GlaxoSmithKline (GSK), along with its partner PATH, has reached a product transfer agreement with Indian biotechnology firm Bharat Biotech, for its malaria vaccine RTS,S/AS01E.

PATH is an international non-profit organisation, engaged in the development and scaling of advanced solutions to the world’s public health challenges.

Under the terms of the agreement, GSK will transfer the production of the RTS,S antigen part of the vaccine to Bharat Biotech, while it will retain the manufacturing of adjuvant of the vaccine (AS01E) and supply it to Bharat Biotech.

Also, Bharat Biotech will receive the license on rights to the RTS,S/AS01 vaccine.

GSK said that the product transfer is based on its commitment to donate up to 10 million doses of malaria vaccine to support the pilot programme in Ghana, Kenya, and Malawi regions and supply up to 15 million doses per annum by 2028.

GSK vaccines chief medical officer and vaccines global health lead Thomas Breuer said: “Our 30-year and ongoing commitment to RTS,S/AS01E represents significant leadership and investment in global health vaccines, but also a huge scientific achievement in the fight against malaria.

“With a child still dying of malaria every two minutes, helping secure the long-term future of the only vaccine available by working with an established leader like Bharat Biotech is vital for the continued fight against this devastating disease. GSK is delighted to sign this agreement with Bharat Biotech”.

RTS,S/AS01E is a malaria vaccine being developed by GSK for more than three decades, and in partnership with PATH since 2001.

The vaccine is currently being studied under pilot programmes in regions of Ghana, Kenya, and Malawi under the Malaria Vaccine Implementation Programme (MVIP).

GSK claimed that its RTS,S/AS01E is the first and the only malaria vaccine to receive a positive review by regulatory authorities, as the vaccine has been granted positive opinion from the European Medicines Agency.

Also, the vaccine has been approved by the regulatory authorities of Ghana, Kenya, and Malawi for use in the MVIP.

GSK and PATH, in consultation with the World Health Organization (WHO), have selected Bharat Biotech through a complete competitive process.

Bharat Biotech is focused on delivering safe, affordable, and high-quality vaccines and bio-therapeutics against infectious diseases.

The agreement underlines the firm’s expertise in developing and supplying vaccines against infectious diseases, and as an established supplier of global health vaccines to Gavi, the Vaccine Alliance, and to UNICEF.

Bharat Biotech is expected to become the sole supplier of the vaccine by 2029, with GSK supplying the adjuvant AS01E for the production.

Bharat Biotech chairman and managing director Krishna Ella said: “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.”