GlaxoSmithKline (GSK) is preparing to launch a first-ever malaria vaccine that could change the lives of billions of people around the world, Fortune reports.
According to Sophie Biernaux, head of Glaxo's malaria vaccine program, this was a key moment in GSK's 30-year journey to develop RTS,S.''
She said the company has taken a step closer to making available the world's first vaccine that could help protect children in Africa from malaria.
In 2012, 207 million people were infected of whom 627,000 died as a result of the disease. Of those deaths, 91 per cent were in sub-Saharan Africa and 77 per cent were children under the age of 5.
Malaria, which is prevalent across 106 countries, impacts nearly 3.4 billion people, according to the Centers for Disease Control.
According to the CDC, it is ''one of the most severe public health problems worldwide.'' According to CDC's estimates, direct costs from illness, treatments and premature death amounted to around $12 billion per year.
A vaccine for combating the disease, spread by mosquitoes, had been difficult to develop as malaria parasites had a complex life cycle. Also the body's immune response had not been understood fully.
Experts had long hoped that scientists would be able to develop an effective vaccine against the disease, and scientists at GSK had been working on this one for 30 years, Reuters reported.
However, hopes that RTS,S would be the final answer to wiping out malaria received a setback when results from a final-stage trial in babies aged six to 12 weeks showed the shot provided only modest protection, cutting episodes of the disease by 30 per cent as against immunisation with a control vaccine.
According to GSK, data from that and other final-stage Phase III trials - conducted at 13 African research centres across Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania had also been included to support the application.
The use was recommended as early as 2015.
"An effective vaccine for use alongside other measures such as bed nets and anti-malarial medicines would represent an advance in malaria control," the company said in a statement.
The WHO had earlier indicated it might recommend use of RTS,S from as early as 2015 if EMA drugs regulators backed its licence application.
The vaccine also contained an adjuvant, or booster, made by US biotech company Agenus, which received an undisclosed milestone payment for the regulatory submission.