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 The safety fears involve possible increased risk to people who had
not previously been exposed to the dengue virus prior to vaccination
with Dengvaxia.
Sanofi SA <SASY.PA> attempted to allay concerns, saying in a
statement that "the vast majority of those vaccinated to date live
in high endemic settings and, therefore, will have had a prior
dengue infection before vaccination."
Dengvaxia, the first approved Dengue vaccine, had been forecast by
Sanofi to eventually bring in nearly $1 billion in annual sales. But
even recent more modest analysts' sales forecasts are now looking
unattainable given the safety issue and clinical evidence revealing
unequal protection against different strains of dengue.
The vaccine so far has been approved in 19 countries and launched in
11, Sanofi said. Most sales have come from the Philippines through
its government immunization program involving more than 730,000
children, and Brazil, where the state of Parana has seen a
three-fold increase in dengue in the past few years.
Dengue is a mosquito-borne tropical disease that kills about 20,000
people a year and infects hundreds of millions.
The WHO, which issued a report identifying the vaccine's safety risk
in mid-2016, recommended it only be used in people who had prior
dengue infection.
Brazil confirmed it already had recommended restricting use of the
vaccine to those previously infected with dengue but had not
suspended it entirely.
Brazilian health regulator Anvisa, in an emailed statement to
Reuters, said it had not received any reports of vaccine recipients
dying or falling more severely ill because of the drug. It does not
know how many people have received the vaccine in Brazil since its
2015 approval.
Sanofi, whose shares rose 0.4 percent in Paris on Monday, explained
its "new findings" of increased risk at a news conference in Manila.
It did not say why action was not taken when the WHO raised the
issue last year.
The Philippines Department of Health halted use of Dengvaxia last
week after Sanofi reported it could worsen the disease in some
people.
"As far as we know, as far as we are made aware, there are no
reported deaths that are related to dengue vaccination," said Ruby
Dizon, medical director at Sanofi Pasteur Philippines.
A Philippine health official said the deaths of three children who
received Dengvaxia, reported by a non-government organization, were
not related to the vaccine.
Nearly 734,000 children aged 9 and over in the Philippines have
received one dose of the vaccine as part of a program that cost 3.5
billion pesos ($69.54 million).
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Sanofi said it had not seen any evidence of increased incidence of
severe dengue in vaccinated individuals in the real world experience
with the vaccine. The drugmaker said the long-term safety evaluation
of Dengvaxia showed significantly fewer hospitalizations due to
dengue in vaccinated people over 9 years old compared with those who
had not been vaccinated.
Singapore's Health Sciences Authority said last week it was working
with Sanofi to strengthen risk warnings on the drug's packaging.
Sanofi spent 20 years developing the world's first dengue vaccine at
a cost of around 1.5 billion euros ($1.78 billion).
In addition to Brazil, the Philippines and Singapore, Dengvaxia is
being sold in Mexico, Indonesia, Thailand, Paraguay, Peru, Costa
Rica, El Salvador and Guatemala.
Health officials in Mexico, the first country to approve the vaccine
in 2015, and in Peru had no immediate comment. Paraguay's health
officials said Dengvaxia is not widely used due to cost but that
they have not received reports of problems from doctors who provide
the vaccine.
It is approved but not yet launched in Honduras, Malaysia,
Australia, Argentina, Venezuela, Bolivia, Bangladesh and Cambodia.
Sanofi said it plans to discuss with the U.S. Food and Drug
Administration moving forward with its U.S. regulatory filing for
Dengvaxia with new labeling recommendations.
Dengvaxia is under review by European health regulators. A
spokeswoman said in an email that regulators there could not comment
on the status of the application but that any emerging data will be
taken into account during the assessment of the vaccine.
Consensus analyst forecasts collated by Thomson Reuters before the
latest problems pointed to Dengvaxia sales of about 360 million
euros ($426.5 million) by 2022. Some analysts now expect that figure
to fall significantly as national vaccination programs are curtailed
and usage restrictions put in place.
(Additional reporting by Neil Jerome Morales and Karen Lema in
Manila, John Geddie in Singapore, Brad Brooks in Sao Paulo and
Anthony Boadle in Brasilia, Ben Hirschler in London and Matthias
Blamont in Paris; Editing by Bill Trott and Marguerita Choy)
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