Late-stage clinical trials of what could become the world’s first anti-malaria vaccine successfully protected a significant percentage of infants and young children in sub-Saharan Africa from contracting malaria up to 18 months after vaccination, leading drug company GlaxoSmithKline (GSK) to announce on Tuesday that it will apply for regulatory approval of the vaccine next year.
GSK partnered with research centers in seven African countries and the PATH Malaria Vaccine Initiative (MVI), a non-profit that’s funded by the Bill and Melinda Gates Foundation, to test its malaria vaccine, called RTS,S.
They vaccinated nearly 15,000 infants and children in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania, and after following up 18 months later, the research teams found that cases of malaria had decreased by nearly one-half in children who were vaccinated when they were between ages 5 to 17 months old. Among infants who were between 6 to 12 weeks old when they were vaccinated, malaria cases decreased by about one-quarter, according to the researchers, who presented their data at a conference in South Africa.
“While we have seen some decline in vaccine efficacy over time, the sheer number of children affected by malaria means that the number of cases of the disease the vaccine can help prevent is impressive,” said Sir Andrew Witty, the chief executive officer of GSK, in a release. “These data support our decision to submit a regulatory application for the vaccine candidate which, if successful, would bring us a step closer to having an additional tool to fight this deadly disease.”
GSK said it will submit an application to the European Medicines Agency, the regulatory authority for new medicines in the European Union, with the hopes to bring RTS,S to market by 2015 “if it is granted a positive scientific opinion” by the agency.
Malaria, a parasitic illness that is transmitted by mosquito bites, can disrupt blood flow to vital organs if unchecked, and kills some 660,000 people each year, mostly in sub-Saharan Africa,according to the World Health Organization (WHO). Malaria deaths have decreased by more than 25 percent worldwide since 2000, but in Africa, a child dies every minute from the illness. More than 40 percent of the world’s malaria fatalities happen in the Democratic Republic of Congo and Nigeria, reports the WHO.
In high-risk areas, anti-malarial drugs and bed nets treated with insecticide can be used as preventive measures, but organizations like the Gates Foundation have pledged billions of dollars to fight malaria and conduct research and development for better treatments.
Development of the RTS,S vaccine first began in 2005, and while a number of other malaria vaccines are in development worldwide (PDF), RTS,S is the only one that has completed late-stage clinical trials, according to the WHO.
The Global Malaria Action Plan, which was created by a coalition of institutions like the WHO, the World Bank and the United Nations Development Program, has pledged to decrease global malaria cases by 75 percent in 2015 and eliminate malaria deaths to near zero in the same year.
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