The World Health Organization (WHO) has backed the first malaria vaccine, which could be especially beneficial in areas such as sub-Saharan Africa with moderate to high malaria transmission rates. In 2019, malaria caused 409,000 deaths, according to WHO.
The vaccine from GlaxoSmithKline (NYSE:GSK) specifically targets plasmodium falciparum, a malaria strain common in sub-Saharan Africa. Plasmodium falciparum tends to be more dangerous and resistant to antimalarial drugs than other plasmodium species.
“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 Dr. 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.”
WHO recommended that eligible children five months of age and older receive a schedule of four vaccine doses.
The organization also notes that the vaccine has a strong safety profile based on data from 2.3 million doses administered in Ghana, Kenya and Malawi.
GSK stated that new data indicate that the vaccine, when used in tandem with seasonal antimalarials, can reduce clinical episodes of malaria, hospital admissions with severe malaria and deaths by around 70%.
According to a Phase 3 study published in The Lancet in 2015 and on ClinicalTrials.gov, GSK 257049 was moderately effective at preventing severe malaria. In one statistical analysis, three doses of the vaccine yielded an estimated vaccine efficacy of 55.8% in children between 5 and 17 months of age. The estimated efficacy was 31.3% for children initially vaccinated between six and 12 weeks of age. Both estimates analyzed data between 2.5 to 14 months after administering three doses of the vaccine.
GSK plans to market the vaccine as Mosquirix. The vaccine is also known as GSK 257049 or RTS,S/AS01 (RTS,S).
The company issued a statement pointing to the decades of research work it performed with partners on the vaccine and highlighting its life-saving potential following WHO’s support of it. “This long-awaited landmark decision can reinvigorate the fight against malaria in the region at a time when progress on malaria control has stalled,” said Thomas Breuer, chief global health officer of GSK. “Both real-world evidence and clinical trial data show that RTS,S, alongside other malaria prevention measures, has the potential to save hundreds of thousands of lives.”
The Bill & Melinda Gates Foundation provided funding for late-stage development of RTS,S between 2001 and 2015.
Filed Under: Infectious Disease