Malaria vaccine endorsement demonstrates benefits of life sciences collaboration and risk sharing

On Wednesday the World Health Organization (WHO) announced that it was recommending the use of RTS,S/AS01e (RTS,S) malaria vaccine among children in sub-Saharan Africa and other regions where there is moderate to high transmission of the disease. Mosquirix is the brand name given to RTS,S by GSK, the pharmaceutical company that has led on the development of the treatment.

The endorsement follows findings from the pilot use of the vaccine in Ghana, Kenya and Malawi in the past two years. The WHO said the pilots had shown the vaccine to significantly reduce deadly severe malaria and listed a range of other benefits, including the feasibility of delivery and “strong safety profile”.

GSK said a separate study has shown that use of the vaccine in combination with “seasonal administration of antimalarials lowered clinical episodes of malaria, hospital admissions with WHO-defined severe malaria, and deaths from malaria by about 70%” compared to using the antimalarials in isolation.

WHO director-general Dr Tedros Adhanom Ghebreyesus said that “tens of thousands of young lives” a year could be saved by using this vaccine in combination with “existing tools to prevent malaria”, which include the use of insecticide treated bednets and administration of other anti-malarial drugs.

GSK has developed RTS,S over the course of 30 years. Its work has been supported by a range of partners.

GSK worked with PATH, a body that works towards “health equity” globally. Between 2001 and 2015 the Bill & Melinda Gates Foundation provided funding for GSK’s and PATH’s research. A series of global health funding bodies has helped finance the pilot use of the vaccine in Ghana, Kenya and Malawi.

The pharmaceutical manufacturer agreed to donate up to 10 million RTS,S doses for use in the pilots, and to supply up to 15 million doses annually, following a recommendation and funding for wider use. It said it would supply those doses at a price that is “no more than 5% above cost of production”. It further announced that, it would complete a “product transfer” to enable Bharat Biotech, an Indian biotech company, to produce antigens, and that it would continue to work with partners, funders, and governments to secure future supply.

“The WHO endorsement for GSK’s malaria vaccine, Mosquirix, demonstrates what ingenuity, boldness and collaboration can achieve,” said Helen Cline of Pinsent Masons, the law firm behind Out-Law.

“The experience with development of vaccines against Covid-19 has shown the value of taking early measured risks in manufacturing concurrent with research and development, to ensure timely access when countries were ready to implement a vaccination program. GSK and its partners have likely applied this approach to malaria. Collaboration has been key to this project,” she said.

Cline said she hoped GSK’s vaccine would be the “first of many novel, game-changing approaches to the malaria crisis”. GSK itself has vowed to continue its research in malaria. However, Cline said there are broader questions for policymakers over how best to incentivise investment in new treatments.

Cline said: “Constant efforts must be made to ensure the development of new treatments for malaria and other infectious diseases. However the question is how incentives to encourage the development of such treatments can be reimagined.”

“Whilst the debate on how best to incentivise innovation is not new, it is still very much a live debate and raises particular considerations in the context of medicines for diseases prevalent in the developing world, for new antibiotics or for rare diseases,” said Nicole Jadeja, also of Pinsent Masons.   

Cline said: “Incentives can generally be split into two categories: ‘push’ and ‘pull’. Push mechanisms enhance the funds available to research and development, in the hope that a useful drug will be produced; pull mechanisms provide enhanced incentives for investments in R&D by increasing the value of the end product to the innovator. Reducing the burden of taxation on R&D investments made by private corporations is one example of a “push” mechanism for targeted research projects. An example of a pull mechanism is the offer of a reward to the inventor of a drug that treats a specified disease,” she said.

“A potentially useful way to stimulate investment into treatments for infectious disease is advance bulk purchase orders of a drug that meets a set of pre-established criteria. These have been used during the pandemic,” Cline said.