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 The British drugmaker said the shot, called RTS,S, is intended
exclusively for use outside the European Union but will be evaluated
by the European Medicines Agency (EMA) in collaboration with the
World Health Organisation (WHO).
Malaria, a mosquito-borne parasitic disease, kills more than 600,000
people a year, mainly babies in the poorest parts of sub-Saharan
Africa.
Experts have long hoped that scientists would be able to develop an
effective vaccine against the disease, and scientists at GSK have
been working on this one for 30 years.
Yet hopes that RTS,S would be the final answer to wiping out malaria
were dampened when results from a final-stage trial in babies aged
six to 12 weeks showed the shot provided only modest protection,
reducing episodes of the disease by 30 percent compared to
immunization with a control vaccine.
GSK said data from that and other final phase III trials - conducted
at 13 African research centers across Burkina Faso, Gabon, Ghana,
Kenya, Malawi, Mozambique, Nigeria, and Tanzania - have also been
included to support the application.
"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 has previously indicated it may recommend use of RTS,S from
as early as 2015 if EMA drugs regulators back its license
application.
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GSK has been developing RTS,S with the non-profit PATH Malaria
Vaccine Initiative (MVI), with grant funding from the Bill & Melinda
Gates Foundation to MVI.
If approved, the vaccine is unlikely to be anything other than
neutral for GSK's bottom line. The firm has promised it will be
priced at cost of manufacture plus a 5 percent margin, and the
margin would be reinvested in research on malaria and other
neglected tropical diseases.
"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,"
Sophie Biernaux, head of GSK's malaria vaccine franchise said in the
statement.
(Reporting by Kate Kelland; editing by Jason Neely and Pravin Char)
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