is getting closer to its launch of a first-ever malaria vaccine that could change the lives of billions of people around the world.
Glaxo has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine RTS,S, the company announced Thursday. The regulatory submission is a first step toward launching the vaccine in malaria-infected regions across Africa and parts of South Asia.
“This is a key moment in GSK’s 30-year journey to develop RTS,S,” Sophie Biernaux, head of Glaxo’s malaria vaccine program, said. “And brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria.”
In 2012, 207 million people were infected and 627,000 died as a result of the disease. Of those deaths, 91% were in sub-Saharan Africa and 77% were children under the age of 5.
Malaria is prevalent across 106 countries, impacting nearly 3.4 billion people, according to the Centers for Disease Control. The CDC calls it “one of the most severe public health problems worldwide.” The center estimates that direct costs from illness, treatments and premature death amounts to around $12 billion per year.
A vaccine to combat the disease, which is spread by mosquitos, has been difficult to develop because malaria parasites have a complex life cycle and there is poor understanding of the body’s immune response.
Glaxo’s RTS,S vaccine is intended for use against the Pasmodium falciparum malaria parasite, which is the most common in sub-Saharan Africa. The vaccine is designed to prevent the parasite from infecting, maturing and multiplying in the liver, which would allow the parasite to re-enter the bloodstream and infect red blood cells, leading to disease symptoms.
Approval by the EMA is required for all vaccines and medications manufactured in a European Union member state, though the RTS,S vaccine is intended for use exclusively outside the EU. The EMA’s blessing is required by the World Health Organization, which will issue a policy recommendation on its use as soon as the end of 2015, pending regulatory approval.
A go-ahead from EMA is also required for marketing authorization by the National Regulatory Authorities in sub-Saharan Africa countries, which would pave the way for large-scale implementation of the vaccine through African national immunization programs.
Glaxo has invested more than $350 million to date and expects to spend an additional $260 million through final development.
To ensure the vaccine is affordable, especially to communities in lower-income areas, Glaxo promised that the price will cover the cost of manufacturing plus a small return of about 5% that the company plans to reinvest in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.
The Bill & Melinda Gates Foundation, which has been a major advocate for malaria eradication across the globe, invested $200 million towards a malaria vaccine through the PATH Malaria Vaccine Initiative, which contributes financial, scientific and managerial expertise to the development of Glaxo’s RTS,S.