In order to ensure long-term sustainable supply of the malaria vaccine (RTS,S) GSK, PATH and Bharat Biotech (BBIL) have signed a product transfer agreement for the vaccine.
The agreement includes the transfer of manufacturing the RTS,S antigen part of the vaccine and the grant of a licence on all rights pertaining to the malaria vaccine to BBIL.
GSK will retain the production of the adjuvant of the vaccine (AS01E) and supply it to BBIL.
The malaria vaccine (RTS,S) is the first, and to date, the only vaccine to have received a positive review by regulatory authorities — scientific opinion from the European Medicines Agency and approval by the regulatory authorities of Ghana, Kenya, and Malawi for use in the Malaria Vaccine Implementation Programme (MVIP).
The first dose of the vaccine has reached more than 500,000 children since the pilots were initiated by the ministries of health in the three participating countries in 2019.
Sustainable supply of vaccine
In a press release, it said: “This agreement with BBIL was the result of efforts by GSK, PATH, and WHO to help ensure long-term sustainable vaccine supply, in the event of a World Health Organisation (WHO) policy recommendation for broader use and a commitment of sustained funding”.
“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. 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 such as 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 lead.
For his part, the Africa Lead, Vaccine Implementation, PATH, Mr John Bawa, said thanks to the pilot programme, children in some of the areas hardest hit by malaria — in Ghana, and in Kenya and Malawi had been receiving the 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” he added.
The Chairman and Managing Director of Bharat Biotech, Krishna M Ella, said they were honoured to support the partnership and to provide global access to the malaria vaccine.
In an interview on how the agreement will affect the current MVIP in the three African countries, Mr Bawa said the agreement had no direct impact on the ongoing pilot because adequate doses (10 million doses) had been secured for all three countries up to 2023.
He added that GSK would continue full production of the vaccines till 2028.
Mr Bawa said the agreement provided reasonable assurance to African countries about the future availability of the vaccine to meet their needs if they decided to include vaccine in their existing strategies for malaria control and management.