GlaxoSmithKline Seeks Approval For First Ever Malaria Vaccination
July 25, 2014
By David Sohn, BioSpace.com Breaking News Staff
GlaxoSmithKline announced yesterday that a regulatory application has been submitted to the European Medicines Agency (EMA) for their malaria vaccine candidate, RTS,S. The EMA is a regulatory agency of the European Union that evaluates the quality, safety, and efficacy of candidate drugs developed in the EU. As part of a combined effort with the World Health Organization, GlaxoSmithKline seeks to reduce the number of malaria-related deaths and lessen the severity of outbreaks, particularly in sub-Saharan Africa where a majority of cases occur.
If approved by the EMA, RTS,S will be on track to be the first ever, clinically-effective vaccination for malaria. Increased drug-resistance by P. falciparum, one of the pathogens attributed to the disease, has made the development of an effective vaccine an increasingly challenging endeavor. SPf66, a candidate vaccine developed and extensively tested in the 90s, failed to show sufficient prevention of the disease. Other candidates are currently in development.
Maryland-based, Sanaria, is currently in phase 1 clinical trials with its vaccine, PfSPZ. However, RTS,S, currently in phase 3, has shown to be the most promising. Studies conducted by GlaxoSmithKline demonstrated a near 50 percent reduction of cases in young children, where the mortality rate is particularly high. Epidemiological studies have reported that 65 percent of global malaria cases occur in children under 15 and an estimated 200,000 infant deaths occur yearly due to the disease.
The British pharmaceutical manufacturer has spent 30 years and more than $350 million on the development of an effective vaccine, with a majority of the funds contributed by the Bill and Melinda Gates Foundation. RTS,S is a part of a non-profit initiative to eradicate malaria in Africa, where a majority of the 660,000 malaria-related deaths reported in 2010 occurred. If approved, GlaxoSmithKline plans on making a 5 percent profit off sales of the drug, which will be reinvested into further development of the vaccine and treatments for other tropical diseases.
RTS,S may be available for use as early as 2015 if found effective by the EMA. Once approved by the agency, the drug must receive further marketing authorization by National Regulatory Authorities before seeing widespread implementation. Dr. Sophie Biernaux, Head of the Malaria Vaccine Franchise, at GlaxoSmithKline remains optimistic regarding the vaccine: “This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria.”
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