• The vaccine is being piloted in Kenya, Malawi and Ghana to test the safety and feasibility of offering four doses.
• Path, a non-profit organisation that is supporting the pilot in Kenya, also backed the transfer.
Image: D POLAND/PATH
The malaria vaccine being piloted in Kenya has been acquired by an Indian company.
The vaccine was developed by British pharmaceutical GlaxoSmithKline plc (GSK), which on Wednesday announced it has transferred it to India’s Bharat Biotech (BBIL), a fast-rising pharma that has also developed its own Covid-19 vaccine.
A GSK spokesman told the Star that although Bharat will own the vaccine, it did not buy it.
"This is not a sale, BBIL is not paying GSK for the product transfer. This deal is about securing a long-term manufacturing solution for the vaccine beyond existing commitments through to 2029," the spokesman said.
Bharat will progressively take over manufacturing of the vaccine (called RTS,S/AS01E) and own all rights pertaining to it by 2029, GSK said.
GSK said it will only retain the adjuvant (AS01E) of the vaccine, which it will continue to supply to Bharat until 2042.
An adjuvant is an agent added to a vaccine to create a stronger immune response in people, thus minimising the dosages needed.
The vaccine is being piloted in Kenya, Malawi and Ghana to test the safety and feasibility of offering four doses.
At least 65,000 children - in Kakamega, Vihiga, Bungoma, Busia, Kisumu, Homa Bay, Migori and Siaya counties - have received three doses and will receive the final dose next month.
GSK said in a statement that Bharat has a global track record of supplying World Health Organization prequalified vaccines at affordable prices to Gavi-eligible countries.
“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,” Thomas Breuer, the GSK chief medical officer and lead of vaccines global health, said.
Path, a non-profit organisation that is supporting the pilot in Kenya, also backed the transfer.
“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,” John Bawa, Africa head for vaccine implementation at Path, said.
GSK and Path said the transfer will ensure adequate production if WHO recommends RTS,S for wider use – with more than 50 million doses needed annually.
The transfer is part of GSK’s current strategy to cut back operations in Africa, and slim down its vaccine R&D programme to focus on more profitable areas.
GSK is said to have spent about Sh100 billion ($1 billion) on the malaria vaccine over 30 years, but there was no clear way to make it profitable.
Each vaccine dose is expected to cost about Sh500 ($5), and it will cost about Sh2,000 ($20) to fully immunise a child, from six months of age.
With most of Kenya being at risk of malaria, a nationwide vaccination is largely unfeasible unless supported by donors.
Also, there are challenges regarding the vaccine’s safety, which the pilot is investigating.
During the clinical trials, children who received the vaccine, also called Mosquirix, had a risk of meningitis 10 times higher than those who received a control vaccine.
In all cases, mortality also doubled in girls who received the vaccine.
The vaccine may not have triggered the meningitis cases, experts say.
Convulsions after vaccination, though rare, also occurred more often in malaria vaccine recipients than in controls.
In the trials, the vaccine reduced a child’s chance of contracting malaria by 40 per cent, with efficacy wearing off drastically four years after the final dose.
Experts believe that the number of children who complete the four doses over two years will be much lower than the total number who began.