Global pharma major GSK, non-profit health organisation PATH and Bharat Biotech have signed a product transfer agreement pertaining to malaria vaccine RTS,S/AS01.
The agreement includes transfer of manufacturing of the RTS,S antigen part of the vaccine and grant of a licence on all rights pertaining to the RTS,S/AS01 malaria vaccine to Bharat Biotech.
A joint release on Wednesday said GSK will retain production of the adjuvant of the vaccine (AS01E) and supply the same to Bharat Biotech.
The Hyderabad-based vaccine maker was selected through a comprehensive, competitive process undertaken by GSK and PATH, in consultation with the World Health Organisation.
Developed by GSK for 30 years and in partnership with PATH since 2001, the malaria vaccine is being piloted in regions of Ghana, Kenya and Malawi under the Malaria Vaccine Implementation Programme (MVIP). Young children are getting the vaccine under the three countries’ routine immunisation programmes. WHO is providing technical and scientific leadership and working in collaboration with GSK, PATH, and other partners. The first dose of the vaccine has reached more than five lakh children since the pilot projects were initiated in the three countries in 2019.
RTS,S/AS01E is the first and 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). GSK has committed to donate upto 10 million doses for use in the pilot projects and supply upto 15 million doses annually until 2028 if the product is recommended for wider use by WHO. It is expected by 2029, at the latest, Bharat Biotech will be the sole supplier of the vaccine, with GSK supplying the adjuvant, the release said.
GSK Vaccines Chief Medical Officer and Vaccines Global Health lead Thomas Breuer said “with a child still dying of malaria every two minutes, helping secure 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.”
Bharat Biotech CMD Krishna M. Ella said the company is geared up for large-scale manufacturing and to provide continuous long-term supply of the life-saving vaccine.
