Bharat Biotech to make antigen for first-ever anti-malaria vaccine

Global healthcare company GSK nonprofit 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 RTSSAS01E1The agreement includes the transfer of manufacturing of the RTSS antigen part of the vaccine and the grant of a license on all rights pertaining to the RTSSAS01 malaria vaccine to Hyderabadbased Bharat Biotech International Ltd BBIL GSK will retain the production of the adjuvant of the vaccine AS01E and will supply it to Bharat BiotechBBIL 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 hereThe RTSSAS01E 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 partnersRTSSAS01E 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 MVIPThe first dose of the vaccine has reached more than 500000 children since the pilots were initiated by Ministries of Health in the three participating countries in 2019This agreement with BBIL is the result of efforts by GSK PATH and WHO to help ensure longterm 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 RTSSAS01E 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 WHOIt is expected that by 2029 at the latest BBIL will be the sole supplier of the vaccine with GSK supplying the adjuvant AS01E to themWith a child still dying of malaria every two minutes helping secure the longterm 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 leadWe 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 PATHWe 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 RTSSAS01E With prior expertise in malaria research WHO prequalified vaccines supplied to more than 70 countries Bharat Biotech is geared up for largescale manufacturing and to provide continuous longterm supply of this lifesaving vaccine Bharat Biotech Chairman and Managing Director Krishna M Ella saidThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever