UK firm seeks to market world's first malaria vaccine



British drug maker GlaxoSmithKline is seeking
regulatory approval for the world's first malaria
vaccine after trial data showed that it had cut the
number of cases in African children.
Experts say that they are optimistic about the
possibility of the world's first vaccine after the trial
results.
Malaria, a mosquito-borne parasitic disease, kills
hundreds of thousands of people worldwide every year.
Scientists say an effective vaccine is key to attempts to
eradicate it.
The vaccine known as RTS,S was found to have almost
halved the number of malaria cases in young children
in the trial and to have reduced by about 25% the
number of malaria cases in infants.
GlaxoSmithKline (GSK) is developing RTS,S with the
non-profit Path Malaria Vaccine Initiative (MVI),
supported by funding from the Bill & Melinda Gates
Foundation.
"Many millions of malaria cases fill the wards of our
hospitals," said Halidou Tinto, a lead investigator on the
RTS,S trial from Burkina Faso.
Malaria is caused by protozoan parasites that are
transmitted by the bites of mosquitoes
"Progress is being made with bed nets and other
measures, but we need more tools to battle this terrible
disease."
The malaria trial was Africa's largest-ever clinical trial
involving almost 15,500 children in seven countries.
The findings were presented at a medical meeting in
Durban, South Africa.
"Based on these data, GSK now intends to submit, in
2014, a regulatory application to the European
Medicines Agency (EMA)," GSK said in a statement.
The company has been developing the vaccine for
three decades.
The statement said that the hope now is that the
Geneva-based World Health Organization (WHO) may
recommend the use of the RTS,S vaccine from as early
as 2015 if EMA drugs regulators back its licence
application.
Testing showed that 18 months after vaccination,
children aged five to 17 months had a 46% reduction
in the risk of clinical malaria compared to unvaccinated
contemporaries.
But in infants aged six to 12 weeks at the time of
vaccination, there was only a 27% reduction in risk.
A spokeswoman for GSK told the AFP news agency that
the company would file its application to the EMA
under a process aimed at facilitating new drugs for
poorer countries.

Comments