The World Health Organization (WHO) has recommended widespread use of RTS,S/AS01 (RTS,S), the malaria vaccine developed by global pharmaceutical major GlaxoSmithkline (GSK), among children in sub-Saharan Africa and other regions with moderate-to-high malaria transmission. It is the first and only malaria vaccine, which has shown high levels of efficacy in long-term clinical trials for significantly reducing malaria in children.

Welcoming the WHO decision, GSK said product transfer, including technology transfer for long-term antigen production to boost supplies is underway with Bharat Biotech of India. GSK has committed to make 15 million annual doses at not more than 5% above the cost of production. Bharat Biotech is yet to comment on the development.

Sources said according to an agreement in January, between Bharat Biotech International (BBIL), GlaxoSmithKline plc and non-profit global health organisation PATH, Bharat Biotech will get technology from GSK to produce the world’s first malaria vaccine, provided it receives a green signal from WHO. Bharat Biotech will manufacture the antigen part of the malaria vaccine (RTS,S/AS01E), and have all the rights pertaining to the vaccine. GSK will retain the production of adjuvant (an ingredient used in some vaccines that helps create a stronger immune response in people) to supply to Bharat Biotech. GSK’s agreement with BBIL includes donation of up to 10 million RTS,S/AS01E doses for use in pilots, and supply up to 15 million doses annually until 2028. Currently GSK is conducting the supplies from one of its plants, but will move the entire production to Bharat Biotech by 2028, sources added.

The WHO recommendation, based on the recommendation of its global advisory bodies for immunisation and malaria, is to administer four doses in children from five months of age to prevent the disease. The vaccine acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa. Also known as Mosquirix, the vaccine is the result of over 30 years of research led by GSK, with PATH and other partners.

Since the launch of the malaria vaccine pilots in 2019, three countries (Ghana, Kenya and Malawi) have led the introduction of the vaccine in selected areas of moderate-to-high malaria transmission, reaching more than 800,000 children with at least one dose of the vaccine since 2019. More than 2.3 million vaccine doses have been administered to date. “GSK is proud that RTS,S, our ground-breaking malaria vaccine, developed over decades by our teams and partners, can now be made available to children in sub-Saharan Africa and other regions with moderate-to-high malaria transmission,” GSK chief global health officer Thomas Breuer said.

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control,” WHO director-general Dr. Tedros Adhanom Ghebreyesus added.

WHO said the next step will include funding initiatives from the global health community for broader rollout, and country specific decisions on whether to adopt the vaccine as part of national malaria control strategies. The Bill & Melinda Gates Foundation had provided catalytic funding for late-stage development of RTS,S between 2001 and 2015.

More than 2,60,000 African children under the age of five die from malaria annually, mainly in sub-Saharan Africa.

Mosquirix won a recommendation from the European Medicines Agency in 2015, but WHO suggested pilot projects to analyse efficacy before a larger and wider rollout.