Given that malaria is one of the world's leading killers, especially of African children, today's launch of a pilot program to immunize babies in Malawi with the RTS, S vaccine offers global health officials and scientists a chance to see if it can jump-start stalled progress in the battle against the disease.
An estimated 450,000 people die of malaria each year, and, according to current estimates, the disease kills one child every 2 minutes. Most are in Africa, where the malaria death toll in kids reaches 250,000 every year.
Promise as a response tool
Developed by GlaxoSmithKline, the RTS,S vaccine has been in the making for 30 years and has shown partial protection against Plasmodium falciparum in young children. Clinical trials found that the vaccine prevent 4 of 10 malaria cases, as well as 3 in 10 cases of severe malaria. The vaccine also cut the level of severe anemia—the most common reason kids die from the disease—by 60%.
In a World Health Organization (WHO) statement today on the launch of the pilot program, designed to assess its role as a control tool alongside other interventions, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said tremendous gains against malaria have been made over the past 15 years with the use of bed nets and other measures, but progress has stalled or 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," he said. "The malaria vaccine has the potential to save tens of thousands of children's lives."
WHO groups spearhead rollout
Along with Malawi, pilot programs to make the RTS,S available along with other routine childhood vaccine are also slated for selected areas of Ghana and Kenya. The WHO's Strategic Advisory Group of Experts (SAGE) has been working on vaccination recommendations, and its Malaria Policy Advisory Committee has been addressing issues related to public health use of the vaccine.
RTS,S vaccination is a fairly rigorous process that requires four doses, and the cooperation of country health ministries is needed to track and administer the vaccines. The first dose is given as soon as possible after 5 months of age, the second and third at monthly intervals following the first dose, and the fourth given 15 to 18 months after the third dose.
Aside from the WHO and the three countries' health ministries, other groups collaborating on the pilot program include PATH, a nonprofit health group based in Seattle. And GSK is donating up to 10 million vaccine doses.
Three global health groups are financing the program at a cost of nearly $50 million: Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis, and Malaria; and Unitaid.
Seth Berkley, MD, Gavi's chief executive officer, said in a statement from the groups today, "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."
How will officials assess impact?
The pilot program's goal is to reach 360,000 children each year in the three countries. Health ministries will guide where the vaccine will be given, focusing on areas with moderate-to-high transmission.
The WHO will use the results from the pilot program to guide its policy recommendations on wider use of the RTS,S vaccine. Specifically, it will be looking at its impact on child deaths, uptake in target populations, whether parents bring their children in for all four doses, and vaccine safety with routine use.
At a media briefing on Apr 5 after the last meeting of the WHO's SAGE group, health officials said they will be evaluating the results of the pilot program while it is under way to potentially make a broader recommendation for deploying the vaccine, based on the findings.
Kate O'Brien, MD, MPH, who directs the WHO's department of immunization, vaccines, and biologicals, said young infants are at the highest risk of severe outcomes, and so having a vaccine that can prevent disease in children and infants would be a groundbreaking new strategy.
The idea of the pilots is to better secure the understanding of the safety profile and to evaluate the opportunity of the vaccine to reduce mortality, which was not shown in the earlier trials, because deaths were so low because of the excellent care the children received.
Apr 23 WHO statement
Apr 23 Gavi statement
Apr 5 WHO SAGE media briefing
January WHO malaria vaccine program Q and A