WHO Welcomes European Regulators' Historic Green Light for First Malaria Vaccine
Key Insights
The European Medicines Agency (search) adopted a positive scientific opinion for Mosquirix, marking the first time a malaria (search) vaccine has reached regulatory review by any authority.
WHO will conduct its own assessment in October 2015, evaluating public health aspects including affordability, cost-effectiveness, and field implementation in developing countries.
The vaccine addresses a critical unmet need, as malaria (search) caused nearly 200 million cases and close to 600,000 deaths in 2013, with African children particularly affected.
The World Health Organization welcomed a historic regulatory milestone for malaria (search) prevention as the European Medicines Agency (search) adopted a "positive scientific opinion" for Mosquirix, the first malaria vaccine to undergo regulatory review by any authority. The development represents a significant step toward addressing a disease that kills one African child every minute.
"This is the first time ever that a malaria (search) vaccine has gotten to the point to be reviewed by a regulatory authority," WHO spokesperson Gregory Hartl told reporters in Geneva. He characterized the EMA decision as "a big development" while emphasizing the process is "not finished yet."
Regulatory Pathway and Timeline
The EMA's clearance does not constitute full regulatory approval, as the vaccine is not intended for use within the European Union. Instead, the agency provided an opinion on Mosquirix's efficacy, quality and safety profile for use outside the EU.
WHO will conduct its own comprehensive assessment in October 2015, examining public health considerations beyond the basic safety and efficacy parameters. This evaluation will address affordability, cost-effectiveness, field implementation in developing countries, and integration with existing malaria (search) control measures including bed nets and rapid diagnostic tests.
The UN health agency expects to issue its policy recommendation in November 2015, determining whether Mosquirix should be added to the current arsenal of malaria (search) prevention tools.
Disease Burden and Unmet Need
Malaria (search) represents one of the world's most pressing public health challenges, with WHO statistics showing nearly 200 million cases and close to 600,000 deaths in 2013. "Most deaths occur among children living in Africa where a child dies every minute from malaria," according to WHO's malaria fact sheet.
The disease is caused by Plasmodium (search) parasites transmitted through bites of infected mosquitoes. Once in the human body, parasites multiply in the liver before infecting red blood cells. Symptoms including fever, headache, and vomiting typically appear 10 to 15 days after infection. Without treatment, malaria (search) can rapidly become life-threatening by disrupting blood supply to vital organs.
Currently, no licensed vaccines exist against malaria (search), making Mosquirix's regulatory progress particularly significant for global health efforts.
Integration with Existing Control Measures
WHO emphasized that any vaccine recommendation will consider how Mosquirix fits within the broader malaria (search) control framework. Current key interventions include prompt treatment with artemisinin-based combination therapies, insecticidal nets for at-risk populations, and indoor residual spraying to control vector mosquitoes.
Hartl clarified that the public health perspective encompasses implementation strategies, field deployment in conjunction with other malaria (search) control measures, and ensuring compatibility with existing vaccination programs in endemic regions.