New plan to make malaria vaccines widely available

Vaccines financier has revealed plans to make the malaria vaccines easily available by 2026.

The first pre-qualified malaria vaccine – RTS,S/AS01e, made by GSK – is available in western Kenya on a pilot basis.

The second, R21/Matrix-M, which is more than 70 per cent effective, is only available to children taking part in clinical tests in Kilifi. It is expected to be prequalified and recommended by WHO soon.

In a new paper, Gavi, the vaccines financier based in Geneva, outlined how the world can increase supply to meet demand by growing the number of manufacturers and supporting scale-up through predictable demand.

Dr Seth Berkley, CEO of Gavi, said: “It has taken the world more than 50 years to develop a malaria vaccine. Yet this year’s launch serves only as a reminder of what needs to happen now if we are to make malaria vaccines accessible to every child that needs them.”

With an estimated 40-60 million doses currently to be needed by 2026 alone, growing to 80-100 million doses of vaccines needed each year by 2030, Gavi said governments, vaccine manufacturers and health agencies must take action to meet this goal.

Malaria remains one of Africa’s biggest killers and is estimated to cause 10,000 deaths in Kenya every year.

The major impediment that now stands in the way of a widespread rollout of malaria vaccines in endemic countries is supply, Gavi said.

Gavi’s outline requires countries and partners to work together in key areas such as demand forecasting, boosting the number of suppliers and technology transfer.

 The report also outlines Gavi’s commitment to additional co-financing to ensure countries can access doses, support for countries to make timely applications, and foster further innovation in malaria vaccination and greater integration with existing interventions.

“We know how long African countries have waited for a vaccine against one of its greatest killers: if global health, countries, suppliers and civil society come together, we can soon contribute to preventing tens of thousands of child deaths every year along with other malaria control interventions," Dr Berkley

The World Health Organization said it already reviewing data to consider approving the R21 vaccine.

The Kenyan Ministry of Health said that Kenya's licensure will follow that.

About 600 Kenyan children are participating in phase three trials for R21 vaccine conducted in Kilifi by Kemri-Wellcome Trust.

Serum Institute of India sponsored the ongoing trials and has also promised to make 200 million doses every year.

Currently, the only WHO-approved malaria vaccine is the RTSS, which has about 30 per cent efficacy.

Ghana and Nigeria’s approval last month marked the first regulatory clearance for the R21/Matrix-M malaria vaccine for use in any country.

The R21 vaccine candidate was developed by the University of Oxford’s Jenner Institute and will be manufactured by the Serum Institute.

However, Ghana said it will collaborate with SII to produce its doses in Accra.

“DEK Vaccines Limited, an upcoming vaccines manufacturing factory in Accra, Ghana, is thankful for the support of the government of Ghana through the Vaccines Manufacturing Committee and Ghana FDA, who have been the first in the world to approve the R21/Matrix-M malaria vaccine,” Dr Kofi Nsiah-Poku, the managing director of DEK Vaccines Limited, said in a statement shared by Oxford University.

“We are focused on supporting the Serum Institute of India for their vaccines to be manufactured at DEK upon completion of the DEK Factory. Furthermore, the DEK regulatory team will stand by the Serum Institute to get the R21/Matrix-M malaria vaccine registered in other African countries and make it available to African children.”

Prof Adrian Hill, chief investigator and director of Jenner Institute, said in a statement, “I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children."