PRESS RELEASE: GSK secures long-term supply for malaria vaccine
PRESS RELEASE: GSK secures long-term supply for malaria vaccine
GSK - Press Release
- Bharat Biotech to produce antigen for world’s first vaccine against Plasmodium falciparum malaria following technology transfer, to help ensure long-term sustainable supply
- Transfer builds on GSK commitments to donate up to 10 million vaccine doses to the pilot implementation in regions of Ghana, Kenya, and Malawi and supply up to 15 million doses annually to 2028 if recommended for wider use
- Bharat Biotech selected as partner based upon its established experience in development, production, and supply of global health vaccines
GSK, PATH, and Bharat Biotech (BBIL) today announced the signing of a product transfer agreement for the malaria vaccine, RTS,S/AS01E[1]. 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 BBIL. GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to BBIL.
The COVID-19 vaccines journey has shown how important it is to put in place robust plans for manufacture and supply to ensure lifesaving tools reach those that urgently need protection. GSK’s announcement that they have secured a manufacturer to ensure long-term supply of their ground-breaking malaria vaccine (the first in history) is a vital step towards ensuring this pioneering vaccine reaches the thousands of children at risk of losing their lives to this terrible disease.
BBIL is an established, innovative biotechnology company based in Hyderabad, India, focused on delivering safe, affordable, and high-quality vaccines and bio-therapeutics against infectious diseases. The agreement recognises the track record and expertise of BBIL in developing and supplying vaccines against infectious diseases, including as an established supplier of global health vaccines to Gavi, the Vaccine Alliance, and to UNICEF. BBIL was selected through a comprehensive, competitive process undertaken by GSK and PATH, working in consultation with the World Health Organization (WHO).
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 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.
READ THE FULL PRESS RELEASE HERE
More news
