The RTS,S/AS01E malaria vaccine is the focus of a new product transfer agreement between GSK, PATH, and Bharat Biotech (BBIL), which will see manufacturing, supply, and rights split between the three entities.
Under the arrangement, manufacturing of the RTS,S antigen and licensing rights to the larger vaccine will be handed to BBIL. GSK retains production of the adjuvant AS01 portion of the vaccine, which will then be supplied to BBIL. This agreement resulted from GSK, PATH, and the World Health Organization (WHO) joint efforts to guarantee long-term sustainable vaccine supply in case of a WHO policy recommendation for broader use and a commitment of sustained funding.
As a result, BBIL will likely be the sole supplier of the vaccine by 2029, with GSK supplying the adjuvant AS01E. GSK has developed the RTS,S/AS01E malaria vaccine for more than 30 years. It has been piloted in several African nations since 2001 in collaboration with PATH. It is also the first and only malaria vaccine to have received a positive review from regulatory authorities.
“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,” Thomas Breuer, GSK Vaccines Chief Medical Officer and Vaccines Global Health lead, said. “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.”
BBIL is a biotechnology company based in Hyderabad, India. It was selected for its past help developing and supplying vaccines against infectious diseases to global organizations, following a competitive process undertaken by GSK and PATH. The transfer will build on existing GSK commitments to donate up to 10 million doses of the vaccine for pilot use and supply up to 15 million doses annually until 2028 if recommended for wider use by WHO.
“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,” Krishna Ella, Bharat Biotech chairman & managing director, said. “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”.