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 Sanofi Pasteur, the group's vaccines division, said Mexico had
approved the preventive treatment, called Dengvaxia, for all four
dengue virus serotypes, but only for patients aged 9 to 45 who live
in areas where the disease is endemic.
This means the world's first dengue vaccine has no approval yet for
use on young children, a population considered to be most at risk,
or for use by tourists.
Dengue fever is a mosquito-borne disease caused by four virus
serotypes (1 to 4) as categorized by the World Health Organisation.
Overall, the disease is seen as a threat to about half of the
world's population. Some 400 million people are believed to be
infected annually.
Guillaume Leroy, who leads the dengue team at Sanofi Pasteur, said
the vaccine acted best as an immune booster for patients with some
previous exposure.
He told Reuters in an interview that additional data over the coming
years would be needed to assess whether the vaccine may be of use to
travelers.
"Health authorities will have to determine (future)
recommendations," he said, adding Sanofi's first 20 market approval
requests were all in South America and Asia. Europe is the target
for early next year and the United States in early 2017, he said.
"Mexico is one of the countries where we started our clinical
trials, which has been associated with the program from the very
beginning and whose regulatory authority is certified by the WHO,"
said Olivier Charmeil, Sanofi's executive vice president, vaccines.
Charmeil said Mexican regulators had given their green light based
on results from a clinical development program involving over 40,000
people from 15 countries of different ages, geographic and
epidemiological settings as well as of varied ethnic and
socio-economic backgrounds.
Leroy said the vaccine reduced the risk of hospitalization by 80
percent and lowered the possibility of developing the severest,
hemorrhagic form of the disease by 93 percent.
Previous results showed the vaccine had recorded low protection
levels against the serotype 2 form and shown poor performance with
young children.
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The WHO has a target in some 128 countries to reduce dengue
mortality by 50 percent and infections by 25 percent by 2020, using
2010 as the baseline.
"What we want to do is to achieve this (WHO) goal. Results show that
if you vaccinate 20 percent of the population in 10 endemic
countries that have taken part in our phase III studies you can
potentially reduce the dengue burden by 50 percent over a five-year
period," Leroy said.
He and Charmeil declined to give figures on output and sales outlook
but confirmed full scale production was ramping up toward 100
million doses annually and said Dengvaxia should be one of the top
three Sanofi Pasteur products in the next five years.
Deliveries to Mexico from a plant near Lyon, France, would start
early next year, they said.
Sales at Sanofi Pasteur were up 7.2 percent at constant exchange
rates in 2014 at 3.97 billion euros ($4.36 billion). Analysts said
last year the vaccines may generate 1 billion euros in sales every
year although pricing remains unclear.
Other drugmakers including Japan's Takeda and U.S Merck are also
working on dengue vaccines but are several years behind.
(Editing by Andrew Callus)
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