India’s Bharat Biotech will be producing part of the world’s only malaria vaccine that has been developed by Pharma major GSK, and was recently approved by WHO (World Health Organisation).

However, it may take a couple of years before the vaccine is launched in the market for use.

In January, this year, Hyderabad-based vaccine major announced that it entered a product transfer partnership with the pharma major GSK for its malaria vaccine, RTS, S/AS01E1.

As part of this partnership, GSK would transfer RTS manufacturing technology to Bharat Biotech to produce the S antigen component of the malaria vaccine, and the license on all rights pertaining to it.

GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to Bharat Biotech.

“The agreement recognises the track record and expertise of BBIL in developing and supplying vaccines against infectious diseases, including as an established supplier of global health vaccines to Gavi, the Vaccine Alliance, and to UNICEF. BBIL was selected through a comprehensive, competitive process undertaken by GSK and PATH, working in consultation with the World Health Organization (WHO),” read a joint statement issued by both the partners in January.

The RTS, S/AS01E malaria vaccine, developed by GSK for more than 30 years, and in partnership with PATH since 2001, has been piloted in regions of Ghana, Kenya, and Malawi under the Malaria Vaccine Implementation Programme (MVIP).

“This agreement with BBIL is the result of efforts by GSK, PATH, and WHO to help ensure long-term sustainable vaccine supply, in the event of a WHO policy recommendation for broader use and a commitment of sustained funding,” the statement further read.

On Wednesday, WHO recommended widespread use of the malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from the ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800 000 children since 2019.

According to the joint statement issued earlier, GSK committed to donate up to 10 million RTS, S/AS01E doses for use in the pilot, and to supply up to 15 million doses annually until 2028 if the product was recommended for wider use by WHO. It is expected that by 2029, at the latest, Bharat Biotech will be the sole supplier of the vaccine, with GSK supplying the adjuvant AS01E to them.