Gavi, Unitaid and Global Fund welcome WHO recommendation for world’s first malaria vaccine – world

  • The WHO recommendation for wider use of the RTS, S malaria vaccine is largely based on data collected during the malaria vaccine pilot projects that took place in Kenya, Ghana and Malawi.

  • Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the global health agency Unitaid have together committed nearly US $ 70 million to fund the pilot projects.

  • Following the WHO recommendation, global stakeholders, including Gavi, will consider whether and how to fund a new malaria vaccination program for countries in sub-Saharan Africa

Geneva, October 6, 2021 – Gavi, the Vaccine Alliance, global health agency Unitaid and the Global Fund to Fight AIDS, Tuberculosis and Malaria welcome WHO recommendation for wider systematic use of the malaria vaccine RTS, S. The recommendation is based on data collected as part of the Malaria Vaccine Implementation Program (MVIP) which took place in Kenya, Ghana and Malawi over a two-year period and a clinical trial around seasonal vaccine delivery to Mali and Burkina Faso, countries that experience strong seasonal variations in malaria transmission.

RTS, S pilots have achieved and maintained good levels of coverage, despite the COVID-19 pandemic. By September 2021, more than two years after the start of vaccinations, more than 2.3 million doses of RTS, S had been administered in the three countries and more than 800,000 children had received at least one dose of the vaccine. The pilot projects assessed the feasibility of administering four doses of RTS, S under field conditions, where the vaccine has been successfully integrated into existing immunization programs, widely accepted by caregivers and health workers. health, and reduced hospitalizations due to severe malaria by 30%.

Another clinical trial led by the London School of Hygiene & Tropical Medicine assessed the impact of seasonal malaria vaccine administration alongside seasonal malaria chemoprevention in Mali and Burkina Faso, countries with high seasonal variation in malaria. transmission of malaria. The results indicated a reduction of more than 70% in cases of severe malaria in children when the vaccine was given in combination with preventive antimalarials.

“Today marks a historic achievement in our fight against malaria,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “Malaria still kills more than 250,000 children each year. The vaccine is an important additional tool to help control this disease alongside other interventions, such as bed nets, and especially when given seasonally in combination with antimalarial drugs. I applaud the countries and communities who participated in the trials and pilots for providing this essential new tool to African countries. “

Ministries of health led the implementation of the vaccine, which was administered as part of routine immunization programs, with WHO playing a coordinating role, in collaboration with GlaxoSmithKline, PATH and UNICEF. Following its investment of approximately $ 700 million in the development of RTS, S, GSK donated up to 10 million doses for the pilot program. Gavi, the Global Fund and Unitaid have jointly committed nearly US $ 70 million to fund the pilot project, which was designed to answer several outstanding questions related to the use of the vaccine in public health as a result of the phase 3 trial showing efficacy of RTS, S.

“We welcome this new tool in the fight against malaria,” said Peter Sands, Executive Director of the Global Fund. “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. Significant additional resources will be needed to enable wide deployment of the vaccine alongside other innovations, and as part of a sustained and comprehensive response in countries most in need.

“Even before the COVID-19 pandemic hit, progress against malaria had stalled,” said Dr Philippe Duneton, Executive Director of Unitaid. “This vaccine is a welcome new tool that, when used in combination with existing interventions like mosquito nets, has the potential to reduce malaria and extend protection to children across Africa. The pilot implementation demonstrated how we can equitably reach children with this life-saving vaccine – now we need to ensure adequate and affordable supplies to truly jumpstart the fight against malaria.

Data collected through MVIP achieved similar efficacy rates to those seen in the Phase 3 clinical trial conducted from 2009 to 2014. The trial found that among children aged 5 to 17 months who had Received four doses of RTS, S, the vaccine prevented approximately 4 10 (39%) cases of malaria over 4 years of follow-up, and approximately 3 in 10 (29%) cases of severe malaria. Significant reductions were also observed in overall hospital admissions as well as in admissions due to malaria or severe anemia. In addition, the vaccine reduced the need for blood transfusions, which are necessary to treat life-threatening malaria anemia, by 29%.

Following the WHO recommendation, global stakeholders, including Gavi, will consider whether and how to fund a new malaria vaccination program for countries in sub-Saharan Africa. Prior to this important decision, an innovative financing agreement between Gavi, MedAccess and GSK ensures the continued production of the RTS, S antigen for the malaria vaccine. The partnership aims to address vaccine supply challenges and reduce barriers to initial deployment in the event the Gavi Board of Directors decides in favor of a Gavi-supported malaria immunization program.

The vaccine will be a complementary tool in the fight against malaria which will be added to the set of measures recommended by the WHO for the prevention of malaria. This includes the routine use of insecticide-treated bednets, indoor spraying of insecticides, malaria chemoprevention strategies, and the timely use of malaria detection and treatment.

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