|
 The shot, called Mosquirix and developed by British drugmaker
GlaxoSmithKline and the PATH Malaria Vaccine Initiative, would be
the first licensed human vaccine against a parasitic disease and
could help to prevent millions of cases of the killer disease in
countries that use it.
It still faces hurdles before being rolled out in Africa, including
winning agreement from governments and other funders that it is
worth using, since it offers only partial protection.
Mosquirix, also known as RTS,S and part-funded by the Bill & Melinda
Gates Foundation, will now be assessed by the World Health
Organization (WHO), which said on Friday it would begin a review in
October on when and where it could be used. The WHO aims to make a
recommendation by November.
"We will look at the vaccine from the point of view of public
health," said WHO spokesman Gregory Hartl. "We need to think closely
about how best to add - and if to add - a malaria vaccine across
certain malaria endemic areas."
Malaria is one of the biggest killers of children in the world,
claiming the life of one child every minute. It infects around 200
million people a year and killed an estimated 584,000 people in
2013, the vast majority of them babies in sub-Saharan Africa.
Andrew Witty, GSK's chief executive, said the European Medicines
Agency's (EMA) positive opinion was an important step towards making
the world's first malaria vaccine available.
"While RTS,S on its own is not the complete answer to malaria, its
use alongside those interventions ... such as bed nets and
insecticides would provide a very meaningful contribution to
controlling the impact of malaria on children in those African
communities that need it the most," he said.
Mosquirix was assessed for quality, safety and efficacy under a
special procedure that allows the EMA to evaluate a product even if
it will not be marketed in the European Union.
Beyond the WHO's November recommendation, Mosquirix would still have
to be reviewed by national regulatory authorities in any country
wishing to use it. The WHO's Hartl said this meant it is unlikely to
be rolled out anywhere until at least 2017.
Global health experts have long hoped scientists would be able to
develop an effective malaria vaccine, and researchers at GSK have
been working on RTS,S for 30 years. The shot also contains an
adjuvant, or booster, made by U.S. biotech company Agenus.
Expectations that Mosquirix could be a final answer to wiping out
malaria were dampened when trial data released in 2011 and 2012
showed it reduced episodes of malaria in babies aged 6-12 weeks by
only 27 percent, and by around 46 percent in children aged 5-17
months.
[to top of second column] |
The EMA recommendation is that the shot should nevertheless be used
in babies in the full age range covered in the trials, from six
weeks to 17 months.
Some malaria specialists have expressed concern that the
complexities and potential costs of deploying this first vaccine
when it provides only partial protection make it less attractive and
more risky.
"The timing, duration, and outcomes of some of the critical steps to
possible vaccine implementation in African countries are not yet
known," said David Kaslow, PATH's vice president of product
development.
However Joe Cohen, a GSK scientist who has led the development of
Mosquirix since 1987, said on he had no doubt the vaccine could
significantly reduce the toll of sickness and death caused by the
malaria among African children.
"I have absolutely no reservations in terms of rolling this vaccine
out," he told Reuters. "Why? Because the efficacy, when translated
into cases averted and deaths averted, is just tremendous. It will
have an enormously significant public health impact."
GSK has promised it will make no profit from Mosquirix, pricing it
at the cost of manufacture plus a 5 percent margin, which it will
reinvest in research on malaria and other neglected tropical
diseases.
Sources involved in planning for Mosquirix's potential future use
have told Reuters they've been advised to work with a price tag of
around $5 per dose, which would bring the cost of a recommended
four-dose immunization to $20.
(Additional reporting by Ben Hirschler in London and Stephanie
Nebehay in Geneva, editing by Alison Williams and David Stamp)
[© 2015 Thomson Reuters. All rights
reserved.] Copyright 2015 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
