GSK-Bharat Biotech Partnership To Produce World's First Malaria Vaccine Approved By WHO

The World Health Organisation (WHO) on Wednesday (Oct 6) recommended the use of RTS,S/AS01 (RTS,S), the malaria vaccine developed by global pharmaceutical major GlaxoSmithkline (GSK), as part of childhood immunisation drive in in sub-Saharan Africa and other regions with high transmission of Plasmodium falciparum, the deadliest of the five parasites that cause malaria.

In 2018, f Plasmodium falciparum accounted for 99.7% of estimated malaria cases in the African Region, 50% of cases in the South-East Asia Region, 71% of cases in the Eastern Mediterranean and 65% in the Western Pacific.

Malaria remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260 000 African children under the age of five die from malaria annually.

The WHO reached its decision after reviewing results from Ghana, Kenya and Malawi, where more than 800,000 infants were vaccinated with a four-dose regimen. In these countries RTS,S was included among the routine childhood vaccines distributed by primary health-care centres. The results showed that use of vaccine led to reduction in hospital admissions by 30%.

In August, data from a study of 6,000 children by the London School Hygiene and Tropical Medicine, published in the New England Journal of Medicine, showed that after three years the combination of seasonal administration of antimalarials (known as Seasonal Malaria Chemoprevention/SMC) and RTS,S vaccination lowered clinical episodes of malaria, hospital admissions with WHO-defined severe malaria, and deaths from malaria by about 70% compared to SMC alone.

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.

The RTS,S/AS01 malaria vaccine has been under development by GSK for more than 30 years, and in partnership with PATH since 2001. PATH is a global nonprofit dedicated to ending health inequity.

In January this year, GSK, PATH, and Indian vaccine maker Bharat Biotech (BBIL) announced the signing of a product transfer agreement for the malaria vaccine, RTS,S/AS01.

The agreement included the transfer of manufacturing of the RTS,S antigen part of the vaccine and the grant of a license on all rights pertaining to the RTS,S/AS01 malaria vaccine to Bharat Biotech. While GSK retained the production of the adjuvant of the vaccine (AS01_E) , it will supply it to Bharat Biotech.

GSK’s agreement with Bharat Biotech 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,

Krishna M. Ella, Bharat Biotech, Chairman & Managing Director said: on the agreement “We salute the commitment by GSK, PATH, and partners, in developing a novel vaccine against malaria, a dreaded disease with more than 200 million cases worldwide. We are truly honoured to support this partnership and to provide global access to RTS,S/AS01E. With prior expertise in malaria research, WHO prequalified vaccines, supplied to more than 70 countries, Bharat Biotech is geared up for large-scale manufacturing, and to provide continuous long-term supply of this life-saving vaccine