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The board of Gavi, the Vaccine Alliance, announced its intention to finance the rollout of the RTS,S/AS01 malaria vaccine in sub-Saharan Africa. This is the world’s first approved malaria vaccine and the first vaccine approved for a human parasitic disease.
With its decision, announced Thursday, Gavi commits to funding the rollout of the vaccine including procurement, technical assistance for vaccine introduction, and other associated costs. Its initial investment is $155.7 million between 2022 and 2025.
This announcement follows a historic move in October by the World Health Organization, which recommended the broad use of the vaccine in sub-Saharan Africa and other regions that experience significant levels of malaria transmission.
“Today’s decision by the Gavi board is critically important for those of us living in Africa,” Nanthalile Mugala, chief of the Africa region at the global nonprofit PATH, said in a press release. “This commitment will make it possible for low- and middle-income countries in the region that face the greatest malaria burden to consider adding the RTS,S vaccine to their immunization programs as an additional tool to combat malaria. The program could also support other malaria vaccines that become available in the future.”
Gavi is a public-private partnership that works to increase immunizations in low- and middle-income countries by centralizing donor funds so that vaccines can be purchased in bulk. GlaxoSmithKline developed the vaccine with support from the Bill & Melinda Gates Foundation and in partnership with PATH. It took more than 30 years to develop, costing GSK about $700 million.
While the vaccine is only considered modestly effective — with trials showing 40% efficacy in reducing cases of clinical malaria and a 30% reduction in severe cases of malaria — health experts have said that with the high burden of malaria, it is still expected to make a sizable impact on mortality. More than 260,000 children under 5 years of age die from malaria in Africa each year.
The World Health Organization has recommended the broad use of the world’s first malaria vaccine.
“We believe that the vaccine, if properly deployed — particularly prioritizing areas with high mortality — could avert somewhere between 40,000 and 80,000 further deaths every year,” Dr. Pedro Alonso, director of WHO’s Global Malaria Programme, told Devex. “This vaccine will help enormously in terms of reducing deaths. It is likely to have very little impact in terms of reducing transmission and will therefore not bring us rolling a lot closer to an elimination scenario. But it will do what is most important in public health, which is to avert deaths.”
The expectation, according to health experts, is that this is only the first malaria vaccine — and that researchers will continue to work for improved versions.
Before the vaccine was recommended by WHO, pilot programs were held in Ghana, Kenya, and Malawi in which about 830,000 children were vaccinated, with clinical trials in Mali and Burkina Faso also. It is seen as a complement to other malaria control efforts, such as insecticide-treated bed nets and malaria chemoprevention, and not as a replacement.
WHO’s recommendations include providing four doses to children starting at 5 months of age through about 18 months.
And while Gavi’s announcement is welcome, funding alone is not enough, Alonso said. There is also a need to “massively” increase production of the vaccine. Current yearly production stands at about 7 million doses, which could easily be increased to about 15 million. But WHO estimates that around 80 million to 120 million doses will be required per year.
Alonso added that the global community has shown with the COVID-19 pandemic that it is possible to scale up production rapidly, if the will is there.
“When the world feels threatened — particularly certain parts of the world feel threatened — money is not a limitation and production capacity can be massively enhanced in a matter of months — not of years, [but] of months. That same sense of urgency I would like to see deployed with this vaccine,” he said.
And the advantage is the technology around this vaccine is not new. That was the case for the messenger RNA COVID-19 vaccines, which has made scaling up production more complicated.
“It’s a pretty standard technical process — one that is performed every day,” Alonso said. “I cannot possibly imagine that now that we have a first-generation malaria vaccine to save the lives of African children, the world will not mobilize in a vigorous, convincing way and show that we can step up our game and ensure access to this lifesaving intervention.”
There was also an innovative financing agreement agreed upon by Gavi, GSK, and MedAccess to support the bulk production of the RTS,S antigen to ensure that its production continued even amid uncertainties around the vaccine’s rollout. MedAccess said it provided a production guarantee, which “guaranteed the majority of the production costs if the vaccine had not received policy and funding approval.”
“MedAccess’ guarantee means bulk RTS,S antigen stockpiles have built up over the past three months and production can now be accelerated rapidly,” it said.
“The vaccine, if properly deployed … could avert somewhere between 40,000 and 80,000 further deaths every year.”
— Dr. Pedro Alonso, director, WHO’s Global Malaria Programme
“However, broad access to the vaccine could be accelerated by mobilization of resources to further scale up production: in the absence of a financially lucrative market, there is a need for the global community to share risk with manufacturers,” said Ashley Birkett, head of malaria vaccine development at PATH, in the organization’s press release.
Mugala also said that even with Gavi’s funding, countries will make individual decisions on whether to adopt the vaccine and may need additional financial support.
“The challenge is: How do we roll it out as fast as possible and avert as many deaths as possible?” Alonso said.