Hyderbad, Jan 27 : Global healthcare company GSK, non-profit agency working to end health inequity PATH, and vaccine maker Bharat Biotech on Wednesday announced the signing of a product transfer agreement for malaria vaccine RTS,S/AS01E1.
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 Hyderabad-based Bharat Biotech International Ltd (BBIL). GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to Bharat Biotech.
BBIL was selected through a comprehensive, competitive process undertaken by GSK and PATH, working in consultation with the World Health Organisation (WHO), the vaccine maker said in a statement here.
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 Programme (MVIP). Ministries of Health concerned are leading the implementation of the vaccine, which is being given to young children through the three countries’ routine immunisation programmes, with WHO providing technical and scientific leadership, playing a coordinating role, and working in collaboration with GSK, PATH, and a range of other partners.
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.
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