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Thursday, September 4, 2014
MS sufferers leave NY for Italy
we already have Tiger mosquitos in Manhattan but the US /NY/NYC don't care about useful vaccines, science and art the way people do in Boston and Rome.
An
experimental vaccine against dengue fever being developed by Sanofi
proved about 60 percent effective in its second large clinical trial.
The results could clear the way for the introduction of the world’s
first inoculation against the disease, which is mosquito-borne and
becoming an increasing threat.
Sanofi,
a French drug company, said on Wednesday that use of the vaccine cut
the risk of getting dengue by 60.8 percent in the trial, which involved
20,875 children ages 9 to 16 from several countries in Latin America and
the Caribbean.
Those
who received the vaccine also had an 80.3 percent lower risk of being
hospitalized for dengue compared with children who received injections
of a placebo.
The results are roughly similar to those from the first large clinical trial,
in which the vaccine reduced the incidence of dengue fever by 56.5
percent. That trial involved about 10,000 children in Southeast Asia.
“For
the first time ever, after 20 years of research and industrial
commitment, dengue is set to become a vaccine-preventable disease,”
Olivier Charmeil, chief executive of Sanofi Pasteur, the vaccine
division of Sanofi, said in a statement.
Photo
Workers in the Sanofi Pasteur
plant in Neuville-sur-Saône, France. The company hopes to be able to
make 100 million doses of the vaccine a year by 2016.Credit
Robert Pratta/Reuters
A
question now is how widely such a vaccine would be adopted. Some
experts hoped for a greater effectiveness, especially since in the first
large trial, the vaccine was somewhat less effective in younger
children, who are most vulnerable to the disease. Both trials were
late-stage versions known as Phase 3.
“It’s
certainly not anywhere close to what we had hoped, something that would
reach up into the 90s,” said Dr. Scott B. Halstead, scientific adviser
to the nonprofit Dengue Vaccine Initiative.
Still,
he said, the vaccine does appear to prevent severe disease. Moreover,
Sanofi is a few years ahead of others in developing a vaccine. Those
factors could persuade countries to use the product.
Sanofi
executives argue that with no other vaccine and no treatments available
for dengue, a vaccine that reduces the number of cases by more than
half and hospitalizations by 80 percent represents a big advance.
“When
I talk to health ministers, they’re pretty excited about this,
actually,” Christopher A. Viehbacher, Sanofi’s chief executive, told
analysts in a conference call discussing quarterly earnings in late
July.
Mr.
Viehbacher said the company would apply for approvals in the first
quarter of 2015 and hoped to begin sales in the fourth quarter of that
year. He said the priority countries would be Mexico, Brazil and
Colombia and possibly Singapore and Malaysia.
The company plans to apply eventually for approval in the United States as well, executives said.
Sanofi
has invested more than 1.3 billion euros, or $1.7 billion, in
developing the vaccine. Guillaume Leroy, dengue vaccine chief at Sanofi
Pasteur, said the company had already begun manufacturing vaccine in a
new factory it built outside Lyon so as to have enough ready by 2015. He
said that beginning in 2016, the company would have the capacity to
make 100 million doses a year.
An
estimated 50 million to 100 million people a year are sickened by
dengue, though that might be an underestimate. The disease, also known
as breakbone fever, can cause high temperatures and intense joint and
muscle pain.
In
the most severe cases, infection causes hemorrhagic fever, which is
characterized by bleeding and shock and can be fatal. The number of
dengue cases has been increasing rapidly worldwide in part because of
urbanization, since the mosquito that carries the disease is well
adapted to urban areas. Dengue is even moving out of tropical areas in
developing countries to industrialized countries in more temperate
zones.
There
is now an outbreak in Tokyo, the first one in Japan in nearly 70 years.
Yoyogi Park is being fumigated to try to eliminate disease-carrying
mosquitoes. The Florida Keys had its first cases in decades in 2009.
Sanofi
said that in the second trial, as in the first, the vaccine was more
effective in people previously exposed to dengue. That might make the
vaccine especially useful in endemic areas, where people often are
exposed more than once, but it would probably make it less useful for
tourists traveling to an infected area.
The
vaccine is a live weakened yellow fever virus that is genetically
engineered to make proteins from the four subtypes of dengue virus. It
is given as three shots spaced over a year.
The
vaccine seems particularly weak against one of the four subtypes of
dengue, known as Serotype 2. In the Latin America trial, the protection
against that serotype was only 42.3 percent, compared with 50.3 percent
protection against Serotype 1, and greater than 70 percent protection
against Serotypes 3 and 4.
Sanofi
said the vaccine seemed safe in the new trial, as it had in the
previous trial, with the rate of so-called adverse events being the same
in the vaccine arm and the control arm.
Sanofi
announced the results in a news release, saying more detail would be
presented at a medical conference in November and published in a
journal. The trial took place in Brazil, Colombia, Honduras, Mexico and
Puerto Rico.
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