First Malaria Vaccine Approved by WHO: 'This Is a Historic Moment'

The vaccine is the first of its kind—not only for malaria, but for parasitic diseases in general.

The World Health Organization (WHO) on Wednesday announced an "historic" recommendation: The global health agency endorsed the use of a new malaria vaccine—the first of its kind—which could "save tens of thousands of lives each year," according to a press release.

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The malaria vaccine—technically known as RTS,S (Mosquirix)—is made by GlaxoSmithKline (GSK), and helps protect children specifically against Plasmodium falciparum, the most deadly malaria parasite globally, and the most prevalent one in Africa. Though the mosquito-borne disease only affects about 2,000 people each year in the US, it's far more prevalent in less developed nations. Malaria killed an estimated 409,000 people in 2019 alone, mainly in sub-Saharan Africa, per the WHO; children under 5 accounted for 274,000 of those deaths, making them the population most vulnerable to the disease.

"For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering," Dr. Matshidiso Moeti, WHO Regional Director for Africa, said in Wednesday's press release. "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."

The "groundbreaking" news comes following an ongoing pilot program that's taking place in Ghana, Kenya and Malawi—more than 2.3 million doses have been given to 800,000 children as part of the vaccine's inclusion in routine vaccination schedules.

Plainly speaking: This news is a big deal for global health—not only as a first-of-its-kind vaccine to combat a disease that has plagued the world's population for centuries, but as a medical technology that works against parasitic diseases overall, which are notoriously more complex than both bacterial and viral diseases, per The New York Times. Here, we'll dig a bit deeper into what this news really means for global health—and health in the US specifically—and what still needs to happen before the new malaria vaccine is ready to be put into more arms.

What do we know about the new malaria vaccine?

As of right now, the WHO is recommending—through a global advisory body for immunization and another for malaria—that the malaria vaccine be given to children in "regions with moderate to high transmission as defined by WHO." That may mean mostly sub-Saharan Africa, which is still where most malaria cases and deaths occur, but the WHO also cites regions in South-East Asia, Eastern Mediterranean, Western Pacific, and the Americas as at-risk areas. The vaccine should be given in four separate doses in children starting at 5 months of age.

The WHO is making these recommendations based on data from pilot programs that have been taking place over the last two years in Ghana, Kenya and Malawi. In providing the vaccine to 800,000 children in those areas to date, the WHO says researchers found a 30% decrease—a "significant reduction," though less effective than hoped—in deadly severe malaria. When layered with sleeping under insecticide treated bednets, the other preventive intervention for malaria, over 90% of children benefitted from protection.

Another positive: While at first researchers feared that the introduction of a vaccine would negatively impact the use of preventive methods like bednets, regular vaccinations, seeking treatment for febrile illness (a fever lasting days, a key symptom of malaria), that was found not to be the case. The WHO says the new vaccine had no impact on any of those factors.

Some data, however, painted a slightly less promising picture: According to a phase 3 controlled trial of the vaccine published in The Lancet, the vaccine's efficacy waned over time. The vaccine was also found to be more effective with a booster dose—the best-case scenario for protection occurred when children were given three primary doses over the course of three months, followed by a fourth "booster" dose 18 months later.

What happens next with the malaria vaccine?

While the WHO officially endorsed the malaria vaccine for use in children in moderate- or high-risk regions starting at 5 months old, not much can happen outside of clinical trials—yet.

According to Wednesday's press release, the next steps for the vaccine includes "funding decisions from the global health community for broader roll-out and country decision-making on whether to adopt the vaccine as part of national malaria control strategies."

That funding decision is at least partially up to Gavi, the global vaccine alliance—along with "global stakeholders," per the alliance—as to whether and how to finance the a new malaria vaccination program for sub-Saharan African countries.

More research on the malaria vaccine is still needed, too. As the pilot program continues in the three African countries, researchers will continue to look at how the fourth "booster" dose adds to the vaccine, and how immunization impacts child deaths from the disease.

Still, Wednesday's news was a huge advancement for vaccine technology. Researchers have tried (and failed) many times in the past to create a vaccine that would be effective against malaria, Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, tells Health (Dr. Russo was not involved in the research mentioned above). "It's a tough vaccine to make, and there have been numerous attempts that haven't worked out," he says. According to the WHO, the malaria vaccine is a culmination of 30 years of research and development by GSK, along with partnerships and support from other entities.

Though the vaccine is likely to go through future modifications to make it more effective—Dr. Russo calls it a "starting point"—it's overall a step in the right direction. "This is a big deal in terms of it being the first vaccine that at least shows significant activity against the disease." Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, who shared Wednesday's news in an online news conference as well, feels the same way: ""We still have a very long road to travel, but this is a long stride down that road."

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