Indian firm steps in to ensure long-term supply of malaria vaccine

KOLKATA – India’s vaccine production capacity has come in for praise from various quarters as the world seeks to vaccinate its way out of the Covid-19 pandemic.

Last month, UN Secretary-General António Guterres even described it as “one of the best assets the world has today” as he lauded India for supplying Covid-19 vaccine doses to various nations to support their fight against the coronavirus.

This global asset has now come as a shot in the arm for the campaign against another dreaded disease that affected 229 million individuals and killed 409,000 globally in 2019 – malaria.

Bharat Biotech, an Indian firm that has developed the country’s first indigenous vaccine against the coronavirus, has been roped in to ensure long-term sustainable supplies of a malaria vaccine that is being piloted in three African countries under the World Health Organisation’s (WHO) Malaria Vaccine Implementation Programme (MVIP).

According to an agreement announced on Jan 27, multinational pharmaceutical company GSK, which developed the vaccine known as RTS,S/AS01 in 1987, will transfer manufacturing rights of the RTS,S antigen component of the vaccine to Bharat Biotech. Vaccines contain weakened or inactive parts of a particular organism (referred to as antigen) that trigger an immune response within the body.

GSK, headquartered in the UK, will retain production of the adjuvant, an ingredient that is used in some vaccines to help create a stronger immune response, and supply it to the Indian firm. GSK has committed to supply the adjuvant to the new manufacturer and product license holder through the year 2042.

Effective against Plasmodium falciparum, the deadliest malaria parasite globally and the most prevalent in Africa, GSK’s vaccine provides partial protection against malaria in young children. It has been approved for use in Ghana, Kenya and Malawi, where it was rolled out under the MVIP in 2019. Phase 3 trials of the vaccine ended in 2014.

About 1.5 million doses of the vaccine have been administered under immunisation programmes across these three countries and around 560,000 children have received at least the first dose of the recommended four-dose regimen.

“The pilot programme aims to reach approximately 360,000 children per year in the areas selected for the pilots across the three countries-meaning that more than 1 million children will have been reached by the time the evaluations of the pilots are completed in 2023,” Ms Sally Ethelston, a spokesman for non-profit public health organisation PATH, told The Straits Times by e-mail.

PATH is in partnership with GSK and WHO on the MVIP Collaboration Agreement, and provides technical and project management support.

The product transfer agreement for the malaria vaccine with Bharat Biotech has been described as a “cost-effective solution” to ensure long-term supply of the malaria vaccine as demand is anticipated to rise.

A new manufacturing partner for the vaccine is also important because GSK estimates that its antigen manufacturing facility has less than 10 years remaining in service.

If recommended by WHO for wider use, the demand has been estimated to exceed 50 million doses annually by Gavi, the Vaccine Alliance. This estimated minimum level of demand would be reached over the course of a number of years (at least six or seven years after broader implementation starts) as countries make adoption decisions and implement vaccination, added Ms Ethelston.

GSK is donating up to 10 million doses of the vaccine for use in the MVIP and has committed to provide up to 15 million doses of the vaccine per year till the end of 2028. It is expected that by 2029, Bharat Biotech will be the sole supplier of the vaccine, with GSK continuing to supply the adjuvant to them.

The Hyderabad-based firm has facilities in place to support a supply of at least 15 million doses and plans to expand its manufacturing capacity, some of which could be used for the RTS,S antigen.

Dr Krishna M. Ella, Bharat Biotech’s chairman and managing director, has said that the firm is “geared up for large-scale manufacturing, and to provide continuous long-term supply of this life-saving vaccine”.

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