In 'historic' public health step, WHO fully endorses GlaxoSmithKline's malaria shot
GlaxoSmithKline won a big endorsement from the WHO on Wednesday.
The organization has approved the British drugmaker’s malaria vaccine for children, it announced, paving the way for full deployment throughout sub-Saharan Africa after a pilot program in Ghana, Kenya and Malawi rolled out in 2019. It’s largely seen as a huge win in a parasitic disease that kills roughly half a million people each year, including more than a quarter million children under 5, almost all of whom live on the African continent.
“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 Tedros Adhanom Ghebreyesus in a statement. “Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”
GSK’s vaccine was first approved by the EMA in 2015, but didn’t impress the WHO immediately. Concerns arose over the shot’s efficacy, which in clinical trials reached 50% against severe malaria after the first year but fell to zero two to three years later. Some experts also questioned the shot’s ability to prevent death, given that studies did not directly measure mortality.
The shot must also be administered in four doses, beginning when children reach five months of age until they turn three years old. But currently, the best tools to fight malaria have been spraying insecticides in the home and wrapping mattresses with special nets to ward off the mosquitoes that carry the parasite.
Rather than approve the shot for wide use, the WHO launched a pilot program in 2019 to examine the shot’s effectiveness. Per Wednesday’s announcement, the program showed that more than two-thirds of children in the three countries who are not sleeping under a bednet are benefiting from the vaccine, which is known as Mosquirix or RTS,S.
The WHO also highlighted that even in areas where nets are in high use, adding the shot reduced deaths from severe malaria by 30%. One outside model showed the shot will prevent more than 5 million cases and 23,000 deaths annually in children under five in areas with the highest incidence rates.
GSK had previously announced plans to provide 10 million doses for use in the pilots and will commit to 15 million doses annually now that the shot has been approved for wider use. The Big Pharma recently shifted production of its vaccine to Bharat Biotech in India, aiming for the biotech to be the sole manufacturer of the shot’s protein by 2029.
There are other malaria vaccines in development, but GSK’s shot is the first to gain WHO approval — and the first shot ever OK’ed in any parasitic disease. Novavax and Oxford University touted a 75% efficacy in a Phase III study in April, while BioNTech is gearing up to make an mRNA-based malaria shot following the success of its Covid-19 vaccines.