W.H.O approves first malaria vaccine: History Made

The world has a new weapon in its arsenal in the fight against malaria, one of the oldest and deadliest infectious diseases: W.H.O approves the first malaria vaccine shown to help prevent the disease

W.H.O approves first malaria vaccine: History Made which according to one estimate, it will save the lives of tens of thousands of children each year.

Malaria kills approximately 500,000 people each year, nearly all of whom are in Sub-Saharan Africa, including 260,000 children under the age of five.

GlaxoSmithKline’s new vaccine stimulates a child’s immune system to combat Plasmodium falciparum, the deadliest of five malaria pathogens and the most common in Africa.

The World Health Organization approved the vaccine on Wednesday, marking the first step in a process that should result in widespread distribution in developing countries.

The development of a malaria vaccine that is safe, moderately effective, and ready for distribution is a “historic event,” according to Dr. Pedro Alonso, director of the World Health Organization’s global malaria program.

Malaria is extremely rare in the developed world. Each year, there are only 2,000 cases in the United States, mostly among travelers returning from countries where the disease is endemic.

The vaccine, called Mosquirix, is not only a first for malaria, but also for any parasitic disease. Parasites are far more complex than viruses or bacteria, and the search for a malaria vaccine has been ongoing for over a century.

“From a scientific standpoint, having a first-generation vaccine against a human parasite is a huge leap,” Dr. Alonso said.

In clinical trials, the vaccine had an efficacy of about 50% against severe malaria in the first year, but by the fourth year, the figure had dropped close to zero.

Furthermore, the trials did not directly measure the vaccine’s impact on deaths, prompting some experts to question whether it is a worthwhile investment in countries with a plethora of other intractable issues.

However, severe malaria accounts for up to half of malaria deaths and is regarded as “a reliable proximal indicator of mortality,” according to Dr. Mary Hamel, who leads the World Health Organization’s malaria vaccine implementation program. “I believe we will see that effect.”

A modeling study published last year estimated that if the vaccine were distributed to malaria-endemic countries, it could prevent 5.4 million cases and 23,000 deaths in children under the age of five each year.

A recent trial of the vaccine in combination with preventive drugs given to children during high-transmission seasons discovered that the dual approach was far more effective than either method alone in preventing severe disease, hospitalization, and death.

The malaria parasite, which is spread by mosquitoes, is a particularly insidious foe because it can infect the same person repeatedly.

Children in many parts of Sub-Saharan Africa, including those where most people sleep under insecticide-treated bed nets, have six malaria episodes per year on average.

Even if the disease does not kill them, the repeated assault on their bodies can permanently alter their immune systems, leaving them weak and vulnerable to other pathogens.

At the Ewim Polyclinic in Cape Coast, Ghana, a nurse discussed the new malaria vaccine. More than 2.3 million doses have been administered, with over 800,000 children benefiting.

Vaccine candidates that never made it past clinical trials litter the landscape of malaria research. Bed nets, the most widely used preventive measure, reduced malaria deaths in children under the age of five by only about 20%.

Against this backdrop, some experts believe the new vaccine, despite its modest efficacy, is the best new development in the fight against the disease in decades.

“Progress against malaria has really stalled over the last five or six years, particularly in some of the world’s hardest hit countries,” said Ashley Birkett, who heads malaria programs at PATH, a global health nonprofit.

“There’s potential for very, very significant impact there,” Dr. Birkett said of the new vaccine.

Mosquirix is administered in three doses between the ages of 5 and 17 months, with a fourth dose administered approximately 18 months later.

Following clinical trials, the vaccine was tested in three countries: Kenya, Malawi, and Ghana, where it was implemented as part of routine immunization programs.

In those countries, over 2.3 million doses were administered, reaching over 800,000 children. According to Dr. Hamel, this increased the percentage of children who were protected against malaria in some way from less than 70% to more than 90%.

“It’s important to be able to reduce inequities in access to malaria prevention,” Dr. Hamel said. “It was impressive to see that this has the potential to reach children who are currently unprotected.”

It took years to develop a reliable system for delivering insecticide-treated bed nets to families.

Dr. Hamel added that including Mosquirix in routine immunizations made it surprisingly easy to distribute, even during the coronavirus pandemic, which prompted lockdowns and disrupted supply chains.

“We’re not going to have to spend a decade figuring out how to get this to kids,” he said.

This week, a working group of independent experts in malaria, child health epidemiology, and statistics, as well as the World Health Organization’s vaccine advisory group, met to review data from the pilot programs and make a formal recommendation to Dr. Tedros Adhanom Ghebreyesus, W.H.O. director-general.

“We still have a long road ahead of us, but this is a big step,” Dr. Tedros said at a news conference on Wednesday.

Gavi, the global vaccine alliance, will then assess whether the vaccine is a worthwhile investment.

If the organization’s board of directors approves the vaccine — which is unlikely given the vaccine’s modest efficacy and the organization’s many competing priorities — Gavi will purchase the vaccine for countries that request it, a process that is expected to take at least a year.

However, as with Covid-19, issues with vaccine production and supply could significantly slow progress. In addition, the pandemic has diverted resources and attention away from other diseases, according to Deepali Patel, who leads Gavi’s malaria vaccine programs.

“In terms of where capacity is currently in countries, Covid is a big unknown in the room, and rolling out Covid-19 vaccines is a huge effort,” Ms. Patel said. “We’ll have to wait and see how the pandemic unfolds next year to see when countries are ready to pick up all of these other priorities.”