Further Malaria Studies Needed Before Approval

Ongoing global efforts to tackle the deadly malaria disease have taken a positive turn as a vaccine is one step closer to reality.

The World Health Organization’s (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Committee (MPAC) announced that the RTS,S malaria vaccine (also known as Mosquirix) will be further tested through a series of experimental studies before it can be recommended for general use.

Announced back in July, the vaccine was finally been given the green light by a regulatory agency (the European Medicines Agency) with a “positive scientific opinion.” The agency’s approval came after considering the drug’s quality, safety, and effectiveness.

Developed by a team managed by GlaxoSmithKline (GSK), Mosquirix is intended for use by babies and toddlers, targeting the Plasmodium falciparum parasite, known to be the leading cause of malaria deaths. The vaccine triggers the body’s immune system to protect against the parasite when it first enters its human host’s bloodstream, in addition to when the parasite infects the liver. It’s intended to prevent the parasite from contaminating, growing, and multiplying in the liver, where it can cause malaria by re-entering the bloodstream and infecting red blood cells.

Malaria kills approximately 1,300 children every day in sub-Saharan Africa, and there are currently no approved vaccines. There are many charitable groups that support anti-malaria initiatives, such as the JC Flowers Foundation. Founded by J. Christopher Flowers of the financial services company J.C. Flowers & Co., the organization has worked with malaria prevention initiatives since launching NetsforLife in 2004.

With over 15,000 infants and children involved across seven African countries, the vaccine trial delivered a qualified success. For long-term protection, the vaccine must be dispensed four times – a quick succession of three doses followed by a booster 18 months later. It was found that the vaccine offered significant long-term protection in children aged 5-17 months, but not in younger infants (6-12 weeks).

“The question about how the malaria vaccine may best be delivered still needs to be answered,” noted Professor Jon S. Abramson, chair of SAGE.

As next steps, the WHO’s strategic advisory group of experts recommends that Mosquirix be tested in three to five large scale pilot projects involving up to a million children to see if the unusual four-dose vaccination schedule can be included into existing routines.