GSK, PATH, and Bharat Biotech (BBIL) have entered into a product transfer agreement for malaria vaccine.

The agreement includes the transfer of manufacturing of the RTS,antigen part of the vaccine and the grant of a licence on all rights pertaining to the RTS,S/AS01 malaria vaccine to BBIL. GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to BBIL.

“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,” Hyderabad-based Bharat Biotech said in a release on Wednesday.

BBIL was selected through a comprehensive, competitive process undertaken by GSK and PATH, working in consultation with the World Health Organization (WHO). The RTS,S/AS01E malaria vaccine, developed by GSK for more than 30 years, and in partnership with PATH since 2001, is currently being piloted in Ghana, Kenya, and Malawi under the Malaria Vaccine Implementation Programme (MVIP).

RTS,S/AS01E is the first, and to date, the only malaria vaccine to have received a positive review by regulatory authorities (positive scientific opinion from the European Medicines Agency and approval by the regulatory authorities of Ghana, Kenya, and Malawi for use in the MVIP).

The first dose of the vaccine has reached more than 500,000 children since the pilots were initiated by ministries of health in the three participating countries in 2019, the release said.

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