WHO Approves Widespread Use of World’s First Malaria Vaccine

In a historic moment for malaria prevention, the World Health Organization (WHO) has recommended the widespread use of GSK’s Mosquirix or RTS,S/AS01 (RTS,S), the first only approved malaria vaccine among children in sub-Saharan Africa and other regions where there are moderate to high levels of malaria transmission caused by Plasmodium falciparum.

The recommendation is based on results from an ongoing pilot program in Ghana, Kenya, and Malawi that has reached more than 800 000 children since 2019, WHO said in a statement.

The New York Times said that RTS,S is also the first vaccine ever approved for use against a parasitic disease in humans.

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health, and malaria control,” said WHO Director-General, Dr. Tedros Adhanom Ghebreyesus. “Using this vaccine on top of existing  tools to prevent malaria could save tens of thousands of young lives each year.”

Primary Cause of Death in African Children

As per the latest World Malaria Report, 229 million malaria cases were reported in 2019, accounting for 409,000 deaths worldwide. The disease remains a primary cause of childhood illness and death in sub-Saharan Africa. More than 260,000 African children under the age of five die from malaria annually. In recent years, WHO and its partners have been reporting a stagnation in progress against the deadly disease.

“For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering,” said Dr. Matshidiso Moeti, WHO Regional Director for Africa. “We have long hoped for an effective malaria vaccine, and now for the first time ever, we have such a vaccine recommended for widespread use. Today’s recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease, and we expect many more African children to be protected from malaria and grow into healthy adults.”

Key Trial Findings That Led to WHO Recommendation

WHO recommends that in the context of comprehensive malaria control, the RTS,S malaria vaccine be used for the prevention of P. falciparum malaria in children living in regions with moderate to high transmission as defined by WHO.

RTS,S malaria vaccine should be provided in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden. Large scale clinical trials showed a 39% efficacy (prevented around 4 in 10 cases of malaria) in newborn children between the ages of five and 17 months. This further reduces to 29% efficacy in severe malaria cases.

Key findings from the pilot program in Ghana, Kenya, and Malawi showed that the vaccine introduction was feasible, improved health, and saved lives even when the world was suffering from the COVID-19 pandemic. Data showed that more than two-thirds of children in the 3 countries who are not sleeping under a bednet benefitted from the vaccine.

More than 2.3 million doses of the RTS,S vaccine have been administered in the three countries. So far, it has demonstrated a strong safety profile. In addition, modeling estimates that the vaccine is cost-effective in areas of moderate to high malaria transmission.

Author

Rajaneesh K. Gopinath