Clinical Trials & Research News

WHO Recommends Broad Roll-Out of GSK’s Malaria Vaccine For Children

GSK’s malaria vaccine, RTS,S is the first and only malaria vaccine studied in pivotal long-term trials that significantly reduces malaria in children.

Malaria Vaccine

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By Samantha McGrail

- GSK recently welcomed the World Health Organization’s (WHO) recommendation for the broader development of GSK’s RTS, S malaria vaccine to reduce childhood illness and deaths from malaria in sub-Saharan Africa and other regions.

WHO gathered its recommendations from the malaria vaccine pilot programs in Ghana, Kenya, and Malawi. The positive results are the second key milestone for the RTS,S malaria vaccine in recent weeks.

In August, data from a study of 6,000 children by the London School Hygiene and Tropical Medicine showed that the combination of seasonal administration of Seasonal Malaria Chemoprevention (SMC) and RTS,S after three years vaccination lowered clinical episodes of malaria by nearly 70 percent compared to SMC alone.

The results suggest that the impact of RTS,S vaccination can be increased to further reduce mortality, especially when combined with other recommended malaria control interventions in a seasonal setting.

“GSK is proud that RTS,S can now be made available to children in sub-Saharan Africa and other regions with moderate to high malaria transmission,” Thomas Breuer, chief global health officer of GSK, said in the announcement.

“Both real world evidence and clinical trial data show that RTS,S, alongside other malaria prevention measures, has the potential to save hundreds of thousands of lives,” Breuer continued.

RTS,S is the first and only malaria vaccine studied in pivotal long-term clinical trials that significantly reduces malaria in children. The vaccine development is a result of 30 years of research between GSK and PATH.

GSK is working with partners to develop solutions to ensure equitable and long-term access to the RTS,S vaccine for individuals who need it in anticipation of the wider roll-out beyond the pilot programs in Malawi, Kenya, and Ghana.

The company will also donate up to 10 million doses annually following funding for wider use. And 15 million annual doses will be available at no more than 5 percent above the cost of production.

A Product Transfer, including technology transfer from long-term antigen production, is also underway with Bharat Biotech of India.

So far, over 2.3 million doses of the malaria vaccine have reached more than 800,000 children in Ghana, Kenya, and Malawi.

GSK said it will continue to actively research malaria and work with partners, including Comic Relief and AMREF Health Africa, to increase public health awareness, train health workers in underserved communities, and increase access to testing and medications.