GSK, PATH, and Bharat Biotech (BBIL) have announced the signing of a product transfer agreement for the malaria vaccine, RTS, S/AS01E. The agreement includes 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 BBIL. GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to BBIL. 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 regions of Ghana, Kenya, and Malawi under the Malaria Vaccine Implementation Program (MVIP). Ministries of health are leading the implementation of the vaccine, which is being given to young children through the three countries’ routine immunization programs, with WHO providing technical and scientific leadership, playing a coordinating role, and working in collaboration with GSK, PATH, and a range of other partners.
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. This builds on existing GSK commitments 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 is recommended for wider use by WHO. It is expected that by 2029, at the latest, BBIL will be the sole supplier of the vaccine, with GSK supplying the adjuvant AS01E to them.