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.
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.
“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,” said Thomas Breuer, GSK Vaccines Chief Medical Officer and Vaccines Global Health lead.
“We at PATH are proud to be a part of this remarkable effort — together with partners across Africa, GSK, and WHO — to get to this point. Now, with the signing of this agreement with Bharat Biotech, we have an additional, new partner to help ensure that this vaccine can be more widely available for use in Africa, alongside other malaria interventions, in the years to come,” said John Bawa, Africa Lead, Vaccine Implementation, PATH.
“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,” Bharat Biotech Chairman and Managing Director Krishna M. Ella said.