Landmark Malaria Vaccine Launched In Malawi – Kenya, Ghana Next

The World Health Organization today announced that a new vaccine for malaria, which has been in development for 30 years and recently passed clinical trials, is being introduced as part of the routine childhood immunization programmes of Malawi, soon to be followed by Kenya and Ghana.

This is part of a WHO-led pilot programme to evaluate the effectiveness of the malaria vaccine in routine settings before scaling it up to other countries in Sub-Saharan Africa. Through the initiative, around 360,000 children will be vaccinated per year over the next five years in the three countries.

A child receives a dose of the malaria vaccine at a health centre in Malawi. Photo: WHO/M. Nieuwenhof

This is “a historical moment in the very long fight against malaria,” Pedro Alonso, director of the WHO Global Malaria Programme, said today in a press briefing on the launch. “We believe that this [vaccine] may be yet another tool, an imperfect tool with a modest efficacy, just like all of our other malaria control tools, which when used imperfectly may actually have massive impact and help us get back on track to our ultimate goal of seeing a world free of malaria.”

“This is a day to celebrate as we begin to learn more about what this tool can do to change the trajectory of malaria through childhood vaccination,” Matshidiso Moeti, WHO Regional Director for Africa, said in a WHO press release.

The vaccine, RTS,S, is “the first, and to date the only, vaccine that has demonstrated it can significantly reduce malaria in children. In clinical trials, the vaccine was found to prevent approximately 4 in 10 malaria cases, including 3 in 10 cases of life-threatening severe malaria,” according to the release.

It will be given to children “in 4 doses: 3 doses between 5 and 9 months of age and the fourth dose provided around the 2nd birthday,” it says.

“We have seen tremendous gains from bed nets and other measures to control malaria in the last 15 years, but progress has stalled and even reversed in some areas. We need new solutions to get the malaria response back on track, and this vaccine gives us a promising tool to get there,” WHO Director-General Dr Tedros Adhanom Ghebreyesus (Dr Tedros) said in the release. “The malaria vaccine has the potential to save tens of thousands of children’s lives.”

The pilot programme will be coordinated by WHO in collaboration with the ministries of health of Malawi, Kenya and Ghana, along with a range of partners including GSK, the vaccine developer and manufacturer. Nearly US$ 50 million in funding has been provided for the first phase of the pilot by Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.

“Malaria is still one of the biggest killers of children worldwide, taking the lives of over 200,000 children every year,” Seth Berkley, CEO of Gavi, said in a joint statement by the funders. “These pilots will be crucial to determine the part this vaccine could play in reducing the burden this disease continues to place on the world’s poorest countries.”

“To step up the fight against malaria, we need every available tool,” Peter Sands, executive director of the Global Fund, said in the statement. “If this pilot shows that RTS,S is a cost-effective tool against malaria, it will help us save more children’s lives.”

“The malaria vaccine… is also a shining example of the kind of inter-agency coordination that we need,” Lelio Marmora, executive director of Unitaid said in the statement. “We look forward to learning how the vaccine can be integrated for greatest impact into our work.”

The pilot programme is “designed to generate evidence and experience to inform WHO policy recommendations on the broader use of the RTS,S malaria vaccine,” according to the release. “It will look at reductions in child deaths; vaccine uptake, including whether parents bring their children on time for the four required doses; and vaccine safety in the context of routine use.”

“This is not a research study,” Kate O’Brien, director of the WHO Department of Immunization, Vaccines and Biologicals, clarified today in the press briefing. “They are deploying the vaccine in a routine setting,” she said, emphasising that the vaccine has already passed clinical trials and has been deemed safe by stringent regulatory authorities.

In approximately two years, she said, the evidence from the pilot immunization programme will be reviewed by WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization and its Malaria Policy Advisory Committee to assess the efficacy of the vaccine in routine settings and to make recommendations regarding the possibility of scaling up implementation of the vaccine to other Sub-Saharan countries.

This vaccine, if proven effective in routine settings, will be “a complementary malaria control tool “to be added to the core package of WHO-recommended measures for malaria prevention, including the routine use of insecticide-treated bed nets, indoor spraying with insecticides, and the timely use of malaria testing and treatment,” the release says.

The Phase 3 clinical trials for the vaccine, conducted in Africa from 2009 to 2014, found that the vaccine “prevented 4 in 10 cases of clinical malaria; 3 in 10 cases of severe malaria; and 6 in 10 cases of severe malaria anaemia, the most common reason children die from malaria,” the release notes. “Significant reductions were also seen in overall hospital admissions and the need for blood transfusions, which are required to treat severe malaria anaemia.”

Image Credits: WHO/M. Nieuwenhof.

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