Medicine assessed the impact of seasonal delivery of the malaria vaccine alongside seasonal malaria chemoprevention in Mali and Burkina Faso, countries that experience high seasonal variation of malaria transmission.
The findings indicated a decrease of more than 70% in severe malaria cases in children when the vaccine was administered in combination with preventive antimalarials.
Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, said: “Today marks a historic achievement in our fight against malaria. Malaria still kills over 250,000 children every year. The vaccine is an important additional tool to help control this disease alongside other interventions, such as bed nets, and especially when delivered seasonally in combination with antimalarial medication. I applaud the countries and communities who participated in the trials and pilots to provide this critical new tool for African countries.”
Ministries of Health led the implementation of the vaccine, which was delivered through routine immunisation programmes, with WHO playing a coordinating role, working in collaboration with GlaxoSmithKline, PATH and UNICEF. Following its investment of around US$ 700 million in the development of RTS,S, GSK has donated up to 10 million doses for the pilot programme.
Gavi, the Global Fund and Unitaid have together committed nearly US$ 70 million to fund the pilot, which was designed to address several outstanding questions related to the public health use of the vaccine following the Phase 3 trial showing efficacy of RTS,S.
Peter Sands, Executive Director of the Global Fund uttered: “We welcome this new tool in the fight against malaria,” said “In countries where the Global Fund invests, we have reduced malaria deaths by 45% since 2002 with testing, treatment and prevention tools such as mosquito nets. In the vaccine pilots, the RTS,S vaccine was most effective when used together with these existing tools. Significant additional resources will be necessary to enable wide deployment of the vaccine alongside other innovations, and as part of a sustained and comprehensive response in the countries that need it the most.”
The data collected through MVIP achieved similar rates of efficacy as seen in the Phase 3 clinical trial conducted from 2009 to 2014.
The trial found that among children aged 5–17 months who received four doses of RTS,S, the vaccine prevented approximately 4 in 10 (39%) cases of malaria over 4 years of follow-up, and about 3 in 10 (29%) cases of severe malaria.
Dr Philippe Duneton, Executive Director of Unitaid, said: “Even before the COVID-19 pandemic hit, progress against malaria was stalling. This vaccine is a welcome new tool that, when used in combination with existing interventions like bed nets, has the potential to drive down malaria and extend protection to children across Africa. Pilot implementation has demonstrated how we can equitably reach children with this life-saving vaccine – now we need to ensure adequate and affordable supply to truly reignite the fight against malaria.”
Significant reductions were also seen in overall hospital admissions as well as in admissions due to malaria or severe anaemia. In addition, the vaccine reduced the need for blood transfusions, which are required to treat life-threatening malaria anaemia, by 29%.
Following the WHO recommendation, global stakeholders, including Gavi, will consider whether and how to finance a new malaria vaccination programme in sub-Saharan Africa.
Ahead of this important decision, an innovative financing agreement between Gavi, MedAccess and GSK guarantees continued production of the RTS,S antigen for the malaria vaccine.
The partnership aims to address vaccine supply challenges and reduce barriers to initial roll-out in the event that the Gavi Board makes a decision in favour of a Gavi-supported malaria vaccination programme.
The vaccine will be a complementary malaria control tool to be added to the core package of WHO-recommended measures for malaria prevention. This includes the routine use of insecticide-treated bed nets, indoor spraying with insecticides, malaria chemoprevention strategies, and the timely use of malaria testing and treatment.