DENGUE, UN VACCIN ... LA SOLUTION ?
DENGUE, UNE
SOLUTION ?
Ayant été personnellement victime de cette maladie dans les années 70,
deux de mes gamins ayant également été récemment victimes de ce virus,
Je pense savoir de quoi je parle.
Mon post, ‘’Une histoire de dengue’’ résume
bien nos connaissances et nos moyens de lutte contre cette maladie à l’heure
actuelle.
Y-a-t-il du nouveau ?
Y-a-t-il du nouveau ?
Je vous laisse juge.
One of the grimmest
legacies of the war in the Pacific is still being fought 70 years on, but a
victory over dengue, the intensely painful "breakbone fever" which
that conflict helped spread around the world, may be in sight.
The U.S. Army, which
like its Japanese enemy lost thousands of men to the mosquito-borne disease in
the 1940s, has piled resources into defeating the tropical killer. But it may
be about to see the battle to develop the first vaccine won not in the United
States but by French drug company Sanofi .
The Paris-based firm
hopes for positive results in September from a key trial among children in Thailand
that would set it on course to market a shot in 2015 which would prevent an
estimated 100 million cases of dengue infection each year. Of 20,000 annual
deaths, many are of children.
For Sanofi, which has
invested 350 million euros in a new French factory to make the three-dose
vaccine, it could mean a billion euros in yearly sales as half the world is
exposed to the disease, notably in fast-expanding tropical cities from Rio and
Mexico to Manila and Mumbai.
But like British rival
GlaxoSmithKline , whose new malaria shot has shown promise against another
mosquito-carried scourge, Sanofi is also preparing for pressure to make its
drug accessible to billions too poor to pay the likely market price.
It has been long wait.
Identified in local outbreaks in the Americas, Africa and Asia since the 18th
century - and noted as a serious military hindrance by U.S. generals in their
1898 war against Spain in Cuba and the Philippines - dengue was spread to
global pandemic proportions in part due to the massive movements of armies
through the Pacific theatre in World War Two.
That conflict, in
which some 90,000 American troops were put in hospital by dengue, prompted the
first efforts to develop a vaccine, as U.S. and Japanese scientists isolated
the virus spread by the bite of the Aedes aegypti mosquito. But the disease,
which can cause intense joint and muscle pain, has gone on sapping the health
of troops, from Vietnam to Somalia and Haiti, and made lives miserable for
millions of civilians.
In the past 50 years
there has been a thirty-fold jump in cases. The World Health Organisation
officially puts infections at 50 to 100 million a year, though many experts
think this assessment from the 1990s badly under-estimates the disease. Most
patients survive but it is estimated to kill about 20,000 every year, many of
these children less able to fight it off.
TALE OF TWO VACCINES
The U.S. Army's quest
for a vaccine had most recently been pursued in partnership with
GlaxoSmithKline. But Sanofi now seems closest to offering a viable treatment.
And, unlike GSK's malaria injection designed for African babies, it promises to
be the commercial blockbuster the French firm needs to refresh a portfolio
weakened by expiring patents.
Its estimate of over 1
billion euros in annual sales - Sanofi's 2011 turnover was 33.4 billion euros -
assumes that it is added to routine immunisation schedules in Latin America and
Asia and is also adopted by travellers from farther afield and by military
medics in the United States and Europe.
Meeting that sales
potential, while getting the vaccine to hundreds of millions who need it across
the tropics, will require a careful balancing act on pricing and supply of a
product that has yet to be given a commercial brand name.
Orin Levine, executive
director of the International Vaccine Access Center (IVAC) at the Johns Hopkins
Bloomberg School of Public Health, says the new vaccine is a potential
breakthrough but warned its roll-out may not be straightforward.
First up, the vaccine
needs to be given in three instalments over the course of a year in order to
counter the threat from four different types of dengue virus, none of which
confers immunity for the others.
"There are going
to be some challenges," says Levine. "There's really good economic
potential from this vaccine but I think it may take a ramp-up of three to five
years."
SANOFI'S BET
In an ideal world,
healthcare experts would like a single-dose or, at most, a two-dose vaccine for
mass immunisation.
A simpler regimen
would also be better for travellers, although Pascal Barollier of Sanofi
Pasteur, Sanofi's vaccine arm, says many users will be people making regular
trips to see families in Latin America or Asia with time to plan ahead. The
military, too, often has lead time for troop movements.
In any case, Sanofi is
putting its money where its mouth is by spending 350 million euros on a new
dengue vaccine factory near Lyon, which is already in test production.
It is a substantial
gamble, since Sanofi will only learn whether the vaccine really works when it
analyses data from a first study of its efficacy on 4,000 Thai children.
Results from that
clinical study, in what is known as the Phase IIb of the international standard
three-stage process of assessment, are expected in the third quarter - most
likely September. They will also be presented for scientific scrutiny at the
annual meeting of the American Society of Tropical Medicine and Hygiene in
Atlanta in November.
If the data is good,
Sanofi will file for market approval in countries where dengue is endemic like
Australia, Malaysia, Singapore, Thailand and Mexico in 2013, suggesting a
regulatory green light in 2014 and commercial launch in early 2015.
Submissions in other
countries and for the travellers market would follow in 2014 and 2015.
LOOKING GOOD
Early tests have shown
a balanced immune response against all four dengue types and Duane Gubler of
the Duke-N.U.S. Graduate Medical School, who has researched dengue for four
decades, is optimistic.
"Everything
they've done so far looks very good," he says. "I think it will be a
much better vaccine than malaria."
He expects Sanofi's
vaccine will show an efficacy rate of at least 75 to 80 percent, well above the
50 percent or so seen with GSK's malaria shot, which faces the added technical
problem of fighting a complex parasite rather than a virus.
The efficacy rate
refers to the reduction in the prevalence of subsequent infection among those
vaccinated.
Despite both being
transmitted by mosquitoes, dengue and malaria are notably different enemies.
Malaria, which is
carried by a different mosquito, typically attacks rural populations living
near swamps. Dengue, by contrast, has adapted to life in the city and is one of
the winners of mankind's accelerating rush to urbanise.
The number of people
living in urban areas is projected to rise to 6.3 billion by 2050 from 3.4
billion today, leading to more mega-cities with poor sanitation where dengue
and other diseases can thrive, according to a study in The Lancet medical
journal last week.
Globalisation has also
brought cases of dengue into southern Europe and the United States,
particularly Texas and Florida, although Gubler believes higher living
standards mean it is not likely to take off in these regions.
PRICING DECISION
For the middle classes
of Latin America and Asia, an out-of-pocket purchase of a dengue vaccine
probably seems affordable and worthwhile, especially for their children. Yet
dengue takes its biggest toll among the poor, who lack money for immunisation
and are also less likely to get medical help when the disease leads to
potentially deadly haemorrhagic fever.
Getting vaccine to
them will need the involvement of international agencies like the GAVI
Alliance, which provides routine childhood immunisations in poor countries with
funds granted by public and private donors.
Nina Schwalbe, GAVI's
managing director for policy and performance, says she is monitoring the dengue
vaccine programme closely but needs hard evidence that it offers value for
money, based on public health impact, efficacy and price.
Sanofi is not ready to
set a price before it sees the full clinical trial results and has a clearer
sense of vaccine yields at its factory. But the drugmaker will embrace
"tiered pricing" to make the product affordable, Barollier at the
company said.
That has not stopped
the guessing.
"I would expect,
for middle-income countries, they would be looking at prices similar to those
of other new vaccines - for example HPV (human papillomavirus), pneumococcal
and rotavirus vaccines - which sell for $15 to $70 per course in countries like
Brazil, South Africa, Venezuela and Thailand," said IVAC's Levine.
Setting the price will
be a test for Sanofi Chief Executive Chris Viehbacher. He reckons his vaccine
is about five years ahead of any others and he knows he has a major opportunity
to boost his company's reputation by getting the roll-out right.
With no specific drugs
to treat or prevent dengue - in contrast to malaria - the world needs a
success. Likewise, Viehbacher's shareholders, who have seen the company lose
top-selling drugs as patents expire, need a commercial winner.
They will be watching
closely those results from Thailand in September.
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