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European Business News
Glaxo Files Its Entry in Race for a Malaria Vaccine
Treatment Would Be a First, but a Small Rival's Compound Could Prove Still More Effective
Updated July 24, 2014 5:29 p.m. ET
A nurse in Tanzania administers Glaxo's experimental malaria vaccine to a child at a district hospital.
Frederic Courbet
An experimental malaria vaccine
GlaxoSmithKline
GSK.LN -3.16%
PLC filed with regulators Thursday could help fight one of the
world's biggest killers—but rival company Sanaria Inc. has a potentially
more effective shot in the works.
If
Europe's regulators give Glaxo's vaccine—called RTS,S—the green light,
it could be in use as soon as 2015, paving the way for a mass
vaccination program across sub-Saharan Africa.
That
would make RTS,S the world's first vaccine against malaria or any
parasitic disease. In clinical trials, RTS,S almost halved malaria cases
in children aged 5 months to 17 months, and by around a quarter in
young babies. Malaria kills an estimated 600,000 people a year, most of
them African children.
Colin Sutherland,
head of the department of immunology and infection at the London
School of Hygiene and Tropical Medicine, said Glaxo's vaccine could make
an important public-health contribution.
"If
you can protect kids in Africa—or partially protect them—for that
period in life when they're at most risk of severe illness or death,
then even if that protection wanes you've got them through the worst,"
Mr. Sutherland said.
While RTS,S is a
major advance, it is far from a perfect solution. Its efficacy is lower
than had been hoped, and its protection appears to diminish over time.
Data released in October showed its effects after 18 months were less
than had previously been seen over a year.
Vaccines
are one of the drug industry's biggest success stories, having disabled
many formerly deadly diseases like smallpox, polio and measles, but
parasitic diseases have evaded efforts at prevention.
That
is because they are more complex organisms than bacteria or viruses,
with more genes and more ways of evading the body's immune response.
"It's very difficult to sustain natural immunity against a parasite—it's not well understood," said
Sophie Biernaux,
who led Glaxo's RTS,S project.
Many malaria-vaccine candidates, including a program by Crucell NV, a division of
Johnson & Johnson,
JNJ -0.09%
have been shelved in recent years. RTS,S, which has been
supported by the Path Malaria Vaccine Initiative and the Bill and
Melinda Gates Foundation, took 30 years to develop.
Big
drug companies have typically shunned the field as too complex and
unprofitable: Glaxo plans to sell RTS,S at just 5% above cost.
Still,
there is another player in the race: Rockville, Md.-based biotech
company Sanaria, founded by
Stephen Hoffman,
an infectious-disease expert, in his kitchen. Dr. Hoffman worked
on an early predecessor of RTS,S and has been testing experimental
malaria vaccines on himself since 1987.
Sanaria's
vaccine, called PfSPZ, showed impressive results in an early-stage
clinical trial involving 57 people last year. PfSPZ demonstrated
complete protection against malaria in all six patients that received
the highest dose.
"This is a vaccine
aimed at elimination, and that's quite different from what's being
talked about with RTS,S," Dr. Hoffman said.
Sanaria
is now testing the vaccine in larger trials in Mali, Tanzania,
Equatorial Guinea, the U.S. and Germany. Dr. Hoffman said he hopes that
if all goes well, it could be filed with regulators in 2017.
Unlike
RTS,S, which focuses on a single protein of the parasite, PfSPZ uses a
version of the whole parasite, made by hand-dissecting mosquitoes. That
may confer greater protection. "When you try and make a
one-size-fits-all vaccine with just one single form of that protein,
there is a risk that you haven't covered all the bases," Mr. Sutherland
said.
Glaxo's Ms. Biernaux said she would welcome any progress from Sanaria or others in fighting the disease.
Critics
question the feasibility of PfSPZ's large-scale production and delivery
in Africa, since it must be stored in supercold liquid nitrogen. But
Dr. Hoffman is confident his team can scale up production if the vaccine
is approved, and cites several veterinary vaccines used in Africa that
are delivered in similar ways.
"Along
the way we were told we couldn't make this vaccine aseptically, we
couldn't purify it, we couldn't make it potent, and we just keep
marching on," he said.
Mr. Sutherland
said he is excited about the possibility of both programs. "My feeling
is, you can't have too many people developing vaccines," he said.
Write to Hester Plumridge at Hester.Plumridge@wsj.com
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