British pharmaceutical giant Glaxo Smith Kline GSK yesterday July 24 2014 submitted a regulatory application to the European Medicines Agency EMA, for its malaria vaccine RTS.S one of the first steps before the recognition of its breakthrough vaccine that could save millions of lives. If approved by EMA, the new vaccine might be available for use by the end of 2015.
A statement from GSK said EMA now has to “assess the quality, safety and efficacy of a candidate vaccine, or medicine, manufactured in a European Union (EU) member state, for a disease recognised by the World Health Organization (WHO) as of major public health interest, but intended exclusively for use outside the EU”. The vaccine will be evaluated and monitored in close collaboration with the WHO and must meet standards of any vaccine approved in the EU.
.The new vaccine is intended exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). Around 90 per cent of estimated deaths from malaria occur in SSA, and 77 per cent of these are in children under the age of five.
It took the British pharmaceutical company 30 years to develop the vaccine for malaria that kills more than 600.000 people annually around the world making it the most dangerous disease on earth
Dr Sophie Biernaux, Head of the Malaria Vaccine Franchise at GSK described the development as 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.”
Data from the phase III vaccine trial programme conducted at 13 African research centers in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania) including over 16,000 infants and young children have also been included to support the filing.
The new vaccine is intended o trigger the body’s immune system to defend against the P falciparummalaria parasite when it first enters the human host’s bloodstream and/or when the parasite infects liver cells.
The vaccine 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. In the phase III efficacy trial, RTS,S was administered in three doses, one month apart.
Because the drug is targeted mostly at people in developing countries who can least afford it, GSK has promised the cost of the vaccine will be be minimal and intended to cover the cost of production and a 5 percent profit margin to help the company re-invest in research.
Though a global deadly killer, it has taken more than 134 years to get a possible vaccine for two main reasons; malaria is a parasite and not a virus or bacteria which is less complicated to get a vaccine. Also,
the economics of producing a vaccine for mainly poor beneficiaries has significantly reduced the incentive by drug companies to invest in a malaria vaccine development programme. The parasite causing malaria, Plasmodium, was first identified in 1880. The role of mosquitoes in its spread was discovered in 1898
According to Prof Kevin Marsh, Director of the KEMRI–Wellcome Collaborative Research Programme in Kenya
” Malaria is a protozoal parasite, bigger and considerably more complex than viruses. Developing a vaccine against malaria is, therefore, more similar in concept to developing one against cancer than measles”.
Malaria Facts and figures
The WHO estimates approximately 3.4 billion people, almost half of the world’s population are at risk of contracting malaria. In 2007, about 207 million people globally contracted the disease with more than 600.000 deaths. More than 90 percent of the deaths were in sub Saharan Africa. Early diagnosis and treatment prevents deaths and increased awareness and campaigning has led to a dramatic reduction in the death rate in Africa and across the globe. In densely populated hot areas that are good conditions for the malaria causing mosquitoes to breed, malaria can affect families and communities negatively in a downward spiral of poverty and ill heath especially for people who cannot afford or have limited access to health care.