World’s First Malaria Vaccine receives Positive opinion from European Regulators

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The world’s first malaria vaccine was given a positive opinion by the European Medicines Agency, Europe’s drug regulator, according to an announcement made today by GlaxoSmithKline (Read the Press Release here), the vaccine’s maker. The positive review does not mean that the vaccine is approved for use. Rather, the WHO will now take this opinion into consideration when they come up with their own recommendation. If the vaccine gains approval from the WHO, then GlaxoSmithKline will market the drug to individual African countries.

The vaccine, Mosquirix, is safe for use in children aged 6 weeks to 17 months. Another experimental malaria vaccine in the works, called PfSPZ, was also found to have a positive effect, but it has yet to reach this stage in the approval process.

Mosquirix, also called RTS,S, helps protect against infection with the Plasmodium falciparum parasite, the deadliest of the four parasite species that infect humans and cause malaria. The vaccine aims to boost the immune system to fight the parasite, specifically to prevent the parasite from infecting the liver. Typically, the parasite infects the liver first, multiplies there, and then re-enters the bloodstream to infect red blood cells, prompting symptoms to occur.

Its success is not without limitations. At the end of the trial, four doses of the vaccine reduced the cases of malaria by just 39 percent in children aged 5 to 17 months over a four-year follow-up period and by 27% over a three-year follow-up period in infants.

“While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available such as bed nets and insecticides, would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most,” said Andrew Witty, the CEO of GlaxoSmithKline.

“This is not the big game-changer that we were hoping for,” Martin De Smet, a malaria expert at Doctors Without Borders. But malaria remains one of the world’s most severe health problems, especially in regions across Africa. In 2012, malaria accounted for 627,000 deaths, and 91 percent of the deaths from malaria in 2010 were in Africa, according to the CDC. De Smet remains hopeful though. “The vaccine itself remains disappointing but this is an important step forward,” he said.

The WHO is expected to make an assessment about the use of the vaccine by November of this year. WHO will assess how the world’s first malaria candidate vaccine might be used alongside other tools to prevent malaria.

GlaxoSmithKline_LogoAccording to GSK, RTS,S aims to trigger the body’s immune system to defend against the Plasmodium falciparum malaria parasite when it first enters the human host’s bloodstream and/or when the parasite infects liver cells. It is designed to prevent the parasite from infecting, maturing and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms.

The safety and efficacy of RTS,S has been evaluated in a large-scale phase III trial, in which it was administered in three doses, one month apart, with an additional fourth dose given 18 months later. Results from this trial have consistently demonstrated that RTS,S can help to protect children against malaria in endemic countries, when used in addition to other malaria control measures such as bed nets.

Sources: Popular Science, Associated Press, GSK.

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Scientist-entrepreneur-manager-journalist: -Co-founder, Author; Former Assistant Editor and Director, Biotechin.Asia, Biotech Media Pte. Ltd.; -Founder & CEO, SciGlo (www.sciglo.com); -Programme Management Officer, SBIC, A*STAR (former Research Fellow). --Sandhya graduated from University of Madras, India (B.Sc Microbiology and M.Sc Biotechnology) and received her Ph.D from the Nanyang Technological University, Singapore. She worked on oxidative stress in skin, skeletal, adipose tissue and cardiac muscle for a decade from 2006-2016. She is currently working as a Programme Management Officer handling projects and grants at Singapore Bioimaging Consortium (SBIC), Agency for Science, Technology and Research (A*STAR). Earlier to this she was a Research Fellow in the Fat Metabolism and Stem Cell Group at SBIC. Sandhya was also the Vice President and Publicity Chair of A*PECSS (A*STAR Post Doc Society) (2014-2016). Recently she founded a platform for scientists - SciGlo (www.sciglo.com) and is a startup mentor at Vertical VC (Finland). She is an ardent lover of science and enjoys globe trotting and good vegetarian food.