Bharat Biotech, global healthcare firm GSK and non-profit entity focusing on public health PATH on Wednesday announced the signing of a product transfer agreement for a malaria vaccine to ensure its long-term supply.
The agreement includes the transfer of manufacturing of the antigen part of the malaria vaccine against Plasmodium falciparum malaria and the grant of a license on all rights pertaining to the vaccine to Bharat Biotech, they said in a statement.
GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to Bharat Biotech (BBIL), it added.
“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),” the statement said.
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, it added.
The 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, the statement 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,” GSK Vaccines Chief Medical Officer and Vaccines Global Health lead Thomas Breuer said.
We are delighted to announce today with our partners @PATHtweets and @BharatBiotech a product transfer agreement to help ensure the long-term supply of our malaria vaccine and help #FightMalaria. Read more: https://t.co/OPrjmnJLwH pic.twitter.com/xpXc7veXmK
— GSK (@GSK) January 27, 2021
On the agreement, PATH Vaccine Implementation Africa Lead John Bawa said, “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.”
The timing of the 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, according to the statement.
“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,” Bharat Biotech Chairman and Managing Director Krishna M Ella said.
With prior expertise in malaria research, WHO pre-qualified 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, he added.
