The World Health Organization (WHO) has given its endorsement to the world’s first malaria vaccine, which is now in Phase 3 clinical trials. This vaccine will be used to protect children from the disease before they are infected by mosquitos carrying malaria.

The World Health Organization suggested on Wednesday that the world’s first malaria vaccine be widely distributed to young children in Sub-Saharan Africa and other at-risk areas, in the hopes of reviving the battle against the mosquito-borne disease that kills over 400,000 people each year.

The WHO’s approval—a critical step toward attracting additional funding for the vaccine’s manufacturing and distribution—comes more than three decades after scientists at GlaxoSmithKline PLC began working on it.

Concerns about the shot’s poor effectiveness, which needs four doses over around 18 months, and the difficulty of deploying it in some of the world’s most vulnerable health systems had delayed the Geneva-based agency’s favorable recommendation.

Despite this, WHO Director-General Tedros Adhanom Ghebreyesus, who began his career as a malaria researcher, said on Wednesday that a widespread deployment of the vaccine may save tens of thousands of children’s lives each year.

He added, “I yearned for the day when we’d have an effective vaccination against this old and horrible illness.” “Today is the day,” says the narrator. “This is a historic day.”

The vaccine, according to Dr. Tedros, would have to be used in conjunction with other preventative measures such as bed nets, antimalarials, and insecticides. Since the century, they have helped reduce malaria mortality by about 45 percent, although progress has slowed in recent years, particularly in Africa.

Malaria kills 95 percent of people on the continent, mostly children under the age of five.

The vaccine, known as RTS,S or Mosquirix, protects against Plasmodium falciparum, the deadliest of all malaria parasites and the most prevalent in Africa. According to Dr. Tedros, the WHO recommends that the vaccine be widely distributed in Sub-Saharan Africa and other areas where Plasmodium falciparum is widespread.

A late-stage clinical study published in 2015 found that the vaccine averted approximately 32% of severe malaria infections in young children over a four-year period. This is much lower than the effectiveness of other children vaccinations, such as those for measles and chickenpox, which are both over 90% effective.

The WHO held off on recommending a wide-scale deployment of the vaccine at the time. Instead, the agency’s scientists chose to test it in three African countries—Kenya, Malawi, and Ghana—in order to get additional information on its safety, efficacy in a real-world context, and the feasibility of incorporating it into regular early-childhood vaccination programs.

The WHO’s Strategic Advisory Group of Experts on Immunization issued a recommendation on Wednesday based on preliminary findings from those pilot projects.

The vaccine was well-received in the eight counties where it was offered, according to Rose Jalang’o, a public-health expert from Kenya’s health ministry who helped supervise the trial.

“In Kenya, it’s been very simple to introduce since moms are aware of the illness,” she said. “They were ecstatic to get this vaccination.”

Around 80% of eligible 6-month-old infants in Kenya got a first dose of the vaccination, according to evidence presented to the WHO, with 41% still coming in for a fourth shot around their second birthday. The early uptake and subsequent decrease were consistent with other multidose children vaccinations in Kenya, such as the two-dose measles and rubella vaccine.

According to Ashley Birkett, who heads the malaria program at the Seattle-based PATH Center for Vaccine Innovation and Access, which helped fund the vaccine, early findings from the pilot programs appeared to confirm the vaccine’s effectiveness, with severe cases of malaria down around 30% among vaccinated children.

He claimed it was too early to get definitive statistics on how many fatalities the vaccination saved.

Worlds-First-Malaria-Vaccine-Gets-WHO-Backing

Over the course of four years, a late-stage clinical study showed that the vaccination averted approximately 32% of severe episodes of malaria in young children.

Getty Images/Cristina Aldehuela/Agence France-Presse

The vaccine’s poor effectiveness, according to Dr. Birkett, is balanced by the danger malaria presents to young infants. “We will save one life for every 230 youngsters that are immunized,” he added.

Even yet, it will most certainly be years before the vaccine is widely accessible across Sub-Saharan Africa. By 2030, the WHO predicts that between 50 million and 100 million doses would be required. Aid organizations such as Gavi and the Vaccine Alliance, which promotes children vaccination in poor countries, as well as African governments, will have to spend billions of dollars, including in additional manufacturing capacity, to get there.

Glaxo now produces the vaccine at one of its facilities, but by 2028, it intends to shift manufacturing to India’s Bharat Biotech. Until then, it has pledged to provide at least 15 million doses each year. The firm claimed it will sell the vaccine at a profit of no more than 5% over the cost of manufacturing, with the proceeds going toward additional research into illnesses that afflict low-income countries.

“At a time when progress on malaria control has stagnated, this long-awaited historic decision may revitalize the battle against malaria in the area,” said Thomas Breuer, Glaxo’s chief global health officer.

One of the reasons why a vaccine has taken so long to develop is a lack of investment in malaria compared to illnesses that are more prevalent in wealthy nations, according to health experts. Another factor is the malaria parasite’s complexity, which contains approximately 5,000 genes that might be targeted by a vaccine.

“You’re dealing with a parasite that has been in an arms race with humans since the dawn of time,” said Jake Baum, co-director of Imperial College London’s Institute of Infection. SARS-CoV-2, the virus that causes Covid-19, has just around 13 genes and an apparent spike protein that vaccines can target, according to him.

Other researchers, such as those at Oxford University’s Jenner Institute and the Sanaria biotech firm in the United States, are working on malaria vaccines, but they are at least five years behind Mosquirix and it is uncertain if they will be more effective.

Prof. Baum, who is doing early-stage research into alternative malaria vaccine methods, stated, “As a stopgap for now, [Mosquirix] is fantastic.” “What it mustn’t do is suffocate innovation and vaccine development.”

Gabriele Steinhauser and Denise Roland can be reached at [email protected] and [email protected], respectively.

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