Bharat Biotech, UK drug giant GSK and US-based non-profit PATH on January 27 announced the signing of a product transfer agreement for the malaria vaccine.
As per the agreement, GSK will transfer the manufacturing technology of the RTS,S antigens of the vaccine and will grant license on all rights pertaining to the RTS,S/AS01 malaria vaccine to Bharat Biotech. GSK will retain the production of the adjuvant of the vaccine (AS01E) and supply it to Bharat Biotech.
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," Bharat Biotech said in a statement.
RTS,S/AS01E is the first, and to date, the only malaria vaccine to have received approval by the regulatory authorities of Ghana, Kenya, and Malawi for use in the Malaria Vaccine Implementation Programme (MVIP) countries. The vaccine has also received positive review by regulatory authorities from the European Medicines Agency.
GSK has existing commitments of donating 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, Bharat Biotech will be the sole supplier of the vaccine, with GSK supplying the adjuvant.
Bharat Biotech said 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.
The timing of the new agreement will help ensure the maintenance of long-term vaccine supply, given the time required for a successful technology transfer. GSK has strong expertise in transferring vaccine manufacturing technologies to partners, with more than 20 technology transfers currently ongoing. This expertise, with support from BBIL and PATH, will now be applied to deliver a successful transfer of production of the RTS,S antigen to BBIL.
“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 a continuous long-term supply of this life-saving vaccine,” said Krishna Ella, Chairman & Managing Director of Bharat Biotech.
Ella said every year more than 200 million cases of malaria are reported. Malaria is caused by a parasite that's been spread by mosquitoes.
“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," said Thomas Breuer, GSK Vaccines Chief Medical Officer and Vaccines Global Health lead
"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,” Breuer said.
"Thanks to the pilot programme, children in some of the areas hardest hit by malaria—here in Ghana, and in Kenya and Malawi—have been receiving this vaccine through routine immunisation programmes for more than one year. 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.