London-based drug manufacturer GlaxoSmithKline (GSK) has announced that the European Medicines Agency (EMA) gave its nod of approval for the company's malaria vaccine known as RTS,S (Mosquirix).
In its official statement released on Friday, GSK reported that the EMA's Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Mosquirix, the drug maker's malaria vaccine designed for children between the ages of six weeks to 17 months old.
The World Health Organization (WHO) will now begin its formulation of a policy recommendation on the use of the malaria vaccine in programs for national immunization once the new drug receives approval from various state regulatory authorities.
GSK's Mosquirix vaccine was developed together with the PATH Malaria Vaccine Initiative (MVI). It is considered as the first malaria vaccine to reach this point in terms of regulatory approval. Compared to other types of vaccines that treat bacteria or viruses, Mosquirix is designed to prevent the spread of the malaria-causing parasite known as Plasmodium falciparum. The microorganism has been found to be prevalent in areas covered by sub-Saharan Africa.
Approximately 584,000 people died from complications due to malaria in 2013, with 90 percent of cases coming from sub-Saharan Africa and 83 percent were children below the age of five years old.
The positive scientific opinion from the CHMP is viewed as an important step in the regulatory process which would lead to the approval of Mosquirix for use along with other tools recommended for the prevention of malaria. The opinion for the use of the drug for young children was dependent on the review of the vaccine's quality, efficacy and safety.
Majority of the clinical data given provided to the CHMP for review came from the third phase of a clinical trial program that involved over 16,000 children from research centers in eight African nations, including Kenya, Nigeria, Ghana and Mozambique.
The clinical trial showed that for the first 18 months following the distribution of three doses of Mosquirix to patients, the number of malaria cases dropped by half in young patients between the ages of five to 17 months old during the first vaccination and by around 27 percent in infants between six to 12 weeks old.
When the study reached its end, four doses of Mosquirix was able to reduce malaria cases by as much as 39 percent throughout the four-year follow-up program for children and 27 percent throughout the three-year follow-up program for infants.
The efficacy of GSK's malaria vaccine was evaluated together with other existing measures for malaria control, such as bed nets treated with insecticide, which were used by around 80 percent of the infants and children featured in the clinical trial.
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